Patients with untreated advanced NSCLC with EGFR mutations achieved improved progression-free survival with treatment with gefitinib and carboplatin plus pemetrexed compared with gefitinib alone.
The EGFR tyrosine kinase inhibitor gefitinib showed superiority over platinum-based regimens in the NEJ002 study for the treatment of advanced non–small-cell lung cancer (NSCLC) harboring activating EGFR mutations.1 NEJ009 was a randomized phase 3 study comparing the concurrent use of gefitinib + carboplatin + pemetrexed with gefitinib alone in the first-line treatment of patients with advanced NSCLC with EGFR mutations.2
A total of 345 patients with newly diagnosed metastatic, EGFR-mutated NSCLC were randomized to gefitinib 250 mg once daily with carboplatin (area under the curve 5) and pemetrexed (500 mg/m2) given in a 3-week cycle (N = 172) or gefitinib 250 mg once daily alone (N = 173).2 The primary end points were progression-free survival (PFS), PFS2 (defined as the period from randomization to disease progression on the second-line therapy or death), and overall survival (OS). Secondary end points included objective response rate (ORR), safety, and quality of life.2
The median PFS was 20.9 months in patients who received the combination treatment versus 11.2 months in those who received gefitinib alone (hazard ratio [HR], 0.49; P <.001).2 The median PFS2 did not significantly differ between the groups (20.9 months vs 18.0 months; HR, 0.99; P = .092). The ORR was also higher in the combination treatment group compared with the gefitinib group (84% vs 67%; P <.001). With a median follow-up of 45 months, the median OS was 50.9 months in patients who received the combination treatment versus 38.8 months in those who received gefitinib alone (HR, 0.72; P = .021).2
Similar percentages of patients in the 2 groups received osimertinib post-treatment (21.8% in the combination group and 23.3% of patients in the gefitinib group).2 Among these patients, median OS was not reached in the combination group and was 74.4 months in the gefitinib group. For those who did not receive osimertinib post-treatment, median OS was 43.8 months in the combination group and 29.8 months in the gefitinib group.2
Treatment-related adverse events of grade ≥3 were more common in the combination group compared with the gefitinib group (65.3% vs 31.0%) and included neutropenia (31.2% vs 0.6%), anemia (21.2% vs 2.3%), and thrombocytopenia (17.1% vs 0%).2 More patients in the gefitinib group than in the combination group experienced grade ≥3 liver toxicity (22.2% vs 12.4%). The rate of treatment discontinuation was similar in the 2 groups (combination, 10.7%; gefitinib, 9.9%). One treatment-related death was reported in the combination group. The study results showed no differences in quality of life between the groups.2
The researchers concluded that combination treatment with gefitinib and carboplatin plus pemetrexed improved PFS compared with gefitinib alone in patients with untreated advanced NSCLC with EGFR mutations.2
References 1. Miyauchi E, et al. Jpn J Clin Oncol. 2015;45:670-676. 2. Hosomi Y, et al. J Clin Oncol. 2020;38:115-123.
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