High-dose intensity oxaliplatin added to the simplified bimonthly leucovorin and 5-fluorouracil regimen as second-line therapy for metastatic colorectal cancer (FOLFOX 7)

This phase II study examined a regimen (FOLFOX7) of leucovorin (LV), high-dose intensity oxaliplatin. and 5-fluorouracil (5-FU). as second-line therapy for metastatic colorectal cancer. 48 patients were enrolled 36 refractory and 12 resistant to prior therapy with LV 5-FU. Oxaliplatin (130 mg/m(2)) was infused with LV (400 mg/m(2)) over 2 h on day 1, followed by bolus 400 mg/m(2) and a 46-h infusion (2400 g/m(2)) of 5-FU, every 2 weeks. Patients who responded or were stable received eight cycles. Patients were evaluated every 2 months. 20 patients (42%) had partial responses (95% confidence interval(CI): 28-56%), 19 (40%) had stable disease and 9 (19%) progressed. Median progression-free survival (PFS) was 6 months and median survival 16.1 months. Toxic effects of National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade 3/4 were: peripheral neuropathy 15%, nausea 8%, diarrhoea 11%. neutropenia 9%. thrombocytopenia 11%. Overall. 38% of patients experienced grade 3/4 toxicities, and 64% received 90% or more of the scheduled oxaliplatin dose intensity during the first four cycles. FOLFOX7 was highly active, with good tolerability, in pretreated patients resistant to LV-5-FU, (C) 2001 Elsevier Science Ltd. All rights reserved.