, suggests the Chinese Thoracic Oncology Group’s EMERGING trial.
Investigators led by Wen-Zhao Zhong, MD, a professor at Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China, enrolled 72 patients with stage IIIA-N2 EGFR-mutant NSCLC in the phase 2 randomized controlled trial. The patients were randomized to receive either erlotinib, an EGFR tyrosine kinase inhibitor (TKI), or the chemotherapy doublet of gemcitabine (Gemzar) and cisplatin as both neoadjuvant and adjuvant therapy.
Results reported in the Journal of Clinical Oncology showed that the objective response rate was 54.1% with neoadjuvant erlotinib (median, 42 days of therapy) versus 34.3% with neoadjuvant chemotherapy (with most patients receiving two cycles). However, the difference was not significant (odds ratio, 2.26; P = .092).
None of the patients in either arm achieved a pathologic complete response, but 9.7% in the erlotinib arm achieved a major pathologic response (less than 10% residual viable tumor cells) versus none of those in the chemotherapy arm.
With a median follow-up of 14.1 months, median progression-free survival was 21.5 months with erlotinib, nearly double the 11.4 months seen with chemotherapy (hazard ratio for events, 0.39; P less than .001). Overall survival did not differ significantly but was immature at the time of analysis.
Adverse events were largely as expected for each therapy. Incidence of grade 3 or 4 adverse events was 0% with erlotinib versus 29.4% with chemotherapy.
“These results suggest that biomarker-guided neoadjuvant/adjuvant EGFR-TKI treatment strategies in stage IIIA-N2 NSCLC are promising,” Dr. Zhong and colleagues wrote. “Our promising findings warrant additional investigation.”
“The optimal duration of neoadjuvant TKI also warrants additional investigation to validate the role of perioperative TKI therapy in oncogene-driven NSCLC,” they concluded. “Future studies should investigate the translational value of sequential plasma and tissue samples in a neoadjuvant setting using multiomics-based assays to identify predictive characteristics of patients who would benefit from neoadjuvant targeted therapies and predict prognosis.”
Dr. Zhong disclosed receiving honoraria from AstraZeneca, Eli Lilly, Pfizer, Roche, and Sanofi. The trial was supported by the Chinese Thoracic Oncology Group and Shanghai Roche Pharmaceutical.
SOURCE: Zhong W-Z et al. J Clin Oncol. 2019 June 13. doi: 10.1200/JCO.19.00075.