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Weekly Infusional High-Dose Fluorouracil (HD-FU), HD-FU Plus Folinic Acid (HD-FU/FA), or HD-FU/FA Plus Biweekly Cisplatin in Advanced Gastric Cancer: Randomized Phase II Trial 40953 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group and the Arbeitsgemeinschaft Internistische Onkologie

Manfred P. Lutz, Hansjochen Wilke, D.J. Theo Wagener, Udo Vanhoefer, Krzysztof Jeziorski, Susanna Hegewisch-Becker, Leopold Balleisen, Eric Joossens, Rob L. Jansen, Muriel Debois, Ullrich Bethe, Michel Praet, Jacques Wils, Eric Van Cutsem

From the Caritasklinik St Theresia, Saarbrücken; Kliniken Essen-Mitte, Essen; Universitätsklinikum Essen, Essen; Universitätskrankenhaus Eppendorf, Hamburg; Evangelisches Krankenhaus, Hamm, Germany; UMC St Radboud, Nijmegen; AZ Maastricht, Maastricht; Laurentius Ziekenhuis, Roermond, the Netherlands; Maria Sklodowska-Curie Memorial Cancer Center, Warsaw, Poland; AZ Middelheim, Middelheim; European Organisation for Research and Treatment of Cancer Data Center, Brussels; and UZ Leuven, Leuven, Belgium

Address reprint requests to Manfred P. Lutz, MD, Caritasklinik St Theresia, Rheinstr 2, 66113 Saarbrücken, Germany; e-mail: m.lutz{at}caritasklinik.de

Purpose This multicentric, randomized, two-stage phase II trial evaluated three simplified weekly infusional regimens of fluorouracil (FU) or FU plus folinic acid (FA) and cisplatin (Cis) with the aim to select a regimen for future phase III trials.

Patients and Methods A total of 145 patients with advanced gastric cancer where randomly assigned to weekly FU 3,000 mg/m²/24 hours (HD-FU), FU 2,600 mg/m²/24 hours plus dl-FA 500 mg/m² or l-FA 250 mg/m² (HD-FU/FA), or FU 2000 mg/m²/24 hours plus FA plus biweekly Cis 50 mg/m², each administered for 6 weeks with a 1-week rest. The primary end point was the response rate.

Results Confirmed responses were observed in 6.1% (two of 33) of the eligible patients treated with HD-FU, in 25% (12 of 48, including one complete remission [CR]) with HD-FU/FA, and in 45.7% (21 of 46, including four CRs) with HD-FU/FA/Cis. The HD-FU arm was closed after stage 1 because the required minimum number of responses was not met. The median progression-free survival of all patients in the HD-FU, HD-FU/FA, and HD-FU/FA/Cis arm was 1.9, 4.0, and 6.1 months, respectively. The median overall survival was 7.1, 8.9, and 9.7 months, and the survival rate at 1 year was 24.3%, 30.3%, and 45.3%, respectively. Grade 4 toxicities were rare. The most relevant grade 3/4 toxicities were neutropenia in 1.9%, 5.4%, and 19.6%, and diarrhea in 2.7%, 1.9%, and 3.9% of the cycles in the HD-FU, HD-FU/FA, and HD-/FU/Cis arms, respectively.

Conclusion Weekly infusional FU/FA plus biweekly Cis is effective and safe in patients with gastric cancer.

Supported by Grants No. 5U10 CA11488-26 through 5U10 CA11488-33 from the National Cancer Institute (Bethesda, MD). The contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

M.P.L. and H.W. contributed equally to this publication.

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

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• Modulation of FU With High-Dose Folinic Acid Is Effective for Treatment of Patients With Gastric Carcinoma
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