The following is a summary of “A Randomized Controlled Trial of Fluorouracil Plus Leucovorin, Irinotecan, and Oxaliplatin Combinations in Patients With Previously Untreated Metastatic Colorectal Cancer,” published in the July 2023 issue of Oncology by Goldberg, et al.

For a study, researchers sought to compare the activity and toxicity of three different two-drug combinations in patients with metastatic colorectal cancer who had not received prior treatment for advanced disease.

A total of 795 patients were randomly assigned to receive one of three treatment regimens between May 1999 and April 2001. The regimens included irinotecan and bolus fluorouracil plus leucovorin (IFL, control combination), oxaliplatin and infused fluorouracil plus leucovorin (FOLFOX), or irinotecan and oxaliplatin (IROX). The primary endpoint was time to progression, with secondary endpoints including response rate, survival time, and toxicity. Patient outcomes and adverse events were monitored throughout the study.

For patients receiving the FOLFOX regimen, the median time to progression was 8.7 months, the response rate was 45%, and the median survival time was 19.5 months. The results were significantly better than those observed in the IFL group (time to progression: 6.9 months, response rate: 31%, median survival time: 15.0 months) and the IROX group (time to progression: 6.5 months, response rate: 35%, median survival time: 17.4 months). The FOLFOX regimen also exhibited significantly lower rates of severe nausea, vomiting, diarrhea, febrile neutropenia, and dehydration than the other treatment regimens. However, sensory neuropathy and neutropenia were more common with regimens containing oxaliplatin.

The FOLFOX regimen, comprising oxaliplatin, infused fluorouracil, and leucovorin, demonstrated superior activity and a comparatively safer profile than the other two-drug combinations. Based on the findings, the FOLFOX regimen should be considered the standard therapy for previously untreated patients with advanced colorectal cancer.

Source: ascopubs.org/doi/full/10.1200/JCO.22.02759