N-of-1 Trials in Cancer Drug Development

被引：19

作者：

Gouda, Mohamed A. ^{[1
]}

Buschhorn, Lars ^{[2
]}

Schneeweiss, Andreas ^{[2
]}

Wahida, Adam ^{[2
]}

Subbiah, Vivek ^{[1
,3
,4
,5
]}

机构：

[1] Univ Texas MD Anderson Canc Ctr, Dept Invest Canc Therapeut, Houston, TX USA

[2] Natl Ctr Tumor Dis NCT, Div Gynecol Oncol, Heidelberg, Germany

[3] Univ Texas MD Anderson Canc Ctr, Div Pediat, Houston, TX USA

[4] Univ Texas MD Anderson Canc Ctr, MD Anderson Canc Network, Houston, TX USA

[5] Univ Texas MD Anderson Canc Ctr, Dept Invest Canc Therapeut, Phase Clin Trials Program 1, Unit 455,Div Canc Med, 1515 Holcombe Blvd, Houston, TX 77030 USA

来源：

CANCER DISCOVERY | 2023年 / 13卷 / 06期

关键词：

ACQUIRED-RESISTANCE; RANDOMIZED-TRIALS; CLINICAL-TRIAL; FUSION; SELPERCATINIB; THERAPY; EFFICACY; LUNG; INHIBITION; IMPACT;

D O I：

10.1158/2159-8290.CD-22-1377

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The current approaches for cancer drug development lag behind an accelerated need in the field for a fast and effi cient method for evaluating drugs in the personalized medicine era. In that regard, N-of-1 studies emerge as a potential addition to the drug development arsenal, although there are several considerations before its broad application becomes feasible. In essence, N-of-1 trials are a departure from the traditional "drug -centric" model to a "patient-centric" model. Herein, we review the concept of N-of-1 trials and provide real-world examples of their use in the developmental therapeutics field. N-of-1 trials offer an exceptional opportunity for fast-tracking of cancer drug development in the precision oncology era.

引用

页码：1301 / 1309

页数：9