Gefitinib With or Without Chemotherapy in NSCLC

In the recent GAP BRAIN trial, researchers evaluated gefitinib, a tyrosine kinase inhibitor (TKI), with or without chemotherapy in treatment-naïve patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with brain metastases.

Based on their findings, the study’s lead author, Xue Hou, reported that gefitinib combined with chemotherapy of pemetrexed and platinum significantly improved intracranial progression-free survival (PFS), PFS, and overall survival (OS) compared with gefitinib alone. The data were published in JAMA Network Open.

Adjunct Chemotherapy Improves EGFR-Mutated NSCLC Survival

This was an open-label, multicenter, phase 3 randomized controlled trial which enrolled 161 prospective patients (54% female) with a mean age of 55±9.8 years (range, 26-80). Between January 2016 to August 2021, 80 patients received gefitinib with chemotherapy and 81 received gefitinib monotherapy.

The primary end point of the study was intracranial PFS, and secondary end points included PFS, OS, intracranial objective response rate, overall objective response rate, and safety.

After a median follow-up time of 21.1 months (interquartile range, 13.5-31.8), the authors noted patients in the gefitinib plus chemotherapy group had a median intracranial PFS of 15.6 months (95% CI, 14.3-16.9) compared with a median of 9.1 months (95% CI, 8.0-10.2) in the gefitinib monotherapy group (hazard ratio, 0.36; 95% CI, 0.23-0.53; P<.001).

In addition, the gefitinib plus chemotherapy had a longer median PFS compared with the gefitinib monotherapy group at 16.3 months (95% CI, 14.4-18.2) versus 9.5 months (95% CI, 8.3-10.8; P<.001), respectively. The combined therapy group had an intracranial objective response rate of 85.0% (95% CI, 77.0-93.0) compared with 63% (95% CI, 52.2-73.7; P=.002) in the monotherapy group.

Ultimately, the authors summarized that “gefitinib plus chemotherapy significantly improved intracranial PFS, PFS, and OS compared with gefitinib alone in patients with untreated EGFR-mutant NSCLC brain metastases and could be an optional first-line treatment for these patients.”

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