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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
I. Vergote, LJ. Copeland, T. Van Gorp, A. Laenen, G. Scambia, PH. Thaker, D. Cibula, N. Colombo, J. Lea, A. Gonzalez-Martin, J. Korach, J. Sehouli, BJ. Monk, V. Heinzelmann-Schwarz, R. Berger, J. Buscema, S. Lau, R. Mądry, H. Denys, JT. Pepin, V....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, randomizované kontrolované studie, klinické zkoušky, fáze III, multicentrická studie
- MeSH
- chemorezistence * MeSH
- dospělí MeSH
- elektrostimulační terapie metody škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- nádory vaječníků * farmakoterapie terapie mortalita patologie MeSH
- paclitaxel * terapeutické užití MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladý dospělý MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
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.
AGO Austria Arbeitsgemeinschaft Gynäkologische Onkologie Österreich Vienna Austria
Arizona Oncology Associates PC HOPE USOR Tucson AZ USA
Belgium and Luxembourg Gynaecological Oncology Group Namur Belgium
Department of Gynecological Oncology Poznan University of Medical Sciences Poznan Poland
Department of Medical Oncology University Hospital Ghent Belgium
Department of Medicine and Surgery University of Milan Bicocca Italy
Department of Obstetrics and Gynaecology Medical University of Innsbruck Innsbruck Austria
Division of Gynecologic Oncology University of Florida Gainesville FL USA
Florida Cancer Specialists and Research Institute West Palm Beach FL USA
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Gynecologic Oncology Unit Roma Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Gynecologic Oncology Department National Institute of Oncology Budapest Hungary
Gynecologic Oncology Program European Institute of Oncology IRCCS Milan Italy
Gynecological Tumor Center University Hospital Basel Basel Switzerland
McGill University Jewish General Hospital Montreal Quebec Canada
Medical Oncology Department Hospital Universitario 12 de Octubre Madrid Spain
Minnesota Oncology PA USOR Maplewood MN USA
Ospedale Alessandro Manzoni ASST Lecco Lecco Italy
RAMBAM Health Care Campus Technion Israel Institute of Technology Haifa Israel
Sheba Medical Center Tel Aviv University Tel Hashomer Israel
The Ohio State University and James Cancer Center Division of Gynecologic Oncology Columbus OH USA
Uro Gynecological Department National Cancer Institute of Naples Naples Italy
Washington University School of Medicine and Siteman Cancer Center St Louis MO USA
Citace poskytuje Crossref.org
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- $a Vergote, Ignace $u Division of Gynecological Oncology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, and Luxembourg Gynaecological Oncology Group, Belgium. Electronic address: ignace.vergote@uzleuven.be
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- $a Tumor Treating Fields therapy in platinum-resistant ovarian cancer: Results of the ENGOT-ov50/GOG-3029/INNOVATE-3 pivotal phase 3 randomized study / $c I. Vergote, LJ. Copeland, T. Van Gorp, A. Laenen, G. Scambia, PH. Thaker, D. Cibula, N. Colombo, J. Lea, A. Gonzalez-Martin, J. Korach, J. Sehouli, BJ. Monk, V. Heinzelmann-Schwarz, R. Berger, J. Buscema, S. Lau, R. Mądry, H. Denys, JT. Pepin, V. Salutari, A. Bagaméri, A. Ardizzoia, S. Henry, SC. Cecere, M. Hruda, DA. Iglesias, L. Manso, A. Shai, DM. O'Malley, ENGOT-ov50/GOG-3029/INNOVATE-3 Study Investigators
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- $a 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.
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- $a Copeland, Larry J $u The Ohio State University and James Cancer Center, Division of Gynecologic Oncology, Columbus, OH, USA. Electronic address: Larry.Copeland@osumc.edu
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- $a Van Gorp, Toon $u Division of Gynecological Oncology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, and Luxembourg Gynaecological Oncology Group, Belgium. Electronic address: toon.vangorp@uzleuven.be
- 700 1_
- $a Laenen, Annouschka $u Division of Gynecological Oncology, University Hospitals Leuven, KU Leuven, Leuven, Belgium, and Luxembourg Gynaecological Oncology Group, Belgium. Electronic address: annouschka.laenen@kuleuven.be
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- $a Thaker, Premal H $u Washington University School of Medicine and Siteman Cancer Center, St. Louis, MO, USA. Electronic address: thakerp@wustl.edu
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- $a Cibula, David $u 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
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- $a Colombo, Nicoletta $u 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
- 700 1_
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- 700 1_
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- 700 1_
- $a Korach, Jacob $u Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel. Electronic address: Jacob.Korach@sheba.health.gov.il
- 700 1_
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- 700 1_
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- 700 1_
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