Issues surrounding clinical trial endpoints in solid malignancies with a focus on metastatic non-small cell lung cancer.

ABSTRACT: Relative to best supportive care alone, cytotoxic chemotherapy has an established role in prolonging overall survival (OS) in patients with or without previous treatment for metastatic non-small cell lung cancer (NSCLC). OS has been the principal endpoint influencing regulatory decisions regarding targeted therapies for metastatic NSCLC, including the vascular endothelial growth factor monoclonal antibody bevacizumab in the frontline setting and the epidermal growth factor receptor tyrosine kinase inhibitors gefitinib and erlotinib in patients after prior treatment. Progression-free survival (PFS), another common endpoint in oncology clinical trials, has been discussed as a potential surrogate for OS in metastatic NSCLC. A number of phase III clinical trials of investigational targeted age

SUBMITTER: Garon EB 

PROVIDER: S-EPMC3737740 | biostudies-literature | 2012 Sep

REPOSITORIES: biostudies-literature