Progression-free survival: gaining on overall survival as a gold standard and accelerating drug development.
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.
Lebwohl
David
D
Novartis Pharmaceuticals Corporation, Florham Park, NJ 07932, USA. david.lebwohl@novartis.com
Kay
Andrea
A
Berg
William
W
Baladi
Jean Francois
JF
Zheng
Ji
J
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
D000970:Antineoplastic Agents