Article (Scientific journals)
Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup.
Vergote, Ignace; Gonzalez-Martin, Antonio; Lorusso, Domenica et al.
2022In The Lancet Oncology, 23 (8), p. 374 - e384
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Keywords :
Carcinoma, Ovarian Epithelial; Consensus; Female; Forecasting; Humans; Ovarian Neoplasms/therapy; Ovarian Neoplasms; Oncology
Abstract :
[en] 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.
Disciplines :
Oncology
Author, co-author :
Vergote, Ignace;  Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven, Belgium, University Hospitals Leuven, Leuven, Belgium. Electronic address: ignace.vergote@uzleuven.be
Gonzalez-Martin, Antonio;  Grupo Español de Cáncer de Ovario (GEICO), Madrid, Spain, Clinica Universidad de Navarra, Madrid, Spain, Program for Solid Tumors at Madrid, and Center for Applied Medical Research (CIMA), Universidad de Navarra, Pamplona, Spain
Lorusso, Domenica;  Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples, Italy, Fondazione Policlinico Gemelli IRCCS, Rome, Italy
Gourley, Charlie;  Scottish Gynaecological Cancer Trials Group (SGCTG), Cancer Research UK, Edinburgh, UK, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK
Mirza, Mansoor Raza;  Nordic Society of Gynecologic Oncology Clinical Trial Unit (NSGO-CTU), Copenhagen, Denmark, Rigshospitalet, Copenhagen, Denmark
Kurtz, Jean-Emmanuel;  Groupe d'Investigateurs National des Etudes des Cancers Ovariens et du Sein (GINECO), Paris, France, Strasbourg Cancer Institute, Strasbourg, France
Okamoto, Aikou;  Japanese Gynecologic Oncology Group (JGOG), Tokyo, Japan, The Jikei University School of Medicine, Tokyo, Japan
Moore, Kathleen;  Gynecologic Oncology Group-Foundation (GOG-F), Philadelphia, PA, USA, OU Health Stephenson Cancer Center, Oklahoma City, OH, USA
Kridelka, Frédéric ;  Centre Hospitalier Universitaire de Liège - CHU > > Service de gynécologie-obstétrique
McNeish, Iain;  National Cancer Research Institute (NCRI), London, UK, Department of Surgery and Cancer, Imperial College London, London, UK
Reuss, Alexander;  Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Study Group, Munich, Germany, Coordinating Center for Clinical Trials, Philipps University, Marburg, Germany
Votan, Bénédicte;  Association de Recherche Cancers Gynécologiques (ARCAGY)-GINECO, Paris, France
du Bois, Andreas;  Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Study Group, Munich, Germany, Kliniken Essen Mitte (KEM), Essen, Germany
Mahner, Sven;  Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Study Group, Munich, Germany, University Hospital, Ludwig Maximilians University, Munich, Germany
Ray-Coquard, Isabelle;  Groupe d'Investigateurs National des Etudes des Cancers Ovariens et du Sein (GINECO), Paris, France, Centre Leon Berard and University Claude Bernard Lyon I, Lyon, France
Kohn, Elise C;  National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
Berek, Jonathan S;  Women's Cancer Research Network-Cooperative Gynecologic Oncology Investigators (WCRN-COGI), Fresno, CA, Stanford Cancer Institute, Stanford, CA, USA
Tan, David S P;  Asia Pacific Gynecologic Oncology Trials Group (APGOT), Seoul, South Korea, Gynecologic Cancer Group Singapore (GCGS), Singapore, Cancer Science Institute, National University of Singapore, Singapore
Colombo, Nicoletta;  Mario Negri Gynecologic Oncology (MaNGO), Milan, Italy, European Institute of Oncology, Milan, Italy, University of Milano-Bicocca, Milan, Italy
Zang, Rongyu;  Shanghai Gynecologic Oncology Group (SGOG), Shanghai, China, Zhongshan Hospital, Fudan University, Shanghai, China
Concin, Nicole;  AGO -Austria, Innsbruck, Austria, Kliniken Essen Mitte (KEM), Essen, Germany, Medical University of Innsbruck, Innsbruck, Austria
O'Donnell, Dearbhaile;  Cancer Trials Ireland (CTI), Dublin, Ireland, St James's Hospital, Dublin, Ireland
Rauh-Hain, Alejandro;  Global Gynecologic Oncology Consortium (G-GOC), Houston, TX, USA, MD Anderson Cancer Center, The University of Texas, Houston, TX, USA
Herrington, C Simon;  Scottish Gynaecological Cancer Trials Group (SGCTG), Cancer Research UK, Edinburgh, UK, Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK
Marth, Christian;  AGO -Austria, Innsbruck, Austria, Medical University of Innsbruck, Innsbruck, Austria
Poveda, Andres;  Grupo Español de Cáncer de Ovario (GEICO), Madrid, Spain, Hospital Quironsalud, Valencia, Spain
Fujiwara, Keiichi;  Gynecologic Cancer Clinical Trials and Investigation Consortium (GOTIC), North Kanto, Japan, Saitama Medical University International Medical Center, Saitama, Japan
Stuart, Gavin C E;  Canadian Cancer Trials Group (CCTG), Kingston, ON, Canada, University of British Columbia, Vancouver, BC, Canada
Oza, Amit M;  Princess Margaret Hospital Consortium (PMHC), Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada
Bookman, Michael A;  Gynecologic Oncology Group-Foundation (GOG-F), Philadelphia, PA, USA, San Francisco Medical Center, San Francisco, CA, USA
participants of the 6th Gynecologic Cancer InterGroup (GCIG) Ovarian Cancer Consensus Conference on Clinical Research
More authors (21 more) Less
Language :
English
Title :
Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup.
Alternative titles :
[fr] Recherche clinique dans le cancer de l'ovaire: guidelines du GCIC
Original title :
[en] Clinical research in ovarian cancer: consensus recommendations from the Gynecologic Cancer InterGroup.
Publication date :
August 2022
Journal title :
The Lancet Oncology
ISSN :
1470-2045
eISSN :
1474-5488
Publisher :
Elsevier
Volume :
23
Issue :
8
Pages :
e374 - e384
Peer reviewed :
Peer Reviewed verified by ORBi
Funding text :
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.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.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.
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