A phase II study of carboplatin and pemetrexed for elderly patients with advanced non-squamous non-small cell lung cancer. (2016)

• Record Type: Journal Article
• Authors: Nishizawa, Hironari; Horiike, Atsushi; Saito, Ryota; Ohyanagi, Fumiyoshi; Kudo, Keita; Yanagitani, Noriko; Tambo, Yuichi; Kitazono, Satoru; Kobayashi, Hiroshi; Nishio, Makoto
• Is Part Of: Cancer treatment and research communications. Number 9(2016)
• Page Start: 100
• Page End: 105
• Publication Date: 2016
• Subjects: Carboplatin -- Pemetrexed -- Non-squamous non-small cell lung cancer -- First-line chemotherapy -- Elderly
• DOI: 10.1016/j.ctarc.2016.08.003
• Languages: English
• ISSNs: 2468-2942

Abstract

Abstract: Introduction: The 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). Methods: The 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). Results: From 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). Conclusions: CBDCA (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.