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Bolus Fluorouracil and Leucovorin With Oxaliplatin as First-Line Treatment in Metastatic Colorectal Cancer

From the Department of Oncology, Infermi Hospital, Rimini; Department of Oncology, Santa Maria delle Croci Hospital, Ravenna; Department of Oncology, Cervesi Hospital, Cattolica; Department of Oncology, Bufalini Hospital, Cesena; Department of Oncology, Pierantoni Hospital, Forlì; and Department of Oncology Hospital, Lugo, Italy.

Address reprint requests to Alberto Ravaioli, MD, Department of Oncology, Infermi Hospital, Via Settembrini, 2, 47900 Rimini, Italy; email: aravaiol{at}auslrn.net

PURPOSE: A phase II trial investigated the activity and toxicity of a bolus administration schedule of oxaliplatin, fluorouracil (5-FU), and leucovorin (LV) therapy in patients with untreated advanced colorectal cancer.

PATIENTS AND METHODS: Forty-five patients in this multicenter, open, nonrandomized study received oxaliplatin 130 mg/m² on the first day of each course and 5-FU and LV 350 mg/m² and 20 mg/m², respectively, as a daily bolus for 5 days, every 21 days, for a maximum of six courses.

RESULTS: Partial responses occurred in 18 patients, giving an intent-to-treat response rate of 40.0%. Median time to response was 12.7 weeks; median duration of response was 18.4 weeks. Median progression-free survival was 5.9 months; median survival was 14 months. The independent prognostic factors for improved overall survival were good performance status and negative carcino-embryonic antigen blood level. Incidences of adverse effects were reduced after the 5-FU dose was reduced to 300 mg/m². Reversible neurologic toxicity occurred in 44.4% of patients.

CONCLUSION: Bolus administration of oxaliplatin, 5-FU, and LV as first-line therapy for untreated advanced colorectal cancer is efficacious and safe. In addition to a more favorable safety profile, the 300 mg/m² dosage offered improved dose-intensity compared with the initial dosage.

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