To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Taxol Combination Therapy Highly Active for Advanced Ovarian Cancer URL: http://www.pslgroup.com/dg/8E62.htm Doctor's Guide May 20, 1996
PHILADELPHIA, May 20, 1996 -- Researchers have found that the use of TAXOL(R) (paclitaxel) in combination with a platinum-containing compound to treat advanced ovarian cancer patients is highly active and well-tolerated, according to three new clinical studies presented here at the 32nd Annual Meeting of the American Society of Clinical Oncology (ASCO). "Results from clinical trials presented at ASCO this year show consistently high response rates, particularly when TAXOL is combined with platinum-based therapy and used in early treatment of ovarian cancer," said Renzo Canetta, M.D., Vice President - Clinical Cancer Research, Bristol-Myers Squibb. "Data from these studies support published results from more than 50 studies of TAXOL -- as a single agent and given in combination with a platinum-containing regimen -- in both initial and second-line treatment of thousands of ovarian cancer patients. In initial therapy, TAXOL can be given safely in combination and prolongs lives." Ovarian cancer, termed "the silent disease" because there are no obvious signs or symptoms until late in its development, will cause an estimated 14,800 deaths in the U.S. alone this year. According to the American Cancer Society, an estimated 26,700 new cases of the disease will be reported in the U.S. in 1996. One study cited by Dr. Canetta included women who had received prior chemotherapy for advanced ovarian cancer and were then given a regimen of TAXOL as a 3-hour infusion combined with PARAPLATIN(R) (carboplatin), another anticancer agent. In this study, under the auspices of the GINECO Group, Lyon, France, the overall response rate, as demonstrated by reduction in tumor size among 64 patients, was 41% and median response duration was 8 months. Researchers concluded that the combination regimen produced significant responses in previously treated patients, and was very well-tolerated under the 3-hour outpatient infusion schedule. Another study of TAXOL and carboplatin used in combination as a first-line treatment for advanced ovarian cancer, conducted at S. Orsola-Malpighi Hospital, Bologna, Italy, while still underway, shows a response rate of 84% among 12 evaluable patients. Researchers said that while the maximum tolerated dose has not yet been reached, the combination of TAXOL and a platinum-containing compound is highly active. A third study that is underway now, by the Clinical Pharmacology Branch of the National Cancer Institute, Bethesda, Md., showed a 79% response rate among 46 evaluable patients with newly diagnosed ovarian cancer who were treated with a combination of TAXOL, cisplatin and cyclophosphamide. "Of note, the rate of complete response documented by secondary surgery was reported to be 35%, which is an extremely high figure for a patient group such as this." Dr. Canetta said. "We are seeing significantly high response rates both in patients who are receiving TAXOL combination therapy for the first time and in those patients who have had prior treatment for this disease," Dr. Canetta said. "Women who received this therapy have seen an overall improvement in their quality of life as their disease has stabilized, and we expect to see similar trends in increased survival time." TAXOL/Cisplatin Extends Women's Lives by 50% A study published earlier this year in the New England Journal of Medicine showed that women with advanced ovarian cancer extended their median survival time by 50% or 13 months when they received a first-line regimen combining TAXOL and a platinum-containing compound as initial chemotherapy. This large study, conducted by the Gynecologic Oncology Group (GOG) in the U.S., was the first trial in 15 years that had shown a notable improvement in survival for advanced ovarian cancer patients. TAXOL/PLATINOL therapy extended median survival to 37.5 months, compared to 24.4 months with the standard chemotherapy of PLATINOL and cyclophosphamide. William McGuire, M.D., Professor of Medicine at Emory University and lead investigator of the study stated: "The results of this trial are extremely significant. In this trial we were able to demonstrate an improvement in median survival by 50%, and therefore it is my strong feeling that all women with this type of ovarian cancer should be primarily treated with TAXOL and PLATINOL(R) (cisplatin). This therapy should become the new standard for advanced ovarian cancer." The most common side effects associated with TAXOL are a reduction in white blood cell count (myelosuppression) and hair loss. Numbness in the extremities (peripheral neuropathy) and muscle or bone pain (myalgia/arthralgia) also can occur. Other side effects are listed on the package inserts for TAXOL, PLATINOL, and PARAPLATIN. More Than 150 TAXOL Clinical Studies Presented at ASCO Results from more than 150 clinical studies in which TAXOL was used to treat a range of tumor types were presented at ASCO this year. These are among more than 400 trials now underway, many of which use TAXOL in combination with other compounds in early treatment of cancer. Bristol-Myers Squibb is a diversified worldwide health and personal care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is a leading maker of innovative therapies for cardiovascular, metabolic and infectious diseases, central nervous system and dermatological disorders, and cancer. The company is also a leader in consumer medicines, orthopaedic devices, ostomy care, wound management, nutritional supplements, infant formulas, and hair and skin care products. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. 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