Raltitrexed plus weekly oxaliplatin as first-line chemotherapy in metastatic colorectal cancer - A multicenter non-randomized phase II study

Aim: The primary aims of this study were activity and toxicity evaluation of a new raltitrexed and oxaliplatin-based regimen, as a first-line chemotherapy, in patients with metastatic colorcctal cancer (MCC). Survival evaluation was considered a secondary endpoint. Patients and Methods: Forty-four patients were enrolled into this phase 11 trial. Treatment consisted of raltitrexed 3 mg/m(2) iv on d 1 and oxaliplatin 70 mg/m(2) iv on d I and d 8 every 3 wk. Results: Twenty patients (45.5%) achieved a response [95% confidence interval (Cl): 30.1% to 54.1%], 18 (40.9%) had stable disease, and only 6 (13.6%) developed progressive disease. After a median follow-up time of 14.7 mo (range 6.3-18.6 mo), the median time to disease progression was 6 mo (range 2.0-16.7) (95% Cl: 4.4-7.6) and the overall survival was 14.8 mo (range 3-23) (95% CI: 11.2-18.4). Neutropenia was the most common hematological side effect, while transient AST/ALT increase, neurotoxicity, asthenia, and diarrhea were the most common nonhematological side effects. Conclusions: Our data confirmed that oxaliplatin administered weekly plus raltitrexed is an active combination in newly diagnosed patients with advanced colorectal carcinoma that merits further investigation versus the classic schedule in a randomized, phase III trial.