Elderly Patients Benefit From Second-Line Cytotoxic Chemotherapy: A Subset Analysis of a Randomized Phase III Trial of Pemetrexed Compared With Docetaxel in Patients With Previously Treated Advanced Non–Small-Cell Lung Cancer

Abstract

PURPOSE: Numerous prospective and retrospective studies have concluded that elderly patients (> or = 70 years old) achieve a similar survival benefit, with acceptable toxicity, from first-line cytotoxic chemotherapy for the treatment of advanced non-small-cell lung cancer (NSCLC) compared with their younger counterparts. However, few published data exist on the efficacy and tolerability of second-line cytotoxic therapy in this population. PATIENTS AND METHODS: Retrospective analysis of a large second-line trial was performed. Data from 571 patients randomly assigned to docetaxel 75 mg/m2 or pemetrexed 500 mg/m2 every 3 weeks were analyzed for efficacy and toxicity comparisons between age groups and treatment arms. RESULTS: Eighty-six of 571 patients (15%) were > or = 70 years old, similar to rates of elderly observed in the first-line setting. Elderly patients receiving pemetrexed (n = 47) or docetaxel (n = 39) had a median survival of 9.5 and 7.7 months compared with 7.8 and 8.0 months for younger patients receiving pemetrexed (n = 236) or docetaxel (n = 249), respectively. Elderly patients treated with pemetrexed had a longer time to progression and a longer survival than their counterpart patients treated with docetaxel (not statistically significant). Febrile neutropenia was less frequent in elderly patients treated with pemetrexed (2.5%) compared with docetaxel (19%; P = .025), with only one death as a result of toxicity (docetaxel arm). CONCLUSION: Elderly patient participation was similar to rates observed in the first-line setting. There was no significant difference in outcome or toxicity between elderly and younger patients. For elderly patients with advanced NSCLC and good performance status, second-line cytotoxic therapy is appropriate. In this subset, pemetrexed produced a more favorable toxicity profile.