Addition of Chemotherapy to Gefitinib in First-Line Treatment of Advanced NSCLC With EGFR Mutations

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In an updated analysis of the Japanese phase III NEJ009 trial reported in the Journal of Clinical Oncology, Miyauchi et al found that gefitinib plus carboplatin/pemetrexed was associated with prolonged progression-free survival and progression-free survival 2—but loss of significance in overall survival benefit—vs gefitinib alone in previously untreated patients with advanced non–small cell lung cancer (NSCLC) and EGFR mutations.

The initial report from the trial showed that gefitinib plus chemotherapy was associated with significantly improved progression-free survival and overall survival vs gefitinib alone.

Study Details

In the open-label multicenter trial, 242 patients were randomly assigned to receive gefitinib at 250 mg once daily (n = 172) or gefitinib combined with carboplatin/pemetrexed (GCP) in 3-week cycles for six cycles followed by concurrent gefitinib and pemetrexed maintenance. Approximately 80% of patients in both groups had stage IV disease.

Key Findings

Median follow-up for the current analysis was 84 months. Any subsequent second-line treatment after protocol treatment was received by 74% of the GCP group and 89% of the gefitinib group, with third-line treatment received by 52% and 66%; osimertinib was received by 22% and 23% of patients in any line of therapy.

Updated median progression-free survival was 32.5 months (95% confidence interval [CI] = 29.0–36.6 months) in the GCP group vs 20.7 months (95% CI = 17.9–24.6 months) in the gefitinib group (hazard ratio [HR] = 0.58, 95% CI = 0.46–0.73, P < .001). Median progression-free survival 2 was 20.9 months (95% CI = 18.0–24.0 months) in the GCP group vs 18.0 months (95% CI = 16.3–20.7 months) in the gefitinib group (HR = 0.77, 95% CI = 0.62–0.97, P = .027).

Updated median overall survival was 49.0 months (95% CI = 41.8–56.7 months) in the GCP group vs 38.5 months (95% CI = 31.1–47.1 months in the gefitinib group (HR = 0.82, 95% CI = 0.64–1.06, P = .127). Restricted mean survival time analysis showed benefits of GCP vs gefitinib in 5-year restricted mean survival time (43.6 vs 38.6 months, P = .017) and 7-year restricted mean survival time (51.6 vs 45.3 months, P = .037).

No severe adverse events occurred since the initial report.

The investigators concluded, “This updated analysis revealed that the GCP regimen improved progression-free survival and progression-free survival 2 with an acceptable safety profile compared with gefitinib alone. GCP is more efficient than gefitinib monotherapy as a first-line treatment for NSCLC with EGFR mutations.”

Eisaku Miyauchi, MD, PhD, of the Department of Respiratory Medicine, Tohoku University Hospital, Sendai, is the corresponding author for the Journal of Clinical Oncology article.  

Disclosure: The study was supported by the Japan Society for Promotion of Science and Japanese Foundation for the Multidisciplinary Treatment of Cancer. For full disclosures of the study authors, visit

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