Objective: To compare the efficacy and safety of TOMOX and FOLFOX regimens for the treatment of advanced colorectal cancer. Methods: Electronic databases for randomized controlled trials comparing TOMOX and FOLFOX regimens for the treatment of advanced colorectal cancer were systematically searched using the following terms: "raltitrexed" or "Tomudex" or "TOMOX" and "fluorouracil" or "FOLFOX" and "advanced colorectal cancer" or "metastatic colorectal cancer". Conference proceedings and relevant journals were also screened. The outcomes included overall response rate, disease control rate, and toxicities. Results: Initial screening led to the selection of 19 studies, consisting of 1220 patients for the overall meta-analysis. The meta-analysis results showed that patients in TOMOX group had significantly higher overall response rate (RR 1.69, 95% CI 1.42-2.02, P<0.00001), disease control rate (RR 1.17, 95% CI 1.09-1.26, P<0.0001), partial response (RR 1.71, 95% CI 1.42-2.06, P<0.00001), and lower progressive disease (RR 0.59, 95% CI 0.48-0.72, P<0.00001) than those of FOLFOX group. The grade 1-2 toxicity analysis suggested that FOLFOX group had higher occurrence of nausea/vomiting, alopecia, diarrhea, mucositis and phlebitis, while TOMOX group had increased incidence of hepatic disorders. In addition, the grade 3-4 toxicity analysis revealed that FOLFOX group had significantly higher nausea/vomiting, while there were no statistically significant differences between the two groups for neutropenia, diarrhea, anemia, thrombocytopenia, peripheral neurotoxicity, asthenia, or hepatic disorders. Conclusion: TOMOX regimen is an effective and tolerable chemotherapy option for advanced colorectal cancer patients, particularly for those who cannot tolerate 5-Fu/capecitabine-based regimens.
