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Randomized Multicenter Phase II Trial of a Biweekly Regimen of Fluorouracil and Leucovorin (LV5FU2), LV5FU2 Plus Cisplatin, or LV5FU2 Plus Irinotecan in Patients With Previously Untreated Metastatic Gastric Cancer: A Fédération Francophone de Cancérologie Digestive Group Study—FFCD 9803

From the Centre Hospitalier Universitaire de Reims, Reims; Centre Eugène Marquis, Rennes; Equipe Mixte Inserm 106; Centre Hospitalier Universitaire de Dijon; and Fédération Francophone de Cancérologie Digestive, Faculté de Médecine, Dijon; Institut Paoli Calmettes; and Hôpital La Timone Assistance Publique Hôpitaux de Marseille, Marseille; Clinique Radiologique Armoricaine, Saint Brieuc; Clinique Saint Jean, Lyon; Centre Hospitalier Universitaire de Caen, Caen; Centre Hospitalier de La Rochelle, La Rochelle; Centre Paul Papin, Angers; Centre Hospitalier Universitaire Ambroise Paré Assistance Publique Hôpitaux de Paris, Boulogne; Centre Hospitalier Universitaire de Nantes, Nantes; and Centre Alexis Vautrin, Nancy, France

Address reprint requests to Olivier Bouché, MD, Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire Robert Debré, Avenue du Général Koenig, F-51092 Reims Cedex, France; e-mail: obouche{at}chu-reims.fr

PURPOSE: To determine the efficacy and safety of a biweekly regimen of leucovorin (LV) plus fluorouracil (FU) alone or in combination with cisplatin or irinotecan in patients with previously untreated metastatic gastric adenocarcinoma and to select the best arm for a phase III study.

PATIENTS AND METHODS: One hundred thirty-six patients (two were ineligible) were enrolled onto the randomized multicenter phase II trial. Patients received LV 200 mg/m² (2-hour infusion) followed by FU 400 mg/m² (bolus) and FU 600 mg/m² (22-hour continuous infusion) on days 1 and 2 every 14 days (LV5FU2; arm A), LV5FU2 plus cisplatin 50 mg/m² (1-hour infusion) on day 1 or 2 (arm B), or LV5FU2 plus irinotecan 180 mg/m² (2-hour infusion) on day 1 (arm C).

RESULTS: The overall response rates, which were confirmed by an independent expert panel, were 13% (95% CI, 3.4% to 23.3%), 27% (95% CI, 14.1% to 40.4%), and 40% (95% CI, 25.7% to 54.3%) for arms A, B, and C, respectively. Median progression-free survival and overall survival times were 3.2 months (95% CI, 1.8 to 4.6 months) and 6.8 months (95% CI, 2.6 to 11.1 months) with LV5FU2, respectively; 4.9 months (95% CI, 3.5 to 6.3 months) and 9.5 months (95% CI, 6.9 to 12.2 months) with LV5FU2-cisplatin, respectively; and 6.9 months (95% CI, 5.5 to 8.3 months) and 11.3 months (95% CI, 9.3 to 13.3 months) with LV5FU2-irinotecan, respectively.

CONCLUSION: Of the three regimens tested, the combination of LV5FU2-irinotecan is the most promising and will be assessed in a phase III trial.

Supported by grants from Aventis, Baxter, and the Association pour la Recherche Contre le Cancer.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

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

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