Purpose: To evaluate the efficacy and safety of oxaliplatin (L-OHP) fractionated over two days, with bimonthly 5-fluorouracil (5-FU) and leucovorin (LV), as first-line treatment of metastatic colorectal cancer (MCC) patients. Patients and Methods: Fifty-four patients with inoperable MCC (median age, 60 years) were entered into the study. Outpatient treatment consisted of L-OHP 50 mg/m(2) and LV 200 mg/m(2) administered in a 2-hour i.v. infusion, followed by 5-FU 400 mg/m(2) bolus and 5-FU 600 mg/m(2) in a 22-hour continuous infusion, on days 1 and 2 every 2 weeks. Results: A total of 488 courses of chemotherapy were administered. Responses were as follows: 3 complete responses (5.6%) and 24 partial responses (44.4%), giving an overall response rate of 50% (95% CI. 36% to 64%). Median time to progression and overall survival were 10.3 and 19.2 months, respectively. Grade 3-4 neutropoenia, leucopoenia, thrombocythopoenia and anaemia occurred in 33%, 9%, 2% and 2% of patients, respectively, while peripheral neuropathy occurred in 10% of patients. Conclusion: The fractionated bimonthly schedule of L-OHP plus de Gramont gave a less than anticipated neurological toxicity profile, while maintaining expected efficacy.
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