Disease-free survival as an end-point in the treatment of solid tumours--perspectives from clinical trials and clinical practice

Andrew G Robinson; Christopher M Booth; Elizabeth A Eisenhauer

doi:10.1016/j.ejca.2014.05.016

Disease-free survival as an end-point in the treatment of solid tumours--perspectives from clinical trials and clinical practice

Eur J Cancer. 2014 Sep;50(13):2298-302. doi: 10.1016/j.ejca.2014.05.016. Epub 2014 Jun 12.

Authors

Andrew G Robinson¹, Christopher M Booth², Elizabeth A Eisenhauer²

Affiliations

¹ Department of Oncology, Queens University and Kingston General Hospital, Kingston, Canada. Electronic address: robinsa4@kgh.kari.net.
² Department of Oncology, Queens University and Kingston General Hospital, Kingston, Canada.

PMID: 24930623
DOI: 10.1016/j.ejca.2014.05.016

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.

Keywords: Clinical trials; Disease-free survival; Drug approval; Patient perspectives; Solid tumours.

Publication types

Review

MeSH terms

Antineoplastic Agents / therapeutic use*
Disease-Free Survival
Drug Approval
Endpoint Determination
Humans
Neoplasms / drug therapy*
Treatment Outcome

Substances

Antineoplastic Agents