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

Autor:	Vergote I; Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven, Belgium; University Hospitals Leuven, Leuven, Belgium. Electronic address: ignace.vergote@uzleuven.be., Gonzalez-Martin A; 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 D; Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples, Italy; Fondazione Policlinico Gemelli IRCCS, Rome, Italy., Gourley C; Scottish Gynaecological Cancer Trials Group (SGCTG), Cancer Research UK, Edinburgh, UK; Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK., Mirza MR; Nordic Society of Gynecologic Oncology Clinical Trial Unit (NSGO-CTU), Copenhagen, Denmark; Rigshospitalet, Copenhagen, Denmark., Kurtz JE; Groupe d'Investigateurs National des Etudes des Cancers Ovariens et du Sein (GINECO), Paris, France; Strasbourg Cancer Institute, Strasbourg, France., Okamoto A; Japanese Gynecologic Oncology Group (JGOG), Tokyo, Japan; The Jikei University School of Medicine, Tokyo, Japan., Moore K; Gynecologic Oncology Group-Foundation (GOG-F), Philadelphia, PA, USA; OU Health Stephenson Cancer Center, Oklahoma City, OH, USA., Kridelka F; Belgium and Luxembourg Gynaecological Oncology Group (BGOG), Leuven, Belgium; Centre Hospitalier Universitaire de Liège, Liège, Belgium., McNeish I; National Cancer Research Institute (NCRI), London, UK; Department of Surgery and Cancer, Imperial College London, London, UK., Reuss A; Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Study Group, Munich, Germany; Coordinating Center for Clinical Trials, Philipps University, Marburg, Germany., Votan B; Association de Recherche Cancers Gynécologiques (ARCAGY)-GINECO, Paris, France., du Bois A; Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Study Group, Munich, Germany; Kliniken Essen Mitte (KEM), Essen, Germany., Mahner S; Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Study Group, Munich, Germany; University Hospital, Ludwig Maximilians University, Munich, Germany., Ray-Coquard I; 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 EC; National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Berek JS; Women's Cancer Research Network-Cooperative Gynecologic Oncology Investigators (WCRN-COGI), Fresno, CA; Stanford Cancer Institute, Stanford, CA, USA., Tan DSP; 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 N; Mario Negri Gynecologic Oncology (MaNGO), Milan, Italy; European Institute of Oncology, Milan, Italy; University of Milano-Bicocca, Milan, Italy., Zang R; Shanghai Gynecologic Oncology Group (SGOG), Shanghai, China; Zhongshan Hospital, Fudan University, Shanghai, China., Concin N; AGO -Austria, Innsbruck, Austria; Kliniken Essen Mitte (KEM), Essen, Germany; Medical University of Innsbruck, Innsbruck, Austria., O'Donnell D; Cancer Trials Ireland (CTI), Dublin, Ireland; St James's Hospital, Dublin, Ireland., Rauh-Hain A; Global Gynecologic Oncology Consortium (G-GOC), Houston, TX, USA; MD Anderson Cancer Center, The University of Texas, Houston, TX, USA., Herrington CS; Scottish Gynaecological Cancer Trials Group (SGCTG), Cancer Research UK, Edinburgh, UK; Institute of Genetics and Cancer, University of Edinburgh, Edinburgh, UK., Marth C; AGO -Austria, Innsbruck, Austria; Medical University of Innsbruck, Innsbruck, Austria., Poveda A; Grupo Español de Cáncer de Ovario (GEICO), Madrid, Spain; Hospital Quironsalud, Valencia, Spain., Fujiwara K; Gynecologic Cancer Clinical Trials and Investigation Consortium (GOTIC), North Kanto, Japan; Saitama Medical University International Medical Center, Saitama, Japan., Stuart GCE; Canadian Cancer Trials Group (CCTG), Kingston, ON, Canada; University of British Columbia, Vancouver, BC, Canada., Oza AM; Princess Margaret Hospital Consortium (PMHC), Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada., Bookman MA; Gynecologic Oncology Group-Foundation (GOG-F), Philadelphia, PA, USA; San Francisco Medical Center, San Francisco, CA, USA.
Jazyk:	angličtina
Zdroj:	The Lancet. Oncology [Lancet Oncol] 2022 Aug; Vol. 23 (8), pp. e374-e384.
DOI:	10.1016/S1470-2045(22)00139-5
Abstrakt:	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. Competing Interests: Declaration of interests 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. (Copyright © 2022 Elsevier Ltd. All rights reserved.)
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