Researchers from The University of Texas M. D. Anderson Cancer Center report that in a small study of women with advanced or recurrent endometrial cancer, gemcitabine and cisplatin, when used in combination, produced a response rate in fifty percent of patients.
Jubilee Brown, M.D., associate professor in M. D. Anderson's Department of Gynecologic Oncology, presented the findings at the plenary session of the Society of Gynecologic Oncologists' 41st Annual Meeting on Women's Cancer.
While early-stage endometrial cancer typically responds well to standard therapies, low survival rates for advanced or recurrent disease result from limited and ineffective chemotherapy and hormonal treatment options. The American Cancer Society estimates that 15 percent, or three out of every 20 of women with stage IV endometrial cancer, will survive more than five years.
The Phase II study of 20 patients found that the combination of gemcitabine and cisplatin, two drugs currently used to treat other types of cancer, limited the disease's progression, increasing progression-free survival while maintaining tolerable toxicity levels. It is believed that when administered together, gemcitabine helps overcome cell resistance to cisplatin, throwing tumor cells a potent one-two punch.
"These results are encouraging, offering a new direction for our research for women who suffer from advanced disease," said Brown, the study's lead author. "The findings have the potential to offer another option to these patients, but establishing this treatment as a standard of care will require more research."
Researchers enrolled patients with stage IV or recurrent endometrial cancer between November 2004 and September 2009 in the single-institution study. Women were treated with gemcitabine and then cisplatin twice during each chemotherapy cycle, undergoing an average of five cycles. Patient response was evaluated with physical and pelvic examinations and imaging studies (computed tomography or magnetic resonance imaging) after every three cycles.
Of the 20 patients, two had a complete remission; eight had a partial response, or a decrease in the size of a tumor or in the extent of cancer in the body; six patients experienced a stabilization of disease, meaning their cancer neither decreased nor increased in extent or severity; and four experienced a progression in disease, meaning their tumor grew or cancer metastasized.
Findings demonstrated a 50 percent overall response rate, or improvement in disease. Additionally, the clinical benefit of the two-drug combination was 80 percent, as 16 of the 20 women experienced either an improvement or stabilization of disease. All side effects resulting from the therapy were manageable. Brown noted that results from the study warrant investigation of the chemotherapy combination in a larger, definitive trial at multiple institutions.
According to the National Cancer Institute, endometrial cancer is the most common gynecologic malignancy and the fourth most common cancer among women in the United States. Nearly 8,000 women died from the disease in 2009.
Gemcitabine and cisplatin in combination have been investigated extensively in other disease sites, and synergism of the two agents has been confirmed in cell lines of human endometrial, ovarian, colon, lung and squamous cell head and neck carcinomas.
In addition to Brown, researchers contributing to the all-M. D. Anderson study include: Judith K. Wolf, M.D., professor and associate director; Judith A. Smith, Pharm. D., associate professor; Lois M. Ramondetta, M.D., associate professor; Pedro T. Ramirez, M.D., associate professor; Robert L. Coleman, M.D., professor and director of clinical research; Charles F. Levenback, M.D., professor; Mark Munsell, M.S., senior research statistician; and Maria Jung, R.N., all from the Department of Gynecologic Oncology, and Anil K. Sood, M.D., professor and director of ovarian cancer research in the Department of Gynecologic Oncology and professor in the Department of Cancer Biology.
The study was funded by a grant from Eli Lilly.
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