Robinson Andrew G, Booth Christopher M, Eisenhauer Elizabeth A
Department of Oncology, Queens University and Kingston General Hospital, Kingston, Canada.
Department of Oncology, Queens University and Kingston General Hospital, Kingston, Canada.
Eur J Cancer. 2014 Sep;50(13):2298-302. doi: 10.1016/j.ejca.2014.05.016. Epub 2014 Jun 12.
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.
无病生存期（DFS）是越来越多辅助性和根治性癌症治疗临床试验的一个终点，为监管机构和临床实践提供依据。在临床试验中，DFS既被视为替代终点，也被视为自身的终点。需要了解DFS的历史，以及以这个主要终点设计的研究的一些假设、局限性和易受影响之处。本评论回顾了近期辅助和根治性实体瘤抗癌药物的批准情况，并从临床试验和临床实践的角度考虑DFS的意义。
