Phase I study of weekly nab-paclitaxel plus carboplatin and concurrent thoracic radiotherapy in elderly patients with unresectable locally advanced non-small cell lung cancer

Abstract

Few clinical studies have been designed for elderly patients with locally advanced non-small cell lung cancer (NSCLC). We conducted a phase I study to evaluate the tolerability of carboplatin/nab-paclitaxel and concurrent thoracic radiotherapy in elderly patients with locally advanced NSCLC. The eligibility criteria were: unresectable stage III NSCLC, performance status 0 or 1, and age ≥75 years. Eligible patients received 6 weeks of weekly carboplatin/nab-paclitaxel and concurrent thoracic radiotherapy with a total dose of 64 Gy in 32 fractions. Carboplatin was xed to an area under the plasma concentration time curve (AUC) of 2 mg/mL/min, and the recommended dose of nab-paclitaxel was evaluated using a dose-escalation study (30 or 40 mg/m 2 ). Tolerability at the recommended dose was evaluated in an expansion study. Nineteen patients were enrolled at four institutions, all of whom were eligible and assessable. The recommended nab-paclitaxel dose was set at 30 mg/m 2 because two patients experienced dose-limiting toxicity at 40 mg/m 2 . The treatment completion rate of the 17 patients analyzed at the recommended dose was 100% (80% con dence interval (CI), 83.8-100%). The overall response rate was 76.5%, and the median progression free survival was 13.4 months (95% CI, 4.2-21.4 months). Common grade 3 and 4 toxicities included leukopenia (23.5%), neutropenia (17.6%), anemia (5.9%), and infection (5.9%). One treatment-related death due to pneumonitis was observed six months after the end of the study. In conclusion, carboplatin/nab-paclitaxel and concurrent thoracic radiotherapy show good tolerability and exhibit promising e cacy in elderly patients with locally advanced NSCLC.

A Phase I Trial of Weekly Nab-paclitaxel Plus Carboplatin With Thoracic Radiotherapy for Non-small Cell Lung Cancer

“…Focusing on elderly patients, Omori et al reported a phase I study of this regimen. They showed that 30 mg/m 2 of nab-PTX is recommended for elderly patients and that this regimen is tolerable and effective for elderly, with an ORR of 76.5% (11). Biweekly administrational has also been reported (12).…”