East Asian patients with advanced nonsquamous non-small cell lung cancer (NSCLC) and epidermal growth factor receptor mutations may benefit from treatment with pemetrexed plus gefitinib, results from a phase II randomized trial show.
Nearly 200 patients with chemotherapy-naïve NSCLC from 35 sites in China, Japan, Korea, and Taiwan were included in the trial and randomly assigned to receive pemetrexed plus gefitinib (n=129) or gefitinib alone (n=66). The primary endpoint was progression-free survival, though investigators also looked at progressive disease, overall survival, tumor response rate, duration of response, and safety. Results were published in the Journal of Clinical Oncology.
-----
Related Content
Head-to-Head Trial Compares Outcomes With EGFR+ NSCLC Treatments
Class of lung cancer drugs associated with toxic skin effects
-----
Overall, progression-free survival was significantly longer in patients treated with pemetrexed plus gefitinib (median, 15.9 months to 18.3 months) compared with gefitinib alone (10.9 months to 13.8 months). Subgroup analysis of EGFR exon 19 and EGFR exon 21 L858R produced similar results to those found in the intent-to-treat groups.
Treatment with pemetrexed plus gefitinib also performed better than gefitinib alone in regards to secondary objects as well, resulting in significantly longer time to progressive disease (median 16.2 months vs 10.9 months, respectively) and a numerically longer duration of response (median 15.4 months vs 11.3 months, respectively). However, tumor response rates did not differ and overall survival data were immature. Further, treatment-related, grade 3 or 4 adverse events were more common in those treated with pemetrexed plus gefitinib, although toxicities were manageable.
From these results, investigators, led by James Chih-Hsin Yang, MD, PhD, National Taiwan University Hospital (Taipei, Taiwan), concluded that pemetrexed plus gefitinib improved progression-free survival compared with gefitinib alone in East Asian patients with advanced nonsquamous non-small cell lung cancer and activating EGFR mutations. They added that this combination could also be beneficial for other EGFR-positive patients compared with current standards of care.
