A comparative effectiveness study found adjuvant treatment with a tyrosine kinase inhibitor (TKI) to be more effective than the standard of care for resected stage II-IIIA non-small cell lung cancer (NSCLC).
Results of the study were published in The Lancet Oncology (online November 21, 2017; doi:10.1016/S1470-2045(17)30729-5).
The current standard of care for patients with resected stage II-IIIA NSCLC is cisplatin-based adjuvant chemotherapy. However, recent research suggests that patients with EGFR-mutant stage IB-IIIA resected disease may benefit form adjuvant EGFR TKI therapy.
Yi-Long Wu, MD, Guangdong Lung Cancer Institute (China), and colleagues conducted a study to compare the efficacy of adjuvant gefitinib vs vinorelbine plus cisplatin in patients with resected EGFR-mutant stage II-IIIA NSCLC. The randomized, open-label, phase III trial enrolled 222 patients (1:1) to receive either gefitinib (250 mg once daily) for 24 months or vinorelbine (25 mg/m2 on days 1 and 8) plus cisplatin (75 mg/m2 on day 1) every 3 weeks for four cycles.
The primary endpoint of the study was disease-free survival in the intention-to-treat population.
After a median follow-up of 36.5 months, the median disease-free survival was significantly longer for patients in the gefitinib arm (28.7 months, 95% CI, 24.9-32.5) than for those in the vinorelbine plus cisplatin arm (18.0 months; HR, 0.60; 95% CI, 0.42-0.87; P = .0054).
Among patients in the safety population, the most common grade 3 or worse adverse events were raised alanine aminotransferase and asparate aminotransferase in the gefitinib arm, as well as neutropenia, leucopenia, and vomiting in the vinorelbine plus cisplatin arm. Serious adverse events were reported for 7% (n = 7) of patients in the gefitinib arm and 23% (n = 20) of patients in the vinorelbine plus cisplatin arm.
“Based on the superior disease-free survival, reduced toxicity, and improved quality of life, adjuvant gefitinib could be a potential treatment option compared with adjuvant chemotherapy in these patients,” authors of the study concluded. They acknowledged, however, that the duration of benefit with gefitinib after 24 months might be limited and overall survival data are not yet mature, prompting further research.—Zachary Bessette