Pemetrexed Therapy in Elderly Patients With Good Performance Status: Analysis of Two Phase III Trials of Patients With Nonsquamous Non-Small-Cell Lung Cancer

The efficacy and safety of pemetrexed treatment was evaluated in elderly patients with nonsquamous advanced non-small-cell lung cancer and a performance status of 0-1. Data from 2 large randomized studies were retrospectively analyzed for patients aged < 65 years, >= 65 years and < 70 years, >= 70 years. Safety and efficacy were similar between older and younger groups. Pemetrexed (first-line treatment combined with cisplatin or as maintenance therapy) is a viable treatment option for these patients. Introduction: A widely held misperception contends that all elderly patients, even those with good performance status (PS 0-1), are unable to tolerate aggressive chemotherapy. The objective of these analyses was to evaluate the survival and safety of treatment with pemetrexed in elderly patients with nonsquamous non-small-cell lung cancer (NSCLC) and PS 0-1. Patients and Methods: Two randomized studies, 1 reporting the activity of pemetrexed in combination with cisplatin vs. cisplatin and gemcitabine in chemotherapy-naive patients (N = 1725) and another comparing single-agent pemetrexed with placebo in the maintenance setting (N = 663) were retrospectively considered. Data from patients with nonsquamous advanced NSCLC with PS 0-1 in these studies were evaluated in 2 separate dichotomous analyses (< 65 years and >= 65 years and < 70 years and >= 70). Cox proportional hazard models were used to estimate covariate-adjusted between-arm hazard ratios (HRs) with 95% confidence intervals for each age group. Results: In the first-line study, 32.7% of the 1252 patients with nonsquamous NSCLC were < 65 years and 12.8% were >= 70 years old. In the maintenance study, 33.1% of the 481 patients with nonsquamous NSCLC were >= 65 years and 16.0% were >= 70 years old. In both studies, the adjusted HRs for overall survival (range, 0.62-0.89) favored pemetrexed and were similar between the older and younger age groups. Dose intensity delivered and toxicities observed for patients treated with pemetrexed were manageable and similar between the older and younger age groups. Conclusions: For elderly patients with nonsquamous advanced NSCLC and PS 0-1, pemetrexed therapy, with its favorable toxicity profile, is a viable option, either in combination with cisplatin in the first-line setting or as maintenance therapy after initial chemotherapy.