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EGFR inhibitors are being explored as adjuvant therapies for patients with resected non-small cell lung cancer (NSCLC), as a result of the efficacy seen with these agents in the metastatic setting. However, there is not currently enough evidence to support the use of EGFR inhibitors in this setting, notes Mark A. Socinski, MD. At this point, adjuvant platinum-based chemotherapy appears to be the most effective option.
The phase III National Cancer Institute of Canada BR.19 study explored adjuvant gefitinib in comparison with placebo for patients with completely resected stage IB, II, or IIIA NSCLC. This study was stopped early due to futility. In the 15 patients with EGFR mutations enrolled in the study, the hazard ratio (HR) for disease-free survival was 1.84 and the HR for overall survival was 3.16. Neither data point was statistically significant. These results suggest patients are unlikely to benefit from adjuvant EGFR inhibition, Socinski suggests.
The BR.19 study was flawed and contained a small number of patients with EGFR mutations, Heather A. Wakelee, MD, believes. To further address the question, the phase III RADIANT trial will compare adjuvant erlotinib to placebo in 975 patients with resected NSCLC who harbor EGFR mutations that are confirmed by either IHC or FISH. This study will allow patients to receive up to 4 cycles of platinum-based adjuvant chemotherapy prior to randomization.
The five-year survival rate for patients with stage II resected NSCLC who receive adjuvant chemotherapy is 35% to 45%, warranting the continued investigation of novel adjuvant treatment strategies, notes Benjamin P. Levy, MD. The ALCHEMIST trial will explore tumor samples from thousands of patients following the complete resection of NSCLC in order to identify patients with an EGFR or ALK mutations. Following identification, patients will be followed as they receive treatment, in order to simultaneously assess long-term outcomes for various therapies.