Phase III Trial in Metastatic Gastroesophageal Adenocarcinoma with Fluorouracil, Leucovorin Plus Either Oxaliplatin or Cisplatin: A Study of the Arbeitsgemeinschaft Internistische Onkologie

作者：Salah‐Eddin Al‐Batran, J. T. Hartmann, Stephan Probst, Harald Schmalenberg, Stephan Hollerbach, Ralf‐Dieter Hofheinz, Volker Rethwisch, G. Seipelt, Nils Homann, G. Wilhelm, Gunter Schuch, Jan Stoehlmacher, Hans Günter Derigs, Susanna Hegewisch‐Becker, Johannes Grossmann, Claudia Pauligk, Akin Atmaca, Carsten Bokemeyer, Alexander Knuth, Elke Jäger · 发表于：Journal of Clinical Oncology · 年份：2008 · 被引用次数：788 · 研究领域：Gastric Cancer Management and Outcomes、Esophageal Cancer Research and Treatment、Colorectal Cancer Treatments and Studies

PURPOSE: This study was designed to compare fluorouracil, leucovorin, and oxaliplatin with fluorouracil, leucovorin, and cisplatin in patients with advanced gastric cancer. PATIENTS AND METHODS: Patients with previously untreated advanced adenocarcinoma of the stomach or esophagogastric junction were randomly assigned to receive either fluorouracil 2,600 mg/m(2) via 24-hour infusion, leucovorin 200 mg/m(2), and oxaliplatin 85 mg/m(2) (FLO) every 2 weeks or fluorouracil 2,000 mg/m(2) via 24-hour infusion, leucovorin 200 mg/m(2) weekly, and cisplatin 50 mg/m(2) every 2 weeks (FLP). The primary end point was progression-free survival (PFS). RESULTS: Two hundred twenty patients (median age, 64 years; metastatic, 94%) were randomly assigned. FLO was associated with significantly less (any grade) anemia (54% v 72%), nausea (53% v 70%), vomiting (31% v 52%), alopecia (22% v 39%), fatigue (19% v 34%), renal toxicity (11% v 34%), thromboembolic events (0.9% v 7.8%), and serious adverse events related to the treatment (9% v 19%). FLP was associated with significantly less peripheral neuropathy (22% v 63%). There was a trend toward improved median PFS with FLO versus FLP (5.8 v 3.9 months, respectively; P = .077) and no significant difference in median overall survival (10.7 v 8.8 months, respectively). However, in patients older than 65 years (n = 94), treatment with FLO resulted in significantly superior response rates (41.3% v 16.7%; P = .012), time to treatment failure (5.4 v 2.3 mo...