Andreas du Bois1, Jørn Herrstedt1, Anne-Claire Hardy-Bessard1, Hans-Helge Müller1, Philipp Harter1, Gunnar B. Kristensen1, Florence Joly1, Jens Huober1, Elisabeth Åvall‐Lundqvist1, B. Weber1, Christian Kurzeder1, S. Jelić1, Éric Pujade-Lauraine1, Alexander Burges1, Jacobus Pfisterer1, M. Gropp1, A. Staehle1, Pauline Wimberger1, Christian Jackisch1, Jalid Sehouli1
1From the Dr Horst Schmidt Klinik (HSK), Wiesbaden; Coordinating Center for Clinical Trials, Philipps-Universität, Marburg; University Hospital Tuebingen, Tuebingen; University Hospital Ulm, Ulm; Klinikum Großhadern, München; University Hospital Schleswig-Holstein, Campus Kiel, Kiel; Evangelisches Krankenhaus, Duesseldorf; St Vincentius Kliniken, Karlsruhe; University Hospital Essen, Essen; Klinikum Offenbach, Offenbach; Charité, Campus Virchow-Klinikum, Berlin, Germany; Odense University Hospital, Odense...
Tóm tắt
Purpose One attempt to improve long-term survival in patients with advanced ovarian cancer was thought to be the addition of more non–cross-resistant drugs to platinum-paclitaxel combination regimens. Gemcitabine was among the candidates for a third drug. Patients and Methods We performed a prospective, randomized, phase III, intergroup trial to compare carboplatin plus paclitaxel (TC; area under the curve [AUC] 5 and 175 mg/m2, respectively) with the same combination and additional gemcitabine 800 mg/m2 on days 1 and 8 (TCG) in previously untreated patients with advanced epithelial ovarian cancer. TC was administered intravenously (IV) on day 1 every 21 days for a planned minimum of six courses. Gemcitabine was administered by IV on days 1 and 8 of each cycle in the TCG arm. Results Between 2002 and 2004, 1,742 patients were randomly assigned; 882 and 860 patients received TC and TCG, respectively. Grades 3 to 4 hematologic toxicity and fatigue occurred more frequently in the TCG arm. Accordingly, quality-of-life analysis during chemotherapy showed a disadvantage in the TCG arm. Although objective response was slightly higher in the TCG arm, this did not translate into improved progression-free survival (PFS) or overall survival (OS). Median PFS was 17.8 months for the TCG arm and 19.3 months for the TC arm (hazard ratio [HR], 1.18; 95% CI, 1.06 to 1.32; P = .0044). Median OS was 49.5 for the TCG arm and 51.5 months for the TC arm (HR, 1.05; 95% CI, 0.91 to 1.20; P = .5106). Conclusion The addition of gemcitabine to carboplatin plus paclitaxel increased treatment burden, reduced PFS time, and did not improve OS in patients with advanced epithelial ovarian cancer. Therefore, we recommend no additional clinical use of TCG in this population.
