title: Progression-free survival: gaining on overall survival as a gold standard and accelerating drug development.
abstract: In clinical trials of oncology drugs, overall survival (OS) is a direct measure of clinical efficacy and is considered the gold standard primary efficacy end point. The purpose of this study was to discuss the difficulties in using OS as a primary efficacy end point in the setting of evolving cancer therapies. We suggest that progression-free survival is an appropriate efficacy end point in many types of cancer, specifically those for which OS is expected to be prolonged and for which subsequent treatments are expected to affect OS.
authors.affiliation: Novartis Pharmaceuticals Corporation, Florham Park, NJ 07932, USA. david.lebwohl@novartis.com
authors.forename: David
authors.initials: D
authors.lastname: Lebwohl
authors.forename: Andrea
authors.initials: A
authors.lastname: Kay
authors.forename: William
authors.initials: W
authors.lastname: Berg
authors.forename: Jean Francois
authors.initials: JF
authors.lastname: Baladi
authors.forename: Ji
authors.initials: J
authors.lastname: Zheng
mesh_terms: D000970:Antineoplastic Agents / Q000592:standards* / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D018450:Disease Progression; D018572:Disease-Free Survival; D017277:Drug Approval; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents