WS4-4 - A Phase II Study of Pemetrexed in Chemotherapy-Naive Elderly Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer: Hanshin Oncology Group 003

Abstract

ABSTRACT Background Single-agent chemotherapy (i.e. doxetaxel, gemcitabine or vinorelbine) is one of the standard treatments for elderly patients with advanced NSCLC. Pemetrexed has clinically equivalent efficacy, but with less toxicity compared with doxetaxel in the second-line setting of patients with advanced NSCLC. We conducted a phase II trial to evaluate the efficacy and safety of frontline pemetrexed in elderly patients with advanced non-squamous (non-Sq) NSCLC. Methods In this multicenter phase II trial, we recruited elderly patients with non-Sq NSCLC. Eligibility criteria were as follows: chemonaive; locally advanced or metastatic non-Sq NSCLC; age 75 or older; ECOG performance status 0-1; adequate organ function. Patients received pemetrexed (500 mg/m2) intravenously on day 1 every 3 weeks until disease progression had been confirmed. The primary end point was response rate (RR). The secondary end points included progression free survival (PFS), overall survival (OS), disease control rate (DCR) and safety. The planned sample size was 45 patients. Results Between August 2009 and July 2011, 47 patients were enrolled. Median age was 79 years (range: 75–91), 57% (20 of 47) were male, 36% (17 of 47) had never smoked, 85% (40 of 47) had adenocarcinoma, 72% (34 of 47) had stage IV and 41% (16 of 39) had EGFR tyrosine kinase activating mutation. Median number of cycles was 4 (1 to 15). RR was 13.3% (95% CI: 5.1, 26.8), DCR was 66.7% (95% CI: 51.0, 80.0), PFS was 4.9 months (95% CI: 3.0, 6.2 months), median OS was not reached. The most frequent treatment-related AEs were anemia, fatigue, hypocalcemia, mostly grade 1/2. Treatment-related grade 3/4 AEs were reported in 17.8% of patients (mostly neutropenia and fatigue). No treatment-related death occurred. Conclusions The efficacy and limited side-effects of pemetrexed are promising in elderly patients with non-Sq NSCLC.