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Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer: A position paper from the GCIG symptom benefit committee

Authors
 Jean-Emmanuel Kurtz  ;  Val Gebski  ;  Vladyslav Sukhin  ;  Mark Carey  ;  Iwa Kong  ;  Rosalind M Glasspool  ;  Jonathan S Berek  ;  Mariana de Paiva Batista  ;  Marcia Hall  ;  Jae-Weon Kim  ;  Effi Yeoshoua  ;  Noriko Fujiwara  ;  Byung-Ho Nam  ;  Sandra Polleis  ;  Jung-Yun Lee  ;  Aleksandra Strojna  ;  Laura Farrelly  ;  Richard Schwameis  ;  Roldano Fossati  ;  Anne-Sophie Darlington  ;  Chyong-Huey Lai  ;  Alexi A Wright  ;  Orgad Rosenblat  ;  Phillip Harter  ;  Patricia Roxburgh  ;  Rahul Roy Chowdhury  ;  Ting-Chang Chang  ;  Xavier Paoletti  ;  Michael Friedlander 
Citation
 GYNECOLOGIC ONCOLOGY, Vol.161(2) : 502-507, 2021-05 
Journal Title
GYNECOLOGIC ONCOLOGY
ISSN
 0090-8258 
Issue Date
2021-05
MeSH
Female ; Humans ; Maintenance Chemotherapy ; Ovarian Neoplasms / diagnosis ; Ovarian Neoplasms / drug therapy ; Ovarian Neoplasms / therapy* ; Patient Reported Outcome Measures ; Patient-Centered Care / methods* ; Quality of Life ; Randomized Controlled Trials as Topic / methods*
Keywords
Maintenance ; Ovarian cancer ; PROMs ; Quality of life
Abstract
Background: Quality of life and patient reported outcome measures (PROMs) are important secondary endpoints and incorporated in most contemporary clinical trials. There have been deficiencies in their assessment and reporting in ovarian cancer clinical trials, particularly in trials of maintenance treatment where they are of particular importance. The Gynecologic Cancer InterGroup (GCIG) symptom benefit committee (SBC) recently convened a brainstorming meeting with representation from all collaborative groups to address questions of how to best incorporate PROMs into trials of maintenance therapies to support the primary endpoint which is usually progression free survival (PFS). These recommendations should harmonize the collection, analysis and reporting of PROM's across future GCIG trials.

Methods: Through literature review, trials analysis and input from international experts, the SBC identified four relevant topics to address with respect to promoting the role of PROMs to support the PFS endpoint in clinical trials of maintenance treatment for OC.

Results: The GCIG SBC unanimously accepted the importance of integrating PROM's in future maintenance trials and developed four guiding principles to be considered early in trial design. These include 1) adherence to SPIRIT-PRO guidelines, 2) harmonization of selection, collection and reporting of PROM's; 3) combining Health Related Quality of Life (HRQL) measures with clinical endpoints and 4) common approaches to dealing with incomplete HRQL data.

Conclusions: Close attention to incorporating HRQL and PROM's is critical to interpret the results of ovarian cancer clinical trials of maintenance therapies. There should be a consistent approach to assessing and reporting patient centered benefits across all GCIG trials to enable cross trial comparisons which can be used to inform practice.
Full Text
https://www.sciencedirect.com/science/article/pii/S0090825821001554
DOI
10.1016/j.ygyno.2021.02.018
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Obstetrics and Gynecology (산부인과학교실) > 1. Journal Papers
Yonsei Authors
Lee, Jung-Yun(이정윤) ORCID logo https://orcid.org/0000-0001-7948-1350
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/186758
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