Factors predicting for efficacy of oxaliplatin in combination with 5-fluorouracil (5-FU)+/- folinic acid (FA) in a compassionate-use cohort of 370 5-FU-resistant advanced colorectal cancer (CRC) patients

Univariate and multivariate analyses were performed on data from 370 5-fluo rouracil (5-FU)-resistant advanced colorectal cancer patients treated with oxaliplatin (Eloxatin(R))/5-FU+/-folinic acid (FA) to identify prognostic f actors for oxaliplatin-based treatment. The response rate was 14.6% (95% co nfidence interval (CT): 11.0-18.2%), median time to progression was 4.3 mon ths (95% CI, 3.9-4.7), and median overall survival 9.7 months (95% CT: 8.5- 10.8). Multivariate analysis indicated <2 prior chemotherapy regimens, bi-w eekly treatment administration schedule (versus tri-weekly) and continuous chronomodulated delivery (CCM) as significantly associated (P < 0.05) with a higher overall response rate. Performance status (PS) <2, having only one involved organ, biweekly schedule and CCM were associated (P<0.05) with a longer time to progression. Good PS, one involved organ, low alkaline phosp hatase (AP) serum levels, bi-weekly schedule and CGM were significantly cor related with longer overall survival, while confirming the efficacy of oxal iplatin/5-FU+/-FA in this indication. (C) 2000 Elsevier Science Ltd. All ri ghts reserved.