Cisplatin-based chemotherapy plus concurrent radiotherapy (RT) represent the current standard for unresectable, locally advanced NSCLC, but long-term overall survival (OS) in these patients is poor. The IFCT-0803 trial aimed to evaluate the benefit of adding cetuximab to a combination of chemotherapy with cisplatin and pemetrexed plus RT for patients with Stage III, inoperable nonsquamous (NS)-NSCLC (Tredaniel J, et al. ASCO 2014. Abstract 7511). Of 106 patients accrued to the study, 99 were considered eligible and received thoracic RT (66 Gy) along with cisplatin + pemetrexed for 4 cycles and weekly cetuximab. At 16 weeks of follow-up, 62% of the treated patients showed a complete or partial response, and 28% had stable disease. Disease control was achieved in 90% of the patients, with progressive disease noted in 3%. The median progression-free survival was 13.8 months, but OS was not reported in the study. Toxicity due to therapy was primarily hematologic and Grade 1 or 2, but late Grade 1/2 esophageal toxicity was noted in 51% of patients. Radiation pneumonitis (Grade 1/2) was observed in only 4% of patients, with no Grade 3 and only 1 Grade 4 events. This study demonstrated the feasibility and high disease control rate for the combination of chemotherapy + RT + cetuximab and may become a reasonable option in unresectable Stage III NS-NSCLC.
