2009 Society of Gynecologic Oncologists Annual Meeting Ovarian Cancer Highlights

From February 5th through 8th, 2009, the Society of Gynecologic Oncologists’ (SGO) held its 40th Annual Meeting on Women’s Cancer in San Antonio, Texas. The meeting, viewed as the preeminent scientific and educational conference for women’s cancer care specialists, featured more than 350 scientific oral and poster presentations as well as educational sessions dealing with advances in the care and treatment of women’s cancers.

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From February 5th through 8th, 2009, the Society of Gynecologic Oncologists‘ (SGO)  held its 40th Annual Meeting on Women’s Cancer in San Antonio, Texas.  The meeting, viewed as the preeminent scientific and educational conference for women’s cancer care specialists, featured more than 350 scientific oral and poster presentations as well as educational sessions dealing with advances in the care and treatment of women’s cancers.  Several important presentations relating to ovarian cancer were made during the meeting and are highlighted below:

  • SGO: IVF Confers Slight Long-Term Risk of Ovarian Cancer, by Charles Bankhead, Medical News from SGO: Society of Gynecologic Oncologists Meeting, February 6, 2009 [Presentation Source:  Burger C, et al; The risk of borderline and invasive ovarian tumors after ovarian stimulation for in vitro fertilization in a large Dutch cohort after 15 years of follow-up, SGO 2009; 112(Suppl 1): Abstract 6].
  • SGO: Optimal Surgery Holds Benefits in Ovarian Cancer with Upper Abdominal Disease, by Charles Bankhead, Medical News from SGO: Society of Gynecologic Oncologists Meeting, February 6, 2009 [Presentation Source:  Zivanovic O, et al; Upper abdominal disease cephalad to the greater omentum and the impact on progression-free survival in patients with stage IIIC ovarian cancer;  SGO 2009; 112(Suppl 1): Abstract 1].
  • SGO: Rectovaginal Nodules Predict Bowel Perforation Risk with Bevacizumab, by Charles Bankhead, Medical News from SGO: Society of Gynecologic Oncologists Meeting, February 9, 2009 [Presentation Source:  Richardson DL, et al; Which factors predict bowel complications in patients with recurrent epithelial ovarian cancer being treated with bevacizumab? SGO 2009; 112(Suppl 1): Abstract 41].
  • Low Completion Rates for GOG 172 Intraperitoneal Chemotherapy Regimen: See Aletti G, et al Intraperitoneal chemotherapy for ovarian cancer: Exploring the “dark side” of the moon” SGO 2009; 112(Suppl 1): Abstract 40 (Source:  SGO: Few Ovarian Cancer Patients Tolerate Intraperitoneal Regimen, by Charles Bankhead, Medical News from SGO: Society of Gynecologic Oncologists Meeting, February 11, 2009).
  • Vermillion Presents Critical Data From Its OVA1 Clinical Trial, Vermillion Inc. News Release, February 10, 2009 [Presentation based upon a study entitled, A biomarker panel for distinguishing between malignant and benign ovarian tumors, which was co-authored by Fred Ueland, MD, Associate Professor of Gynecologic Oncology at the University of Kentucky and Principal Investigator of the OVA1 clinical trial, and Zhen Zhang, PhD, Associate Professor of Pathology at the Johns Hopkins University School of Medicine as well as Vermillion scientists].

About the Society of Gynecologic Oncologists

The SGO is a national medical specialty organization of physicians 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 1280, is primarily comprised of gynecologic oncologists, as well as other related medical specialists including medical oncologists, radiation oncologists 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 http://www.sgo.org.

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.

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:

Epirubicin Improves Overall Survival Better Than Ifosfamide When Combined with Paclitaxel and Cisplatin

Epirubicin (Ellence®) produced longer median overall survival (OS) than ifosfamide (Ifex®) in a recent phase II randomized clinical trial comparing (i) cisplatin, paclitaxel and ifosfamide, with (ii) cisplatin, paclitaxel and epirubicin, in newly diagnosed advanced epithelial ovarian cancer patients. In this trial, patients with histologically proven epithelial ovarian cancer were randomly assigned to receive first-line polychemotherapy with cisplatin/paclitaxel/epirubicin (CEP arm) or cisplatin/paclitaxel/ifosfamide (CIP arm) for six cycles every 21 days. Two hundred and eight patients were randomised between the two treatment arms. The Phase II clinical trial finds were as follows:

  • After a median follow-up of 82 months, median overall survival (OS) was 51 months in the CIP arm, and 65 months in the CEP arm; and
  • 5-year survival rates were 43% in the CIP arm, and 50% in the CEP arm.

The trial investigators note that the OS findings seem longer in duration than is commonly reported, especially considering that more than 50% of the newly diagnosed advanced ovarian cancer patients were suboptimally debulked or cytoreduced after their first surgery. The trial investigators concluded that this unexpected finding might be a consequence of the close surgical surveillance and aggressive chemotherapeutic approach.

[Source: “A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis;” Fruscio R. et. al.; Br J Cancer. 2008 Feb 26;98(4):720-7.]

Comment: Although small in size, this Phase II randomized clinical trial suggests that aggressive surgical intervention followed by aggressive polychemotherapy (involving epirubicin or ifosfamide in tandem with paclitaxel and cisplatin) may increase overall survival in newly diagnosed, advanced-stage ovarian cancer survivors. The findings of at least one major clinical study cite that optimal cytoreduction, as a stand-alone independent factor, provides up to a 50% increase in actuarial survival. In the U.S., an “optimal” cytoreduction is generally defined as a surgical procedure that results in 1 centimeter or less of macroscopic cancer present within the body after surgery. The surprising results of the study discussed above seem to indicate that a suboptimal cytoreduction or debulking surgery followed by aggressive polychemotherapy may be beneficial in extending overall survival in newly diagnosed, advanced-stage ovarian cancer survivors. The issue of what measure should be used to define an “optimal” cytoreduction or debulking is not without controversy with the ovarian cancer arena.

Who? Where? Two of the Most Important Choices When Facing An Ovarian Cancer Diagnosis.

Robert Bristow, M.D., Director of the Kelly Gynecologic Oncology Service and the Johns Hopkins Ovarian Cancer Center of Excellence, and colleagues highlight the importance of referring patients with suspected ovarian cancer to expert centers for their first surgery. By combining multiple studies of patients with stage III or IV ovarian carcinoma (6,885 patients) Bristow et al showed that consistent referral of patients with apparent advanced ovarian cancer to expert centers for primary surgery may be the best means currently available for improving overall survival. Even with the use of platinum based chemotherapy, maximal (or optimal or complete) cytoreduction was one of the most powerful determinants of cohort survival among patients with stage III or IV ovarian carcinoma. While the influence of platinum dose-intensity upon survival was not statistically significant, maximal cytoreduction was associated with a 50% increase of actuarial survival.

PubMed medical study abstract: “Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis,”Bristow, R.E., Tomacruz, R.S., Armstrong, D.K., Trimble, E.L., Montz, F.J., Kelly Gynecologic Oncology Service, Department of Gynecology and Obstetrics, Johns Hopkins Medical Institutions, Baltimore, MD 21287-1248, USA. rbristo@jhmi.edu, J. Clin. Oncol. 2002 Mar 1;20(5):1248-59.

Full Text of medical study: Journal of Clinical Oncology, Vol. 20, Issue 5 (March), 2002: pp.1248-1259.

Additional medical studies:

COMMENT: If you were recently diagnosed with ovarian cancer, these studies suggest that you should seek treatment from a medical institution(s) that (i) utilizes Gynecologic Oncologists as an essential part of the cancer diagnosis and treatment process, (ii) utilizes surgeons that possess high-end expertise with respect to gynecologic oncology surgical procedures such as maximum cytoreduction (e.g., gynecologic oncology surgeons), and (iii) conducts a high volume of gynecologic oncology surgeries and procedures resulting in best outcome. Refer to the resources below.