Yue D, et al. -Researchers gauged if 2-year disease-free survival was improved by adjuvant erlotinib therapy vs chemotherapy in epidermal growth factor receptor (EGFR) mutation-positive stage IIIA non-small-cell lung cancer (NSCLC). In patients with EGFR mutation-positive stage IIIA NSCLC, compared with chemotherapy, 2-year disease-free survival was seen to improve with adjuvant erlotinib, and had a better tolerability profile. Findings suggested a potentially vital role of tyrosine kinase inhibitors as adjuvant therapy in EGFR mutation-positive stage IIIA NSCLC.

Methods

• Experts conducted a randomized, open-label, phase 2 trial and enrolled patients aged 18-75 years who had undergone complete (R0) resection of histologically or pathologically confirmed stage IIIA EGFR mutation-positive NSCLC and had not received any previous anticancer therapies.
• They randomly assigned (1:1) patients to receive either adjuvant erlotinib (150 mg once daily administered orally) or vinorelbine and cisplatin chemotherapy (four cycles of vinorelbine [25 mg/m²intravenously on days 1 and 8 of each 21-day cycle] plus cisplatin [75 mg/m² intravenously on day 1 of each 21-day cycle]).
• Randomization was by Simon's minimization with a random element and stratified it by EGFR activating mutation type (exon 19 vs 21), histology (adenocarcinoma vs non-adenocarcinoma), and smoking status (smoker vs non-smoker).
• Two-year disease-free survival was the primary endpoint in the unblinded intention-to-treat analysis.

Results

• As per data, 102 patients from 16 centers across China were enrolled and randomly assigned to receive erlotinib (n=51) or chemotherapy (n=51) between September 8, 2012 and May 21, 2015.
• According to results, 33.0 months was the median follow-up (IQR 17.8–43.1).
• In the erlotinib group, 2-year disease-free survival was 81.4% (95% CI 69.6–93.1) and in the chemotherapy group it was 44.6% (26.9-62.4) (relative risk 1.823 [95% CI 1.194-2.784; p=0.0054); 36.7% was the the difference in 2-year disease-free survival between the groups (95% CI 15.5–58.0; p=0.0007).
• In 29 (58%) of 50 patients in the erlotinib group and 28 (65%) of 43 patients in the chemotherapy group, occurrence of adverse events of any grade was noted.
• In the erlotinib group, 6 (12%) of 50 patients demonstrated grade 3 or worse adverse events vs 11 (26%) of 43 in the chemotherapy group; the most common of these in the erlotinib group was rash (in two [4%] of 50 patients) and in the chemotherapy group were decreased neutrophil count (in seven [16%] of 43 patients) and myelosuppression (in four [9%]). No treatment-related deaths were reported
• Results did not reveal any treatment-related deaths.