Non-Small Cell Lung Cancer Coverage from Every Angle

Gefitinib Alone and in Combination for Untreated EGFR-Mutated Lung Cancer

By: Kelly M. Hennessey, PhD
Posted: Monday, February 3, 2020

The EGFR tyrosine kinase inhibitor gefitinib combined with chemotherapy improved progression-free survival over gefitinib alone in patients with untreated EGFR-mutated non–small cell lung cancer (NSCLC), according to the findings of the phase II NEJ009 trial, published in the Journal of Clinical Oncology. However, whether the combination offers an overall survival benefit requires further validation.

A recent study by Yukio Hosomi, MD, PhD, of Tokyo Metropolitan Komagome Hospital, Japan, and colleagues compared the efficacy and safety of a concurrent regimen of gefitinib and carboplatin plus pemetrexed with the standard EGFR tyrosine kinase inhibitor monotherapy in untreated patients with EGFR-mutated NSCLC. In this study, 345 patients from 47 institutions in Japan were randomly assigned to two groups: 173 were assigned to gefitinib and 172, to gefitinib plus chemotherapy. A total of 22% of study patients received the third-generation EGFR tyrosine kinase inhibitor osimertinib after initial treatment with a tyrosine kinase inhibitor.

In the gefitinib group, 67% of patients had an objective response, 3% achieved a complete response, and 64% had a partial response. The gefitinib-plus-chemotherapy group had an 84% objective response rate, a 4% complete response rate, and a 79% partial response rate. Progression-free survival was significantly longer with gefitinib plus chemotherapy than with gefitinib alone (median, 20.9 months vs. 11.2 months, respectively.) The reported median overall survival in the combination-therapy group was longer than in the gefitinib group (50.9 vs. 38.8 months), although the authors noted “the interpretation of the overall survival results needs to take into account the multiple comparisons issue.”

“Although its overall survival benefit requires further validation, the gefitinib plus chemotherapy regimen improved progression-free survival with an acceptable safety profile and a similar quality of life profile compared with gefitinib alone,” concluded Dr. Hosomi and colleagues.

Disclosure: The study authors’ disclosure can be found at

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