Both pemetrexed (Alimta) and gefitinib (Iressa) are standard second-line treatments for advanced nonsquamous non–small cell lung cancer (NSCLC) in East Asia. In a phase II trial (CTONG 0806) reported at the International Association for the Study of Lung Cancer’s 15th World Conference on Lung Cancer, Qing Zhou, MD, of Guangdong Lung Cancer Institute in China, and colleagues evaluated the efficacy of pemetrexed vs gefitinib as second-line treatment in advanced nonsquamous NSCLC with wild-type EGFR (Abstract O15.07).
This multicenter, randomized, controlled, open-label study enrolled 157 patients with locally advanced or metastatic nonsquamous NSCLC from February 2009 to August 2012. The patients had previously been treated with platinum-based chemotherapy and had wild-type EGFR. Patients were randomly assigned to receive oral gefitinib or intravenous pemetrexed until disease progression or unacceptable toxicity. The primary endpoint of the study was progression-free survival.
The median progression-free survival for patients in the pemetrexed arm was 4.8 months vs 1.6 months in the gefitinib arm (hazard ratio = 0.54, 95% confidence interval = 0.40–0.75, P < .001). A significant difference between the two arms in 4-month progression-free survival (59% vs 33% for pemetrexed vs gefitinib, respectively), 6-month progression-free survival (43% vs 23%), and disease-control rate (60.5% vs 29.6%) was also observed. A trend toward improved overall survival was seen in the pemetrexed arm (12.4 vs 9.6 months).
This is the first study to show significant improvement in progression-free survival, disease-control rate, and a trend of improving overall survival with pemetrexed compared with gefitinib in the second-line setting for patients in this population. “This study will likely change the way patients with advanced nonsquamous NSCLC are treated with second-line therapy,” said Dr. Zhou. ■
Disclosure: Dr. Zhou reported no potential conflicts of interest.
1. Zhou Q, Cheng Y, Zhao MF, et al: Final results of CTONG 0806: A phase II trial comparing pemetrexed with gefitinib as second-line treatment of advanced non-squamous NSCLC patients with wild-type EGFR. Abstract O15.07. Presented at the 15th World Conference on Lung Cancer, Sydney, Australia, October 29, 2013.