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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

Glen J. Weiss, Corey Langer, Rafael Rosell, Nasser Hanna, Frances Shepherd, Lawrence H. Einhorn, Binh Nguyen, Sofia Paul, Patrick McAndrews, Paul A. Bunn, Jr, Karen Kelly

From the University of Colorado Health Sciences Center, Division of Medical Oncology Center, Aurora, CO; Fox Chase Cancer Center, Philadelphia, PA; Catalan Institute of Oncology, Barcelona, Spain; Indiana University Medical Center; Eli Lilly and Co, Indianapolis, IN; and the Princess Margaret Hospital, Toronto, Ontario, Canada

Address reprint requests to Karen Kelly, MD, University of Colorado Health Sciences Center, Division of Medical Oncology Center, Aurora, CO 80010; e-mail: Karen.Kelly{at}uchsc.edu

PURPOSE: Numerous prospective and retrospective studies have concluded that elderly patients ( 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 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.

Supported by a grant from Eli Lilly and Co, Indianapolis, IN.

Presented in part at the 11th World Conference on Lung Cancer, Barcelona, Spain, July 3-6, 2005.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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