18161 Background: Single-agent chemotherapy has been considered as standard treatment for elderly patients with non-small cell lung cancer (NSCLC). However recent subset analyses suggest that platinum-based combination chemotherapy may be safely administered to the elderly with good performance status (PS). We evaluated the efficacy and safety of carboplatin and docetaxel in a phase II study of elderly patients aged 70 years or older. Methods: Chemotherapy-naive patients aged =70 years with advanced NSCLC (IIIB-IV), ECOG performance status (PS) of 0–2, a measurable lesion, and adequate organ functions were enrolled. Patients received carboplatin (AUC 5) and docetaxel (60 mg/m2) administered on day 1 every 3 weeks. The primary endpoint was response rate (RR). This study, with a planned sample size of 25, had 80% power to support the hypothesis that the true RR was >30%, and 5% significance to deny the hypothesis that the true RR was <10%. Results: Between October 2003 and April 2006, 30 elderly patients with NSCLC were enrolled in the study and all patients were treated. Demographics: M/F 20/10; PS 0/1/2 2/23/5; median age 75 (range 70–84). Median number of treatment cycles was 3.5. Responses in the 30 evaluable patients included 1CR; 13PR; for an objective RR of 46.7% (95% CI 28.8–64.6%). By January 4, 2007, 21 (70.0%) of 30 patients had died. Median follow-up for survival was 8.4 months. The median time to tumor progression was 4.4 months, and the median survival was 9.9 months. The 1-year survival rate was 43.3%.Grade 3/4 hematologic toxicities included leukopenia (80.0%), neutropenia (86.7%), anemia (16.7%) and thrombocytopenia (3.3%). Non-hematologic toxicities were mild with no grade 4 toxicities; grade 3 nausea (10.0%), anorexia (30.0%), diarrhea (13.3%), fatigue (6.7%), allergic reaction (6.7%), pneumonitis (3.3%), febril neutropenia (16.7%) and infection (10.0%) were observed. Conclusions: The combination of carboplatin and docetaxel was safe and promising for the treatment of chemotherapy-naive elderly patients with advanced NSCLC. This regimen warrants further evaluation in a phase III trial. No significant financial relationships to disclose.
A Phase II Study of Pemetrexed in Chemotherapy-naive Elderly Patients Aged >=75 years with Advanced Non-squamous Non-small-cell Lung Cancer (HANSHIN Oncology Group 003)