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Phase III Study Comparing a Semimonthly With a Monthly Regimen of Fluorouracil and Leucovorin As Adjuvant Treatment for Stage II and III Colon Cancer Patients: Final Results of GERCOR C96.1

Thierry André, Emmanuel Quinaux, Christophe Louvet, Philippe Colin, Erik Gamelin, Olivier Bouche, Emmanuel Achille, Pascal Piedbois, Nicole Tubiana-Mathieu, Arnaud Boutan-Laroze, Michel Flesch, Gérard Lledo, Yves Raoul, Isabelle Debrix, Marc Buyse, Aimery de Gramont

From the Hôpital Tenon, Assistance Public Hôpitaux de Paris and CancerEst; Hôpital Saint-Antoine, Assistance Public Hôpitaux de Paris and CancerEst; GERCOR, Paris; Clinique Courlancy, Reims; Centre Hospitalier Universitaire de Reims, Reims; Centre Paul Papin, Angers; Clinique Claude Bernard, Metz; Hôpital Henri Mondor, Assistance Public Hôpitaux de Paris, Creteil; Astra-Zeneca, Rueil-Malmaison; Centre Hospitalier Universitaire de Limoges, Limoges; Centre Hospitalier d'Argenteuil, Argenteuil; Hôpital Devron, Dijon; Clinique St Jean, Lyon; Clinique St Vincent, St Grégoire, France; and the International Drug Development Institute, Ottignies Louvain-La-Neuve, Belgium

Address reprint requests to Thierry André, MD, Service d'Oncologie Médicale, Hôpital Tenon, 4, rue de la Chine, F-75970 Paris Cedex 20, France; e-mail: thierry.andre{at}tnn.aphp.fr

Purpose: This randomized, 2 x 2 factorial study compared a semimonthly regimen (fluorouracil [FU] and leucovorin [LV] semi-monthly is LV5FU2) with a monthly regimen of FU and LV (mFU/LV) as well as 24 weeks versus 36 weeks of each regimen as adjuvant treatment of stage II and III colon cancer.

Patients and Methods: LV5FU2 was administered semimonthly for 2 days as racemate (dl) or levogyre (l-; 200 or 100 mg/m²) as a 2-hour infusion, followed by 400 mg/m² FU bolus and a 600-mg/m² FU 22-hour continuous infusion. FU and LV were administered monthly (mFU/LV) for 5 days as dl- or l-LV 15-minute infusion, followed by a 400 mg/m² FU 15-minute infusion. The primary end point was disease-free survival (DFS).

Results: Between September 1996 and November 1999, 905 patients with stage II (43%) and III (57%) colon cancer were enrolled. The median follow-up was 6 years. There was no statistically significant difference between mFU/LV and LV5FU2 in terms of DFS (150 v 148 events; hazard ratio [HR],1.01; 95% CI, 0.806 to 1.269; P = .94) and overall survival (OS; 104 v 103 events; HR,1.02; 95% CI, 0.77 to 1.34; P = .91). No statistical difference was observed between 24 or 36 weeks of chemotherapy. Median survival from metastatic relapse was 24 months. The survival of patients with metastatic relapse (n = 243) was significantly longer for patients with a longer time from random assignment to relapse (< 1, 1 to 2, 2 years; log-rank test for trend P, .0497).

Conclusion: DFS and OS were not statistically different between treatment groups and treatment durations. These data confirm the value of LV5FU2 as control arm in the Multicenter International Study of Oxaliplatin/5FU-LV in the Adjuvant Treatment of Colon Cancer and Pan-European Trials in Adjuvant Colon Cancer studies.

Supported by grants from the Association Pour la Recherche en Cancérologie (APREC) and from Wyeth (Lederle and Puteaux, France) and Baxter (Maurepas, France).

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 13-17, 2005.

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

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