Tumor Treating Fields therapy in platinum-resistant ovarian cancer: Results of the ENGOT-ov50/GOG-3029/INNOVATE-3 pivotal phase 3 randomized study

Ignace Vergote¹, Larry J Copeland², Toon Van Gorp³, Annouschka Laenen⁴, Giovanni Scambia⁵, Premal H Thaker⁶, David Cibula⁷, Nicoletta Colombo⁸, Jayanthi Lea⁹, Antonio Gonzalez-Martin¹⁰, Jacob Korach¹¹, Jalid Sehouli¹², Bradley J Monk¹³, Viola Heinzelmann-Schwarz¹⁴, Regina Berger¹⁵, Joseph Buscema¹⁶, Susie Lau¹⁷, Radoslaw Mądry¹⁸, Hannelore Denys¹⁹, Jessica Thomes Pepin²⁰, Vanda Salutari²¹, Andrea Bagaméri²², Antonio Ardizzoia²³, Stéphanie Henry²⁴, Sabrina Chiara Cecere²⁵, Martin Hruda²⁶, David A Iglesias²⁷, Luis Manso²⁸, Ayelet Shai²⁹, David M O'Malley³⁰; ENGOT-ov50/GOG-3029/INNOVATE-3 Study Investigators

Affiliations

¹ Division of Gynecological Oncology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, and Luxembourg Gynaecological Oncology Group, Belgium. Electronic address: ignace.vergote@uzleuven.be.
² The Ohio State University and James Cancer Center, Division of Gynecologic Oncology, Columbus, OH, USA. Electronic address: Larry.Copeland@osumc.edu.
³ Division of Gynecological Oncology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, and Luxembourg Gynaecological Oncology Group, Belgium. Electronic address: toon.vangorp@uzleuven.be.
⁴ Division of Gynecological Oncology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, and Luxembourg Gynaecological Oncology Group, Belgium. Electronic address: annouschka.laenen@kuleuven.be.
⁵ Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Gynecologic Oncology Unit, Roma, Italy. Electronic address: giovanni.scambia@policlinicogemelli.it.
⁶ Washington University School of Medicine and Siteman Cancer Center, St. Louis, MO, USA. Electronic address: thakerp@wustl.edu.
⁷ Department of Gynaecology, Obstetrics and Neonatology, General University Hospital in Prague, First Faculty of Medicine, Charles University, Prague, Czech Republic. Electronic address: dc@davidcibula.cz.
⁸ Gynecologic Oncology Program, European Institute of Oncology IRCCS, Milan, Italy; Department of Medicine and Surgery, University of Milan-Bicocca, Italy. Electronic address: nicoletta.colombo@ieo.it.
⁹ Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: Jayanthi.Lea@UTSouthwestern.edu.
¹⁰ Medical Oncology Department, Translational Oncology Group, Cima Universidad de Navarra, Cancer Center Clínica Universidad de Navarra, Madrid, Spain. Electronic address: agonzalezma@unav.es.
¹¹ Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel. Electronic address: Jacob.Korach@sheba.health.gov.il.
¹² Department of Gynecology with Center of Gynecological Oncology, Charité, University Medicine of Berlin, Berlin, Germany. Electronic address: jalid.sehouli@charite.de.
¹³ Florida Cancer Specialists and Research Institute, West Palm Beach, FL, USA. Electronic address: bmonk@gog.org.
¹⁴ Gynecological Tumor Center, University Hospital Basel, Basel, Switzerland. Electronic address: Viola.Heinzelmann@usb.ch.
¹⁵ Department of Obstetrics and Gynaecology, Medical University of Innsbruck, Innsbruck, Austria; AGO Austria, Arbeitsgemeinschaft Gynäkologische Onkologie Österreich, Vienna, Austria. Electronic address: regina.berger@tirol-kliniken.at.
¹⁶ Arizona Oncology Associates, PC - HOPE - USOR, Tucson, AZ, USA. Electronic address: Joseph.Buscema@USOncology.com.
¹⁷ McGill University, Jewish General Hospital, Montreal, Quebec, Canada. Electronic address: susie.lau@mcgill.ca.
¹⁸ Department of Gynecological Oncology, Poznan University of Medical Sciences, Poznan, Poland. Electronic address: radoslaw.madry@skpp.edu.pl.
¹⁹ Department of Medical Oncology, University Hospital Ghent, Belgium. Electronic address: Hannelore.Denys@UGent.be.
²⁰ Minnesota Oncology, PA - USOR, Maplewood, MN, USA. Electronic address: Jessica.ThomesPepin@usoncology.com.
²¹ Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy. Electronic address: vanda.salutari@policlinicogemelli.it.
²² Gynecologic Oncology Department, National Institute of Oncology, Budapest, Hungary. Electronic address: bagameria@t-email.hu.
²³ Ospedale Alessandro Manzoni-ASST Lecco, Lecco, Italy. Electronic address: a.ardizzoia@asst-lecco.it.
²⁴ Belgium and Luxembourg Gynaecological Oncology Group (BGOG) and Université Catholique de Louvain CHU UCL Namur Site Ste Elisabeth, Service d'onco-hématologie (SORMIN), Namur, Belgium. Electronic address: stephanie.henry@chuuclnamur.uclouvain.be.
²⁵ Uro-Gynecological Department National Cancer Institute of Naples, Naples, Italy. Electronic address: s.cecere@istitutotumori.na.it.
²⁶ Department of Gynecology and Obstetrics, Third Faculty of Medicine and University Hospital Kralovske Vinohrady, Prague, Czechia. Electronic address: martin.hruda@fnkv.cz.
²⁷ Division of Gynecologic Oncology, University of Florida, Gainesville, FL, USA. Electronic address: iglesiad@ufl.edu.
²⁸ Medical Oncology Department, Hospital Universitario, 12 de Octubre, Madrid, Spain. Electronic address: lmanso@salud.madrid.org.
²⁹ RAMBAM Health Care Campus, Technion Israel Institute of Technology, Haifa, Israel. Electronic address: A_SHAI@rambam.health.gov.il.
³⁰ The Ohio State University and James Cancer Center, Division of Gynecologic Oncology, Columbus, OH, USA. Electronic address: David.O'Malley@osumc.edu.

PMID: 40010134
DOI: 10.1016/j.ejca.2025.115306

Free article

Clinical Trial

Tumor Treating Fields therapy in platinum-resistant ovarian cancer: Results of the ENGOT-ov50/GOG-3029/INNOVATE-3 pivotal phase 3 randomized study

Ignace Vergote et al. Eur J Cancer. 2025.

Free article

. 2025 Mar 26:219:115306.

doi: 10.1016/j.ejca.2025.115306. Epub 2025 Feb 17.

Authors

Affiliations

¹ Division of Gynecological Oncology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, and Luxembourg Gynaecological Oncology Group, Belgium. Electronic address: ignace.vergote@uzleuven.be.
² The Ohio State University and James Cancer Center, Division of Gynecologic Oncology, Columbus, OH, USA. Electronic address: Larry.Copeland@osumc.edu.
³ Division of Gynecological Oncology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, and Luxembourg Gynaecological Oncology Group, Belgium. Electronic address: toon.vangorp@uzleuven.be.
⁴ Division of Gynecological Oncology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, and Luxembourg Gynaecological Oncology Group, Belgium. Electronic address: annouschka.laenen@kuleuven.be.
⁵ Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Gynecologic Oncology Unit, Roma, Italy. Electronic address: giovanni.scambia@policlinicogemelli.it.
⁶ Washington University School of Medicine and Siteman Cancer Center, St. Louis, MO, USA. Electronic address: thakerp@wustl.edu.
⁷ Department of Gynaecology, Obstetrics and Neonatology, General University Hospital in Prague, First Faculty of Medicine, Charles University, Prague, Czech Republic. Electronic address: dc@davidcibula.cz.
⁸ Gynecologic Oncology Program, European Institute of Oncology IRCCS, Milan, Italy; Department of Medicine and Surgery, University of Milan-Bicocca, Italy. Electronic address: nicoletta.colombo@ieo.it.
⁹ Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: Jayanthi.Lea@UTSouthwestern.edu.
¹⁰ Medical Oncology Department, Translational Oncology Group, Cima Universidad de Navarra, Cancer Center Clínica Universidad de Navarra, Madrid, Spain. Electronic address: agonzalezma@unav.es.
¹¹ Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel. Electronic address: Jacob.Korach@sheba.health.gov.il.
¹² Department of Gynecology with Center of Gynecological Oncology, Charité, University Medicine of Berlin, Berlin, Germany. Electronic address: jalid.sehouli@charite.de.
¹³ Florida Cancer Specialists and Research Institute, West Palm Beach, FL, USA. Electronic address: bmonk@gog.org.
¹⁴ Gynecological Tumor Center, University Hospital Basel, Basel, Switzerland. Electronic address: Viola.Heinzelmann@usb.ch.
¹⁵ Department of Obstetrics and Gynaecology, Medical University of Innsbruck, Innsbruck, Austria; AGO Austria, Arbeitsgemeinschaft Gynäkologische Onkologie Österreich, Vienna, Austria. Electronic address: regina.berger@tirol-kliniken.at.
¹⁶ Arizona Oncology Associates, PC - HOPE - USOR, Tucson, AZ, USA. Electronic address: Joseph.Buscema@USOncology.com.
¹⁷ McGill University, Jewish General Hospital, Montreal, Quebec, Canada. Electronic address: susie.lau@mcgill.ca.
¹⁸ Department of Gynecological Oncology, Poznan University of Medical Sciences, Poznan, Poland. Electronic address: radoslaw.madry@skpp.edu.pl.
¹⁹ Department of Medical Oncology, University Hospital Ghent, Belgium. Electronic address: Hannelore.Denys@UGent.be.
²⁰ Minnesota Oncology, PA - USOR, Maplewood, MN, USA. Electronic address: Jessica.ThomesPepin@usoncology.com.
²¹ Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy. Electronic address: vanda.salutari@policlinicogemelli.it.
²² Gynecologic Oncology Department, National Institute of Oncology, Budapest, Hungary. Electronic address: bagameria@t-email.hu.
²³ Ospedale Alessandro Manzoni-ASST Lecco, Lecco, Italy. Electronic address: a.ardizzoia@asst-lecco.it.
²⁴ Belgium and Luxembourg Gynaecological Oncology Group (BGOG) and Université Catholique de Louvain CHU UCL Namur Site Ste Elisabeth, Service d'onco-hématologie (SORMIN), Namur, Belgium. Electronic address: stephanie.henry@chuuclnamur.uclouvain.be.
²⁵ Uro-Gynecological Department National Cancer Institute of Naples, Naples, Italy. Electronic address: s.cecere@istitutotumori.na.it.
²⁶ Department of Gynecology and Obstetrics, Third Faculty of Medicine and University Hospital Kralovske Vinohrady, Prague, Czechia. Electronic address: martin.hruda@fnkv.cz.
²⁷ Division of Gynecologic Oncology, University of Florida, Gainesville, FL, USA. Electronic address: iglesiad@ufl.edu.
²⁸ Medical Oncology Department, Hospital Universitario, 12 de Octubre, Madrid, Spain. Electronic address: lmanso@salud.madrid.org.
²⁹ RAMBAM Health Care Campus, Technion Israel Institute of Technology, Haifa, Israel. Electronic address: A_SHAI@rambam.health.gov.il.
³⁰ The Ohio State University and James Cancer Center, Division of Gynecologic Oncology, Columbus, OH, USA. Electronic address: David.O'Malley@osumc.edu.

PMID: 40010134
DOI: 10.1016/j.ejca.2025.115306

Abstract

Purpose: Tumor Treating Fields (TTFields) are electric fields that disrupt processes critical for cancer cell viability and tumor progression. The pivotal, phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 study evaluated efficacy and safety of TTFields therapy with paclitaxel (PTX) vs PTX in patients with platinum-resistant ovarian cancer (PROC).

Patients and methods: Adult patients with PROC with ≤ 5 total prior lines of therapy (LOT), including ≤ 2 prior LOT for platinum-resistant disease, and ECOG PS of 0-1 were randomized 1:1 to receive TTFields (200 kHz; ≥ 18 h/day) + PTX (80 mg/m² weekly) or PTX. Primary endpoint was overall survival (OS). Exploratory post-hoc analyses assessed OS in pegylated liposomal doxorubicin (PLD)-naive patients.

Results: Between March 2019 and November 2021, 558 patients (ECOG PS 0, 60.2 %; median [range] age, 62 [22-91] years) were assigned TTFields+PTX (n = 280) or PTX (n = 278). 24.4 % had 4 + prior LOT. Median OS was 12.2 months with TTFields+PTX vs 11.9 months with PTX (HR, 1.01; 95 % CI, 0.83-1.24; p = 0.89). Grade ≥ 3 adverse events (AEs) were similar between treatment groups. Grade 1/2 device-related skin AEs occurred in 83.6 % of patients receiving TTFields therapy. In exploratory post-hoc analysis in PLD-naive patients, median OS was 16 months with TTFields+PTX (n = 113) vs 11.7 months with PTX (n = 88; nominal HR, 0.67; 95 % CI, 0.49-0.94; p = 0.03).

Conclusions: No new safety signals were identified. TTFields+PTX did not significantly improve OS compared with PTX in the intent-to-treat population. An exploratory post-hoc analysis suggests a potentially favorable benefit-risk profile for TTFields therapy in PLD-naive patients.

Keywords: Antineoplastic agents; Neoplasm drug resistance; Ovarian epithelial carcinoma; Ovarian neoplasm; Survival analysis.

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Conflict of interest statement

Declaration of Competing Interest The author is an Editorial Board Member/Editor-in-Chief/Associate Editor/Guest Editor for this journal and was not involved in the editorial review or the decision to publish this article. The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: I Vergote has participated in consulting advisory boards for Akesobio, Bristol Myers Squibb, Deciphera Pharmaceuticals, Eisai, Elevar Therapeutics, F. Hoffmann-La Roche, Genmab, GlaxoSmithKline, ITM, Jazz Pharmaceuticals, Karyopharm, MSD, Novocure, Oncoinvent, Sanofi, Regeneron, Seagen, Sotio, and Zentalis and has participated in consulting data monitoring committees for Agenus, AstraZeneca, Corcept, Exelixis, F. Hoffmann-La Roche, ImmunoGen, Kronos Bio, Mersana, Novartis, OncXerna, and Verastem Oncology. L J Copeland has received research funding from AbbVie, Advaxis, Agenus, Ajinomoto, Array BioPharm, AstraZeneca, Bristol Myers Squibb, Clovis Oncology, Deciphera Pharma, Eisai, EMD Serono Inc, ERGOMED Clinical Research, Exelixis, Genentech/Roche, Genmab, GlaxoSmithKline, F. Hoffmann-La Roche, ImmunoGen, Incyte, Iovance, InVentive Health Clinical, Janssen R&D, Leap Therapeutics, Ludwig Institute for Cancer Research, MSD, Mersana Therapeutics, Novartis Pharmaceuticals, Novocure, OncoQuest, PRA International, Regeneron Pharmaceuticals, Seattle Genetics, Serono, and Sutro Biopharma and received honoraria from A28 Therapeutics, Celsion Corp, Corcept Therapeutics, Elevar Therapeutics, GOG Foundation, Inc, Immunocore, ImmunoGen Inc., InxMed, Inc, Luzsana Biotechnology, Novocure, OncoNova, Inc, Toray Therapeutics, and VBL Therapeutics. T Van Gorp has received research funding from Amgen, AstraZeneca, and Roche; received institutional honoraria from AbbVie, AstraZeneca, BioNTech, Eisai, GlaxoSmithKline, ImmunoGen, Incyte, Karyopharm, MSD, OncXerna, Seagen, Tubulis, and Zentalis; participated in institutional speaker’s bureaus for AstraZeneca, GlaxoSmithKline, ImmunoGen, and MSD; and received nonfinancial support (travel expenses) from AstraZeneca, GlaxoSmithKline, ImmunoGen, MSD, and PharmaMar. A Laenen has nothing to disclose. G Scambia has received research funding from MSD Italia Srl; received honoraria from AstraZeneca/MSD and Covidien AG, a Medtronic company; and participated in speaker’s bureaus for Baxter Healthcare SA, GlaxoSmithKline SpA, Intuitive Surgical Inc., and Olympus Europa SE & Co. P H Thaker has received research funding from GlaxoSmithKline and Merck; received honoraria from AstraZeneca, Clovis, Eisai, Imunon, GlaxoSmithKline, ImmunoGen, Merck, Mersana, Novocure, Verastem, Incyte, and Zentalis; and is a shareholder of Imunon. D Cibula has received honoraria from AstraZeneca, GlaxoSmithKline, MSD, Novocure, Roche, and Karyopharm. N Colombo has received research funding from AstraZeneca, GlaxoSmithKline, and Roche; received honoraria from AstraZeneca, Clovis, Eisai, GlaxoSmithKline, ImmunoGen, Mersana, MSD, Nuvation Bio, Onxerna, Roche, and Novocure; and participated in speaker’s bureaus for AstraZeneca, Clovis Oncology, GlaxoSmithKline, MSD/Merck, and Eisai. J Lea has received honoraria from AstraZeneca. A Gonzalez-Martin has received research funding from AECC, GlaxoSmithKline, ISCiii, and Roche; received honoraria from Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GlaxoSmithKline, HederaDx, ImmunoGen, Kartos, Karyopharm, Illumina, Mersana, MSD, Novartis, Novocure, Oncoinvent, PharmaMar, Roche, SOTIO, SUTRO, Seagen, Takeda, and Tubulis; and participated in speaker’s bureaus for AstraZeneca, Clovis, GlaxoSmithKline, ImmunoGen, Mersana, MSD, Novocure, PharmaMar, Roche, and Takeda. J Korach has nothing to disclose. J Sehouli received research funding from AstraZeneca, Bayer, Clovis Oncology, Merck, MSD Oncology, PharmaMar, Pfizer, Roche, and Tesaro; received honoraria from AstraZeneca, Bayer, Clovis Oncology, Eisai, GlaxoSmithKline, Ingress Health, Johnson & Johnson, Eli Lilly, Merck, MSD Oncology, Novartis, Novocure, Olympus Medical Systems, PharmaMar, Pfizer, Riemser, Roche, Sobi, Tesaro, and Teva; and received nonfinancial support (travel expenses) from AstraZeneca, Clovis Oncology, MSD Oncology, Olympus Medical Systems, PharmaMar, Roche Pharma AG, and Tesaro. B J Monk received honoraria from Acrivon, Adaptimmune, Agenus, Akeso Bio, Amgen, Aravive, AstraZeneca, Bayer, Clovis, Eisai, Elevar, EMD Merck, Genmab/Seagen, GOG Foundation, Gradalis, Heng Rui, ImmunoGen, Karyopharm, Iovance, Laekna Health Care, Merck, Mersana, Myriad, Novartis, Novocure, OncoC4, Panavance, Pieris, Pfizer, Puma, Regeneron, Roche/Genentech, Sorrento, Tesaro/GlaxoSmithKline, US Oncology Research, VBL, Verastem, and Zentalis; and participated in speaker’s bureaus for AstraZeneca, Clovis, Eisai, Merck, Roche/Genentech, and Tesaro/GlaxoSmithKline. V Heinzelmann-Schwarz has nothing to disclose. R Berger has nothing to disclose. J Buscema received honoraria from GlaxoSmithKline and holds stock as a shareholder in Johnson & Johnson. S Lau received research funding from AstraZeneca and Merck and honoraria from Eisai, Intuitive Surgical, and Merck. R Mądry has received research funding from AstraZeneca and GlaxoSmithKline; received honoraria from AstraZeneca, GlaxoSmithKline, MSD, and Roche; and participated in a speaker’s bureau for AstraZeneca, GlaxoSmithKline, and Roche. H Denys has received research funding from Gilead; received honoraria from Amgen, AstraZeneca, Eli Lilly, Gilead, GlaxoSmithKline, MSD, Novartis, Pfizer, PharmaMar, Roche, and Seagen; and received nonfinancial support (travel expenses) from AstraZeneca, Gilead, GlaxoSmithKline, MSD, Pfizer, PharmaMar, Roche, and Teva. J Thomes Pepin has nothing to disclose. V Salutari received honoraria from and has participated in speaker’s bureaus for AstraZeneca, GlaxoSmithKline, Eisai, MSD, and Novocure. A Bagaméri has nothing to disclose. A Ardizzoia has participated in a speaker’s bureau for Sever Pharma. S Henry received honoraria from AstraZeneca, BMSi, Gilead, GlaxoSmithKline, Merck, MSD Oncology, Novartis, and Sanofi and received travel accommodation expenses from Gilead, GlaxoSmithKline, MSD Oncology, and Roche. S Chiara Cecere has participated in a speaker’s bureau for AstraZeneca, GlaxoSmithKline, and MSD. M Hruda has nothing to disclose. D A Iglesias received research funding from Aravive, Genmab, GlaxoSmithKline, Mersana, Novocure, and OncoQuest and received honoraria from Novocure. L Manso has nothing to disclose. A Shai has received honoraria from Eli Lily, Gilead, and Stemline. D M O’Malley has received consulting and/or advisory board fees from AbbVie, AdaptImmune, Agenus, Inc, Arquer Diagnostics, Arcus Biosciences, Inc, AstraZeneca, Atossa Therapeutics, Boston Biomedical, Cardiff Oncology, Celcuity, Clovis Oncology, Corcept Therapeutics, Duality Bio, Eisai, Elevar, Exelixis, F. Hoffmann-La Roche, Inc, Genentech, Inc, Genelux, GlaxoSmithKline, GOG Foundation, ImmunoGen, Inc, Imvax, InterVenn, INXMED, Iovance Biotherapeutics, Janssen, Jazz Pharmaceuticals, Laekna, Leap Therapeutics, Inc, Luzsana Biotechnology, Merck & Co, MSD, Mersana Therapeutics, Myriad, Novartis, Novocure, OncoC4, Inc, Onconova, Regeneron Pharmaceuticals, Inc, RepImmune, R Pharm, Roche Diagnostics, Seagen, Sorrento, Sutro Biopharma, Tarveda Therapeutics, Toray, Trillium, Umoja, Verastem, Inc, VBL Therapeutics, Vincerx Pharma, Xencor, and Zentalis. His institution received research funds from AbbVie, Advaxis, Agenus, Inc, Alkermes, Aravive, Inc, Arcus Biosciences, Inc, AstraZeneca, BeiGene USA, Inc, Boston Biomedical, Bristol Myers Squibb, Clovis Oncology, Deciphera Pharma, Eisai, EMD Serono, Inc, Exelixis, F. Hoffmann-La Roche, Inc, Genentech, Inc, Genmab, GlaxoSmithKline, GOG Foundation, ImmunoGen, Inc, Incyte Corporation, Iovance Biotherapeutics, Karyopharm, Leap Therapeutics, Inc, Ludwig Institute for Cancer Research, Merck & Co, MSD, Mersana Therapeutics, Inc, NCI, Novartis, Novocure, NRG Oncology, OncoC4, Inc, OncoQuest, Inc, Pfizer, Inc, Precision Therapeutics, Inc, Prelude Therapeutics, Regeneron Pharmaceuticals, Inc, RTOG, Rubius Therapeutics, Seagen, Sutro Biopharma, SWOG, Tesaro, and Verastem, Inc.

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Tumor Treating Fields therapy in platinum-resistant ovarian cancer: Results of the ENGOT-ov50/GOG-3029/INNOVATE-3 pivotal phase 3 randomized study

Affiliations

Tumor Treating Fields therapy in platinum-resistant ovarian cancer: Results of the ENGOT-ov50/GOG-3029/INNOVATE-3 pivotal phase 3 randomized study

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Conflict of interest statement

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