Introduction In Cuba, colorectal cancer (CRC) is the malignant neoplasm with the fourth-highest incidence and third-highest mortality. Over one-third of CRC patients exhibit metastatic disease at the time of diagnosis. Standard treatment for metastatic CRC is a 5-fluorouracil (5-FU) + Folinic Acid (FA) continuous infusion regimen. International studies have shown, however, that systemic therapy using oxaliplatin combined with 5-FU and FA (FOLFOX-4) improves results in terms of both tumor response and survival in patients with inoperable metastatic CRC.

Objective Evaluate the FOLFOX-4 regimen as a first-line therapy for patients with inoperable metastatic CRC in Cuba. 

Methods FOLFOX-4 therapy was administered to 56 patients with metastatic CRC, in a treatment cycle repeated every 2 weeks for 6–8 cycles. Patients were followed up for a period of 2 years.

Results Objective response was attained in 44.6% of patients, and complete response in 12.5%. Median duration of response and of progression-free survival was 9.6 and 8.9 months, respectively. Estimated survival at 2 years was 17% (95% CI: 6.89–26.8). The most frequent adverse events were nausea, vomiting, diarrhea and neutropenia, the majority grade 1–2, according to Common Terminology Criteria for Adverse Events (CTCAE) classification.

Conclusions In patients studied, the FOLFOX-4 combination was shown to be an effective and well-tolerated therapeutic option for treating inoperable metastatic colorectal cancer.

Keywords FOLFOX, antineoplastic combined chemotherapy protocols, anticancer drug combinations, antineoplastic agents, polychemotherapy, colorectal neoplasms, colorectal cancer, neoplasm metastasis, neoplasm invasiveness