par Piccart-Gebhart, Martine ;Bertelsen, K;James, K;Cassidy, J;Mangioni, C;Simonsen, E;Stuart, G;Kaye, Steve;Vergote, Ignace;Blom, R;Grimshaw, R;Atkinson, R J;Swenerton, K D;Trope, C;Nardi, M;Kaern, J;Tumolo, Salvatore;Timmers, P;Roy, J A;Lhoas, F;Lindvall, B;Bacon, M;Birt, A;Andersen, J E;Zee, B;Paul, J;Baron, Benoît;Pecorelli, Sërgio
Référence Journal of the National Cancer Institute, 92, 9, page (699-708)
Publication Publié, 2000-05
Référence Journal of the National Cancer Institute, 92, 9, page (699-708)
Publication Publié, 2000-05
Article révisé par les pairs
Résumé : | BACKGROUND: A randomized trial conducted by the Gynecologic Oncology Group (GOG, study #111) in the United States showed a better outcome for patients with advanced ovarian cancer on the paclitaxel-cisplatin regimen than for those on a standard cyclophosphamide-cisplatin regimen. Before considering the paclitaxel-cisplatin regimen as the new "standard," a group of European and Canadian investigators planned a confirmatory phase III trial. METHODS: This intergroup trial recruited 680 patients with broader selection criteria than the GOG #111 study and administered paclitaxel as a 3-hour instead of a 24-hour infusion; progression-free survival was the primary end point. Patient survival was analyzed by use of the Kaplan-Meier technique. Treatment effects on patient survival were estimated by Cox proportional hazards regression models. All statistical tests were two-sided. RESULTS: The overall clinical response rate was 59% in the paclitaxel group and 45% in the cyclophosphamide group; the complete clinical remission rates were 41% and 27%, respectively; both differences were statistically significant (P =.01 for both). At a median follow-up of 38.5 months and despite a high rate of crossover (48%) from the cyclophosphamide arm to the paclitaxel arm at first detection of progression of disease, a longer progression-free survival (log-rank P =.0005; median of 15.5 months versus 11.5 months) and a longer overall survival (log-rank P =. 0016; median of 35.6 months versus 25.8 months) were seen in the paclitaxel regimen compared with the cyclophosphamide regimen. CONCLUSIONS: There is strong and confirmatory evidence from two large randomized phase III trials to support paclitaxel-cisplatin as the new standard regimen for treatment of patients with advanced ovarian cancer. |