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Journal of Clinical Oncology, Vol 18, Issue 16 (August), 2000: 2938-2947
© 2000 American Society for Clinical Oncology

Leucovorin and Fluorouracil With or Without Oxaliplatin as First-Line Treatment in Advanced Colorectal Cancer

By A. de Gramont, A. Figer, M. Seymour, M. Homerin, A. Hmissi, J. Cassidy, C. Boni, H. Cortes-Funes, A. Cervantes, G. Freyer, D. Papamichael, N. Le Bail, C. Louvet, D. Hendler, F. de Braud, C. Wilson, F. Morvan, A. Bonetti

From the Service de Médecine Interne-Oncologie, Hôpital Saint-Antoine, Paris; Debiopharm, Charenton; Service d’Oncologie Médicale, Centre Hospitalier Lyon Sud, Pierre-Benite; and Centre Hospitalier René Dubos, Pontoise, France; Institute of Oncology, Belinson Medical Center, Petach Tikva, Israel; Imperial Cancer Research Fund Cancer Medicine Research Unit, University of Leeds; Department of Medicine and Therapeutics, University of Aberdeen, Aberdeen; Department of Medical Oncology, St Bartholomew’s Hospital, London; and Addenbrooke’s National Health Service Trust, Cambridge, United Kingdom; Servizio di Oncologia Medica, Arcispedale S. Maria Nuova, Reggio Emilia; Instituto Europeo di Oncologia, Milan; and Clinical Oncology Centre, Service d’Oncologie Médicale, Div Oncologia Medica Azienda, Ospedaliera di Verona, Verona, Italy; Servicio de Oncología, the Hospital 12 de Octubre, Madrid; and Servicio de Onco-Hematologia, Hospital Clinico Universitario, Valencia, Spain.

Address reprint requests to A. de Gramont, MD, Hôpital Saint-Antoine, 184, rue du Faubourg Saint-Antoine, 75571 Paris Cedex 12, France; email aimery.de-gramont{at}sat.ap-hop-paris.fr

PURPOSE: In a previous study of treatment for advanced colorectal cancer, the LV5FU2 regimen, comprising leucovorin (LV) plus bolus and infusional fluorouracil (5FU) every 2 weeks, was superior to the standard North Central Cancer Treatment Group/Mayo Clinic 5-day bolus 5FU/LV regimen. This phase III study investigated the effect of combining oxaliplatin with LV5FU2, with progression-free survival as the primary end point.

PATIENTS AND METHODS: Four hundred twenty previously untreated patients with measurable disease were randomized to receive a 2-hour infusion of LV (200 mg/m2/d) followed by a 5FU bolus (400 mg/m2/d) and 22-hour infusion (600 mg/m2/d) for 2 consecutive days every 2 weeks, either alone or together with oxaliplatin 85 mg/m2 as a 2-hour infusion on day 1.

RESULTS: Patients allocated to oxaliplatin plus LV5FU2 had significantly longer progression-free survival (median, 9.0 v 6.2 months; P = .0003) and better response rate (50.7% v 22.3%; P = .0001) when compared with the control arm. The improvement in overall survival did not reach significance (median, 16.2 v 14.7 months; P = .12). LV5FU2 plus oxaliplatin gave higher frequencies of National Cancer Institute common toxicity criteria grade 3/4 neutropenia (41.7% v 5.3% of patients), grade 3/4 diarrhea (11.9% v 5.3%), and grade 3 neurosensory toxicity (18.2% v 0%), but this did not result in impairment of quality of life (QoL). Survival without disease progression or deterioration in global health status was longer in patients allocated to oxaliplatin treatment (P = .004).

CONCLUSION: The LV5FU2-oxaliplatin combination seems beneficial as first-line therapy in advanced colorectal cancer, demonstrating a prolonged progression-free survival with acceptable tolerability and maintenance of QoL.




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Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) As First-Line Treatment for Metastatic Colorectal Cancer: The Gruppo Oncologico Nord Ovest
J. Clin. Oncol., May 1, 2007; 25(13): 1670 - 1676.
[Abstract] [Full Text] [PDF]

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T. D. Yan, J. King, A. Sjarif, D. Glenn, K. Steinke, A. Al-Kindy, and D. L. Morris
Treatment Failure After Percutaneous Radiofrequency Ablation for Nonsurgical Candidates With Pulmonary Metastases From Colorectal Carcinoma
Ann. Surg. Oncol., May 1, 2007; 14(5): 1718 - 1726.
[Abstract] [Full Text] [PDF]