Large European Ovarian Cancer Study Defines New

Standard of Care / TAXOL/Carboplatin Significantly ImprovesQuality Of Life, Maintains Survival Benefit Atlanta (ots-PRNewswire) - Results from one of the largest-ever European clinical trials in ovarian cancer (OVAR-3) provethat patients who receive the combination of TAXOL (paclitaxel)and carboplatin experienced fewer side effects and asignificantly improved quality of life when directly compared topatients receiving TAXOL + cisplatin. Both cisplatin andcarboplatin are platinum-based compounds. These landmark trial results were presented today at the 35thannual meeting of the American Society of Clinical Oncology(ASCO). "Major landmark clinical trials have demonstrated over thelast several years that TAXOL/cisplatin dramatically improvessurvival in women with ovarian cancer and in certain women canincrease chance of cure," explained Andreas duBois, MD, PhD, ofSt. Vincentius Hospital, Germany and principal investigator ofthe OVAR-3 trial. "This drug combination, however, was limited bynausea and neurotoxicity, which can cause transient tingling,numbness and discomfort. Although the survival benefit afforded by TAXOL/cisplatinregimen is more important than its side effect profile,improvement of this regimen has been a major clinical researchpriority. Results of OVAR-3 prove that the substitution ofcarboplatin for cisplatin is a new standard of care thatmaintains survival benefit while improving safety, quality oflife, and convenience." Dr. duBois emphasized that thesubstitution of carboplatin makes more viable a faster rate ofinfusion (3 hours vs. 24 hours), which is more convenient andalso reduces complications, hospitalization and related costs. Trial design and results The OVAR-3 study recruited 798 patients over a two-year periodwho were randomized to receive either TAXOL and cisplatin orTAXOL and carboplatin, both platinum-based compounds. No relevantdose reductions due to treatment side effects were required ineither arm of the study. However, the TAXOL/carboplatincombination was associated with significantly less nausea,vomiting and neurotoxicity associated with numbness or discomfortin the extremities. Patients receiving TAXOL/carboplatin alsoexperienced significantly less cumulative neurotoxicity, ordamage to the nervous system that can accumulate throughout thecourse of chemotherapy. Results show that this advantage ismaintained for at least two years after completion ofchemotherapy. This improvement in safety corresponded directly with a highlysignificant improvement in quality of life, based on anevaluation of patients' global health status, which was conductedaccording to the European Organization for the Research andTreatment of Cancer's (EORTC) quality of life questionnaire. TheTAXOL/carboplatin combination maintained the efficacy of theTAXOL/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 twoyears. Further analysis with longer follow-up will continuouslyevaluate these results. Analyses conducted at two years in otherlandmark trials have been predictive of long-term results. Results of the OVAR-3 trial were confirmed by results of asimilarly designed large Phase III trial (GOG-158) conducted inthe United States and also presented today at ASCO. "The new information presented today provides a critical massof evidence defining TAXOL/platinum as the gold-standard first-line treatment for advanced ovarian cancer, and TAXOL/carboplatinas the best tolerated of the two TAXOL/platinum regimens. We arenow in a better position than ever before to save and prolong thelives of women with ovarian cancer, while maintaining betterquality of life in the process." A critical mass of evidence Results of the OVAR-3 and GOG-158 clinical trials build onearly landmark research. In 1995, the U.S. Gynecologic OncologyGroup study (GOG-111) first demonstrated the benefits of TAXOL-cisplatin combination therapy in advanced ovarian cancer. TheTAXOL-based regimen in this study extended median survival to37.5 months, compared to 24.4 months achieved with the standardcislatin/cyclophosphamide combination, adding a median of 13 moremonths to patients' lives. Results of GOG-111 were heralded asthe first notable improvement since the advent of platinum-basedtherapy in the early 1980s. These results were confirmed in 1997 and again in 1998 whentwo separate analyses of a major trans-Atlantic trial werepresented at the 33rd and 34th meetings of ASCO. Results of theEuropean-Canadian Intergroup trial confirmed findings of GOG-111in terms of progression-free and overall survival. The morediverse patient population in the Intergroup trial and the use ofTAXOL upon disease progression in the study's control armheightened the significance of the Intergroup's findings. "We are in a rare and privileged position to draw on theresults of at least four powerful large Phase III clinical trialsin the treatment of ovarian cancer," concluded Dr. duBois. "Basedon these results, any woman receiving anything other thanTAXOL/carboplatin is receiving suboptimal care." Ovarian cancer is the most common and lethal form ofgynecological cancer, with new cases occurring in more than25,000 women throughout the E.U. each year. Ovarian cancer killsmore women than all gynecological cancers combined. Because earlystages of the disease typically do not cause symptoms, most womenare diagnosed with later stage disease. OVAR-3 is a trial of the Arbeitsgemeinschaft GynackologiseheOnkologie (AGO) Ovarian Cancer Study Group. The AGO is thelargest gynecologic oncology study group in Germany and includesthe majority of universities and academic teaching hospitals inthe country. Following completion of protocol OVAR-3, the AGO initiated thenext study using TAXOL/carboplatin as a standard regimen,comparing it to the three drug combination of TAXOL, carboplatinand epirubicin. This study (OVAR-5) is run as a German-French-Austrian intergroup trial by the AGO study group, together withthe French GINECO group. The trial already has recruitedapproximately 1,000 patients and will be presented as a poster atthis year's ASCO. More mature results of OVAR-5 are awaited nextyear. ots Original Text Service: AGO Ovarian Cancer Study GroupInternet: http://www.newsaktuell.de Contact: Jeff Smith +44-171-282-1200

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