A randomized phase II study to compare oxaliplatin plus 5-fluorouracil and leucovorin (FOLFOX4) versus oxaliplatin plus raltitrexed (TOMOX) as first-line chemotherapy for advanced colorectal cancer
Clinical and Translational Oncology, 07/23/2012
Gravalos C et al. – TOMOX and FOLFOX4 seem to have similar efficacy and are well tolerated in the first–line treatment for advanced colorectal cancer (CRC) with different profiles of toxicity. The convenient TOMOX regimen may offer an alternative to fluoropyrimidine–based regimens.Methods
- 191 chemotherapy-naïve patients were randomized to receive TOMOX or FOLFOX4.
- Patients were evaluated every 3months and chemotherapy was continued until disease progression or unacceptable toxicity.
- Overall response rate was the primary endpoint.
- 183 patients were included in the intent-to-treat analysis (92 TOMOX and 91 FOLFOX4).
- Overall response rate was 45.6 and 36.3 % (p=0.003) for TOMOX and FOLFOX4, respectively.
- No statistically significant differences were observed in overall survival (15.6 and 17.2 months; p=0.475); progression-free survival (7.7 and 8.7months; p=0.292), and response duration (6.4 and 7.6months; p=0.372) for TOMOX and FOLFOX4, respectively.
- Grades 3 and 4 neutropenia (p<0.0001) and leukopenia (p=0.028) were more common with the FOLFOX4 regimen, while hepatic disorders and asthenia were higher in TOMOX group (p=ns).
- There were two treatment-related deaths in the FOLFOX4 arm and one in the TOMOX arm.
- Quality of life analysis based on the SF-36 revealed differences between the two regimens for physical and mental composite scores after 6 weeks, and for body pain and emotional role functioning after 6 and 12weeks; all of these favored the FOLFOX4 arm (p≤0.05).