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Review
. 2021 May;161(2):502-507.
doi: 10.1016/j.ygyno.2021.02.018. Epub 2021 Feb 19.

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

Jean-Emmanuel Kurtz  1 , Val Gebski  2 , Vladyslav Sukhin  3 , Mark Carey  4 , Iwa Kong  5 , Rosalind M Glasspool  6 , Jonathan S Berek  7 , Mariana de Paiva Batista  8 , Marcia Hall  9 , Jae-Weon Kim  10 , Effi Yeoshoua  11 , Noriko Fujiwara  12 , Byung-Ho Nam  13 , Sandra Polleis  14 , Jung-Yun Lee  15 , Aleksandra Strojna  16 , Laura Farrelly  17 , Richard Schwameis  18 , Roldano Fossati  19 , Anne-Sophie Darlington  20 , Chyong-Huey Lai  21 , Alexi A Wright  22 , Orgad Rosenblat  23 , Phillip Harter  24 , Patricia Roxburgh  25 , Rahul Roy Chowdhury  26 , Ting-Chang Chang  27 , Xavier Paoletti  28 , Michael Friedlander  29 ; Gynecologic Cancer InterGroup (GCIG) symptom benefit committee
Affiliations
Review

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

Jean-Emmanuel Kurtz et al. Gynecol Oncol. 2021 May.

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.

Keywords: Maintenance; Ovarian cancer; PROMs; Quality of life.

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