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

被引：4

作者：

Kurtz, Jean-Emmanuel ^{[1
]}

Gebski, Val ^{[2
]}

Sukhin, Vladyslav ^{[3
]}

Carey, Mark ^{[4
]}

Kong, Iwa ^{[5
,6
]}

Glasspool, Rosalind M. ^{[7
]}

Berek, Jonathan S. ^{[8
]}

Batista, Mariana de Paiva ^{[9
]}

Hall, Marcia ^{[10
]}

Kim, Jae-Weon ^{[11
]}

Yeoshoua, Effi ^{[12
]}

Fujiwara, Noriko ^{[13
]}

Nam, Byung-Ho ^{[14
]}

Polleis, Sandra ^{[15
]}

Lee, Jung-Yun ^{[16
]}

Strojna, Aleksandra ^{[17
]}

Farrelly, Laura ^{[18
]}

Schwameis, Richard ^{[19
]}

Fossati, Roldano ^{[20
]}

Darlington, Anne-Sophie ^{[21
]}

Lai, Chyong-Huey ^{[22
]}

Wright, Alexi A. ^{[23
]}

Rosenblat, Orgad ^{[24
]}

Harter, Phillip ^{[25
]}

Roxburgh, Patricia ^{[26
]}

Chowdhury, Rahul Roy ^{[27
]}

Chang, Ting-Chang ^{[22
]}

Paoletti, Xavier ^{[28
]}

Friedlander, Michael ^{[29
,30
]}

机构：

[1] ICANS, Dept Med & Surg Oncol & Hematol, GINECO, 17 Rue Albert Calmettes, F-67200 Strasbourg, France

[2] Univ Sydney, NHMRC Clin Trials Ctr, ANZGOG, Locked Bag 77, Camperdown, NSW 1450, Australia

[3] Grigoriev Inst Med Radiol, CEEGOG, 82 Pushkinskaya St, UA-61024 Kharkiv, Ukraine

[4] Vancouver Gen Hosp, Div Gynecol Oncol, CCTG, 899 12th Ave, Vancouver, BC V5Z 1M9, Canada

[5] McMaster Univ, Dept Oncol, Div Radiat Oncol, CCTG, 699 Concess St, Hamilton, ON, Canada

[6] Juravinski Canc Ctr, 699 Concess St, Hamilton, ON, Canada

[7] Beatson West Scotland Canc Ctr, Canc Res UK Trials Unit, SGCTG, Level 0,1053 Great Western Rd, Glasgow G12 0YN, Lanark, Scotland

[8] Stanford Univ, Stanford Womens Canc Ctr, Stanford Canc Inst, COGI, 900 Blake Wilbur Dr, Stanford, CA 94305 USA

[9] Hosp Sao Luiz Jabaquara, BRASGYN, Cin Oncol Dept, 1 Floor,Rua Perobas,344 Jabaquara, BR-04321120 Sao Paulo, SP, Brazil

[10] Mt Vernon Canc Ctr, Dept Med Oncol, NCRI, Rickmansworth Rd, Northwood HA6 2RN, Middx, England

[11] Seoul Natl Univ Hosp, Dept Obstet & Gynecol, KGOG, Seoul, South Korea

[12] Rabin Med Ctr, Dept Obstet & Gynecol, ISGO, Zeev Jabutinsky Rd 39, IL-49100 Tel Aviv, Israel

[13] Univ Tokyo, IMSUT Hosp, Inst Med Sci, GOTIC,Dept Palliat Med & Adv Clin Oncol, Tokyo, Japan

[14] Inst Adv Clin & Biomed Res, KGOG, 560 Eonju Ro,14F Gangnam Gu, Seoul 06144, South Korea

[15] AGO Arbeitsgemeinschaft Gynaekolog Onkol Studieng, Kaiser Friedrich Ring 71, D-65185 Wiesbaden, Germany

[16] Yonsei Univ, KGOG, 50 Yonsei Ro, Seoul, South Korea

[17] Adults & Adolescents Pomeranian Med Univ, Dept Gynecol Surg & Gynecol Oncol, CEEGOG, Al Powstancow Wielkopolskich 72, PL-70111 Szczecin, Poland

[18] UCL, NCRI, Canc Res UK & Univ Coll London Canc Trials Ctr, 90 Tottenham Court Rd, London, England

[19] AGO, Dept Gynecol & Obstet, Sect Gynecol & Gynecol Oncol, Waehringer Guertel 18-20, A-1090 Vienna, Austria

[20] Ist Ric Farmacol Mario Negri, IRCCS, MANGO, Via La Masa 19, I-20156 Milan, Italy

[21] Univ Southampton, Fac Hlth Sci, EORTC, Southampton SO17 1BJ, Hants, England

[22] Chang Gung Mem Hosp, Linkou Med Ctr, AGOG, Fuxing St, Taoyuan, Taiwan

[23] Dana Farber Canc Inst, GOG Fdn, GOG F, 450 Brookline Ave, Boston, MA 02215 USA

[24] Tel Aviv Univ, Sackler Fac Med, Sheba Med Ctr, ISGO,Dept Gynecol Oncol, Tel Hashomer, Israel

[25] Ev Kliniken Essen Mitte, Dept Gynecol & Gynecol Oncol, AGO, Henricistr 40, D-45136 Essen, Germany

[26] Univ Glasgow, Wolfson Wohl Canc Res Ctr, SGCTG Scottish Gynaecol Canc Trials Grp, Glasgow G61 1BD, Lanark, Scotland

[27] Chittaranjan Natl Canc Inst, Kolkata Gynecol Oncol Trials & Translat Res Grp, KolGOTrg, Room 40A,37,Shyamaprasad Mukherjee Rd, Kolkata 700026, W Bengal, India

[28] Inst Curie, Biostat Personalized Med Team, GINECO, 26 Rue Ulm, Paris, France

[29] Prince Wales Hosp, Prince Wales Clin Sch UNSW, ANZGOG, Randwick, NSW, Australia

[30] Prince Wales Hosp, Dept Med Oncol, ANZGOG, Randwick, NSW, Australia

来源：

GYNECOLOGIC ONCOLOGY | 2021年 / 161卷 / 02期

关键词：

Quality of life; PROMs; Maintenance; Ovarian cancer; QUALITY-OF-LIFE; CLINICAL-TRIALS; REPORTED OUTCOMES; CONSENSUS; QLQ-C30; VERSION;

D O I：

10.1016/j.ygyno.2021.02.018

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background. Quality of life and patient reported outcome measures (PROMs) are important secondary end-points 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 in-complete 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. (C) 2021 Elsevier Inc. All rights reserved.

引用

页码：502 / 507

页数：6

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