Summary
The FLEX trial, a randomized phase 3 study comparing cisplatin-vinorelbine versus the same regimen plus cetuximab, recently showed that the addition of the monoclonal antibody to chemotherapy significantly prolong survival in chemonaive NSCLC. Several aspects could limit the wide use of cetuximab.
Analysis
A recent study, the flex trial, showed a significant benefit in terms of survival for NSCLC patients receiving cetuximab plus chemotherapy compared with chemotherapy alone. Nevertheless, the benefit in terms of reduction in the risk of death was marginal, there is a possible confounding effect of second-line treatments, and side effects, particularly neutropenia, were significantly higher in the cetuximab arm. These aspects, together with the high cost of the drug, represent potential limitations for the use of this agent against NSCLC. Based on presented data, the use of this agent, in combination with cisplatin and vinorelbine, could be considered as an option in patients with squamous histology, with good performance status, with predictors of cetuximab sensitivity (EGFR FISH positive, KRAS wild type).


