Abstract
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 colorectal cancer (MCC). Survival evaluation was considered a secondary endpoint.
Patients and Methods: Forty-four patients were enrolled into this phase II trial. Treatment consisted of raltitrexed 3 mg/m2 iv on d 1 and oxaliplatin 70 mg/m2 iv on d 1 and d 8 every 3 wk.
Results: Twenty patients (45.5%) achieved a response [95% confidence interval (CI): 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% CI: 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.
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Santini, D., Massacesi, C., D’Angelillo, R.M. et al. Raltitrexed plus weekly oxaliplatin as first-line chemotherapy in metastatic colorectal cancer. Med Oncol 21, 59–66 (2004). https://doi.org/10.1385/MO:21:1:59
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DOI: https://doi.org/10.1385/MO:21:1:59