EMERGING-CTONG 1103 Trial: Neoadjuvant Erlotinib in EGFR-Mutant Lung Cancer
Posted: Wednesday, August 21, 2019
Although the primary endpoint of the phase II EMERGING-CTOG 1103 trial was not reached, the use of neoadjuvant and adjuvant therapies with erlotinib may offer benefits in patients with locally advanced EGFR-mutant–positive non-small cell lung cancer (NSCLC) compared with gemcitabine plus cisplatin chemotherapy, according to the report published in the Journal of Clinical Oncology. Objective response rates for neoadjuvant and adjuvant erlotinib therapies were numerically higher than those for gemcitabine plus cisplatin, although not statistically relevant, concluded Wen-Zhao Zhong, MD, of the Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China, and colleagues. However, progression-free survival in patients was found to be “significantly prolonged” in patients treated with erlotinib.
In this open-label, controlled trial, the investigators enrolled 72 patients from 17 centers across China. Patients had been diagnosed with stage IIIA–N2 NSCLC with EGFR mutations in exon 19 or 21. The authors randomly assigned patients to receive 150 mg/d of erlotinib either adjuvantly or neoadjuvantly (37 patients). The other cohort of patients received 1,250 mg/m2 of gemcitabine plus 75 mg/m2 of cisplatin adjuvantly or neoadjuvantly (34 patients).
The investigators found that the objective response rate for patients treated with neoadjuvant erlotinib compared with gemcitabine plus cisplatin was 54.1% versus 34.3%, respectively, with no pathologic complete responses identified in either cohort. No patients treated with gemcitabine plus cisplatin experienced a major pathologic response, whereas three patients treated with erlotinib did.
The median progression-free survival—a secondary endpoint—for patients who received erlotinib was 21.5 months compared with 11.4 months in the gemcitabine-plus-cisplatin group.
Disclosure: The study authors’ disclosure information may be found at ascopubs.org.