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

Author:

Al-Batran Salah-Eddin1,Hartmann Joerg Thomas1,Probst Stephan1,Schmalenberg Harald1,Hollerbach Stephan1,Hofheinz Ralf1,Rethwisch Volker1,Seipelt Gernot1,Homann Nils1,Wilhelm Gerhard1,Schuch Gunter1,Stoehlmacher Jan1,Derigs Hans Günter1,Hegewisch-Becker Susanna1,Grossmann Johannes1,Pauligk Claudia1,Atmaca Akin1,Bokemeyer Carsten1,Knuth Alexander1,Jäger Elke1

Affiliation:

1. From the Department of Hematology and Oncology, Krankenhaus Nordwest, Frankfurt; Department of Medical Oncology, Hematology, Immunology, Rheumatology and Pulmology South West Cancer Center, Eberhard-Karls-University, Tuebingen; Department of Hematology and Oncology, Städtische Kliniken, Bielefeld; Department of Internal Medicine, Universitätsklinikum, Jena; Division of Gastroenterology, Department of Medicine, Allgemeines Krankenhaus, Celle; III. Department of Medicine, Universitätsklinikum Mannheim,...

Abstract

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/m2 via 24-hour infusion, leucovorin 200 mg/m2, and oxaliplatin 85 mg/m2 (FLO) every 2 weeks or fluorouracil 2,000 mg/m2 via 24-hour infusion, leucovorin 200 mg/m2 weekly, and cisplatin 50 mg/m2 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 months; P < .001), and PFS (6.0 v 3.1 month; P = .029) and an improved OS (13.9 v 7.2 months) as compared with FLP, respectively. Conclusion FLO reduced toxicity as compared with FLP. In older adult patients, FLO also seemed to be associated with improved efficacy.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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