Araujo RLC, Herman P, Riechelmann RP. Recurrence-free survival as a putative surrogate for overall survival in phase III trials of curative-intent treatment of colorectal liver metastases: Systematic review. World J Clin Oncol 2017; 8(3): 266-272 [PMID: 28638797 DOI: 10.5306/wjco.v8.i3.266]
Corresponding Author of This Article
Raphael LC Araujo, MD, PhD, Department of Upper Gastrointestinal and Hepato-Pancreato-Bliliary Sugery, Barretos Cancer Hospital, Rua Antenor Duarte Villela, 1331, Barretos, SP 14784-400, Brazil. raphael.araujo@hcancerbarretos.com.br
Research Domain of This Article
Oncology
Article-Type of This Article
Systematic Reviews
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Clin Oncol. Jun 10, 2017; 8(3): 266-272 Published online Jun 10, 2017. doi: 10.5306/wjco.v8.i3.266
Recurrence-free survival as a putative surrogate for overall survival in phase III trials of curative-intent treatment of colorectal liver metastases: Systematic review
Raphael L C Araujo, Paulo Herman, Rachel P Riechelmann
Raphael L C Araujo, Department of Upper Gastrointestinal and Hepato-Pancreato-Bliliary Sugery, Barretos Cancer Hospital, Barretos, SP 14784-400, Brazil
Raphael L C Araujo, Paulo Herman, Department of Gastroenterology, University of São Paulo, São Paulo, SP 05403-900, Brazil
Rachel P Riechelmann, Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo, SP 01246-000, Brazil
Author contributions: Araujo RLC and Riechelmann RP contributed to study conception and design; Araujo RLC contributed to acquisition of data; Araujo RLC and Riechelmann RP contributed to analysis and interpretation of data; all authors contributed to drafting of manuscript and critical revision.
Conflict-of-interest statement: No conflict of interest for any authors.
Data sharing statement: The statistical code, and dataset are available from the corresponding author at raphael.l.c.araujo@gmail.com.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Raphael LC Araujo, MD, PhD, Department of Upper Gastrointestinal and Hepato-Pancreato-Bliliary Sugery, Barretos Cancer Hospital, Rua Antenor Duarte Villela, 1331, Barretos, SP 14784-400, Brazil. raphael.araujo@hcancerbarretos.com.br
Telephone: +55-17-33216600 Fax: +55-17-33216600
Received: December 1, 2016 Peer-review started: December 5, 2016 First decision: March 28, 2017 Revised: April 12, 2017 Accepted: May 3, 2017 Article in press: May 5, 2017 Published online: June 10, 2017
Abstract
AIM
To verify whether recurrence-free survival (RFS) surrogates overall survival (OS) in phase III trials for resectable colorectal liver metastases (CRLM).
METHODS
MEDLINE, EMBASE, and Scopus databases were consulted. Eligible studies were phase III trials testing any type of systemic therapy (neoadjuvant, adjuvant or perioperative) added to surgery in patients with resectable CRLM. A linear regression model based on hazard ratios (HR) of OS and RFS was performed.
RESULTS
Of 3059 studies, 5 phase III trials (1162 patients) were included for analyses. A linear regression weighted by each trial was used to estimate the association between each HR and RFS. The originated formula was: OS HR = (0.93 × RFS HR) + 0.14; with RFS 95%CI (0.48-1.38), with P = 0.007.
CONCLUSION
This association suggests that RFS could work as a putative surrogate endpoint of OS in this population, avoiding bigger, longer and more resource-consuming trials. The OS could be assumed based on RFS and our model could be useful to better estimate sample size calculations of phase III trials of CRLM aiming for OS.
Core tip: This study addresses a systematic review of curative-intent treatment of colorectal liver metastasis looking for oncologic outcomes. We describe the association between overall survival (OS) and recurrence free survival in the setting of resectable colorectal liver metastases (CRLM). It suggests that recurrence free survival could work as a putative surrogate of OS in this population, avoiding bigger, longer and more resource-consuming trials. We do believe that our model can be useful to better estimate sample size calculations of superiority phase III trials of CRLM aiming for OS.
