Pralatrexate with vitamin supplementation in patients with previously treated, advanced non-small cell lung cancer: Safety and efficacy in a phase 1 trial Academic Article uri icon


MeSH Major

  • Adenocarcinoma
  • Aminopterin
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Dietary Supplements
  • Lung Neoplasms
  • 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.

publication date

  • November 2011



  • Academic Article



  • eng

Digital Object Identifier (DOI)

  • 10.1097/JTO.0b013e31822adb19

PubMed ID

  • 21841501

Additional Document Info

start page

  • 1915

end page

  • 22


  • 6


  • 11