Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Ignace Vergote; Antonio Gonzalez-Martin; Domenica Lorusso; Charlie Gourley; Mansoor Raza Mirza; Jean-Emmanuel Kurtz; Aikou Okamoto; Kathleen Moore; Frédéric Kridelka; Iain McNeish; Alexander Reuss; Bénédicte Votan; Andreas du Bois; Sven Mahner; Isabelle Ray-Coquard; Elise C. Kohn; Jonathan S Berek; David SP Tan; Nicoletta Colombo; Rongyu Zang; Nicole Concin; Dearbhaile O'Donnell; Alejandro Rauh-Hain; C Simon Herrington; Christian Marth; Andres Poveda; Keiichi Fujiwara; Gavin C.E Stuart; Amit Oza; Michael A Bookman

doi:10.1016/S1470-2045(22)00139-5

Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Ignace Vergote^*, Antonio Gonzalez-Martin, Domenica Lorusso, Charlie Gourley, Mansoor Raza Mirza, Jean-Emmanuel Kurtz, Aikou Okamoto, Kathleen Moore, Frédéric Kridelka, Iain McNeish, Alexander Reuss, Bénédicte Votan, Andreas du Bois, Sven Mahner, Isabelle Ray-Coquard, Elise C. Kohn, Jonathan S Berek, David SP Tan, Nicoletta Colombo, Rongyu ZangNicole Concin, Dearbhaile O'Donnell, Alejandro Rauh-Hain, C Simon Herrington, Christian Marth, Andres Poveda, Keiichi Fujiwara, Gavin C.E Stuart, Amit Oza, Michael A Bookman

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

The Gynecologic Cancer InterGroup (GCIG) sixth Ovarian Cancer Conference on Clinical Research was held virtually in October, 2021, following published consensus guidelines. The goal of the consensus meeting was to achieve harmonisation on the design elements of upcoming trials in ovarian cancer, to select important questions for future study, and to identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and adoption of 20 statements within four topic groups on clinical research in ovarian cancer including first line treatment, recurrent disease, disease subgroups, and future trials. Unanimous consensus was obtained for 14 of 20 statements, with greater than 90% concordance in the remaining six statements. The high acceptance rate following active deliberation among the GCIG groups confirmed that a consensus process could be applied in a virtual setting. Together with detailed categorisation of unmet needs, these consensus statements will promote the harmonisation of international clinical research in ovarian cancer.

Original language	English
Pages (from-to)	e374-e384
Journal	The Lancet Oncology
Volume	23
Issue number	8
DOIs	https://doi.org/10.1016/S1470-2045(22)00139-5
Publication status	Published - 25 Jul 2022

Access to Document

10.1016/S1470-2045(22)00139-5

completeAccepted author manuscript, 492 KB

Cite this

Vergote, I., Gonzalez-Martin, A., Lorusso, D., Gourley, C., Raza Mirza, M., Kurtz, J-E., Okamoto, A., Moore, K., Kridelka, F., McNeish, I., Reuss, A., Votan, B., du Bois, A., Mahner, S., Ray-Coquard, I., C. Kohn, E., S Berek, J., SP Tan, D., Colombo, N., ... Bookman, M. A. (2022). Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup. The Lancet Oncology, 23(8), e374-e384. https://doi.org/10.1016/S1470-2045(22)00139-5

@article{7937fcbb6adb48b2a5ed8b9f4cc0625b,

title = "Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup",

abstract = "The Gynecologic Cancer InterGroup (GCIG) sixth Ovarian Cancer Conference on Clinical Research was held virtually in October, 2021, following published consensus guidelines. The goal of the consensus meeting was to achieve harmonisation on the design elements of upcoming trials in ovarian cancer, to select important questions for future study, and to identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and adoption of 20 statements within four topic groups on clinical research in ovarian cancer including first line treatment, recurrent disease, disease subgroups, and future trials. Unanimous consensus was obtained for 14 of 20 statements, with greater than 90% concordance in the remaining six statements. The high acceptance rate following active deliberation among the GCIG groups confirmed that a consensus process could be applied in a virtual setting. Together with detailed categorisation of unmet needs, these consensus statements will promote the harmonisation of international clinical research in ovarian cancer.",

author = "Ignace Vergote and Antonio Gonzalez-Martin and Domenica Lorusso and Charlie Gourley and {Raza Mirza}, Mansoor and Jean-Emmanuel Kurtz and Aikou Okamoto and Kathleen Moore and Fr{\'e}d{\'e}ric Kridelka and Iain McNeish and Alexander Reuss and B{\'e}n{\'e}dicte Votan and {du Bois}, Andreas and Sven Mahner and Isabelle Ray-Coquard and {C. Kohn}, Elise and {S Berek}, Jonathan and {SP Tan}, David and Nicoletta Colombo and Rongyu Zang and Nicole Concin and Dearbhaile O'Donnell and Alejandro Rauh-Hain and Herrington, {C Simon} and Christian Marth and Andres Poveda and Keiichi Fujiwara and {C.E Stuart}, Gavin and Amit Oza and Bookman, {Michael A}",

note = "Funding Information: We thank Katherine Bennett and Jennifer O'Donnell of the GCIG (Kingston, ON, Canada), and Sherill Osborne of The Emmes Company (Rockville, MD, USA) for their technical and administrative support, and Nancy Trolin, Heidi Camps, and Hanne Geleyns of the University Hospitals Leuven (Leuven, Belgium) for their administrative support. For the audio-visual support for the sixth Ovarian Cancer Conference on Clinical Research meeting held in October, 2021, we thank Wim Zwarts, Kit Serverius, Erik van Eycken, Jens Maes, and Marc Krottje of Diverze (Bonheiden, Belgium). This work was supported by unrestricted grants from AstraZeneca (Cambridge, UK), Chugai Pharmaceutical (Tokyo, Japan), Clovis Oncology (Boulder CO, USA), GlaxoSmithKline (Brentford, UK), Immunogen (Waltham MA, USA), Karyopharm (Newton MA, USA), Merck Sharp & Dohme Corp (Kenilworth NJ, USA), Novocure (Jersey, UK), Hoffmann-La Roche (Basel, Switzerland), PharmaMar (Madrid, Spain), Seagen (Zug, Switzerland), Takeda (Osaka, Japan), and Zeria Pharmaceutical (Tokyo, Japan). The funders had no role in the agenda or presentations at the sixth Ovarian Cancer Conference on Clinical Research meeting, or in the development of this paper or the consensus statements presented. Funding Information: We thank Katherine Bennett and Jennifer O'Donnell of the GCIG (Kingston, ON, Canada), and Sherill Osborne of The Emmes Company (Rockville, MD, USA) for their technical and administrative support, and Nancy Trolin, Heidi Camps, and Hanne Geleyns of the University Hospitals Leuven (Leuven, Belgium) for their administrative support. For the audio-visual support for the sixth Ovarian Cancer Conference on Clinical Research meeting held in October, 2021, we thank Wim Zwarts, Kit Serverius, Erik van Eycken, Jens Maes, and Marc Krottje of Diverze (Bonheiden, Belgium). This work was supported by unrestricted grants from AstraZeneca (Cambridge, UK), Chugai Pharmaceutical (Tokyo, Japan), Clovis Oncology (Boulder CO, USA), GlaxoSmithKline (Brentford, UK), Immunogen (Waltham MA, USA), Karyopharm (Newton MA, USA), Merck Sharp & Dohme Corp (Kenilworth NJ, USA), Novocure (Jersey, UK), Hoffmann-La Roche (Basel, Switzerland), PharmaMar (Madrid, Spain), Seagen (Zug, Switzerland), Takeda (Osaka, Japan), and Zeria Pharmaceutical (Tokyo, Japan). The funders had no role in the agenda or presentations at the sixth Ovarian Cancer Conference on Clinical Research meeting, or in the development of this paper or the consensus statements presented. Funding Information: IV reports grants from Amgen and Roche for corporate-sponsored research; payment (institutional) for contracted research from Oncoinvent and Genmab; consulting fees (institutional) from Amgen (Europe), AstraZeneca, Clovis Oncology, Carrick Therapeutics, Deciphera Pharmaceuticals, Elevar Therapeutics, F Hoffmann-La Roche, Genmab, GlaxoSmithKline, Immunogen, Mersana, Millennium Pharmaceuticals, MSD, Novocure, Octimet Oncology, Oncoinvent, Sotio, Verastem Oncology, and Zentalis; consulting fees from Deciphera Pharmaceuticals, Jazzpharma, Oncoinvent; honoraria from Agenus, Aksebio, AstraZeneca, Bristol Myers Squibb (BMS), Deciphera Pharmaceuticals, Eisai, F Hoffmann-La Roche, Genmab, GlaxoSmithKline, Immunogen, Jazzpharma, Karyopharm, MSD, Novocure, Novartis, Oncoinvent, Seagen, and Sotio; participation on a data safety monitoring board or advisory board for Agenus, AstraZeneca, BMS, Deciphera Pharmaceuticals, Eisai, F Hoffmann-La Roche, Genmab, GlaxoSmithKline, Immunogen, MSD, Novocure, Novartis, Seagen, and Sotio; and travel support from Amgen, MSD, Tesaro, AstraZeneca, and Roche. AG-M reports grants from Tesaro/GlaxoSmithKline, and Roche (funding for IST trial); consulting fees from Alkermes, Amgen, AstraZeneca, Clovis Oncology, Genmab, GlaxoSmithKline, ImmunoGen, Merck Sharp & Dohme, Novartis, Oncoinvent, Pfizer/Merck, PharmaMar, Roche, Sotio, and Sutro; honoraria from AstraZeneca, PharmaMar, Roche, GlaxoSmithKline, and Clovis; meeting or travel support from AstraZeneca, Pharmamar Roche, and Tesaro; participation on a data safety monitoring board or advisory board for Alkermes, Amgen, AstraZeneca, Clovis Oncology, Genmab, GlaxoSmithKline, ImmunoGen, Merck Sharp & Dohme, Novartis, Oncoinvent, Pfizer/Merck, PharmaMar, Roche, Sotio, and Sutro; is a member of GEICO; and was Chair of the European Network for Gynaecological Oncological Trials (ENGOT; 2018–20). DL reports grants from GlaxoSmithKline, MSD, and Clovis Oncology; consulting fees from Pharmamar and Merck Serono; honoraria from GlaxoSmithKline, Clovis Oncology, AstraZeneca, and MSD; payment for expert testimony from Clovis Oncology; meeting or travel support from GlaxoSmithKline, Roche, and Pharmamar; participation on a data safety monitoring board or advisory board for Novartis, Seagen, MSD, AstraZeneca, Immunogen, Genmab, Amgen, Clovis Oncology, GlaxoSmithKline, and Merck Serono; and is Chair of the Gynecological Cancer Accademy and on the board of directors of the GCIG. CG reports grants (institutional) for preclinical, clinical, or translational research from AstraZeneca, Novartis, GlaxoSmithKline, Tesaro, Clovis, MSD, BergenBio, Aprea, Nucana, and Medannexin; consulting fees from AstraZeneca, MSD, GlaxoSmithKline, and Tesaro; honoraria for lectures or presentations from AstraZeneca, MSD, GlaxoSmithKline, Tesaro, Clovis, Roche, Nucana, Chugai, Takeda, and Cor2Ed (preparation of educational material); advisory board attendance for AstraZeneca, MSD, GlaxoSmithKline, Tesaro, Roche, Nucana, and Chugai; and is a committee member of the Scottish Medicines Consortium. MRM reports research grants from AstraZeneca, Ultimovacs, Apexigen, and GlaxoSmithKline; honoraria as invited speaker for AstraZeneca and GlaxoSmithKline; participation on advisory boards for AstraZeneca, GlaxoSmithKline, Karyopharm, Nuvation Bio, Roche, Zailab, Merck, Biocad, and Boehringer Ingelheim; is a member of the board of directors for Karyopharm and Sera Prognostics; owns stocks or shares in Karyopharm and Sera Prognostics; and is Study Chair (institutional) for Deciphara and Mersana. J-EK reports honoraria from Clovis; meeting or travel support from AstraZeneca and GlaxoSmithKline; and participation on a data safety monitoring board or advisory board for AstraZeneca and GlaxoSmithKline. AO reports grants (institutional) from Kaken, Chugai, Tsumura & Co, Daiichi Sankyo, Shinnihonseiyaku, Mochida, CMIC Holdings, ASKA, Takeda, Pfizer, AstraZeneca, Terumo, MSD, Fuji Pharma, Kissei, Meiji Holdings, Taiho, Nippon Shinyaku, Linical, and Gyne Mom; and honoraria from Takeda, AstraZeneca, Zeria, MSD, Chugai, Kaken, and Eisai. KM reports consulting fees from Aravive, AstraZeneca, Alkemeres, Blueprint Pharma, Elevar, Eisai/Serono, GlaxoSmithKline/Tesaro, Genentech/Roche, Immunogen, IMab, Lilly, Mereo, Merck, Mersana, Myriad, OncXerna, Onconova, Tarveda, and VBL Therapeutics; honoraria from AstraZeneca, PTC Therapeutics, OncLive, Research to Practice, and Medscape; participation on a data safety monitoring board or advisory board for Incyte and SQZ Biotech; and is the Gynecologic Oncology Group Partners Associate Director and NRG (NSABP, RTOG and GOG) Ovarian Cancer Subcommittee Chair. FK reports consulting fees and honoraria from AstraZeneca, Pharmamar, Roche, Lilly, and Merck; participation on a data safety monitoring board or advisory board for AstraZeneca and Pharmamar; and is a BGOG steering committee member. IM reports honoraria from GlaxoSmithKline and AstraZeneca; participation on an advisory board for Clovis Oncology, AstraZeneca, and GlaxoSmithKline/Tesaro; and is part of the data monitoring committee for Transgene. AdB reports honoraria from AstraZeneca, Zodiac, GlaxoSmithKline/Tesaro, Clovis, Amgen, and MSD; participation on a data safety monitoring board or advisory board for AstraZeneca, Roche, GlaxoSmithKline/Tesaro, Clovis, Amgen, GenMab, and MSD; and is a member of the AGO Study Group and ENGOT. SM reports grants (institutional), consulting fees (institutional), honoraria (institutional), and meeting or travel support from AbbVie, AstraZeneca, Clovis, Eisai, GlaxoSmithKline, Medac, MSD, Novartis, Olympus, PharmaMar, Pfizer, Roche, Sensor Kinesis, Teva, and Tesaro. IR-C reports honoraria from Amgen, AstraZeneca, BMS, Clovis Oncology, Genmab, GlaxoSmithKline, ImmunoGen, Merck Sharp & Dohme, Novartis, Pfizer/Merck-Sereno, Deciphera, Mersana, Agenus, PharmaMar, and Roche; meeting and travel support from Roche, AstraZeneca, GlaxoSmithKline, Clovis, and MSD; and is President of the GINECO group. JSB reports research grants from Immunogen and Tesaro; and participation on a data safety monitoring board or advisory board for ENGOT (MK-7339-001 ENGOT-ov43 Safety DMC MK-3475 B96 DMC) and OncoQuest. DSPT reports grants or contracts (institutional) from National Medical Research Council Singapore, Karyopharm Therapeutics, Pangestu Family Foundation Gynaecological Cancer Research Fund, BMS, AstraZeneca, Roche, Bayer; consulting fees from AstraZeneca, Bayer, Eisai, Merck Serono, GlaxoSmithKline, Genentech/Roche, MSD, and Genmab; honoraria from AstraZeneca, GlaxoSmithKline, Roche, Eisai, MSD, Merck Serono; is the President of GCGS and APGOT Chair; and has stock or stock options in Asian Microbiome Library. NCol reports provision of study materials (personal); consulting fees (personal) from Roche, PharmaMar, AstraZeneca, Clovis Oncology, MSD, GlaxoSmithKline, Tesaro, Pfizer, BIOCAD, Immunogen, Mersana, Eisai, and Oncxerna; and honoraria (personal) from AstraZeneca, Tesaro, Novartis, Clovis, MSD, GlaxoSmithKline, and Eisai. NCon reports consulting fees from Seagen, Akesobio, Ensai, GlaxoSmithKline, AstraZeneca, Mersana, Seattle Genetics, and eTheRNA Immunotherapies; honoraria from GlaxoSmithKline, Mersana, MSD, Medscape Oncology, AstraZeneca, and TouchIME; meeting and travel support from Roche, Genmab, and Amgen; participation on a data safety monitoring board or advisory board for Seagen, Akesobio, Ensai, GlaxoSmithKline, AstraZeneca, Mersana, Seattle Genetics, and eTheRNA Immunotherapies; and is President of the European Society of Gynaecological Oncology and Co-Chair of the ENGOT Early Drug Development Network. AR-H reports support for the present manuscript and grants from the US National Institutes of Health National Cancer Institute (K08 CA234333). CM reports consulting fees from Roche, Novartis, Amgen, MSD, AstraZeneca, Pfizer, Pharmamar, Curelean, Vertex, Tesaro, GlaxoSmithKline, and Seagen; honoraria from Roche, Novartis, Amgen, MSD, Pharmamar, AstraZeneca, Tesaro, GlaxoSmithKline, and Seagen; meeting or travel support from Roche and AstraZeneca; and participation on data safety monitoring board or advisory board for Roche, Novartis, Amgen, MSD, AstraZeneca, Pfizer, Pharmamar, Cerulean, Vertex, Tesaro, GlaxoSmithKline, and Seagen. AP reports participation on an advisory board (personal payment) from AstraZeneca and GlaxoSmithKline. KF reports participation on a data safety monitoring board or advisory board for Merck (ENGOT-en11/MK-3475-B21/GOG-3053); and is a member of GenomeBC. GCES reports participation on a data safety monitoring board or advisory board for Merck (ENGOT-en11/MK-3475-B21/GOG-3053); and is a member of GenomeBC. AMO is Chair or GCIG (unpaid) and Chief Executive Officer of Ozmosis Research (unpaid). MAB reports participation on a data safety monitoring board or advisory board (institutional) for Aravive (protocol steering committee), Immunogen, Genentech, Merck, and Sharp & Dohme. All other authors declare no competing interests. Publisher Copyright: {\textcopyright} 2022 Elsevier Ltd",

year = "2022",

month = jul,

day = "25",

doi = "10.1016/S1470-2045(22)00139-5",

language = "English",

volume = "23",

pages = "e374--e384",

journal = "The Lancet Oncology",

issn = "1470-2045",

publisher = "Lancet Publishing Group",

number = "8",

}

Vergote, I, Gonzalez-Martin, A, Lorusso, D, Gourley, C, Raza Mirza, M, Kurtz, J-E, Okamoto, A, Moore, K, Kridelka, F, McNeish, I, Reuss, A, Votan, B, du Bois, A, Mahner, S, Ray-Coquard, I, C. Kohn, E, S Berek, J, SP Tan, D, Colombo, N, Zang, R, Concin, N, O'Donnell, D, Rauh-Hain, A, Herrington, CS, Marth, C, Poveda, A, Fujiwara, K, C.E Stuart, G, Oza, A & Bookman, MA 2022, 'Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup', The Lancet Oncology, vol. 23, no. 8, pp. e374-e384. https://doi.org/10.1016/S1470-2045(22)00139-5

TY - JOUR

T1 - Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup

AU - Vergote, Ignace

AU - Gonzalez-Martin, Antonio

AU - Lorusso, Domenica

AU - Gourley, Charlie

AU - Raza Mirza, Mansoor

AU - Kurtz, Jean-Emmanuel

AU - Okamoto, Aikou

AU - Moore, Kathleen

AU - Kridelka, Frédéric

AU - McNeish, Iain

AU - Reuss, Alexander

AU - Votan, Bénédicte

AU - du Bois, Andreas

AU - Mahner, Sven

AU - Ray-Coquard, Isabelle

AU - C. Kohn, Elise

AU - S Berek, Jonathan

AU - SP Tan, David

AU - Colombo, Nicoletta

AU - Zang, Rongyu

AU - Concin, Nicole

AU - O'Donnell, Dearbhaile

AU - Rauh-Hain, Alejandro

AU - Herrington, C Simon

AU - Marth, Christian

AU - Poveda, Andres

AU - Fujiwara, Keiichi

AU - C.E Stuart, Gavin

AU - Oza, Amit

AU - Bookman, Michael A

N1 - Funding Information: We thank Katherine Bennett and Jennifer O'Donnell of the GCIG (Kingston, ON, Canada), and Sherill Osborne of The Emmes Company (Rockville, MD, USA) for their technical and administrative support, and Nancy Trolin, Heidi Camps, and Hanne Geleyns of the University Hospitals Leuven (Leuven, Belgium) for their administrative support. For the audio-visual support for the sixth Ovarian Cancer Conference on Clinical Research meeting held in October, 2021, we thank Wim Zwarts, Kit Serverius, Erik van Eycken, Jens Maes, and Marc Krottje of Diverze (Bonheiden, Belgium). This work was supported by unrestricted grants from AstraZeneca (Cambridge, UK), Chugai Pharmaceutical (Tokyo, Japan), Clovis Oncology (Boulder CO, USA), GlaxoSmithKline (Brentford, UK), Immunogen (Waltham MA, USA), Karyopharm (Newton MA, USA), Merck Sharp & Dohme Corp (Kenilworth NJ, USA), Novocure (Jersey, UK), Hoffmann-La Roche (Basel, Switzerland), PharmaMar (Madrid, Spain), Seagen (Zug, Switzerland), Takeda (Osaka, Japan), and Zeria Pharmaceutical (Tokyo, Japan). The funders had no role in the agenda or presentations at the sixth Ovarian Cancer Conference on Clinical Research meeting, or in the development of this paper or the consensus statements presented. Funding Information: We thank Katherine Bennett and Jennifer O'Donnell of the GCIG (Kingston, ON, Canada), and Sherill Osborne of The Emmes Company (Rockville, MD, USA) for their technical and administrative support, and Nancy Trolin, Heidi Camps, and Hanne Geleyns of the University Hospitals Leuven (Leuven, Belgium) for their administrative support. For the audio-visual support for the sixth Ovarian Cancer Conference on Clinical Research meeting held in October, 2021, we thank Wim Zwarts, Kit Serverius, Erik van Eycken, Jens Maes, and Marc Krottje of Diverze (Bonheiden, Belgium). This work was supported by unrestricted grants from AstraZeneca (Cambridge, UK), Chugai Pharmaceutical (Tokyo, Japan), Clovis Oncology (Boulder CO, USA), GlaxoSmithKline (Brentford, UK), Immunogen (Waltham MA, USA), Karyopharm (Newton MA, USA), Merck Sharp & Dohme Corp (Kenilworth NJ, USA), Novocure (Jersey, UK), Hoffmann-La Roche (Basel, Switzerland), PharmaMar (Madrid, Spain), Seagen (Zug, Switzerland), Takeda (Osaka, Japan), and Zeria Pharmaceutical (Tokyo, Japan). The funders had no role in the agenda or presentations at the sixth Ovarian Cancer Conference on Clinical Research meeting, or in the development of this paper or the consensus statements presented. Funding Information: IV reports grants from Amgen and Roche for corporate-sponsored research; payment (institutional) for contracted research from Oncoinvent and Genmab; consulting fees (institutional) from Amgen (Europe), AstraZeneca, Clovis Oncology, Carrick Therapeutics, Deciphera Pharmaceuticals, Elevar Therapeutics, F Hoffmann-La Roche, Genmab, GlaxoSmithKline, Immunogen, Mersana, Millennium Pharmaceuticals, MSD, Novocure, Octimet Oncology, Oncoinvent, Sotio, Verastem Oncology, and Zentalis; consulting fees from Deciphera Pharmaceuticals, Jazzpharma, Oncoinvent; honoraria from Agenus, Aksebio, AstraZeneca, Bristol Myers Squibb (BMS), Deciphera Pharmaceuticals, Eisai, F Hoffmann-La Roche, Genmab, GlaxoSmithKline, Immunogen, Jazzpharma, Karyopharm, MSD, Novocure, Novartis, Oncoinvent, Seagen, and Sotio; participation on a data safety monitoring board or advisory board for Agenus, AstraZeneca, BMS, Deciphera Pharmaceuticals, Eisai, F Hoffmann-La Roche, Genmab, GlaxoSmithKline, Immunogen, MSD, Novocure, Novartis, Seagen, and Sotio; and travel support from Amgen, MSD, Tesaro, AstraZeneca, and Roche. AG-M reports grants from Tesaro/GlaxoSmithKline, and Roche (funding for IST trial); consulting fees from Alkermes, Amgen, AstraZeneca, Clovis Oncology, Genmab, GlaxoSmithKline, ImmunoGen, Merck Sharp & Dohme, Novartis, Oncoinvent, Pfizer/Merck, PharmaMar, Roche, Sotio, and Sutro; honoraria from AstraZeneca, PharmaMar, Roche, GlaxoSmithKline, and Clovis; meeting or travel support from AstraZeneca, Pharmamar Roche, and Tesaro; participation on a data safety monitoring board or advisory board for Alkermes, Amgen, AstraZeneca, Clovis Oncology, Genmab, GlaxoSmithKline, ImmunoGen, Merck Sharp & Dohme, Novartis, Oncoinvent, Pfizer/Merck, PharmaMar, Roche, Sotio, and Sutro; is a member of GEICO; and was Chair of the European Network for Gynaecological Oncological Trials (ENGOT; 2018–20). DL reports grants from GlaxoSmithKline, MSD, and Clovis Oncology; consulting fees from Pharmamar and Merck Serono; honoraria from GlaxoSmithKline, Clovis Oncology, AstraZeneca, and MSD; payment for expert testimony from Clovis Oncology; meeting or travel support from GlaxoSmithKline, Roche, and Pharmamar; participation on a data safety monitoring board or advisory board for Novartis, Seagen, MSD, AstraZeneca, Immunogen, Genmab, Amgen, Clovis Oncology, GlaxoSmithKline, and Merck Serono; and is Chair of the Gynecological Cancer Accademy and on the board of directors of the GCIG. CG reports grants (institutional) for preclinical, clinical, or translational research from AstraZeneca, Novartis, GlaxoSmithKline, Tesaro, Clovis, MSD, BergenBio, Aprea, Nucana, and Medannexin; consulting fees from AstraZeneca, MSD, GlaxoSmithKline, and Tesaro; honoraria for lectures or presentations from AstraZeneca, MSD, GlaxoSmithKline, Tesaro, Clovis, Roche, Nucana, Chugai, Takeda, and Cor2Ed (preparation of educational material); advisory board attendance for AstraZeneca, MSD, GlaxoSmithKline, Tesaro, Roche, Nucana, and Chugai; and is a committee member of the Scottish Medicines Consortium. MRM reports research grants from AstraZeneca, Ultimovacs, Apexigen, and GlaxoSmithKline; honoraria as invited speaker for AstraZeneca and GlaxoSmithKline; participation on advisory boards for AstraZeneca, GlaxoSmithKline, Karyopharm, Nuvation Bio, Roche, Zailab, Merck, Biocad, and Boehringer Ingelheim; is a member of the board of directors for Karyopharm and Sera Prognostics; owns stocks or shares in Karyopharm and Sera Prognostics; and is Study Chair (institutional) for Deciphara and Mersana. J-EK reports honoraria from Clovis; meeting or travel support from AstraZeneca and GlaxoSmithKline; and participation on a data safety monitoring board or advisory board for AstraZeneca and GlaxoSmithKline. AO reports grants (institutional) from Kaken, Chugai, Tsumura & Co, Daiichi Sankyo, Shinnihonseiyaku, Mochida, CMIC Holdings, ASKA, Takeda, Pfizer, AstraZeneca, Terumo, MSD, Fuji Pharma, Kissei, Meiji Holdings, Taiho, Nippon Shinyaku, Linical, and Gyne Mom; and honoraria from Takeda, AstraZeneca, Zeria, MSD, Chugai, Kaken, and Eisai. KM reports consulting fees from Aravive, AstraZeneca, Alkemeres, Blueprint Pharma, Elevar, Eisai/Serono, GlaxoSmithKline/Tesaro, Genentech/Roche, Immunogen, IMab, Lilly, Mereo, Merck, Mersana, Myriad, OncXerna, Onconova, Tarveda, and VBL Therapeutics; honoraria from AstraZeneca, PTC Therapeutics, OncLive, Research to Practice, and Medscape; participation on a data safety monitoring board or advisory board for Incyte and SQZ Biotech; and is the Gynecologic Oncology Group Partners Associate Director and NRG (NSABP, RTOG and GOG) Ovarian Cancer Subcommittee Chair. FK reports consulting fees and honoraria from AstraZeneca, Pharmamar, Roche, Lilly, and Merck; participation on a data safety monitoring board or advisory board for AstraZeneca and Pharmamar; and is a BGOG steering committee member. IM reports honoraria from GlaxoSmithKline and AstraZeneca; participation on an advisory board for Clovis Oncology, AstraZeneca, and GlaxoSmithKline/Tesaro; and is part of the data monitoring committee for Transgene. AdB reports honoraria from AstraZeneca, Zodiac, GlaxoSmithKline/Tesaro, Clovis, Amgen, and MSD; participation on a data safety monitoring board or advisory board for AstraZeneca, Roche, GlaxoSmithKline/Tesaro, Clovis, Amgen, GenMab, and MSD; and is a member of the AGO Study Group and ENGOT. SM reports grants (institutional), consulting fees (institutional), honoraria (institutional), and meeting or travel support from AbbVie, AstraZeneca, Clovis, Eisai, GlaxoSmithKline, Medac, MSD, Novartis, Olympus, PharmaMar, Pfizer, Roche, Sensor Kinesis, Teva, and Tesaro. IR-C reports honoraria from Amgen, AstraZeneca, BMS, Clovis Oncology, Genmab, GlaxoSmithKline, ImmunoGen, Merck Sharp & Dohme, Novartis, Pfizer/Merck-Sereno, Deciphera, Mersana, Agenus, PharmaMar, and Roche; meeting and travel support from Roche, AstraZeneca, GlaxoSmithKline, Clovis, and MSD; and is President of the GINECO group. JSB reports research grants from Immunogen and Tesaro; and participation on a data safety monitoring board or advisory board for ENGOT (MK-7339-001 ENGOT-ov43 Safety DMC MK-3475 B96 DMC) and OncoQuest. DSPT reports grants or contracts (institutional) from National Medical Research Council Singapore, Karyopharm Therapeutics, Pangestu Family Foundation Gynaecological Cancer Research Fund, BMS, AstraZeneca, Roche, Bayer; consulting fees from AstraZeneca, Bayer, Eisai, Merck Serono, GlaxoSmithKline, Genentech/Roche, MSD, and Genmab; honoraria from AstraZeneca, GlaxoSmithKline, Roche, Eisai, MSD, Merck Serono; is the President of GCGS and APGOT Chair; and has stock or stock options in Asian Microbiome Library. NCol reports provision of study materials (personal); consulting fees (personal) from Roche, PharmaMar, AstraZeneca, Clovis Oncology, MSD, GlaxoSmithKline, Tesaro, Pfizer, BIOCAD, Immunogen, Mersana, Eisai, and Oncxerna; and honoraria (personal) from AstraZeneca, Tesaro, Novartis, Clovis, MSD, GlaxoSmithKline, and Eisai. NCon reports consulting fees from Seagen, Akesobio, Ensai, GlaxoSmithKline, AstraZeneca, Mersana, Seattle Genetics, and eTheRNA Immunotherapies; honoraria from GlaxoSmithKline, Mersana, MSD, Medscape Oncology, AstraZeneca, and TouchIME; meeting and travel support from Roche, Genmab, and Amgen; participation on a data safety monitoring board or advisory board for Seagen, Akesobio, Ensai, GlaxoSmithKline, AstraZeneca, Mersana, Seattle Genetics, and eTheRNA Immunotherapies; and is President of the European Society of Gynaecological Oncology and Co-Chair of the ENGOT Early Drug Development Network. AR-H reports support for the present manuscript and grants from the US National Institutes of Health National Cancer Institute (K08 CA234333). CM reports consulting fees from Roche, Novartis, Amgen, MSD, AstraZeneca, Pfizer, Pharmamar, Curelean, Vertex, Tesaro, GlaxoSmithKline, and Seagen; honoraria from Roche, Novartis, Amgen, MSD, Pharmamar, AstraZeneca, Tesaro, GlaxoSmithKline, and Seagen; meeting or travel support from Roche and AstraZeneca; and participation on data safety monitoring board or advisory board for Roche, Novartis, Amgen, MSD, AstraZeneca, Pfizer, Pharmamar, Cerulean, Vertex, Tesaro, GlaxoSmithKline, and Seagen. AP reports participation on an advisory board (personal payment) from AstraZeneca and GlaxoSmithKline. KF reports participation on a data safety monitoring board or advisory board for Merck (ENGOT-en11/MK-3475-B21/GOG-3053); and is a member of GenomeBC. GCES reports participation on a data safety monitoring board or advisory board for Merck (ENGOT-en11/MK-3475-B21/GOG-3053); and is a member of GenomeBC. AMO is Chair or GCIG (unpaid) and Chief Executive Officer of Ozmosis Research (unpaid). MAB reports participation on a data safety monitoring board or advisory board (institutional) for Aravive (protocol steering committee), Immunogen, Genentech, Merck, and Sharp & Dohme. All other authors declare no competing interests. Publisher Copyright: © 2022 Elsevier Ltd

PY - 2022/7/25

Y1 - 2022/7/25

N2 - The Gynecologic Cancer InterGroup (GCIG) sixth Ovarian Cancer Conference on Clinical Research was held virtually in October, 2021, following published consensus guidelines. The goal of the consensus meeting was to achieve harmonisation on the design elements of upcoming trials in ovarian cancer, to select important questions for future study, and to identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and adoption of 20 statements within four topic groups on clinical research in ovarian cancer including first line treatment, recurrent disease, disease subgroups, and future trials. Unanimous consensus was obtained for 14 of 20 statements, with greater than 90% concordance in the remaining six statements. The high acceptance rate following active deliberation among the GCIG groups confirmed that a consensus process could be applied in a virtual setting. Together with detailed categorisation of unmet needs, these consensus statements will promote the harmonisation of international clinical research in ovarian cancer.

AB - The Gynecologic Cancer InterGroup (GCIG) sixth Ovarian Cancer Conference on Clinical Research was held virtually in October, 2021, following published consensus guidelines. The goal of the consensus meeting was to achieve harmonisation on the design elements of upcoming trials in ovarian cancer, to select important questions for future study, and to identify unmet needs. All 33 GCIG member groups participated in the development, refinement, and adoption of 20 statements within four topic groups on clinical research in ovarian cancer including first line treatment, recurrent disease, disease subgroups, and future trials. Unanimous consensus was obtained for 14 of 20 statements, with greater than 90% concordance in the remaining six statements. The high acceptance rate following active deliberation among the GCIG groups confirmed that a consensus process could be applied in a virtual setting. Together with detailed categorisation of unmet needs, these consensus statements will promote the harmonisation of international clinical research in ovarian cancer.

U2 - 10.1016/S1470-2045(22)00139-5

DO - 10.1016/S1470-2045(22)00139-5

M3 - Article

VL - 23

SP - e374-e384

JO - The Lancet Oncology

JF - The Lancet Oncology

SN - 1470-2045

IS - 8

ER -

Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup

Abstract

Access to Document

Fingerprint

Cite this