Bolus fluorouracil and leucovorin with oxaliplatin as first-line treatment in metastatic colorectal cancer. |
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Authors: | Alberto Ravaioli Maurizio Marangolo Enzo Pasquini Andrea Rossi Dino Amadori Giorgio Cruciani Davide Tassinari Giovanni Oliverio Petros Giovanis Daniele Turci Federica Zumaglini Mario Nicolini Ilaria Panzini |
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Institution: | Department of Oncology, Infermi Hospital, Via Settembrini 2, 47900 Rimini, Italy. aravaiol@austrn.net |
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Abstract: | 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/m(2) on the first day of each course and 5-FU and LV 350 mg/m(2) and 20 mg/m(2), 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/m(2). 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/m(2) dosage offered improved dose-intensity compared with the initial dosage. |
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