30-Day Mortality Associated With Primary Cytoreductive Surgery In Elderly Advanced Ovarian Cancer Patients Much Higher Than Previously Reported

Researchers affiliated with the University of Washington have determined that the 30-day mortality rate associated with primary cytoreductive surgery in elderly patients with advanced ovarian cancer is much higher than previously reported.

Researchers affiliated with the University of Washington have determined that the 30-day mortality rate associated with primary cytoreductive surgery in elderly patients with advanced ovarian cancer is much higher than previously reported. There research is based upon the analysis of statistics obtained from the National Cancer Institue (NCI) Surveillance, Epidemiology, and End Results (SEER) database (collectively, the NCI SEER database).

Melissa M. Thrall, M.D., Lead Study Author; Fellow, Department of Obstetrics & Gynecology, University of Washington School of Medicine

The lead author of the study is Melissa M. Thrall, M.D., a Fellow in the Department of Obstetrics & Gynecology, University of Washington School of Medicine.

The researchers used the NCI SEER database to identify a cohort of 5,475 women aged 65 and older, who had primary debulking surgery for stage III or IV epithelial ovarian cancer which was diagnosed from 1995 through 2005. Women were stratified by acuity (i.e., average severity of illness) of hospital admission. Multivariable analysis was performed to identify patient-related and treatment-related variables associated with 30-day mortality.

The overall 30-day mortality rate was 8.2% for the 5,475 women who had surgery for advanced ovarian cancer. Women admitted on an elective basis experienced a 30-day mortality rate of 5.6% (251/4,517), while those patients admitted on an emergency basis experienced a 30-day mortality of 20.1% (168/835).  The researcher determined that 84.4% of patients were admitted on an elective basis, 15.6% of patients were admitted on an emergency basis, and 2.2% of patients had an unknown admission status.

Emergency admission was associated with older age (median of 76.9 vs. 75.1 for elective admission), higher comorbidity scores, and stage IV disease (41.9% vs. 32.9%). Women admitted on an emergency basis had surgery performed more frequently in low-volume hospitals, by low-volume surgeons, and by surgeons other than gynecologic oncologists (p value <0.001). Emergency admission was also associated with significantly less use of neoadjuvant chemotherapy (2.99% vs. 13.39%, p <0.001).

Advancing age, increasing disease stage, and increasing comorbidity score were all associated with an increase in 30-day mortality (p <.05) among elective admissions. The mortality risk was not influenced significantly by race, income, marital status and other demographic and clinical factors.

A group of women at high risk who were admitted on an elective basis included those aged 75 or older with stage IV disease, and women aged 75 or older with stage III disease and a comorbidity score of 1 or more. The high risk group experienced a 30-day mortality rate of 12.7% (95% confidence interval: 10.7%–14.9%), and accounted for 25.7% of the study population and approximately 50% of the deaths.

Low-risk patients were defined by age 65 to 74, stage III or IV disease, and a morbidity score of less than or equal to one. The low-risk patients accounted for 48.7% of the study population and experienced a 30-day mortality rate of 3.64%. The remaining intermediate patients experienced a mortality rate of 6.05%.

Based upon their analyses, the researcher concluded that age, cancer stage, and comorbidity scores may be helpful to stratify patients admitted on an elective basis by predicted postoperative mortality risk. If validated in a prospective cohort study, these factors may help identify women who may benefit from alternative treatment strategies, such as neoadjuvant chemotherapy.

The study was supported by the Marsha Rivkin Center for Ovarian Cancer Research and by the National Cancer Institute.

Sources:

• Thrall MM, et al. Thirty-Day Mortality After Primary Cytoreductive Surgery for Advanced Ovarian Cancer in the Elderly. Obstet Gynecol. 2011 Sep;118(3):537-47.

• Postop Risk of Death in Ovarian Cancer Clarified, by Charles Bankhead, Staff Writer, MedPage Today, August 24, 2011.

Related WORD of HOPE Ovarian Cancer Podcast

• Neoadjuvant Chemotherapy or Primary Surgery in Late Stage Ovarian Cancer – 10 Exciting Ovarian Cancer Research Topics From 2010, Episode 6 (Topic 8 of 10), posted August 17, 2011.

2011 SGO Annual Meeting: Ovarian Cancer Abstracts Selected For Presentation

The March 2011 supplemental issue of Gynecologic Oncology sets forth the ovarian cancer and ovarian cancer-related medical abstracts selected by the Society of Gynecologic Oncologists for presentation at its 42nd Annual Meeting on Women’s Cancer™, which is being held in Orlando, Florida from March 6-9, 2011.

The Society of Gynecologic Oncologists (SGO) is hosting its 42nd Annual Meeting on Women’s Cancer™ (March 6–9, 2011) in Orlando, Florida. The SGO Annual Meeting attracts more than 1,700 gynecologic oncologists and other health professional from around the world.

In connection with this premier gynecologic cancer event, 651 abstracts, and 27 surgical films were submitted for consideration. After careful discussion and deliberation, the SGO selected 51 abstracts for oral presentation (27 Plenary session papers, 24 Focused Plenary papers, and 42 Featured Posters, presented in a new, electronic format), along with 227 for poster presentation. Of the 27 surgical films originally submitted, five films were selected for presentation during a featured Focused Plenary session.

The ovarian cancer abstracts listed below were obtained from the March 2011 supplemental issue of Gynecologic Oncology. Each abstract bears the number that it was assigned in the Gynecologic Oncology journal table of contents.

Please note that we provide below (under the heading “Additional Information”) Adobe Reader PDF copies of the 2011 SGO Annual Meeting program summary and the medical abstract booklet (includes all gynecologic cancer topics). If you require a free copy of the Adobe Reader software, please visit http://get.adobe.com/reader/otherversions/.

For your convenience, we listed the 2011 SGO Annual Meeting ovarian cancer abstracts under the following subject matter headings:  (1) ovarian cancer symptoms, (2) ovarian cancer screening, (3) pathology, (4) ovarian cancer staging, (5) chemotherapy, (6) diagnostic and prognostic biomarkers, (7) clinical trial drugs and results, (8) hereditary breast & ovarian cancer syndrome (BRCA gene deficiencies & Lynch Syndrome), (9) gynecologic practice, (10) gynecologic surgery, (11) genetic/molecular profiling, (12) immunotherapy, (13) medical imaging, (14) preclinical studies – general, (15) preclinical studies – potential therapeutic targets, (16) palliative and supportive care, (17) rare ovarian cancers, (18) survival data, (19) survivorship, (20) other, (21) late breaking abstracts.

Ovarian Cancer Symptoms

142. Utility of symptom index in women at increased risk for ovarian cancer. (SGO Abstract #140)

184. Symptom-triggered screening for ovarian cancer: A pilot study of feasibility and acceptability. (SGO Abstract #182)

187. Women without ovarian cancer reporting disease-specific symptoms. (SGO Abstract #185)

Ovarian Cancer Screening

12. Ovarian cancer: Predictors of primary care physicians’ referral to gynecologic oncologists. (SGO Abstract #10)

84. Long-term survival of patients with epithelial ovarian cancer detected by sonographic screening. (SGO Abstract #82)

90. Significant endometrial pathology detected during a transvaginal ultrasound screening trial for ovarian cancer. (SGO Abstract #88)

109. Detection of the tissue-derived biomarker peroxiredoxin 1 in serum of patients with ovarian cancer: A biomarker feasibility study. (SGO Abstract #107)

113. Epithelial ovarian cancer tumor microenvironment is a favorable biomarker resource. (SGO Abstract #111)

127. Stop and smell the volatile organic compounds: A novel breath-based bioassay for detection of ovarian cancer. (SGO Abstract #125)

144. Incidental gynecologic FDG-PET/CT findings in women with a history of breast cancer. (SGO Abstract #142)

156. Discovery of novel monoclonal antibodies (MC1–MC6) to detect ovarian cancer in serum and differentiate it from benign tumors. (SGO Abstract #154)

158. Evaluation of the risk of ovarian malignancy algorithm (ROMA) in women with a pelvic mass presenting to general gynecologists. (SGO Abstract #156)

162. Human epididymis protein 4 increases specificity for the detection of invasive epithelial ovarian cancer in premenopausal women presenting with an adnexal mass. (SGO Abstract #160)

163. Identification of biomarkers to improve specificity in preoperative assessment of ovarian tumor for risk of cancer. (SGO Abstract #161)

171. OVA1 has high sensitivity in identifying ovarian malignancy compared with preoperative assessment and CA-125. (SGO Abstract #169)

172. OVA1 improves the sensitivity of the ACOG referral guidelines for an ovarian mass. (SGO Abstract #170)

182. Sonographic predictors of ovarian malignancy. (SGO Abstract #180)

237. Management of complex pelvic masses using the OVA1 test: A decision analysis. (SGO Abstract #235)

241. Three-dimensional power doppler angiography as a three-step technique for differential diagnosis of adnexal masses: A prospective study. (SGO Abstract #239)

Pathology

145. Accuracy of frozen-section diagnosis of ovarian borderline tumor. (SGO Abstract #143)

Ovarian Cancer Staging

31. Should stage IIIC ovarian cancer be further stratified by intraperitoneal versus retroperitoneal-only disease? A Gynecologic Oncology Group study. (SGO Abstract #29)

173. Peritoneal staging biopsies in early-stage ovarian cancer: Are they necessary? (SGO Abstract #171)

Chemotherapy

29. Treatment of chemotherapy-induced anemia in patients with ovarian cancer: Does the use of erythropoiesis-stimulating agents worsen survival? (SGO Abstract #27)

69. Intraperitoneal chemotherapy for recurrent ovarian cancer appears efficacious with high completion rates and low complications. (SGO Abstract #67)

174. Predictors of severe and febrile neutropenia during primary chemotherapy for ovarian cancer. (SGO Abstract #172)

177. Sequencing of therapy and outcomes associated with use of neoadjuvant chemotherapy in advanced epithelial ovarian cancer in the Medicare population. (SGO Abstract #175)

179. Should we treat patients with ovarian cancer with positive retroperitoneal lymph nodes with intraperitoneal chemotherapy? Impact of lymph node status in women undergoing intraperitoneal chemotherapy. (SGO Abstract #177)

229. Predictors and effects of reduced relative dose intensity in women receiving their primary course of chemotherapy for ovarian cancer. (SGO Abstract #227)

Diagnostic & Prognostic Biomarkers

128. Stress and the metastatic switch in epithelial ovarian carcinoma. (SGO Abstract #126)

130. The cytoskeletal gateway for tumor aggressiveness in ovarian cancer is driven by class III β-tubulin. (SGO Abstract #128)

134. True blood: Platelets as a biomarker of ovarian cancer recurrence. (SGO Abstract #132)

148. CA-125 changes can predict optimal interval cytoreduction in patients with advanced-stage epithelial ovarian cancer treated with neoadjuvant chemotherapy. (SGO Abstract #146)

149. CA-125 surveillance for women with ovarian, fallopian tube or primary peritoneal cancers: What do survivors think? (SGO Abstract #147)

150. Calretinin as a prognostic indicator in granulosa cell tumor. (SGO Abstract #148)

135. Tumor expression of the type I insulin-like growth factor receptor is an independent prognostic factor in epithelial ovarian cancer. (SGO Abstract #133)

147. C-terminal binding protein 2: A potential marker for response to histone deacetylase inhibitors in epithelial ovarian cancer. (SGO Abstract #145)

157. Elevated serum adiponectin levels correlate with survival in epithelial ovarian cancers. (SGO Abstract #155)

175. Prognostic impact of prechemotherapy HE4 and CA-125 levels in patients with ovarian cancer. (SGO Abstract #175)

178. Serum HE4 level is an independent risk factor of surgical outcome and prognosis of epithelial ovarian cancer. (SGO Abstract #176)

Clinical Trial Drugs & Results

8. MicroRNA as a novel predictor of response to bevacizumab in recurrent serous ovarian cancer: An analysis of The Cancer Genome Atlas. (SGO Abstract #6)

9. Prospective investigation of risk factors for gastrointestinal adverse events in a phase III randomized trial of bevacizumab in first-line therapy of advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer: A Gynecologic Oncology Group study. (SGO Abstract #7)

10. First in human trial of the poly(ADP)-ribose polymerase inhibitor MK-4827 in patients with advanced cancer with antitumor activity in BRCA-deficient and sporadic ovarian cancers.  (SGO Abstract #8)

30. An economic analysis of intravenous carboplatin plus dose-dense weekly paclitaxel versus intravenous carboplatin plus every three-weeks paclitaxel in the upfront treatment of ovarian cancer. (SGO Abstract #28)

51. BRCA1-deficient tumors demonstrate enhanced cytotoxicity and T-cell recruitment following doxil treatment. (SGO Abstract #49)

54. A novel combination of a MEK inhibitor and fulvestrant shows synergistic antitumor activity in estrogen receptor-positive ovarian carcinoma. (SGO Abstract #52)

68. An economic analysis of bevacizumab in recurrent treatment of ovarian cancer. (SGO Abstract #66)

71. A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer. (SGO Abstract #69)

72. A phase I clinical trial of a novel infectivity-enhanced suicide gene adenovirus with gene transfer imaging capacity in patients with recurrent gynecologic cancer. (SGO Abstract #70)

73. A phase I study of a novel lipopolymer-based interleukin-12 gene therapeutic in combination with chemotherapy for the treatment of platinum-sensitive recurrent ovarian cancer. (SGO Abstract #71)

74. AMG 386 combined with either pegylated liposomal doxorubicin or topotecan in patients with advanced ovarian cancer: Results from a phase Ib study. (SGO Abstract #72)

86. Pressure to respond: Hypertension predicts clinical benefit from bevacizumab in recurrent ovarian cancer. (SGO Abstract #84)

152. Changes in tumor blood flow as estimated by dynamic-contrast MRI may predict activity of single-agent bevacizumab in recurrent epithelial ovarian cancer and primary peritoneal cancer: An exploratory analysis of a Gynecologic Oncology Group phase II trial. (SGO Abstract #150)

153. Comparing overall survival in patients with epithelial ovarian, primary peritoneal or fallopian tube cancer who received chemotherapy alone versus neoadjuvant chemotherapy followed by delayed primary debulking. (SGO Abstract #151)

154. Consolidation paclitaxel is more cost-effective than bevacizumab following upfront treatment of advanced ovarian cancer. (SGO Abstract #152)

193. Pegylated liposomal doxorubicin with bevacizumab in the treatment of platinum-resistant ovarian cancer: Toxicity profile results. (SGO Abstract #191)

194. Phase II Trial of docetaxel and bevacizumab in recurrent ovarian cancer within 12 months of prior platinum-based chemotherapy. (SGO Abstract #192)

195. A phase I/II trial of IDD-6, an autologous dendritic cell vaccine for women with advanced ovarian cancer in remission. (SGO Abstract #193)

183. STAC: A phase II study of carboplatin/paclitaxel/bevacizumab followed by randomization to either bevacizumab alone or erlotinib and bevacizumab in the upfront management of patients with ovarian, fallopian tube or peritoneal cancer. (SGO Abstract #181)

228. Is it more cost-effective to use bevacizumab in the primary treatment setting or at recurrence? An economic analysis. (SGO Abstract #226)

240. The use of bevacizumab and cytotoxic and consolidation chemotherapy for the upfront treatment of advanced ovarian cancer: Practice patterns among medical and gynecologic oncology SGO members. (SGO Abstract #238)

Hereditary Breast & Ovarian Cancer Syndrome (BRCA gene deficiencies & Lynch Syndrome)

39. BRCAness profile of ovarian cancer predicts disease recurrence. (SGO Abstract #37)

52. A history of breast carcinoma predicts worse survival in BRCA1 and BRCA2 mutation carriers with ovarian carcinoma. (SGO Abstract #52)

137. Does genetic counseling for women at high risk of harboring a deleterious BRCA mutation alter risk-reduction strategies and cancer surveillance behaviors? (SGO Abstract #135)

138. Hereditary breast and ovarian cancer syndrome based on family history alone and implications for patients with serous carcinoma. (SGO Abstract #138)

139. Management and clinical outcomes of women with BRCA1/2 mutations found to have occult cancers at the time of risk-reducing salpingo-oophorectomy. (SGO Abstract #137)

141. The impact of BRCA testing on surgical treatment decisions for patients with breast cancer. (SGO Abstract #139)

136. Compliance with recommended genetic counseling for Lynch syndrome: Room for improvement. (SGO Abstract #134)

Gynecologic Practice

81. Availability of gynecologic oncologists for ovarian cancer care. (SGO Abstract #79)

Gynecologic Surgery

19. Single-port paraaortic lymph node dissection. (SGO Abstract #17)

20. Robotic nerve-sparing radical hysterectomy type C1. (SGO Abstract #18)

21. Urinary reconstruction after pelvic exenteration: Modified Indiana pouch. (SGO Abstract #19)

22. Intrathoracic cytoreductive surgery by video-assisted thoracic surgery in advanced ovarian carcinoma. (SGO Abstract #20)

26. Cost comparison of strategies for the management of venous thromboembolic event risk following laparotomy for ovarian cancer. (SGO Abstract #24)

28. Primary debulking surgery versus neoadjuvant chemotherapy in stage IV ovarian cancer. (SGO Abstract #26)

33. Does the bedside assistant matter in robotic surgery: An analysis of patient outcomes in gynecologic oncology. (SGO Abstract #31)

48. Defining the limits of radical cytoreductive surgery for ovarian cancer. (SGO Abstract #46)

87. Prognostic impact of lymphadenectomy in clinically early-stage ovarian malignant germ cell tumor. (SGO Abstract #85)

93. Secondary cytoreductive surgery: A key tool in the management of recurrent ovarian sex cord–stromal tumors. (SGO Abstract #91)

146. Advanced-stage ovarian cancer metastases to sigmoid colon mesenteric lymph nodes: Clinical consideration of tumor spread and biologic behavior. (SGO Abstract #144)

155. Cytoreductive surgery for serous ovarian cancer in patients 75 years and older. (SGO Abstract #153)

168. Intraperitoneal catheters placed at the time of bowel surgery: A review of complications. (SGO Abstract #166)

169. Laparoscopic versus laparotomic surgical staging for early-stage epithelial ovarian cancer. (SGO Abstract #167)

170. Oncologic and reproductive outcomes of cystectomy compared with oophorectomy as treatment for borderline ovarian tumor. (SGO Abstract #168)

180. Significance of perioperative infectious disease in patients with ovarian cancer. (SGO Abstract #178)

185. The feasibility of mediastinal lymphadenectomy in the management of advanced and recurrent ovarian carcinoma. (SGO Abstract #183)

235. Incidence of venous thromboembolism after robotic surgery for gynecologic malignancy: Is dual prophylaxis necessary? (SGO Abstract #233)

286. Charlson’s index: A validation study to predict surgical adverse events in gynecologic oncology. (SGO Abstract #284)

288. Cost-effectiveness of extended postoperative venous thromboembolism prophylaxis in gynecologic pncology patients. (SGO Abstract #286)

302. Integration of and training for robot-assisted surgery in a gynecologic oncology fellowship program. (SGO Abstract #300)

303. Outcomes of patients with gynecologic malignancies undergoing video-assisted thorascopic surgery and pleurodesis for malignant pleural effusion. (SGO Abstract #301)

304. Perioperative and pathologic outcomes following robot-assisted laparoscopic versus abdominal management of ovarian cancer. (SGO Abstract #302)

307. Predictive risk factors for prolonged hospitalizations after gynecologic laparoscopic surgery. (SGO Abstract #305)

309. Robot-assisted surgery for gynecologic cancer: A systematic review. (SGO Abstract #307)

310. Robotic radical hysterectomy: Extent of tumor resection and operative outcomes compared with laparoscopy and exploratory laparotomy. (SGO Abstract #308)

315. Utilization of specialized postoperative services in a comprehensive surgical cytoreduction program. (SGO Abstract #313)

Genetic/Molecular Profiling

5. A 3’ UTR KRAS variant as a biomarker of poor outcome and chemotherapy resistance in ovarian cancer. (SGO Abstract #3)

15. XPC single-nucleotide polymorphisms correlate with prolonged progression-free survival in advanced ovarian cancer. (SGO Abstract #13)

16. Genomewide methylation analyses reveal a prominent role of HINF1 network genes, via hypomethylation, in ovarian clear cell carcinoma. (SGO Abstract #14)

49. Loss of ARID1A is a frequent event in clear cell and endometrioid ovarian cancers. (SGO Abstract #47)

53. Genetic variants in the mammalian target of rapamycin (mTOR) signaling pathway as predictors of clinical response and survival in women with ovarian cancer. (SGO Abstract #51)

55. BAD apoptosis pathway expression and survival from cancer. (SGO Abstract #53)

59. Molecular profiling of advanced pelvic serous carcinoma associated with serous tubal intraepithelial carcinoma. (SGO Abstract #57)

82. Biologic roles of tumor and endothelial delta-like ligand 4 in ovarian cancer. (SGO Abstract #80)

85. MicroRNA 101 inhibits ovarian cancer xenografts by relieving the chromatin-mediated transcriptional repression of p21waf1/cip1. (SGO Abstract #83)

102. Association between global DNA hypomethylation in leukocytes and risk of ovarian cancer. (SGO Abstract #100)

103. Cisplatin, carboplatin, and paclitaxel: Unique and common pathways that underlie ovarian cancer response. (SGO Abstract #101)

106. Comparison of mTOR and HIF pathway alterations in the clear cell carcinoma variant of kidney, ovary and endometrium. (SGO Abstract #104)

107. Concordant gene expression profiles in matched primary and recurrent serous ovarian cancers predict platinum response. (SGO Abstract #105)

111. Differential microRNA expression in cis-platinum-resistant versus -sensitive ovarian cancer cell lines. (SGO Abstract #109)

112. DNA methylation markers associated with serous ovarian cancer subtypes. (SGO Abstract #110)

118. MicroRNA and messenger RNA pathways associated with ovarian cancer cell sensitivity to topotecan, gemcitabine and doxorubicin. (SGO Abstract #116)

119. Molecular profiling of patients with curatively treated advanced serous ovarian carcinoma from The Cancer Genome Atlas. (SGO Abstract #117)

125. Proteomic analysis demonstrates that BRCA1-deficient epithelial ovarian cancer cell lines activate alternative pathways following exposure to cisplatin. (SGO Abstract #123)

132. The tumor suppressor KLF6, lost in a majority of ovarian cancer cases, represses VEGF expression levels. (SGO Abstract #130)

126. Quantitative PCR array identification of microRNA clusters associated with epithelial ovarian cancer chemoresistance. (SGO Abstract #124)

160. Genes functionally regulated by methylation in ovarian cancer are involved in cell proliferation, development and morphogenesis. (SGO Abstract #158)

181. Single-nucleotide polymorphism in DNA repair and drug resistance genes alone or in combination in epithelail ovarian cancer. (SGO Abstract #179)

278. Expression patterns of p53 and p21 cell cycle regulators and clinical outcome in women with pure gynecologic sarcomas. (SGO Abstract #276)

Immunotherapy

98. Ab-IL2 fusion proteins mediate NK cell immune synapse formation in epithelial ovarian cancer by polarizing CD25 to the target cell–effector cell interface. (SGO Abstract #96)

124. Proteasome inhibition increases death receptors and decreases major histocompatibility complex I expression: Pathways to exploit in natural killer cell immunotherapy. (SGO Abstract #122)

Medical Imaging

164. Impact of FDG-PET in suspected recurrent ovarian cancer and optimization of patient selection for cytoreductive surgery. (SGO Abstract #162)

294. The clinical and financial implications of MRI of pelvic masses. (SGO Abstract #292)

Preclinical Studies

11. A unique microRNA locus at 19q13.41 sensitizes epithelial ovarian cancers to chemotherapy. (SGO Abstract #9)

14. Common single-nucleotide polymorphisms in the BNC2, HOXD1 and MERIT40 regions contribute significantly to racial differences in ovarian cancer incidence. (SGO Abstract #12)

46. Development of a preclinical serous ovarian cancer mouse model. (SGO Abstract #44)

56. Examination of matched primary and recurrent ovarian cancer specimens supports the cancer stem cell hypothesis. (SGO Abstract #54)

58. Modeling of early events in serous carcinogenesis: Molecular prerequisites for transformation of fallopian tube epithelial cells. (SGO Abstract #56)

101. Antiproliferative activity of a phenolic extract from a native Chilean Amaranthaceae plant in drug-resistant ovarian cancer cell lines. (SGO Abstract #99)

115. Identification and characterization of CD44+/CD24–ovarian cancer stem cell properties and their correlation with survival. (SGO Abstract #113)

Preclinical Studies – Potential Therapeutic Targets

57. Hypoxia-mediated activation of signal transducer and activator of transcription 3 (STAT3) in ovarian cancer: A novel therapeutic strategy using HO-3867, a STAT3 inhibitor (and novel curcumin analog). (SGO Abstract #55)

61. The ubiquitin ligase EDD mediates platinum resistance and is a target for therapy in epithelial ovarian cancer. (SGO Abstract #59)

97. A novel hedgehog pathway smoothened inhibitor (BMS-833923) demonstrates in vitro synergy with carboplatin in ovarian cancer cells. (SGO Abstract #95)

100. AMPK activation mimics glucose deprivation and induces cytotoxicity in ovarian cancer cells. (SGO Abstract #98)

104. Clinical significance of vascular cell adhesion molecule 1 (VCAM-1) in the ovarian cancer microenvironment. (SGO Abstract #102)

105. Combined erbB/VEGFR blockade has improved anticancer activity over single-pathway inhibition in ovarian cancer in vivo. (SGO Abstract #103)

114. EZH2 expression correlates with increased angiogenesis in ovarian carcinoma. (SGO Abstract #112)

116. Induction of apoptosis in cisplatin-resistant ovarian cancer cells by G-1, a specific agonist of the G-protein-coupled estrogen receptor GPR30. (SGO Abstract #114)

120. Neuropilin-1 blockade in the tumor microenvironment reduces tumor growth. (SGO Abstract #118)

129. Targeting the hedgehog pathway reverses taxane resistance in ovarian cancer. (SGO Abstract #127)

121. Ovarian cancer lymph node metastases express unique cellular structure and adhesion genes. (SGO Abstract #119)

122. Overexpression of fibroblast growth factor 1 and fibroblast growth factor receptor 4 in high-grade serous ovarian carcinoma: Correlation with survival and implications for therapeutic targeting. (SGO Abstract #120)

131. The pattern of H3K56 acetylation expression in ovarian cancer. (SGO Abstract #129)

133. Thinking outside of the tumor: Targeting the ovarian cancer microenvironment. (SGO Abstract #131)

161. Horm-A domain-containing protein 1 (HORMAD1) and outcomes in patients with ovarian cancer. (SGO Abstract #159)

165. Influence of the novel histone deacetylase inhibitor panobinostat (LBH589) on the growth of ovarian cancer. (SGO Abstract #163)

166. Inhibition of stress-induced phosphoprotein 1 decreases proliferation of ovarian cancer cell lines. (SGO Abstract #164)

167. Insulin-like growth factor receptor 1 pathway signature correlates with adverse clinical outcome in ovarian cancer. (SGO Abstract #165)

230. Therapeutic synergy and resensitization of drug-resistant ovarian carcinoma to cisplatin by HO-3867. (SGO Abstract #228)

Palliative & Supportive Care

159. Factors associated with hospice use in ovarian cancer. (SGO Abstract #226)

190. Age-related preferences regarding end-of-life care discussions among gynecologic oncology patients. (SGO Abstract #188)

192. Palliative care education in gynecologic oncology: A survey of the fellows. (SGO Abstract #190)

Rare Ovarian Cancers

151. Carcinosarcoma of the ovary: A case–control study. (SGO Abstract #149)

Survival Data

80. Ten-year relative survival for epithelial ovarian cancer. (SGO Abstract #78)

83. Impact of beta blockers on epithelial ovarian cancer survival. (SGO Abstract #81)

176. Revisiting the issue of race-related outcomes in patients with stage IIIC papillary serous ovarian cancer who receive similar treatment. (SGO Abstract #174)

186. The impact of diabetes on survival in women with ovarian cancer. (SGO Abstract #184)

284. Survival following ovarian versus uterine carcinosarcoma. (SGO Abstract #282)

285. The unique natural history of mucinous tumors of the ovary. (SGO Abstract #283)

292. Stage IC ovarian cancer: Tumor rupture versus ovarian surface involvement. (SGO Abstract #290)

Survivorship

191. Menopausal symptoms and use of hormone replacement therapy: The gynecologic cancer survivors’ perspective. (SGO Abstract #189)

Other

4. From guidelines to the front line: Only a minority of the Medicare population with advanced epithelial ovarian cancer receive optimal therapy. (SGO Abstract #2)

32. Efficacy of influenza vaccination in women with ovarian cancer. (SGO Abstract #30)

91. Women with invasive gynecologic malignancies are more than 12 times as likely to commit suicide as are women in the general population. (SGO Abstract #89)

231. Attrition of first-time faculty in gynecologic oncology: Is there a difference between men and women? (SGO Abstract #229)

238. Relative impact of cost drivers on the increasing expense of inpatient gynecologic oncology care. (SGO Abstract #236)

Late-Breaking Abstracts

• Adherence with National Comprehensive Cancer Network (NCCN) Guidelines Associated with Improved Survival in Ovarian Cancer Patients, A Study of 144,449 Patients From the National Cancer Data Base: A Project from The Society of Gynecologic Oncologists (SGO) Quality and Outcomes Committee.

About Society of Gynecologic Oncologists (SGO)

The SGO is a national medical specialty organization of physicians and allied healthcare professionals who are trained in the comprehensive management of women with malignancies of the reproductive tract. Its purpose is to improve the care of women with gynecologic cancer by encouraging research, disseminating knowledge which will raise the standards of practice in the prevention and treatment of gynecologic malignancies, and cooperating with other organizations interested in women’s health care, oncology and related fields. The Society’s membership, totaling more than 1,400, is primarily comprised of gynecologic oncologists, as well as other related medical specialists including medical oncologists, radiation oncologists, nurses, social workers and pathologists. SGO members provide multidisciplinary cancer treatment including chemotherapy, radiation therapy, surgery and supportive care. More information on the SGO can be found at www.sgo.org.

About Gynecologic Oncologists

Gynecologic oncologists are physicians committed to the comprehensive treatment of women with cancer. After completing four years of medical school and four years of residency in obstetrics and gynecology, these physicians pursue an additional three to four years of training in gynecologic oncology through a rigorous fellowship program overseen by the American Board of Obstetrics and Gynecology. Gynecologic oncologists are not only trained to be skilled surgeons capable of performing wide-ranging cancer operations, but they are also trained in prescribing the appropriate chemotherapy for those conditions and/or radiation therapy when indicated. Frequently, gynecologic oncologists are involved in research studies and clinical trials that are aimed at finding more effective and less toxic treatments to further advance the field and improve cure rates.

Studies on outcomes from gynecologic cancers demonstrate that women treated by a gynecologic oncologist have a better likelihood of prolonged survival compared to care rendered by non-specialists. Due to their extensive training and expertise, gynecologic oncologists often serve as the “team captain” who coordinates all aspects of a woman’s cancer care and recovery. Gynecologic oncologists understand the impact of cancer and its treatments on all aspects of women’s lives including future childbearing, sexuality, physical and emotional well-being—and the impact cancer can have on the patient’s whole family.

Sources:

• Abstracts Presented For The 42nd Annual Meeting of the Society of Gynecologic Oncologists. Gyn Oncol 2011: Vol 120; Supplement 1; S1-S150.

• The Role of Gynecologic Oncologists, Women’s Cancer Network™.

Additional Information:

• 2011 Society of Gynecologic Oncologists Annual Meeting Program Summary. [Adobe Reader PDF document]

• 2011 Society of Gynecologic Oncologists Annual Meeting Abstract Booklet (includes all gynecologic cancer topics). [Adobe Reader PDF document]

Risk of Death Doubles For Early Stage Ovarian Cancer Patients Who Are Not Checked For Lymph Node Metastases

University of California Davis Cancer Center and California Cancer Registry researchers determined that the risk of death doubles for those women with apparent early stage ovarian cancer who are not checked for lymph node metastases.

Dr. Gary Leiserowitz, Chief of Gynecologic Oncology at the UC Davis Cancer Center & Rosemary Cress, Research Program Director at the California Cancer Registry, reported that early-stage ovarian cancer patients had nearly twice the risk of death if they were not tested for lymph node metastases.

A team of University of California (UC) Davis Cancer Center and California Cancer Registry researchers determined that more than a quarter of women with apparent early ovarian cancer do not receive lymph node biopsies, which have been shown to improve patient survival.

For the study, the researchers identified patients diagnosed with apparent early-stage epithelial ovarian cancer between 1998 and 2000 from cancer registries in New York and California, then collected detailed information from patient medical records on the types of surgical staging procedures performed on 721 of the patients.

The study set forth the critical findings below.

• Approximately 90 percent of patients had removal of the omentum and evaluation of the bowel serosa and mesentery.  In contrast, only 72 percent of patients with presumed early-stage disease had lymph nodes from the pelvis and abdomen tested for signs of cancer spread, despite the existence of published, professional guidelines for proper staging of the disease.

• Only lymph node assessment (as well as node assessment combined with washings and omentectomy) had a statistically significant association with improved survival.

• The five-year survival for women with early-stage disease who had the node biopsies was 84 percent, compared with 69 percent of those who did not have the tests.

• Patients who did not have lymph node assessment had nearly twice the risk of death as those who did.

• Stratification of patients based upon receipt of chemotherapy revealed that lack of lymph node sampling had an effect only on patients who also received no chemotherapy.  Thus, only when patients did not have the lymph nodes tested did chemotherapy improve survival, a finding the researchers attribute to the role chemotherapy likely plays in killing cancer cells that have spread beyond the ovaries.

• Gynecologic oncologists were nearly six-and-a-half times more likely to perform lymph node biopsies than other surgical specialists, and nearly four times more likely to perform all recommended staging biopsies. (See “Additional Information” below for prior medical study findings, regarding the importance of gynecologic oncologists in the evaluation and treatment of ovarian cancer.)

The study results were published online last week in the journal Gynecology Oncology and will be published in the journal’s April print edition.

“Early-stage patients had nearly twice the risk of death if they didn’t have the lymph nodes tested,” said Rosemary Cress, who is an epidemiologist and research program director at the California Cancer Registry, associate adjunct professor in the Department of Public Health Sciences at UC Davis, and the study’s lead author. “Hopefully, this should raise the awareness among physicians that it’s really important to do lymph node biopsies in these patients.”

Why some surgeons don’t remove lymph nodes during ovary surgery for early-stage cancer patients is a matter of speculation, said Gary Leiserowitz, M.D., chief of Gynecologic Oncology at the UC Davis Cancer Center, who is the senior author of the study. But the tests are important, he said, because patients with positive lymph nodes are given a more advanced stage diagnosis and prescribed follow-up chemotherapy treatment.

“Depending on the knowledge and expertise of the surgeon doing the operation, they may not know they need to do all the biopsies,” said Dr. Leiserowitz. “The literature is pretty consistent in showing that the people who have specialized knowledge in this – gynecological oncologists – are much more likely to follow the guidelines.”

Another reason some surgeons may not perform the lymph node biopsies, he said, is that they don’t believe the patient would benefit, either because of advanced age or because they have other serious illnesses, or both.

“If we have a patient who is medically unsuitable because of their age or medical conditions and is not a candidate for chemotherapy, you wouldn’t do all the staging biopsies,” said Dr. Leiserowitz. “But for a woman, say in her 40’s who is otherwise healthy, it turns out to be critical, because chemotherapy could be lifesaving.”

Leiserowitz said he hopes the results of the study will help educate the medical community and patients about the value of appropriate cancer treatment.

“If you are going to treat someone with a cancer, you really have an obligation to understand what the published practice guidelines are, and adhere to them as well as you can, or refer the patient to someone else who will,” he said.

The study was paid for with a grant from the U.S. Centers for Disease Control and Prevention.

About University of California Davis Cancer Center

University of California (UC) Davis Cancer Center is the only National Cancer Institute- designated center serving the Central Valley and inland Northern California, a region of more than 6 million people. Its top specialists provide compassionate, comprehensive care for more than 9,000 adults and children every year, and offer patients access to more than 150 clinical trials at any given time. Its innovative research program includes more than 280 scientists at UC Davis and Lawrence Livermore National Laboratory. The unique partnership, the first between a major cancer center and national laboratory, has resulted in the discovery of new tools to diagnose and treat cancer. Through the Cancer Care Network, UC Davis is collaborating with a number of hospitals and clinical centers throughout the Central Valley and Northern California regions to offer the latest cancer-care services. For more information, visit cancer.ucdavis.edu.

About the California Cancer Registry

The California Cancer Registry (CCR) is a program of the California Department of Public Health’s Cancer Surveillance and Research Branch (CSRB), and works in collaboration with the Public Health Institute, regional cancer registries, health care providers, cancer registrars, and cancer researchers throughout California and the nation. CSRB collects, analyzes, and disseminates information on cancer incidence and mortality. The statewide population-based cancer surveillance system monitors the incidence and mortality of specific cancers over time and analyzes differential cancer risks cancer by geographic region, age, race/ethnicity, sex, and other social characteristics of the population. It gathers cancer incidence data through CCR, and conducts and collaborates with other researchers on special cancer research projects concerning the etiology, treatment, risk factors, and prevention of specific cancers. In addition, the system is designed to monitor patient survival with respect to the type of cancer, extent of disease, therapy, demographics, and other parameters of prognostic importance. In general, data generated from CCR are utilized as set forth below.

• Monitor the amount of cancer and cancer incidence trends by geographic area and time in order to detect potential cancer problems of public health significance in occupational settings and the environment, and to assist in their investigation.

• Provide information to stimulate the development and targeting of resources to benefit local communities, cancer patients, and their families.

• Promote high-quality epidemiologic and clinical research by enabling population-based studies to be performed that can provide better information for cancer control.

• Inform health professionals and educate citizens regarding specific health risks, early detection, and treatment for cancers known to be elevated in their communities.

• Respond to public concerns and questions about cancer.

For more information, visit http://www.ccrcal.org/.

Sources:

• Ovarian Cancer Spread Missed When Recommended Staging Biopsies Not Performed, UC Davis Researchers Find – Risk of death doubles for those who are not checked for lymph node metastases, Press Release, UC Davis Cancer Center, February 2, 2011.

• Cress RD, Bauer K, O’Malley CD, et. al. Surgical staging of early stage epithelial ovarian cancer: Results from the CDC-NPCR ovarian patterns of care study. Gynecol Oncol. 2011 Jan 20. [Epub ahead of print] PMID: 21256581.

Additional Information — The Role of Gynecologic Oncologists and Their Impact on Survival:

• The Role of Gynecologic Oncologists, Women’s Cancer Network™, Gynecologic Cancer Foundation website.

• Burton E, Chase D, Yamamoto M, et al. Surgical management of recurrent ovarian cancer: the advantage of collaborative surgical management and a multidisciplinary approach. Gynecol Oncol. 2011 Jan;120(1):29-32. Epub 2010 Nov 4. PubMed PMID: 21055797.

• Chan JK, Kapp DS, Shin JY, et. al. Influence of the gynecologic oncologist on the survival of ovarian cancer patients. Obstet Gynecol. 2007 Jun;109(6):1342-50. PubMed PMID: 17540806.

• Vernooij F, Heintz P, Witteveen E, van der Graaf Y. The outcomes of ovarian cancer treatment are better when provided by gynecologic oncologists and in specialized hospitals: a systematic review. Gynecol Oncol. 2007 Jun;105(3):801-12. Epub 2007 Apr 12. Review. PubMed PMID: 17433422.

• Engelen MJ, Kos HE, Willemse PH, et. al. Surgery by consultant gynecologic oncologists improves survival in patients with ovarian carcinoma. Cancer. 2006 Feb 1;106(3):589-98. PubMed PMID: 16369985.

• Earle CC, Schrag D, Neville BA, et. al.  Effect of surgeon specialty on processes of care and outcomes for ovarian cancer patients. J Natl Cancer Inst. 2006 Feb 1;98(3):172-80. PubMed PMID: 16449677.

ESMO Clinical Practice Guidelines Regarding BRCA Gene Mutations, Ovarian Cancer & Supportive Cancer Care

The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology, and promoting a multidisciplinary approach to cancer treatment and care. …  The ESMO Clinical Practice Guidelines include coverage of  (i) BRCA gene mutations in breast and ovarian cancer, (ii) gynecologic tumors, and (iii) supportive cancer care …

The European Society for Medical Oncology (ESMO) is the leading European professional organization committed to advancing the specialty of medical oncology, and promoting a multidisciplinary approach to cancer treatment and care.  Since its founding in 1975 as a non-profit organization, ESMO’s mission is to support oncology professionals in providing people with cancer the most effective treatments available at the highest quality of care.

Formerly known as the ESMO Clinical Recommendations, the ESMO Clinical Practice Guidelines (CPG) are intended to provide users with a set of requirements for the highest standard of care for cancer patients. The ESMO CPG represent vital, evidence-based information including the incidence of the malignancy, diagnostic criteria, staging of disease and risk assessment, treatment plans and follow-up.

A growing number of the new guidelines were developed using large, multidisciplinary writing groups, ensuring optimal input from the oncology profession and better geographic representation.

For example, two revised guidelines address the prevention of chemotherapy- and radiotherapy–induced nausea and vomiting, developed as a result of the 3rd Perugia Consensus Conference organized by the Multinational Association of Supportive Care in Cancer (MASCC) and ESMO.

The new guidelines published this month and available online represent the first stage of a process that will include recommendations for more than 55 different clinical situations, covering almost all tumor types as well as various other topics including the therapeutic use of growth factors.

The ESMO Clinical Practice Guidelines include coverage of  (i) BRCA gene mutations in breast and ovarian cancer, (ii) gynecologic tumors, and (iii) supportive cancer care, as provided below.

Breast Cancer

• BRCA [Gene Mutations] In Breast [& Ovarian] Cancer. [PDF doc.]

Gynecologic Tumors

• Newly and relapsed epithelial ovarian carcinoma. [PDF doc.]
• Non-epithelial ovarian cancer. [PDF doc.]
• Cervical cancer. [PDF doc.]
• Endometrial carcinoma. [PDF doc.]

Supportive Care

• Guideline update for MASCC & ESMO in the prevention of chemotherapy and radiotherapy-induced nausea and vomiting. [PDF doc.]
• Erythropoiesis-stimulating agents in the treatment of anemia in cancer patients. [PDF doc.]
• Hematopoietic growth factors. [PDF doc.]
• Management of febrile neutropenia. [PDF doc.]
• Management of cancer pain. [PDF doc.]
• Management of oral and gastrointestinal mucositis. [PDF doc.]
• Cancer, fertility and pregnancy. [PDF doc.]
• Venous thromboembolism in cancer patients. [PDF doc.]
• Cardiotoxicity of chemotherapeutic agents and radiotherapy-related heart disease. [PDF doc.]

Sources:

• ESMO Clinical Practice Guidelines offering the best standards of cancer care with improved methodology, ESMO News, The European Society for Medical Oncology, June 28, 2010.
• ESMO Clinical Practice Guidelines, Education, The European Society for Medical Oncology, Ann Oncol (May 2010): 21(5): 9-282.

Libby’s H*O*P*E*™ National Ovarian Cancer Coalition 6th Annual Women’s Health Expo Presentation

On March 20, 2010, Libby’s H*O*P*E*™ made a presentation at the National Ovarian Cancer Coalition’s 6th Annual Women’s Health Expo.  The presentation was entitled, A Patient Advocate’s Perspective on the Importance of Ovarian Cancer Awareness and Helpful Online Resources.

On March 20, 2010, Libby’s H*O*P*E*™ made a presentation at the National Ovarian Cancer Coalition’s 6th Annual Women’s Health Expo.  The presentation was entitled, A Patient Advocate’s Perspective on the Importance of Ovarian Cancer Awareness and Helpful Online Resources.  The topics covered in the presentation include:

• Genesis of Libby’s H*O*P*E*™,
• Ovarian Cancer Overview,
• Helpful Online Resources,
• Stories of Hope, and
• Making a Difference

The full presentation is provided below in Adobe Reader PDF document format. To view the full presentation, simply click on the image below.  If you require free Adobe Reader software, click here.

I want to extend special thanks to Nancy Long and Paula Kozik, co-presidents of the National Ovarian Cancer Coalition’s Central Maryland Chapter, for the invitation to speak at this worthwhile event.  Nancy and Paula are two very special ovarian cancer survivors, who put together an informative conference that was well attended and enjoyed by all.  It was both an honor and a privilege to meet Nancy, Paula, and many other ovarian cancer survivors during the conference.  Many women shared with me their personal stories of struggle, inspiration and hope.  These women are my “everyday heroes.”  If you have any questions regarding the presentation, please feel free to contact me by clicking on the homepage “Contact” tab.

Libby’s H*O*P*E* to Present At NOCC 6th Annual Women’s Health Expo (REJUVENATE Finding Balance)

On March 20, 2010, the National Ovarian Cancer Coalition (Maryland Chapter) will hold its 6th Annual Women’s Health Expo entitled, REJUVENATE Finding Balance (NOCC Rejuvenate), at the Sheraton Annapolis Hotel. … On behalf of Libby’s H*O*P*E*™, I will conduct a seminar as part of Session II entitled, A Patient Advocate’s Perspective on the Importance of Ovarian Cancer Awareness and Related On-line Resources.

On March 20, 2010, the National Ovarian Cancer Coalition (Maryland Chapter) will hold its 6th Annual Women’s Health Expo entitled, REJUVENATE Finding Balance (NOCC Rejuvenate), at the Sheraton Annapolis Hotel. NOCC Rejuvenate is sponsored by the National Breast & Ovarian Cancer Connection and Cancer Treatment Centers of America.  Additional funding was also provided through a grant from the Maryland Attorney General Settlement.

NOCC Rejuvenate is designed to appeal to all women who want to rejuvenate their mind, body and spirit. The event is divided into three sessions. Each session offers seven to eight different seminars for attendees. The seminars address a variety of topics including make-up and skin care, going green, photography, plastic surgery, decorating, fashion, finance, retirement solutions, nutrition, fitness, and holistic approaches to wellness. A list of all event seminars is provided below.

Informative seminars about ovarian and breast cancer are offered as part of each session. Knowing the signs and symptoms of ovarian cancer, the screening guidelines for breast cancer, and the basics about hereditary breast and ovarian cancer, could save your life or the life of someone you love.  On behalf of Libby’s H*O*P*E*™, I will conduct a seminar as part of Session II entitled, A Patient Advocate’s Perspective on the Importance of Ovarian Cancer Awareness and Related On-line Resources.  My presentation will address the genesis of the Libby’s H*O*P*E*™ website; highlight critical ovarian cancer awareness information; summarize available online ovarian cancer and cancer-related resources; describe stories of hope involving ovarian cancer survivors and their families; and explain how each individual can make a difference in the fight against ovarian cancer.

NOCC Rejuvenate also targets cancer survivors. The devastating effects of these diseases can rob women of hope and peace. This event will offer an opportunity for survivors to reinvent their self-image and gain more knowledge, offering a sense of hope and a chance to connect with other survivors.

An exhibitor’s area will be offered at the event. This area will include informational tables as well as vendor tables that have been specifically chosen to meet the overarching vision of the event. At the completion of the three event sessions, a nutritious lunch will be served while information is provided on the signs and symptoms of ovarian and breast cancer.

NOCC 6th Annual Women's Health Expo

What:  National Ovarian Cancer Coalition 6th Annual Women’s Health Expo entitled, REJUVENTE Finding Balance (click here to view event brochure, including mail-in registration)

When: Saturday, March 20, 2010 (8:00 A.M. – 3:00 P.M.)

Where: Sheraton Annapolis Hotel, 173 Jennifer Road, Annapolis, Maryland 21401 (driving instructions).

Register: To register online click here.

Contact: Nancy Long (NOCC Maryland Chapter Co-President) at 443-433-2597, or email (click here).

Keynote Speaker:  Yarrow, The Energy Whisperer

Session I Presentations (9:30 A.M. – 10:30 A.M.)

• Treating Cancer By Alternative Medicine
• The Survivors’ Connection
• The Skinny on Fat – Cancer Prevention Naturally
• Interior Design in Difficult Times – Cost Saving Design Solutions
• Relaxation & Healing
• Identifying & Solving the Challenges of Baby Boomer Women
• Cancer and The Healing Power of Forgiveness
  
• Belly Dancing

Session II Presentations (10:45-11:45)

• Dr. Zandra Cheng, Breast Surgeon at Anne Arundel Medical Center
• Hereditary Syndromes That Include Ovarian and Breast Cancers
  
• Facial & Body Rejuvenation
• A Patient Advocate’s Perspective On the Importance of Ovarian Cancer Awareness & Related On-line Resources (Paul Cacciatore, Founder, Libby’s H*O*P*E*™)
• Designing Green Interiors
• Creating Better Images with the Camera You Own
• Some Expert Fashion Tips
• Yoga:  A Balanced Life
• Relaxation & Healing

Session III Presentations (12:00 P.M. – 1:00 P.M.)

• New Advances in Ovarian Cancer (William McGuire, M.D., Medical Director of The Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital)
• What is My Daughter’s Chance of Getting My Cancer?
• Planning for your Retirement Lifestyle:  The New Retirement
• Super Health Begins with Super-food Nutrition
• Around the World to Your Backyard
• Balancing Your Life Wheel
• Get Fit & Healthy with the Simple Rules of the Big 3
• Relaxation & Healing
  

About the National Ovarian Cancer Coalition

The mission of the NOCC is to raise awareness and increase education about ovarian cancer. NOCC is committed to improving the survival rate and quality of life for women with ovarian cancer. Through national programs and local Chapter initiatives, the NOCC’s goal is to make more people aware of the early symptoms of ovarian cancer. In addition, the NOCC provides information to assist the newly diagnosed patient, to provide hope to survivors, and to support caregivers. NOCC programs are possible only with the help of its volunteers; committed men and women dedicated to the mission of the NOCC in communities across the country.  For more information go to http://www.ovarian.org/.

About the National Breast & Ovarian Cancer Connection

The mission of the NBOCC is to raise awareness and educate the general public about the link between breast and ovarian cancer. The organization is dedicated to teaching all women about their inherent risks and how to improve their chances of survival through early detection and research developments.  For more information go to http://www.nbocc.org/.

FDA Clears Vermillion’s “OVA1” Test To Determine Likelihood of Ovarian Cancer In Women With Pelvic Mass

The U.S. Food and Drug Administration cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

First Lab Test That Can Indicate Ovarian Cancer Prior To Biopsy Or Exploratory Surgery

The U.S. Food and Drug Administration (FDA) cleared the OVA1™ Test, the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy.

The U.S. Food and Drug Administration (FDA) cleared the OVA1™ Test [formerly, the Ovarian Tumor Triage Test], the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy. The test was developed by Vermillion, Inc. (formerly, Ciphergen Biosystems, Inc. ), a molecular diagnostics company, in cooperation with Quest Diagnostics, the world’s leading provider of cancer diagnostics. Quest Diagnostics, which is a long-time investor in research and development of the OVA1 technology, has exclusive rights to offer the test to the clinical reference laboratory market in the U.S. for three years.

“When combined with other clinical information, the OVA1 biomarker panel can help assess the likelihood of malignancy of an ovarian tumor before surgery and facilitate decisions about referral to a gynecologic oncologist,” said Frederick R. Ueland, M.D., principal investigator of the prospective, multi-center OVA1 clinical trial. Dr. Ueland is an associate professor gynecologic oncology at the University of Kentucky‘s Markey Cancer Center.

The OVA1 Test is an in vitro diagnostic multivariate index [assay] (IVDMIA) test that combines the results of five immunoassays using a proprietary unique algorithm to produce a single numerical score indicating a women’s likelihood of malignancy. The OVA1 Test provides a new option in the pre-operative evaluation to help physicians assess if a pelvic mass is benign or malignant in order to help determine whether to refer a woman to a gynecologic oncologist for surgery. Numerous clinical practice guidelines recommend that women with ovarian cancer be under the care of a gynecologic oncologist. However, only an estimated one third of women who undergo surgery for possible ovarian cancer are referred to these specialist surgeons for their surgery.(1)

Vermillion received the Society for Gynecologic Oncologists (SGO) Basic Science Poster Award for an abstract on the performance of its OVA1 Test presented at SGO’s 38th Annual Meeting on Women’s Cancer in 2007. In reviewing the test application, the FDA evaluated results of a prospective, double-blind clinical trial which included 27 demographically mixed sites representative of institutions where ovarian tumor subjects may undergo a gynecological examination.

“Surgery in the hands of a gynecologic oncologist is usually associated with more favorable patient outcomes,” said Jon R. Cohen, M.D., chief medical officer and senior vice president, Quest Diagnostics. “Physicians often do not know if a woman’s pelvic mass is malignant or benign until she undergoes surgery. The OVA1 Test is the first FDA-cleared blood test to help clinicians determine whether to refer a woman to a gynecologic oncologist or have a gynecologic oncologist present at the time of surgery. We believe this test will help drive more favorable patient outcomes.”

“Unfortunately, advances in ovarian cancer diagnosis and treatment are few and far between. It is fitting that September, Ovarian Cancer Awareness Month, marks FDA’s clearance of OVA1, a test that represents an important step forward toward improved outcomes,” said Gail S. Page, executive chairperson of the board of directors of Vermillion. “Quest Diagnostics had the foresight to recognize the potential value of this novel multivariate assay and supported its development. We look forward to collaborating to bring this new diagnostic option to the many women who will benefit from specialist care.”

"When combined with other clinical information, the OVA1 biomarker panel can help assess the likelihood of malignancy of an ovarian tumor before surgery and facilitate decisions about referral to a gynecologic oncologist," said Frederick R. Ueland, M.D., principal investigator of the prospective, multi-center OVA1 clinical trial. Dr. Ueland is an associate professor gynecologic oncology at the University of Kentucky's Markey Cancer Center.

The FDA clearance of OVA1 makes Quest Diagnostics the only diagnostic testing company to offer FDA cleared tests for ovarian cancer in the pre- and post-surgical settings. In addition to offering the OVA1 Test, Quest Diagnostics was the first laboratory company to provide a new lab test that the FDA cleared in the third quarter of 2008 as an aid for monitoring for recurrence of epithelial ovarian cancer.

The OVA1 Test will be available for physician use in the fourth quarter of this year.

Ovarian cancer is the leading cause of death from gynecologic cancers in the United States and the fifth-leading cause of cancer deaths in women.(2) Approximately 21,600 new cases of ovarian cancer will be diagnosed in the U.S. in 2009, and approximately 14,600 women will die of the disease.(3)

About the OVA1 Test

The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The test utilizes five well-established biomarkers — Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), Beta2-Microglobulin (Beta2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) — and a proprietary algorithm to determine the likelihood of malignancy in women with pelvic mass for whom surgery is planned.

The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Test carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

About Vermillion

Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in oncology, hematology, cardiology and women’s health. Vermillion is based in Fremont, California. Additional information about Vermillion can be found on the Web at www.vermillion.com.

About Quest Diagnostics

Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at www.QuestDiagnostics.com.

(1) Journal of the National Cancer Institute, Vol. 98, No. 3, February 1, 2006

(2) Greenlee RT, Murray T, Bolden S, Wingo PA. Cancer statistics, 2000. CA Cancer J Clin. 2000;50(1):7-33

(3) 2009 American Cancer Society [Leading Sites of New Cancer Cases and Deaths—2009 Estimates]

Contacts:
Quest Diagnostics:
Media: Wendy Bost 973-520-2800
Investors: Kathleen Valentine 973-520-2900

Vermillion:
Jill Totenberg, he Totenberg Group Tel: 212 994 7363
jtotenberg@totenberggroup.com

Select FDA Comments:

The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.

OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.

OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

Sources:

• U.S. Food and Drug Administration Clears Vermillion’s OVA1(TM) Test to Determine Likelihood of Ovarian Cancer in Women with Pelvic Mass – First lab test that can indicate ovarian cancer prior to biopsy or exploratory surgery, Investor Relations, News Release, Vermillion Inc., 11 Sept. 2009.

• FDA Clears a Test for Ovarian Cancer – Test can help identify potential malignancies, guide surgical decisions, News & Events, News Release, U.S. Food & Drug Administration, 11 Sept. 2009.

Women Often Opt to Surgically Remove Their Breasts, Ovaries to Reduce Cancer Risk

Many women at high risk for breast or ovarian cancer are choosing to undergo surgery as a precautionary measure to decrease their cancer risk, according to a report in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

PHILADELPHIA – Many women at high risk for breast or ovarian cancer are choosing to undergo surgery as a precautionary measure to decrease their cancer risk, according to a report in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

Dr. Gareth Evans is an international authority on cancer genetics. Dr. Evans is the Chairman of the National Institute For Health & Clinical Excellence (NICE) familial breast cancer group; Chairman, Cancer Genetics Group & Council Member, British Society of Human Genetics; Consultant, Genesis Prevention Center, Univ. Hospital of South Manchester NHS Trust; Professor, Univ. of Manchester, UK

“Women have their breasts or ovaries removed based on their risk.

Dr. Claudine Isaacs is an Associate Professor of Medicine, Director of the Familial Cancer Registry Shared Resource, Director of the Clinical Breast Cancer Program, and the Co-Medical Director of the Fisher Center for Familial Cancer Research at the Lombardi Comprehensive Cancer Center, Georgetown Univ., Washington, D.C. (photo credit: Phil Humnicky, Georgetown Univ.)

It does not always happen immediately after counseling or a genetic test result and can take more than seven years for patients to decide to go forward with surgery,” said lead researcher D. Gareth Evans, M.D. Evans is a consultant in clinical genetics at the Genesis Prevention Center, University Hospital of South Manchester NHS Trust and a professor at the University of Manchester, United Kingdom.

Evans and colleagues assessed the increase in risk-reduction surgery among women with breast cancer and evaluated the impact of cancer risk, timing and age.

Rate of increase was measured among 211 women with known unaffected BRCA1 or BRCA2 mutation carriers. BRCA1 and BRCA2 are hereditary gene mutations that indicate an increased risk for developing breast cancer. Additionally, more than 3,500 women at greater than 25 percent lifetime risk of breast cancer without mutations also had a documented increase in risk-reduction surgery.

Women who had a biopsy after undergoing risk evaluation were twice as likely to choose a risk-reducing mastectomy. Forty percent of the women who were mutation carriers underwent bilateral risk-reducing mastectomy; 45 percent had bilateral risk-reducing salpingo-oophorectomy (surgical removal of ovaries). These surgeries are widely used by carriers of BRCA1 and BRCA2 gene mutations to reduce the risk for breast and ovarian cancer.

Evaluated by gene type, bilateral risk-reducing salpingo-oophorectomy was more common in women who were BRCA1 gene carriers – 52 percent had the surgery compared with 28 percent of the women who were BRCA2 gene carriers.

“We found that older women were much less likely to have a mastectomy, but were more likely to have their ovaries removed,” said Evans.

Most of the women, specifically those aged 35 to 45 years, opted for surgery within the first two years after the genetic mutation test, but some did not make a decision until seven years later.

“This is a very interesting study. It fleshes out some of what we know about adoption of risk reduction strategies in high-risk women who have participated in a very comprehensive and well thought-out genetic counseling, testing and management program,” said Claudine Isaacs, M.D., an associate professor of medicine and co-director of the Fisher Center for Familial Cancer Research, Lombardi Comprehensive Cancer Center at Georgetown University.

BRCA1 and BRCA2 mutation carriers have a very high lifetime risk of cancer, and for BRCA1 carriers there are unfortunately no clearly proven non-surgical prevention strategies, according to Isaacs. These women face a 50 to 85 percent lifetime risk of breast cancer, and mastectomy is currently the most effective prevention method available.

The findings confirm the expectations that when a woman has a biopsy, even if benign, most are more likely to opt for risk-reduction surgery.

“Screening should be conducted at a place with expertise in an effort to minimize false-positive results, which often lead to biopsy. This will minimize the anxiety that comes along with such a diagnosis. Patients should consult with an expert in advance and stay in contact with them to see how the science may be changing over time,” she advised. “This is an ongoing conversation that needs to be addressed and individualized for each patient.”

Likewise, Evans suggested that additional studies are needed to help evaluate the communication efforts and methods between doctors and/or counselors and women at risk for breast cancer. Questions to be raised should include how is the communication method occurring, are the doctors sympathetic and is there an ongoing dialogue?

“Careful risk counseling does appear to influence women’s decision for surgery although the effect is not immediate,” the researchers wrote.

References:

• Women Often Opt to Surgically Remove Their Breasts, Ovaries to Reduce Cancer Risk, AACR Press Release, American Association For Cancer Research, 06 Aug. 09.

• Evans DG, Lalloo F, Ashcroft L, et. al. Uptake of risk-reducing surgery in unaffected women at high risk of breast and ovarian cancer is risk, age, and time dependent. Cancer Epidemiol Biomarkers Prev. 2009 Aug;18(8):2318-24. PubMed PMID: 19661091.

Young Early-Stage Ovarian Cancer Patients Can Preserve Fertility

A new study finds that young women with early-stage ovarian cancer can preserve future fertility by keeping at least one ovary or the uterus without increasing the risk of dying from the disease. The study is published in the September 15, 2009 issue of CANCER, a peer-reviewed journal of the American Cancer Society.

A new study finds that young women with early-stage ovarian cancer can preserve future fertility by keeping at least one ovary or the uterus without increasing the risk of dying from the disease. The study is published in the September 15, 2009 issue of CANCER, a peer-reviewed journal of the American Cancer Society.

... “Given the potential reproductive and nonreproductive benefits of ovarian and uterine preservation, the benefits of conservative surgical management should be considered in young women with ovarian cancer” ...

Most cases of ovarian cancer are diagnosed at later stages and in older women. However, up to 17 percent of ovarian tumors occur in women 40 years of age or younger, many of whom have early stage disease. Surgery for ovarian cancer usually involves complete removal of the uterus (hysterectomy) and ovaries, which not only results in the loss of fertility, but also subjects young women to the long-term consequences of estrogen deprivation.

Jason Wright, M.D., Assistant Professor, OB/GYN, Columbia University College of Physicians & Surgeons, New York City, NY

Researchers led by Jason Wright, M.D., of Columbia University College of Physicians and Surgeons in New York City conducted a study to examine the safety of fertility-conserving surgery in premenopausal women with ovarian cancer. This type of surgery conserves at least one ovary or the uterus.

The investigators analyzed data from women 50 years of age or younger who were diagnosed with early stage (stage I) ovarian cancer between 1988 and 2004 and who were registered in the National Cancer Institute’s Surveillance, Epidemiology and End Results database, a population-based cancer registry that includes approximately 26 percent of the US population. Patients who had both of their ovaries removed were compared with those who had only the cancerous ovary removed. A second analysis examined uterine conservation verus hysterectomy.

For their first analysis, the researchers identified 1,186 ovarian cancer patients. While most had both ovaries removed, about one in three (36 percent) had one ovary conserved. They found those in whom one ovary was saved had similar survival for up to at least five years.

To examine the effect of uterine preservation, the investigators studied a total of 2,911 women. While most of the women underwent hysterectomy, about one in four (23 percent) had uterine preservation. Uterine preservation also had no effect on survival.

Women who were younger, who were diagnosed in more recent years, and who resided in the eastern or western United States were more likely to undergo ovarian or uterine conservation.

These results are promising for the many young women who are diagnosed with ovarian cancer each year. An estimated 21,650 women in the United States were diagnosed with the disease in 2008. “Given the potential reproductive and nonreproductive benefits of ovarian and uterine preservation, the benefits of conservative surgical management should be considered in young women with ovarian cancer,” the authors concluded.

Source:  Wright JD, Shah M, Mathew L, et. al.  Fertility preservation in young women with epithelial ovarian cancer. CANCER; Published Online: August 10, 2009 (DOI: 10.1002/cncr.24461); Print Issue Date: September 15, 2009.

Comment: The key to this study is the concept that fertility preservation “should be considered in young women with ovarian cancer.”  As part of this consideration, the patient’s subtype of ovarian cancer may play an important role as well.  For example, a diagnosis of ovarian clear cell adenocarcinoma (OCCA) in a young adult woman should create a moment of pause in regard to fertility-sparing. The OCCA subtype of epithelial ovarian cancer can be extremely chemoresistant (even during first-line treatment), especially if the tumor histology indicates that the tumor possesses a dominant clear cell component or is a pure form of OCCA.  In addition, OCCA is a rare form of epithelial ovarian cancer in women worldwide (with the exception of Japanese foreign nationals). My hypothetical does not mean that fertility sparing should not be considered in the event of a OCCA diagnosis, it simply means that each woman should carefully discuss fertility-sparing with her board-certified gynecologic oncologist based upon the specific facts of her case, including tumor histology.

Ovary Removal May Increase Lung Cancer Risk

Women who have premature menopause because of medical interventions are at an increased risk of developing lung cancer, according to a new study published in the International Journal of Cancer.  The startling link was made by epidemiologists from the Université de Montréal, the Research Centre of the Centre Hospitalier de l’Université de Montréal and the INRS—Institut Armand-Frappier. …

Ovary removal may increase lung cancer risk

Press Release, Monday, 20 July 2009

Women who have premature menopause because of medical interventions are at an increased risk of developing lung cancer, according to a new study published in the International Journal of Cancer.  The startling link was made by epidemiologists from the Université de Montréal, the Research Centre of the Centre Hospitalier de l’Université de Montréal and the INRS—Institut Armand-Frappier.

“We found that women who experienced non-natural menopause are at almost twice the risk of developing lung cancer compared to women who experienced natural menopause,” says Anita Koushik, a researcher at the Université de Montréal’s Department of Social and Preventive Medicine and a scientist at the Research Centre of the Centre Hospitalier de l’Université de Montréal. “This increased risk of lung cancer was particularly observed among women who had non-natural menopause by having had both their ovaries surgically removed.”

The scientists studied 422 women with lung cancer and 577 control subjects at 18 hospitals across Montreal, Quebec, Canada. They assessed socio-demographic characteristics, residential history, occupational exposures, medical and smoking history, and (among women) menstruation and pregnancy histories.

Anita Koushik, researcher, Université de Montréal's Department of Social & Preventive Medicine; scientist, Research Centre of the Centre Hospitalier de l'Université de Montréal.

“A major strength of this study was the detailed smoking information which we obtained from all study participants; this is important because of the role of smoking in lung cancer and because smokers generally have lower estrogen levels than non-smokers,” says Dr. Koushik. “Although smoking is the dominant cause of lung cancer, we know other factors can play an important role in enhancing the impact of tobacco carcinogens; this research suggests that in women hormonal factors may play such a role.”

Women were considered menopausal if their menstrual periods had stopped naturally, surgically (by hysterectomy with bilateral surgical ovary removal) or because of radiation or chemotherapy.  Women who had at least one remaining ovary and who still had their menstrual periods at the time of diagnosis/interview were classified as premenopausal.  Among participants with natural menopause, the median age for attaining menopause was 50 years old; among those with non-natural menopause, it was at 43 years.

“Non-natural menopause, particularly surgical menopause, may represent an increased risk with younger age at menopause given that surgery is usually done before natural menopause occurs. It’s possible that vulnerability to lung cancer is caused by early and sudden decrease in estrogen levels or potentially long-term use of hormone replacement therapy and further research is needed to explore these hypotheses,” says Jack Siemiatycki a professor at the Université de Montréal’s Department of Social and Preventive Medicine and a scientist at the Research Centre of the Centre Hospitalier de l’Université de Montréal.

Jack Siemiatycki, professor, Université de Montréal's Department of Social & Preventive Medicine; scientist, Research Centre of the Centre Hospitalier de l'Université de Montréal

About the Study
The article “Characteristics of menstruation and pregnancy and the risk of lung cancer in women,” published in the International Journal of Cancer, was authored by Anita Koushik and Jack Siemiatycki of the Université de Montréal and Research Centre of the Centre Hospitalier de l’Université de Montréal and Marie-Elise Parent of the INRS—Institut Armand-Frappier.

Partners in Research
This study was funded by the Canadian Institutes of Health Research, the Fonds de la recherche en santé du Québec and the Guzzo-SRC Chair in Environment and Cancer.

Source: Ovary Removal May Increase Lung Cancer Risk, Press Release, University of Montreal, 20 Jul. 09 [summarizing the findings of Koushik A, Parent ME, Siemiatycki J. Characteristics of menstruation and pregnancy and the risk of lung cancer in women. Int J Cancer. 2009 May 11. (Epub ahead of print)].

Vermillion Files FDA Pre-Market Application for OVA1 Ovarian Tumor Triage Test

” …The OVA1 [Ovarian Tumor Triage Test] test will help assess the risk of malignancy in the hundreds of thousands of women who require surgery for ovarian tumors each year. ‘This information can be used to identify those who might benefit from referral to a gynecologic oncologist,’ said Fred Ueland, M.D., principal investigator of the study and Associate Professor of Gynecologic Oncology at the University of Kentucky. While most tumors are benign, numerous studies have shown that women with ovarian cancer have better overall outcomes when their surgery is performed by a gynecologic oncologist.”

“ FREMONT, Calif., June 25 /PRNewswire-FirstCall/ — Vermillion, Inc. (Nasdaq: VRML), a molecular diagnostics company, today announced that it has submitted a 510(k) pre-market notification application to the U.S. Food & Drug Administration (FDA) requesting regulatory clearance of its Ovarian Tumor Triage Test known as OVA1™.

As announced previously, the OVA1 prospective clinical trial met its primary endpoints, indicating that the test is capable of stratifying women with pelvic masses into high- and low-risk categories to help determine whether the patient should be referred to a specialist prior to surgery. The clinical trial was one of the largest ovarian cancer studies ever conducted and assessed more than 550 women with a confirmed adnexal mass at 27 clinical sites in the United States. Additionally, the trial was the culmination of more than eight independent studies in more than 2,500 women.

The OVA1 test will help assess the risk of malignancy in the hundreds of thousands of women who require surgery for ovarian tumors each year. ‘This information can be used to identify those who might benefit from referral to a gynecologic oncologist,’ said Fred Ueland, M.D., principal investigator of the study and Associate Professor of Gynecologic Oncology at the University of Kentucky. While most tumors are benign, numerous studies have shown that women with ovarian cancer have better overall outcomes when their surgery is performed by a gynecologic oncologist.

This is an important milestone for Vermillion and a significant step toward the commercialization of OVA1™. ‘We are pleased with the results of the trial and look forward to discussing the significance of our data and our commercialization strategy in an upcoming investor roundtable, planned for July,’ said Gail Page, President and CEO of Vermillion. ‘We also look forward to receiving regulatory clearance from the FDA and making OVA1 available to the hundreds of thousands of women who could benefit considerably from the test.’

Vermillion will host a roundtable teleconference to address the need for OVA1 on Tuesday, July 15. Fred Ueland, M.D., principal investigator of the OVA1 clinical study, will serve as the keynote speaker. Conference call details, including dial-in information and timing, are forthcoming.

About Vermillion’s Ovarian Cancer Diagnostic Program

In addition to developing a diagnostic test designed to distinguish between benign and malignant pelvic masses, Vermillion has a broad program of ovarian cancer diagnostic tests in development. Studies are underway to validate diagnostic tests developed to detect early-stage ovarian cancer, predict prognosis and recurrence, and identify women considered at high-risk for the disease.

Vermillion’s comprehensive diagnostic development program is being conducted with several leading collaborators at The Johns Hopkins School of Medicine, The University of Texas M.D. Anderson Cancer Center, Rigshospitalet (Copenhagen), and the University of Kentucky.

The Company’s OVA1 test is part of a strategic alliance with Quest Diagnostics to jointly develop and commercialize diagnostic tests.

About Vermillion

Vermillion, Inc. is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has diagnostic programs in oncology, hematology, cardiology and women’s health. Vermillion is based in Fremont, California. Additional information about Vermillion can be found on the Web at http://www.vermillion.com.”

[Quoted Source: Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test – Significant Milestone Achieved Based on Compelling Clinical Studies, Vermillion, Inc. Press Release, June 25, 2008.]

Additional Information:  To learn more about molecular diagnostics and proteomics, see Understanding Cancer Series: Molecular Diagnostics, National Cancer Institute, September 1, 2006.

Colectomy “Contributes Significantly” to Ovarian Cancer Maximal Surgical Cytoreduction

“ … Bristow et. al. say: ‘Transverse colectomy can contribute significantly to a maximal ovarian cancer cytoreductive surgical effort and carries acceptable morbidity. Resection of a non-contiguous segment of rectosigmoid colon is frequently necessary, and placement of two separate colonic anastomoses is associated with a low risk of anastomotic breakdown.”

“Transverse colectomy can make a valuable contribution to maximal surgical cytoreduction attempts for ovarian cancer, with acceptable morbidity, researchers have found. The study involved 39 ovarian cancer patients, of whom 33 underwent primary surgery for stage IIIC or stage IV disease, Robert Bristow (The Kelly Gynecologic Oncology Service, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA) and team report.

A third of the patients had no residual gross disease after surgery, while 59.0 percent of patients were left with residual disease of 0.1-1.0 cm, and 7.7 percent with residual disease of >1 cm. Morbidity was “acceptable,” affecting 25.6 percent of patients, with fistulas occurring in 5.1 percent of patients, and the mortality rate was 2.6 percent.

Overall, 33 patients underwent partial and nine underwent total transverse colectomy. Surgery involved rectosigmoid colectomy in 61.5 percent of cases and two separate colonic anastamoses in 48.7 percent.

Bristow et. al. say: ‘Transverse colectomy can contribute significantly to a maximal ovarian cancer cytoreductive surgical effort and carries acceptable morbidity. Resection of a non-contiguous segment of rectosigmoid colon is frequently necessary, and placement of two separate colonic anastomoses is associated with a low risk of anastomotic breakdown.’”

[Quoted Source: Colectomy “contributes significantly” to ovarian cancer cytoreduction, by Cher Thornhill, MedWire News Release, June 25, 2008 (summarizing the findings of Transverse colectomy in ovarian cancer surgical cytoreduction: operative technique and clinical outcome; Bristow, R.E. et. al, Gynecol Oncol. 2008 Jun;109(3):364-9. Epub 2008 Apr 8.)]

Encouraging Survival Data Associated With Maximal Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy Using Pegylated Liposomal Doxorubicin

A recent Phase I clinical trial reported encouraging survival data with respect to the use of maximal cytoreduction combined with hyperthermic intraperitoneal chemotherapy (HIPEC) using pegylated liposomal doxorubicin (PLD)(e.g., Doxil™) to treat patients with advanced intra-abdominal, gastrointestinal and gynecological malignancies.

HIPEC is used in conjunction with surgery and chemotherapy to treat patients with gastrointestinal tract and gynecological cancers and sarcomas that have spread to the lining of the abdomen. Even after surgical removal, cancer often recurs in the abdomen. So when the tumor spreads, it is difficult for doctors to treat with standard chemotherapy.

HIPEC involves using a using a heated sterile solution that is circulated throughout the abdominal cavity. With HIPEC treatment, patients are connected to a series of tubes and a pumping device that bathes the abdominal cavity for two hours with a heated sterile solution containing anticancer (chemotherapeutic) drugs. The high temperature of the chemotherapy increases the effect of the drug. The fluid goes through the abdomen to treat tumor cells that may remain after surgery. Both heat and direct contact with chemotherapy drugs kills the cancer cells.

Twenty-one patients were enrolled in this Phase I clinical trial. The maximum PLD dose evaluated in this trial was 100 mg/m² and was well tolerated. The most common grade 3/4 complications were superficial wound infection and prolonged ileus. One patient developed an anastomotic leak in the postoperative period, requiring re-exploration. The length of the median postoperative hospital stay was 7 days (range, 4-29 days), three patients required readmissions within 30 days, and there were no operative deaths.

The median follow-up time for was 13.7 months (range, 3-38 months). The median overall survival was 30.6 months with a median progression free survival (PFS) of 25 months. Based on these findings, the trial investigators concluded that HIPEC with PLD following maximal cytoreduction in patients with advanced abdominal-only, gastrointestinal or gynecologic malignancies is well tolerated. Moreover, the investigators stated that the encouraging survival period after cytoreduction and HIPEC with PLD suggests that a verification Phase II clinical trial is warranted.

For more information regarding the HIPEC procedure, go to HIPECTREATMENT.org. For a list of open clinical trials testing the HIPEC procedure using various chemotherapeutic agents, click here.

Sources:

• Phase I trial of pegylated liposomal doxorubicin with hyperthermic intraperitoneal chemotherapy in patients undergoing cytoreduction for advanced intra-abdominal malignancy; Harrison, L.E. et. al., Ann. Surg. Oncol. 2008 May;15(5):1407-13.]
• Surgical Oncology – Hyperthermic Intraperitoneal Chemotherapy, Greenebaum Cancer Center, The University of Maryland Website, March 12, 2008.
• HIPEC Illustration: ThermaSolutions.com.