当一项随机试验的期中分析改变肿瘤学实践时：辅助性曲妥珠单抗与HERA试验的教训。

When an interim analysis of randomized trial changes the practice in oncology: The lesson of adjuvant trastuzumab and the HERA trial.

作者信息

De Rossi Costanza, Brunello Antonella, Jirillo Giuseppe, Jirillo Antonio

机构信息

Instituto Oncologic. Veneto IRCCS, Padua, Italy.

出版信息

Immunopharmacol Immunotoxicol. 2009;31(1):1-4.

PMID:19238693

Abstract

About 30% of the randomized clinical trials are stopped early because of appearance of clear clinical benefit. Though interim analyses protect patients in case of significant imbalance between two treatment arms, conclusions drawn from truncated studies can be premature and should be viewed with caution. We report the lesson learnt from the Herceptin adjuvant (HERA) trial.

摘要

约30%的随机临床试验因出现明确的临床获益而提前终止。尽管期中分析可在两个治疗组间出现显著失衡时保护患者，但从截短的研究得出的结论可能不成熟，应谨慎看待。我们报告了从赫赛汀辅助治疗（HERA）试验中吸取的教训。