Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: LBA4016
© 2006 American Society of Clinical Oncology

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Abstract

A randomized phase III trial in patients with advanced adenocarcinoma of the stomach receiving first-line chemotherapy with fluorouracil, leucovorin and oxaliplatin (FLO) versus fluorouracil, leucovorin and cisplatin (FLP)

Krankenhaus Nordwest, Frankfurt, Germany; Eberhard-Karls-University, Tuebingen, Germany; Städtische Kliniken, Bielefeld, Germany; Universitätsklinikum, Mannheim, Germany; University Hospital Carl Gustav Carus, Dresden, Germany; Universitätsklinikum, Jena, Germany; Allgemeines Krankenhaus, Celle, Germany; University Hospital Hamburg - Eppendorf, Hamburg, Germany; Universitätsklinikum Schleswig-Holstein Campus, Luebeck, Germany

LBA4016

Background: Cisplatin-based chemotherapy is a standard option in advanced gastric cancer. However, treatment results have been unsatisfactory so far, with a time to progression (TTP) of 3 to 4 months and an overall survival (OS) of 6 to 9 months. In addition, treatment regimens are too intense and toxicity is considerable. The aim of this 2-arm randomized trial was to determine whether FLO prolongs TTP and reduces toxicity as compared to FLP. Methods: Patients (pts) were randomized to receive FLO: F 2600 mg/m² 24 h infusion, L 200 mg/m², and oxaliplatin 85 mg/m², every two weeks or FLP: F 2000 mg/m² 24 h infusion, L 200 mg/m², weekly, and cisplatin 50 mg/m², every two weeks. The primary end point was TTP. Main secondary endpoints included toxicity, time to treatment failure (TTF), and OS. Based on a planned sample size of 218 pts, the trial was designed to have an 80% power to detect an improvement in median TTP from 3.5 to 5.0 months (1-sided log-rank test; significance level 0.05). Results: 220 pts (FLO/FLP, 112/108) were randomized between Aug 2003 and Jan 2006. Median age was 64 yrs and median ECOG was 1. 162 pts (FLO, 80; FLP, 81) had disease progression and 25 pts (FLO, 18; FLP, 8) are still under treatment. Median TTP was 5.7 months for FLO and 3.8 months for FLP (log-rank p = 0.081, Wilcoxon p = 0.019). Median TTF was 5.3 months for FLO and 3.1 months for FLP (log-rank p = 0.028). Response to FLO (34%) was superior to FLP (27%), with 15% and 30% of pts having disease progression as best response to FLO and FLP, respectively (chi-square for trend p = 0.012). Median treatment duration was 4.3 months with FLO and 3 months with FLP. FLO was associated with significantly less NCI-CTC grade 1–4 leukopenia, nausea, alopecia, fatigue, and renal toxicity and FLP was associated with significantly less peripheral neuropathy (chi-square for trend p < 0.05). Severe adverse events related to treatment were less frequent with FLO (8.9%) as compared to FLP (18.6%; p = 0.046). Conclusions: FLO reduced toxicity and improved efficacy as compared to FLP. This leads us to consider FLO for future studies in combination with targeted drugs to further improve the outcome of pts with gastric cancer.

No significant financial relationships to disclose.

Abstract presentation from the 2006 ASCO Annual Meeting