Monthly Archives: March 2010

Lifestyle Matters: Dietary Factors Influence Ovarian Cancer Survival Rates

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University of Illinois at Chicago researchers identify relationship between healthy eating and prolonged ovarian cancer survival

UIC researchers find that consumption of cruciferous & yellow vegetables provide an ovarian cancer survival advantage

Therese A. Dolecek, Ph.D., M.S., R.D., Research Associate Professor of Epidemiology, Division of Epidemiology & Biostatistics, Institute for Health Research & Policy, School of Public Health, University of Illinois at Chicago

A study published in the March 2010 issue of the Journal of the American Dietetic Association (JADA), is among the first to evaluate possible diet associations with ovarian cancer survival. Researchers from the University of Illinois at Chicago (UIC) determined that there is a strong relationship between healthy eating and prolonged survival.

The subjects included 351 women diagnosed with epithelial ovarian cancer between 1994 to 1998, who participated in a previous case-control study. The original study collected demographic, clinico-pathologic, and lifestyle-related variables including diet. Each subject completed a food frequency questionnaire (FFQ) in which they were asked to report their usual dietary intake during the three to five year period prior to their diagnosis.

To translate the diet estimates in a meaningful way, the FFQ items were assigned to the major food groups reflected in the Dietary Guidelines for Americans 2005 (DGA), including fruits, vegetables, grains, meats, dairy, fats and oils, sweets, and alcohol. Grains, meats, and dairy were further subdivided into “suggested” and “other” groups. The “suggested” subdivisions included healthier food choices, whereas the “other” subdivisions contained less desirable selections.

The researchers found that higher total fruit and vegetable consumption, and higher vegetable consumption alone led to a survival advantage. A subgroup analyses revealed that only yellow and cruciferous vegetables (e.g., broccoli, kale, cauliflower, bok choy) significantly increased survival advantage. At five years, 75% of the women who ate less than one serving a week of yellow vegetables were alive, compared to about 82% of those who had three or more servings of yellow vegetables a week.  Likewise, a statistically significant improvement in survival was observed for the healthier grains.

Higher intakes of less-healthy meats — specifically the red and cured/processed meats subgroups — were associated with a survival disadvantage. Notably, the researchers found a 3-fold increased risk of dying for those women who ate four or more servings of red meat a week compared to those who ate less than one serving per week over the 11-year study period.

A survival disadvantage was also observed in connection with consumption of the milk (dairy – all types) subgroup. Women who had seven or more servings of milk of any type per week were two times as likely to die during the study period as those who had none.  The researchers stress that the milk finding should be interpreted cautiously, because it may have something to do with the fact that some women are genetically predisposed.

Therese A. Dolecek, Ph.D., M.S., R.D., Research Associate Professor of Epidemiology, Division of Epidemiology and Biostatistics, Institute for Health Research and Policy, School of Public Health, UIC, and a member of the Cancer Control and Population Science Research Program at the UIC Cancer Center, and her colleagues state the following in the article:

The study findings suggest that food patterns three to five years prior to a diagnosis of epithelial ovarian cancer have the potential to influence survival time. The pre-diagnosis food patterns observed to afford a survival advantage after an epithelial ovarian cancer diagnosis reflect characteristics commonly found in plant-based or low fat diets. These diets generally contain high levels of constituents that would be expected to protect against cancer and minimize ingestion of known carcinogens found in foods.

In an interview with WebMD.com, Dr. Dolecek said:  “To pinpoint exactly how much survival [was lengthened] is not possible. It varies from person to person.”  Many factors affect survival, such as the stage of the cancer at diagnosis and the woman’s age.

Cynthia A. Thomson, Ph.D., M.S., R.D., Associate Professor, Nutritional Sciences, Univ. of Arizona, Tucson

David S. Alberts, M.D., Director, Arizona Cancer Center, Tucson, Arizona

In an editorial commentary in the same JADA issue, Cynthia A. Thomson, Ph.D., M.S., R.D., Associate Professor, Nutritional Sciences, University of Arizona, Tucson, and David S. Alberts, M.D., Director, Arizona Cancer Center, Tucson, write the following:

The authors provide new evidence that dietary factors, particularly total fruit and vegetable, red and processed meat and milk intakes, may influence ovarian cancer survival. These findings corroborate earlier work by Nagle et. al. and are among only a select few studies of dietary associations with ovarian cancer recurrence and/or prognosis despite a significant and growing body of literature suggesting diet may influence ovarian cancer risk.

About The Journal of the American Dietetic Association

As the official journal of the American Dietetic Association (www.eatright.org), the Journal of the American Dietetic Association (JADA) (www.adajournal.org) is the premier source for the practice and science of food, nutrition and dietetics. The monthly, peer-reviewed journal presents original articles prepared by scholars and practitioners and is the most widely read professional publication in the field. JADA focuses on advancing professional knowledge across the range of research and practice issues such as: nutritional science, medical nutrition therapy, public health nutrition, food science and biotechnology, food service systems, leadership and management and dietetics education.

About The American Dietetic Association

The American Dietetic Association (ADA) (www.eatright.org) is the world’s largest organization of food and nutrition professionals. ADA is committed to improving the nation’s health and advancing the profession of dietetics through research, education and advocacy.

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GOG Says Continuation of Pivotal OPAXIO Maintenance Therapy Trial (GOG-212) Remains High Priority

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Gynecologic Oncology Group (GOG) Notifies CTI That Continuation of GOG-212 Pivotal Trial of OPAXIO Maintenance Therapy in Front Line Ovarian Cancer Remains High Priority.  GOG-218 Bevacizumab Results Do Not Influence Importance of GOG-212

Cell Therapeutics, Inc. (“CTI”) announced today that the company received a statement on March 1, 2010 from the Gynecologic Oncology Group (GOG) leadership that the phase III GOG-212 clinical trial of CTI’s OPAXIO™ (formerly known as Xyotax or CT-2103) used as maintenance therapy for ovarian cancer remains a high priority and enrollment will continue. The GOG made the statement to clarify that the recent results of the GOG-218 clinical trial bevacizumab in maintenance therapy for ovarian cancer has not influenced the importance of completing the GOG-212 clinical trial. The Gynecologic Oncology Group (GOG) is one of the National Cancer Institute’s (NCI) funded cooperative cancer research groups. The GOG is a multidisciplinary cooperative clinical trial research group focused on the study of gynecologic malignancies. The GOG is conducting phase III trials in ovarian cancer and other gynecologic cancers and has established standard treatments for these diseases in the U.S.

GOG leadership noted the following:

GOG-218 and GOG-212 differ in the type of patients under study. It is important to note that some of the patients who completed the initial 6 cycles of chemotherapy in GOG-218 had clinical evidence of persistent tumor and were randomized to either placebo (no treatment) or bevacizumab [Avastin®]. Thus a subset of GOG-218 patients received no therapy, despite the presence of persistent tumor. This is not the typical setting of using maintenance or consolidation therapy and it is not the setting for patients enrolled in GOG-212. In GOG-212, only patients who have achieved a complete clinical response are considered candidates for enrollment in the trial.

Reliance upon the data from GOG-218 to establish the “standard of care” must take into consideration the actual treatment effect (i.e., duration of benefit), the cost of the treatment, and the associated toxicity… [in GOG-212] the toxicity of the intervention may have less associated mortality and the incremental cost-effectiveness ratio may be more acceptable to patients and the health care economists. Thus the GOG has no intention to discontinue enrollment in GOG 212 as they feel that the study is addressing a different scientific question and the primary outcome study goal is survival, not progression free survival, an outcome of greater importance to both physicians and patients.

The Data Monitoring Committee is scheduled to conduct an interim analysis of overall survival when 130 events are recorded among patients in the no maintenance treatment arm. The statistical analysis plan utilizes pre-specified boundaries for early stopping for success. Based on current enrollment and study duration, the interim analysis could be conducted as early as 2011. If successful, CTI could utilize those results to form the basis of its New Drug Application for OPAXIO.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit http://www.celltherapeutics.com/.

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