The addition of pemetrexed to gefitinib improved progression-free survival (PFS) for patients with advanced, non-squamous, EGFR mutation-positive non-small cell lung cancer (NSCLC), a study published in the Journal of Clinical Oncology has shown.1
For this open-label study, researchers enrolled 195 chemotherapy-naive patients from 25 sites in China, Japan, Korea, and Taiwan. Participants were randomly assigned 2:1 to receive pemetrexed plus gefitinib or gefitinib alone.
Median PFS was 15.8 months with the combination, compared with 10.9 months with gefitinib alone (adjusted hazard ratio [aHR], 0.68; 95% CI, 0.48-0.96; P = .029).
Adding pemetrexed to gefitinib was associated with a longer time to disease progression (16.2 versus 10.9 months; HR, 0.66; 95% CI, 0.47-0.93) and a longer duration of response (15.4 versus 11.3 months; HR, 0.74; 95% CI, 0.50-1.08), than with gefitinib alone.
There was no significant difference in the tumor response rates between the 2 treatment arms; overall survival data are not yet reported.
Patients who received gefitinib with pemetrexed were more likely to experience treatment-related grade 3 to 4 adverse events, though the toxicities were manageable.
- Cheng Y, Murakami H, Yang PC, et al. Randomized phase II trial of gefitinib with and without pemetrexed as first-line therapy in patients with advanced nonsquamous non–small-cell lung cancer with activating epidermal growth factor receptor mutations. J Clin Oncol. 2016 Aug 8. doi: 10.1200/JCO.2016.66.9218 [Epub ahead of print]