A phase II study of carboplatin and pemetrexed for elderly patients with advanced non-squamous non-small cell lung cancer

IntroductionThe safety and efficacy of platinum-doublet in elderly has been recently reported worldwide. Combination therapy with carboplatin (CBDCA) and pemetrexed (PEM) is a less toxic regimen. To evaluate the appropriate dose and efficacy of the regimen, we conducted a phase II study in elderly patients with advanced non-squamous non-small cell lung cancer (NSCLC).MethodsThe present study included elderly patients (≥70 years of age) with advanced non-squamous NSCLC and adequate organ function. In the leading cohort, the first 6 patients were treated with CBDCA (AUC=6) and PEM (500 mg/m2), and the toxicities were evaluated. Accordingly, the dose of the subsequent cohort was decided. The primary endpoint was the objective response rate (ORR). The secondary endpoints included toxicity, progression-free survival (PFS) and overall survival (OS).ResultsFrom November 2010 to January 2014, 39 eligible patients were enrolled in this study. In the leading cohort, the first 3 patients experienced Dose-limiting-toxicities in the 1st cycle. The subsequent 36 patients were therefore treated with CBDCA (AUC=5) and PEM (500 mg/m2). Toxicity was evaluated in all of the 39 patients. Efficacy was evaluated in 38 patients. The ORR was 49% (95% confidence interval[CI]: 33-65%). The median PFS and OS were 4.9 months (95%CI: 4.1-5.7 months) and 18.8 months (95%CI: 11.6-26.9 months), respectively. The most common toxicities of grade ≥3 involved myelosuppression (anemia, thrombocytopenia, neutropenia, and leukopenia).ConclusionsCBDCA (AUC=5) and PEM (500 mg/m2) is the recommend dose for elderly patients. The efficacy was similar to that in the non-selected population.