Pralatrexate with vitamin supplementation in patients with previously treated, advanced non-small cell lung cancer: Safety and efficacy in a phase 1 trial
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Vitamin B Complex
Pralatrexate with vitamin supplementation was safely administered to patients with previously treated NSCLC, and durable responses were observed. The recommended starting dose for phase 2 is 190 mg/m(2). A similar safety profile was observed in patients treated at 230 mg/m(2), although a higher serious AE rate was evident. Mucositis remains the dose-limiting toxicity of pralatrexate, and this study failed to demonstrate that vitamin supplementation prevents mucositis and failed to identify clinical predictors of mucositis. Individualized dose-modification strategies and prospective mucositis management will be necessary in future trials.