[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
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.
Bookman, MA, Okamoto, A, Stuart, G, et al. Harmonising clinical trials within the Gynecologic Cancer InterGroup: consensus and unmet needs from the Fifth Ovarian Cancer Consensus Conference. Ann Oncol 28:suppl (2017), viii30–viii35.
du Bois, A, Quinn, M, Thigpen, T, et al. 2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004). Ann Oncol 16 (2005), viii7–vii12.
Stuart, GC, Kitchener, H, Bacon, M, et al. Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer: report from the Fourth Ovarian Cancer Consensus Conference. Int J Gynecol Cancer 21 (2011), 750–755.
du Bois, A, Reuss, A, Pujade-Lauraine, E, Harter, P, Ray-Coquard, I, Pfisterer, J, Role of surgical outcome as prognostic factor in advanced epithelial ovarian cancer: a combined exploratory analysis of 3 prospectively randomized phase 3 multicenter trials: by the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and the Groupe d'Investigateurs Nationaux Pour les Etudes des Cancers de l'Ovaire (GINECO). Cancer 115 (2009), 1234–1244.
du Bois, A, Rochon, J, Pfisterer, J, Hoskins, WJ, Variations in institutional infrastructure, physician specialization and experience, and outcome in ovarian cancer: a systematic review. Gynecol Oncol 112 (2009), 422–436.
Bookman, M, Optimal primary therapy of ovarian cancer. Ann Oncol 27 (2016), 58–62.
Burger, RA, Brady, MF, Bookman, MA, et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med 365 (2011), 2473–2483.
Perren, TJ, Swart, AM, Pfisterer, J, et al. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med 365 (2011), 2484–2496.
Pignata, S, Scambia, G, Katsaros, D, et al. Carboplatin plus paclitaxel once a week versus every 3 weeks in patients with advanced ovarian cancer (MITO-7): a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol 15 (2014), 396–405.
Katsumata, N, Yasuda, M, Isonishi, S, et al. Long-term results of dose-dense paclitaxel and carboplatin versus conventional paclitaxel and carboplatin for treatment of advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer (JGOG 3016): a randomised, controlled, open-label trial. Lancet Oncol 14 (2013), 1020–1026.
Moore, K, Colombo, N, Scambia, G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med 27 (2018), 2495–2505.
Ray-Coquard, I, Pautier, P, Pignata, S, et al. Olaparib plus bevacizumab as first-line maintenance in ovarian cancer. N Engl J Med 19 (2019), 2416–2428.
González-Martín, A, Pothuri, B, Vergote, I, et al. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med 19 (2019), 2391–2402.
Colombo, N, Sessa, C, du Bois, A, et al. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease. Ann Oncology 30 (2019), 672–705.
Wilson, MK, Pujade-Lauraine, E, Aoki, D, et al. Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: recurrent disease. Ann Oncol 28 (2017), 727–732.
Frenel, JS, Kim, JW, Berton-Rigaud, D, et al. Efficacy of subsequent chemotherapy for patients with BRCA1/2 mutated platinum-sensitive recurrent epithelial ovarian cancer (EOC) progressing on olaparib vs placebo: the SOLO2/ENGOT Ov-21 trial. Ann Oncol 31:suppl (2020), 551–589 (abstr).
Aghajanian, C, Blank, SV, Goff, BA, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 30 (2012), 2039–2045.
Aghajanian, C, Goff, B, Nycum, LR, Wang, YV, Husain, A, Blank, SV, Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol 139 (2015), 10–16.
Coleman, RL, Brady, MF, Herzog, TJ, et al. Bevacizumab and paclitaxel–carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 18 (2017), 779–791.
Pfisterer, J, Shannon, CM, Baumann, K, et al. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol 21 (2020), 699–709.
Pignata, S, Lorusso, D, Joly, F, et al. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial. Lancet Oncol 22 (2021), 267–276.
Pujade-Lauraine, E, Selle, F, Scambia, G, et al. Maintenance olaparib rechallenge in patients (pts) with ovarian carcinoma (OC) previously treated with a PARP inhibitor (PARPi): phase IIIb OReO/ENGOT-ov38 trial. Ann Oncol 32:suppl (2021), S1283–S1346 (abstr).
Pujade-Lauraine, E, Fujiwara, K, Ledermann, JA, et al. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncol 22 (2021), 1034–1046.
Moore, KN, Oza, AM, Colombo, N, et al. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Ann Oncol 32 (2021), 757–765.
Gaillard, S, Oaknin, A, Ray-Coquard, I, et al. Lurbinectedin versus pegylated liposomal doxorubicin or topotecan in patients with platinum-resistant ovarian cancer: a multicenter, randomized, controlled, open-label phase 3 study (CORAIL). Gynecol Oncol 163 (2021), 237–245.
Omatsu, K, Hamanishi, J, Katsumata, N, et al. Nivolumab versus gemcitabine or pegylated liposomal doxorubicin for patients with platinum-resistant (advanced or recurrent) ovarian cancer: open-label, randomized trial in Japan (NINJA trial). Ann Oncol 31:suppl (2020), S551–S589.
Pujade-Lauraine, E, Hilpert, F, Weber, B, et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: the AURELIA open-label randomized phase III trial. J Clin Oncol 32 (2014), 1302–1308.
Oza, AM, Lisyanskaya, AS, Fedenko, AA, et al. Subgroup analysis of rucaparib versus chemotherapy as treatment for BRCA-mutated, advanced, relapsed ovarian carcinoma: effect of platinum sensitivity in the randomized, phase 3 study ARIEL4. Proc Am Soc Clin Oncol, 39(suppl), 2021, 5517 (abstr).
O'Malley, DM, Oaknin, A, Matulonis, UA, et al. Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients (pts) with platinum-agnostic ovarian cancer: final analysis. Proc Am Soc Clin Oncol, 39(suppl), 2021, 5504 (abstr).
Harter, P, Sehouli, J, Vergote, I, et al. Randomized trial of cytoreductive surgery for relapsed ovarian cancer. N Engl J Med 385 (2021), 2123–2131.
Coleman, RL, Spirtos, NM, Enserro, D, et al. Secondary surgical cytoreduction for recurrent ovarian cancer. N Engl J Med 381 (2019), 1929–1939.
Shi, T, Zhu, J, Feng, Y, et al. Secondary cytoreduction followed by chemotherapy versus chemotherapy alone in platinum-sensitive relapsed ovarian cancer (SOC-1): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 22 (2021), 439–449.
Hollis, RL, Stanley, B, Thomson, JP, et al. Integrated molecular characterisation of endometrioid ovarian carcinoma identifies opportunities for stratification. NPJ Precis Oncol, 5, 2021, 47.
Zhao, S, Bellone, S, Lopez, S, et al. Mutational landscape of uterine and ovarian carcinosarcomas implicates histone genes in epithelial–mesenchymal transition. Proc Natl Acad Sci 113 (2016), 12238–12243.
Cheung, AN, Ellenson, LH, Gilks, CB, et al. Tumours of the ovary. Female genital tumours, 5th edition. WHO classification of tumours editorial board, 2020, international agency for research on cancer, Lyon, 32–167.
Köbel, M, Bak, J, Bertelsen, BI, et al. Ovarian carcinoma histotype determination is highly reproducible, and is improved through the use of immunohistochemistry. Histopathology 64 (2014), 1004–1013.
Rambau, PF, McIntyre, JB, Taylor, J, et al. Morphologic reproducibility, genotyping, and immunohistochemical profiling do not support a category of seromucinous carcinoma of the ovary. Am J Surg Pathol 41 (2017), 685–695.
Ray-Coquard, I, Harter, P, Lorusso, D, et al. Effect of weekly paclitaxel with or without bevacizumab on progression-free rate among patients with relapsed ovarian sex cord-stromal tumors: the ALIENOR/ENGOT-ov7 randomized clinical trial. JAMA Oncol 6 (2020), 1923–1930.
Banerjee, SN, Tang, M, O'Connell, RL, et al. A phase 2 study of anastrozole in patients with oestrogen receptor and/progesterone receptor positive recurrent/metastatic granulosa cell tumours/sex-cord stromal tumours of the ovary: the PARAGON/ANZGOG 0903 trial. Gynecol Oncol 163 (2021), 72–78.
Monk, BJ, Grisham, RN, Banerjee, S, et al. MILO/ENGOT-ov11: binimetinib versus physician's choice chemotherapy in recurrent or persistent low-grade serous carcinomas of the ovary, fallopian tube, or primary peritoneum. J Clin Oncol 38 (2020), 3753–3762.
Gershenson, DM, Miller, A, Brady, WE, et al. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial. Lancet 39 (2022), 541–553.
Sugiyama, T, Okamoto, A, Enomoto, T, et al. Randomized phase III trial of irinotecan plus cisplatin compared with paclitaxel plus carboplatin as first-line chemotherapy for ovarian clear cell carcinoma: JGOG3017/GCIG trial. J Clin Oncol 34 (2016), 2881–2887.
Kurtz, JE, Kaminsky, MC, Floquet, A, et al. Ovarian cancer in elderly patients: carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in late relapse: a Gynecologic Cancer Intergroup (GCIG) CALYPSO sub-study. Ann Oncol 22 (2011), 2417–2423.
Dodd, LE, Korn, EL, Freidlin, B, et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?. J Clin Oncol 26 (2008), 3791–3796.
Shi, Q, Sargent, DJ, Key statistical concepts in cancer research. Clin Adv Hematol Oncol 13 (2015), 180–185.
Rahman, R, Fell, J, Ventz, S, et al. Deviation from the proportional hazards assumption in randomized phase 3 clinical trials in oncology: prevalence, associated factors, and implications. Clin Cancer Res 25 (2019), 6339–6345.
Basch, E, Reeve, BB, Mitchell, SA, et al. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst, 106, 2014, dju244.
Calvert, M, Kyte, D, Mercieca-Bebber, R, et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. JAMA 319 (2018), 483–494.
Calvert, M, Blazeby, J, Altman, DG, Revicki, DA, Moher, D, Brundage, MD, Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 309 (2013), 814–822.
Eisenhauer, EA, Therasse, P, Bogaerts, J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45 (2009), 228–247.