A phase III study showed that progression-free survival was significantly prolonged with continuation maintenance with gemcitabine or switch maintenance with erlotinib (Tarceva) compared with observation in patients with advanced non–small cell lung cancer (NSCLC) who received first-line treatment with cisplatin/gemcitabine. Median progression-free survival was 1.9 months for observation patients vs 3.8 months for patients receiving gemcitabine and 2.9 months for those receiving erlotinib. The improved duration in disease control was consistent irrespective of gender, smoking status, and response to induction therapy.
Trial Design
The study involved 464 patients with stage IIIB/IV NSCLC who were enrolled in 73 centers in France and did not have tumor progression after four cycles of cisplatin-gemcitabine. “Maintenance gemcitabine and erlotinib were well tolerated with no unexpected adverse events,” researchers reported in the Journal of Clinical Oncology.
“Both maintenance strategies resulted in a nonsignificant improvement in overall survival,” the investigators stated. Patients who received the predefined second-line therapy with pemetrexed or who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 “appeared to derive greater benefit,” the authors added. Exploratory subgroup analysis suggested gemcitabine maintenance therapy might have an overall survival benefit for patients with an objective response to induction chemotherapy, but not those who had stable disease. ■
Pérol M, et al: J Clin Oncol. September 4, 2012 (early release online).
