title: Disease-free survival as an end-point in the treatment of solid tumours--perspectives from clinical trials and clinical practice.
abstract: Disease-free survival (DFS) is an end-point for an increasing number of clinical trials in adjuvant and curative intent cancer treatment informing both regulatory bodies and clinical practice. DFS is seen both as a surrogate end-point and as an end-point in itself in clinical trials. Understanding the history of DFS, and some of the assumptions, limitations, and vulnerabilities for studies designed with this primary end-point are required. This commentary reviews recent drug approvals for anti-cancer agents in solid tumours in the adjuvant and curative settings, and considers the meaning of DFS from the perspectives of clinical trials and clinical practice.
authors.affiliation: Department of Oncology, Queens University and Kingston General Hospital, Kingston, Canada. Electronic address: robinsa4@kgh.kari.net.
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Robinson
authors.affiliation: Department of Oncology, Queens University and Kingston General Hospital, Kingston, Canada.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Booth
authors.affiliation: Department of Oncology, Queens University and Kingston General Hospital, Kingston, Canada.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Eisenhauer
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018572:Disease-Free Survival; D017277:Drug Approval; D023381:Endpoint Determination; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents
keywords: Clinical trials; Disease-free survival; Drug approval; Patient perspectives; Solid tumours