Phase III Randomized Trial of Maintenance Taxanes Versus Surveillance in Women With Advanced Ovarian/Tubal/Peritoneal Cancer: A Gynecologic Oncology Group 0212:NRG Oncology Study
In the world of maintenance, Taxanes don’t add survival benefits.
Optimal Treatment Duration of Bevacizumab as Front-Line Therapy for Advanced Ovarian Cancer: AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15 Open-Label Randomized Phase III Trial
Author(s): Jacobus Pfisterer, MD1; Florence Joly, MD, PhD2; Gunnar Kristensen, MD3; Joern Rau, MSc4; Sven Mahner, MD5,6; Patricia Pautier, MD7; Ahmed El-Balat, MD8,9; Jean-Emmanuel Kurtz, MD10; Ulrich Canzler, MD11; Jalid Sehouli, MD12; Martin L. Heubner, MD13,14; Andreas D. Hartkopf, MD15,16; Klaus Baumann, MD17,18; Annette Hasenburg, MD19,20; Lars C. Hanker, MD21; Antje Belau, MD22,23; Barbara Schmalfeldt, MD24,25; Dominik Denschlag, MD26; Tjoung-Won Park-Simon, MD27; Frédéric Selle, MD28; Christian Jackisch, MD29; Alexander Burges, MD6; Hans-Joachim Lück, MD30; Günter Emons, MD31; Werner Meier, MD32,33; Martina Gropp-Meier, MD34; Willibald Schröder, MD35; Nikolaus de Gregorio, MD36,37; Felix Hilpert, MD38,39; and Philipp Harter, MD40
Source: DOI: 10.1200/JCO.22.01010 Journal of Clinical Oncology 41, no. 4 (February 01, 2023) 893-902.
Dr. Maen Hussein's Thoughts
More is NOT better.
PURPOSE
To compare standard versus extended duration of bevacizumab treatment in combination with front-line chemotherapy in women with newly diagnosed stage IIB-IV ovarian cancer.
METHODS
In this multicenter, open-label, randomized phase III trial (ClinicalTrials.gov identifier: NCT01462890), patients with newly diagnosed International Federation of Gynecology and Obstetrics stage IIB-IV epithelial ovarian, fallopian tube, or peritoneal cancer underwent primary cytoreductive surgery followed by six cycles of chemotherapy (paclitaxel 175 mg/m2 plus carboplatin area under the curve 5 once every 3 weeks) and bevacizumab (15 mg/kg once every 3 weeks). Patients were randomly assigned 1:1 to receive bevacizumab for either 15 or 30 months, stratified by International Federation of Gynecology and Obstetrics stage/residual tumor. The primary end point was investigator-assessed progression-free survival (PFS) according to RECIST version 1.1. Secondary end points included overall survival (OS), safety, and tolerability.
RESULTS
Between November 11, 2011, and August 6, 2013, 927 women were randomly assigned. There was no difference in PFS between treatment arms (hazard ratio, 0.99; 95% CI, 0.85 to 1.15; unstratified log-rank P = .90). Median PFS was 24.2 versus 26.0 months with standard versus extended duration of bevacizumab, respectively; restricted mean PFS was 39.5 versus 39.3 months, respectively. There was no OS difference between treatment arms (hazard ratio, 1.04; 95% CI, 0.87 to 1.23; P = .68). Serious/nonserious adverse events of special interest occurred in 29% versus 34% of patients in the standard versus experimental arms, respectively, and were consistent with the known safety profile of standard bevacizumab.
CONCLUSION
Longer treatment duration with bevacizumab for up to 30 months did not improve PFS or OS in patients with primary epithelial ovarian, fallopian tube, or peritoneal cancer. A bevacizumab treatment duration of 15 months remains the standard of care.
Author Affiliations
1Arbeitsgemeinschaft Gynaekologische Onkologie (AGO) Study Group and Gynecologic Oncology Center, Kiel, Germany2Groupe d’Investigateurs National des Etudes des Cancers Ovariens et du sein (GINECO) and Centre François Baclesse, University Caen Normandie, Caen, France3Nordic Society of Gynaecological Oncology (NSGO) and Oslo University Hospital, Oslo, Norway4AGO Study Group and Coordinating Center for Clinical Trials, Philipps-University Marburg, Marburg, Germany5AGO Study Group and University Medical Center Hamburg-Eppendorf, Hamburg, Germany6Department of Obstetrics and Gynecology, University Hospital LMU Munich, Munich, Germany7GINECO and Gustave Roussy Cancer Center, Villejuif, France8AGO Study Group and University Hospital Frankfurt, Frankfurt, Germany9Spital Uster, Uster, Switzerland10GINECO and Institut de Cancérologie Strasbourg Europe, Strasbourg, France11AGO Study Group and University Hospital Carl Gustav Carus, Technische Universität Dresden and National Center for Tumor Diseases (NCT), Partner Site Dresden, Dresden, Germany12AGO Study Group and Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany13AGO Study Group and University Hospital Essen, Essen, Germany14Cantonal Hospital Baden AG, Baden, Switzerland15AGO Study Group and University Hospital Tübingen, Tübingen, Germany16University Hospital Ulm, Ulm, Germany17AGO Study Group and University Hospital Gießen and Marburg, Site Marburg, Marburg, Germany18Hospital Ludwigshafen, Ludwigshafen, Germany19AGO Study Group and University Hospital Freiburg, Freiburg, Germany20University Medical Center Mainz, Mainz, Germany21AGO Study Group and University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany22AGO Study Group and University Hospital Greifswald, Greifswald, Germany23Frauenarztpraxis Dr. Belau, Greifswald, Germany24AGO Study Group and Hospital Rechts der Isar, Technical University Munich, Munich, Germany25University Medical Center Hamburg-Eppendorf, Hamburg, Germany26AGO Study Group and Hochtaunus-Kliniken, Hospital Bad Homburg, Bad Homburg, Germany27AGO Study Group and Hannover Medical School, Hannover, Germany28GINECO and Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France29AGO Study Group and Sana Hospital Offenbach, Offenbach, Germany30AGO Study Group and Gynäkologisch-Onkologische Praxis Hannover, Hannover, Germany31AGO Study Group and University Medical Center Göttingen, Göttingen, Germany32AGO Study Group and Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany33University Hospital Düsseldorf, Düsseldorf, Germany34AGO Study Group and Onkologie Ravensburg, Ravensburg, Germany35AGO Study Group and GYNAEKOLOGICUM Bremen, Bremen, Germany36AGO Study Group and University Hospital Ulm, Ulm, Germany37SLK-Kliniken Heilbronn, Klinikum am Gesundbrunnen, Heilbronn, Germany38AGO Study Group and University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany39Krankenhaus Jerusalem, Mammazentrum Hamburg, Hamburg, Germany40AGO Study Group and Evangelische Kliniken Essen-Mitte, Essen, GermanyRelated Articles
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