Large European Ovarian Cancer Study Defines New

Standard of Care / TAXOL/Carboplatin Significantly Improves Quality Of Life, Maintains Survival Benefit Atlanta (ots-PRNewswire) - Results from one of the largest- ever European clinical trials in ovarian cancer (OVAR-3) prove that patients who receive the combination of TAXOL (paclitaxel) and carboplatin experienced fewer side effects and a significantly improved quality of life when directly compared to patients receiving TAXOL + cisplatin. Both cisplatin and carboplatin are platinum-based compounds. These landmark trial results were presented today at the 35th annual meeting of the American Society of Clinical Oncology (ASCO). "Major landmark clinical trials have demonstrated over the last several years that TAXOL/cisplatin dramatically improves survival in women with ovarian cancer and in certain women can increase chance of cure," explained Andreas duBois, MD, PhD, of St. Vincentius Hospital, Germany and principal investigator of the OVAR-3 trial. "This drug combination, however, was limited by nausea and neurotoxicity, which can cause transient tingling, numbness and discomfort. Although the survival benefit afforded by TAXOL/cisplatin regimen is more important than its side effect profile, improvement of this regimen has been a major clinical research priority. Results of OVAR-3 prove that the substitution of carboplatin for cisplatin is a new standard of care that maintains survival benefit while improving safety, quality of life, and convenience." Dr. duBois emphasized that the substitution of carboplatin makes more viable a faster rate of infusion (3 hours vs. 24 hours), which is more convenient and also reduces complications, hospitalization and related costs. Trial design and results The OVAR-3 study recruited 798 patients over a two-year period who were randomized to receive either TAXOL and cisplatin or TAXOL and carboplatin, both platinum-based compounds. No relevant dose reductions due to treatment side effects were required in either arm of the study. However, the TAXOL/carboplatin combination was associated with significantly less nausea, vomiting and neurotoxicity associated with numbness or discomfort in the extremities. Patients receiving TAXOL/carboplatin also experienced significantly less cumulative neurotoxicity, or damage to the nervous system that can accumulate throughout the course of chemotherapy. Results show that this advantage is maintained for at least two years after completion of chemotherapy. This improvement in safety corresponded directly with a highly significant improvement in quality of life, based on an evaluation of patients' global health status, which was conducted according to the European Organization for the Research and Treatment of Cancer's (EORTC) quality of life questionnaire. The TAXOL/carboplatin combination maintained the efficacy of the TAXOL/cisplatin combination, causing no change in response rate, progression-free survival and two-year overall survival. Approximately 70-75% of patients in both arms were alive at two years. Further analysis with longer follow-up will continuously evaluate these results. Analyses conducted at two years in other landmark trials have been predictive of long-term results. Results of the OVAR-3 trial were confirmed by results of a similarly designed large Phase III trial (GOG-158) conducted in the United States and also presented today at ASCO. "The new information presented today provides a critical mass of evidence defining TAXOL/platinum as the gold-standard first- line treatment for advanced ovarian cancer, and TAXOL/carboplatin as the best tolerated of the two TAXOL/platinum regimens. We are now in a better position than ever before to save and prolong the lives of women with ovarian cancer, while maintaining better quality of life in the process." A critical mass of evidence Results of the OVAR-3 and GOG-158 clinical trials build on early landmark research. In 1995, the U.S. Gynecologic Oncology Group study (GOG-111) first demonstrated the benefits of TAXOL- cisplatin combination therapy in advanced ovarian cancer. The TAXOL-based regimen in this study extended median survival to 37.5 months, compared to 24.4 months achieved with the standard cislatin/cyclophosphamide combination, adding a median of 13 more months to patients' lives. Results of GOG-111 were heralded as the first notable improvement since the advent of platinum-based therapy in the early 1980s. These results were confirmed in 1997 and again in 1998 when two separate analyses of a major trans-Atlantic trial were presented at the 33rd and 34th meetings of ASCO. Results of the European-Canadian Intergroup trial confirmed findings of GOG-111 in terms of progression-free and overall survival. The more diverse patient population in the Intergroup trial and the use of TAXOL upon disease progression in the study's control arm heightened the significance of the Intergroup's findings. "We are in a rare and privileged position to draw on the results of at least four powerful large Phase III clinical trials in the treatment of ovarian cancer," concluded Dr. duBois. "Based on these results, any woman receiving anything other than TAXOL/carboplatin is receiving suboptimal care." Ovarian cancer is the most common and lethal form of gynecological cancer, with new cases occurring in more than 25,000 women throughout the E.U. each year. Ovarian cancer kills more women than all gynecological cancers combined. Because early stages of the disease typically do not cause symptoms, most women are diagnosed with later stage disease. OVAR-3 is a trial of the Arbeitsgemeinschaft Gynackologisehe Onkologie (AGO) Ovarian Cancer Study Group. The AGO is the largest gynecologic oncology study group in Germany and includes the majority of universities and academic teaching hospitals in the country. Following completion of protocol OVAR-3, the AGO initiated the next study using TAXOL/carboplatin as a standard regimen, comparing it to the three drug combination of TAXOL, carboplatin and epirubicin. This study (OVAR-5) is run as a German-French- Austrian intergroup trial by the AGO study group, together with the French GINECO group. The trial already has recruited approximately 1,000 patients and will be presented as a poster at this year's ASCO. More mature results of OVAR-5 are awaited next year. ots Original Text Service: AGO Ovarian Cancer Study Group Internet: Contact: Jeff Smith +44- 171-282-1200

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