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| Gynecologic oncology. 2021 Feb 18. pii: S0090-8258(21)00155-4. doi: 10.1016/j.ygyno.2021.02.018 |
| 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. |
| Kurtz JE1, Gebski V2, Sukhin V3, Carey M4, Kong I5, Glasspool RM6, Berek JS7, de Paiva Batista M8, Hall M9, Kim JW10, Yeoshoua E11, Fujiwara N12, Nam BH13, Polleis S14, Lee JY15, Strojna A16, Farrelly L17, Schwameis R18, Fossati R19, Darlington AS20, Lai CH21, Wright AA22, Rosenblat O23, Harter P24, Roxburgh P25, Chowdhury RR26, Chang TC27, Paoletti X28, Friedlander M29 |
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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. |
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Copyright © 2021 Elsevier Inc. All rights reserved. |
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KEYWORDS: Maintenance, Ovarian cancer, PROMs, Quality of life |
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Publikations ID: 33612336 Quelle: öffnen |
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