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

Salah-Eddin Al-Batran, Joerg Thomas Hartmann, Stephan Probst, Harald Schmalenberg, Stephan Hollerbach, Ralf Hofheinz, Volker Rethwisch, Gernot Seipelt, Nils Homann, Gerhard Wilhelm, Gunter Schuch, Jan Stoehlmacher, Hans Günter Derigs, Susanna Hegewisch-Becker, Johannes Grossmann, Claudia Pauligk, Akin Atmaca, Carsten Bokemeyer, Alexander Knuth, Elke Jäger

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, Mannheim; Department of Hematology and Oncology, Katholisches Krankenhaus, Hagen; Gemeinschaftspraxis für Hämatologie und Internistische Onkologie, Bad Soden; Department of Medicine I, University of Lübeck, Lübeck; Department of Hematology and Oncology, Harz Klinikum Wernigerode; Department of Oncology and Hematology, Section of Pneumology, Universitätskrankenhaus Eppendorf and Onkologische Schwerpunktpraxis Eppendorf, Hamburg; Department of Internal Medicine I, Universitätsklinikum Carl Gustav Carus, Dresden; III. Department of Medicine, Johannes Gutenberg University, Mainz; Department of Medicine, Ev. Krankenhaus Bethesda, Mönchengladbach, Germany; and Department of Oncology, Universitätsspital, Zürich, Switzerland

Corresponding author: Salah-Eddin Al-Batran, MD, Krankenhaus Nordwest, Steinbacher Hohl 2-26, 60488 Frankfurt am Main, Germany; e-mail: albatran{at}aol.com

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.

A preliminary analysis of the study was presented as a Late Breaking Abstract (LBA4016) at the 42nd Annual Meeting of the American Society of Clinical Oncology, June 2-6, 2006 Atlanta, GA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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