Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) as First-line Treatment for Metastatic Colorectal Cancer
Survival of patients with metastatic colorectal cancer is correlated with the proportion of
patients who receive all the three active drugs in the course of the disease, but not with
the proportion of patients who receive any second-line therapy. In a sequential strategy,
not all patients who progress after first-line chemotherapy are able to receive second-line
treatment. Moreover, there is a correlation between the response rate to chemotherapy and
the postchemotherapy radical resection rate of metastases.
Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to
administer a first-line regimen containing the three active agents.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (RR)
Responses are evaluated every 8 weeks according to WHO criteria. The determination of responses and progression was initially based on investigator-reported measurements; computed tomography scans of all responding patients and of patients with stable disease were subsequently subjected to external review by an independent panel.
Responses are evaluated every 8 weeks according to WHO criteria and reviewed by an independent panel at the end of treatment (6 months)
Alfredo Falcone, MD
University of Pisa
Italy: The Italian Medicines Agency