Neoadjuvant Rectal (NAR) Score: a New Surrogate Endpoint in Rectal Cancer Clinical Trials

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• 作者：Thomas J. George Jr. ; Carmen J. Allegra ; Greg Yothers
• 关键词：Rectal cancer ; NAR score ; Surrogate ; Endpoint ; Pathologic complete response ; Clinical trial ; Neoadjuvant ; Nomogram ; pCR
• 刊名：Current Colorectal Cancer Reports
• 出版年：2015
• 出版时间：October 2015
• 年：2015
• 卷：11
• 期：5
• 页码：275-280
• 全文大小：334 KB
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• 作者单位：Thomas J. George Jr. (1) (3)
  Carmen J. Allegra (1) (3)
  Greg Yothers (2) (3)
  
  1. University of Florida Health Cancer Center, Gainesville, 1600 SW Archer Rd, PO Box 100278, Gainesville, FL, 32610, USA
  3. NRG Oncology, Four Penn Center, 1600 JFK Blvd, Suite 1020, Philadelphia, PA, 19103, USA
  2. University of Pittsburgh, One Sterling Plaza, 201聽N Craig St, Ste 350, Pittsburgh, PA, 15213, USA
  
• 刊物主题：Oncology; Proctology; Colorectal Surgery;
• 出版者：Springer US
• ISSN：1556-3804

文摘

The conduct of clinical trials in colorectal cancer has historically relied upon endpoints such as disease-free (DFS) or overall survival (OS). While ideal, these endpoints require long-term follow-up, thus contributing to a slow pace of scientific progress in clinical research. Identification of short-term endpoints to serve as surrogates for DFS and OS would enable more rapid determination of success or failure of an experimental intervention and thus facilitate more scientific discovery and progress leading to clinical practice improvements. In rectal cancer clinical trials, there have been few validated alternatives to DFS and OS, including pathologic complete response (ypCR). The neoadjuvant rectal (NAR) score was developed as a composite short-term endpoint for clinical trials involving neoadjuvant therapy for rectal cancer. The NAR score is based upon variables routinely collected and available to clinical investigators during the conduct of prospective studies. Based upon two independent validation datasets, the NAR score predicts OS in rectal cancer clinical trials better than ypCR. While final dataset validation is ongoing, the NAR score offers an opportunity to incorporate a novel surrogate endpoint into early phase rectal cancer clinical trials. Keywords Rectal cancer NAR score Surrogate Endpoint Pathologic complete response Clinical trial Neoadjuvant Nomogram pCR