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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

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
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
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.
Maintenance, Ovarian cancer, PROMs, Quality of life
0090-8258
502-507
Kurtz, Jean-emmanuel
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Gebski, Val
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Sukhin, Vladyslav
ed03385e-e661-4154-8f24-677dcf294bfa
Carey, Mark
03811afd-eb8a-4496-a1d8-fbf6e043dc3b
Kong, Iwa
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Glasspool, Rosalind M.
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Berek, Jonathan S.
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De Paiva Batista, Mariana
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Hall, Marcia
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Yeoshoua, Effi
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Fujiwara, Noriko
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Nam, Byung-ho
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Polleis, Sandra
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Lee, Jung-yun
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Strojna, Aleksandra
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Farrelly, Laura
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Schwameis, Richard
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Fossati, Roldano
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Darlington, Anne-sophie
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Lai, Chyong-huey
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Wright, Alexi A.
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Rosenblat, Orgad
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Harter, Phillip
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Roxburgh, Patricia
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Chowdhury, Rahul Roy
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Chang, Ting-chang
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Paoletti, Xavier
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Friedlander, Michael
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Kurtz, Jean-emmanuel
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Gebski, Val
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Sukhin, Vladyslav
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Carey, Mark
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Kong, Iwa
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Glasspool, Rosalind M.
e97b17d5-05ad-4e13-a2ac-8cff6bfd992d
Berek, Jonathan S.
dc5d8f23-137d-45bc-8832-48960b0225df
De Paiva Batista, Mariana
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Hall, Marcia
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Yeoshoua, Effi
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Fujiwara, Noriko
2db9c9c7-5715-44b3-b4e9-5a2745b7cfa3
Nam, Byung-ho
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Polleis, Sandra
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Lee, Jung-yun
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Strojna, Aleksandra
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Farrelly, Laura
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Schwameis, Richard
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Fossati, Roldano
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Darlington, Anne-sophie
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Lai, Chyong-huey
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Wright, Alexi A.
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Rosenblat, Orgad
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Harter, Phillip
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Roxburgh, Patricia
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Chowdhury, Rahul Roy
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Chang, Ting-chang
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Paoletti, Xavier
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Friedlander, Michael
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Kurtz, Jean-emmanuel, Gebski, Val, Sukhin, Vladyslav, Carey, Mark, Kong, Iwa, Glasspool, Rosalind M., Berek, Jonathan S., De Paiva Batista, Mariana, Hall, Marcia, Yeoshoua, Effi, Fujiwara, Noriko, Nam, Byung-ho, Polleis, Sandra, Lee, Jung-yun, Strojna, Aleksandra, Farrelly, Laura, Schwameis, Richard, Fossati, Roldano, Darlington, Anne-sophie, Lai, Chyong-huey, Wright, Alexi A., Rosenblat, Orgad, Harter, Phillip, Roxburgh, Patricia, Chowdhury, Rahul Roy, Chang, Ting-chang, Paoletti, Xavier and Friedlander, Michael (2021) 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. Gynecologic Oncology, 161 (2), 502-507. (doi:10.1016/j.ygyno.2021.02.018).

Record type: Article

Abstract

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.

Text
Incorporating patient centered benefits as endpoints in randomized trials of maintenance therapies in advanced ovarian cancer - Accepted Manuscript
Restricted to Repository staff only until 19 February 2022.
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More information

Accepted/In Press date: 8 February 2021
e-pub ahead of print date: 19 February 2021
Keywords: Maintenance, Ovarian cancer, PROMs, Quality of life

Identifiers

Local EPrints ID: 448433
URI: http://eprints.soton.ac.uk/id/eprint/448433
ISSN: 0090-8258
PURE UUID: f3250e2d-29f4-483a-977a-cc958f87c5a1

Catalogue record

Date deposited: 22 Apr 2021 16:40
Last modified: 25 Nov 2021 19:40

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Contributors

Author: Jean-emmanuel Kurtz
Author: Val Gebski
Author: Vladyslav Sukhin
Author: Mark Carey
Author: Iwa Kong
Author: Rosalind M. Glasspool
Author: Jonathan S. Berek
Author: Mariana De Paiva Batista
Author: Marcia Hall
Author: Effi Yeoshoua
Author: Noriko Fujiwara
Author: Byung-ho Nam
Author: Sandra Polleis
Author: Jung-yun Lee
Author: Aleksandra Strojna
Author: Laura Farrelly
Author: Richard Schwameis
Author: Roldano Fossati
Author: Chyong-huey Lai
Author: Alexi A. Wright
Author: Orgad Rosenblat
Author: Phillip Harter
Author: Patricia Roxburgh
Author: Rahul Roy Chowdhury
Author: Ting-chang Chang
Author: Xavier Paoletti
Author: Michael Friedlander

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