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Journal of Clinical Oncology, Vol 18, Issue 1 (January), 2000: 136
© 2000 American Society for Clinical Oncology

Phase III Multicenter Randomized Trial of Oxaliplatin Added to Chronomodulated Fluorouracil–Leucovorin as First-Line Treatment of Metastatic Colorectal Cancer

By S. Giacchetti, B. Perpoint{dagger}, R. Zidani, N. Le Bail, R. Faggiuolo, C. Focan, P. Chollet, J. F. Llory, Y. Letourneau, B. Coudert, F. Bertheaut-Cvitkovic, D. Larregain-Fournier, A. Le Rol, S. Walter, R. Adam, J. L. Misset, F. Lévi

From the International Organization of Cancer Chronotherapy, Centre de Chronothérapie, Hôpital Paul Brousse, Villejuif, France; and Debiopharm S.A., Lausanne, Switzerland.

Address reprint requests to Sylvie Giacchetti, MD, Centre de Chronothérapie, Hôpital Paul Brousse, 14 avenue Paul-Vaillant-Couturier, 94807 Villejuif Cédex, France; email sylvie.giacchetti@ pbr.ap_hop_paris.fr.

PURPOSE: To study how adding oxaliplatin (l-OHP) to chronomodulated fluorouracil (5-FU)–leucovorin (LV) affected the objective response rate, as first-line treatment of metastatic colorectal cancer.

PATIENTS AND METHODS: Two hundred patients from 15 institutions in four countries were randomly assigned to receive a 5-day course of chronomodulated 5-FU and LV (700 and 300 mg/m2/d, respectively; peak delivery rate at 0400 hours) with or without l-OHP on the first day of each course (125 mg/m2, as a 6-hour infusion). Each course was repeated every 21 days. Response was assessed by extramural review of computed tomography scans.

RESULTS: Grade 3 to 4 toxicity from 5-FU–LV occurred in <= 5% of the patients (<= 1% of the courses). Grade 3 to 4 diarrhea occurred in 43% of the patients given l-OHP (10% of the courses), and less than 2% of the patients had severe hematotoxicity. Thirteen percent of the patients had moderate functional impairment from peripheral sensory neuropathy. Sixteen percent of the patients receiving 5-FU–LV had an objective response (95% confidence interval [CI], 9% to 24%), compared with 53% of those receiving additional l-OHP (95% CI, 42% to 63%) (P < .001). The median progression-free survival time was 6.1 months with 5-FU–LV (range, 4.1 to 7.4 months) and 8.7 months (7.4 to 9.2 months) with l-OHP and 5-FU–LV (P = .048). Median survival times were 19.9 and 19.4 months, respectively.

CONCLUSION: By chronomodulating 5-FU–LV, we were able to add l-OHP without compromising dose-intensities. l-OHP significantly improved the antitumor efficacy of this regimen.

{dagger}Deceased.

Presented in part at the Thirty-Third Annual Meeting of the American Society of Clinical Oncology, Denver, CO, May 17-20, 1997 (abstr 805).




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