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. Issue 4 (1st February 2023)

• Record Type: Journal Article
• Authors: Pfisterer, Jacobus; Joly, Florence; Kristensen, Gunnar; Rau, Joern; Mahner, Sven; Pautier, Patricia; El-Balat, Ahmed; Kurtz, Jean-Emmanuel; Canzler, Ulrich; Sehouli, Jalid; Heubner, Martin L.; Hartkopf, Andreas D.; Baumann, Klaus; Hasenburg, Annette; Hanker, Lars C.; Belau, Antje; Schmalfeldt, Barbara; Denschlag, Dominik; Park-Simon, Tjoung-Won; Selle, Frédéric; Jackisch, Christian; Burges, Alexander; Lück, Hans-Joachim; Emons, Günter; Meier, Werner; Gropp-Meier, Martina; Schröder, Willibald; de Gregorio, Nikolaus; Hilpert, Felix; Harter, Philipp
• Is Part Of: Journal of clinical oncology. Volume 41:Issue 4(2023)
• Page Start: 893
• Page End: 902
• Publication Date: 2023-02-01
• Subjects: Oncology -- Periodicals; Cancer -- Periodicals; Oncology; Medical Oncology; Cancérologie -- Périodiques; Cancer -- Périodiques; Cancérologie; Cancer; Oncology; Oncologia; Càncer; Periodicals; 616.994
• DOI: 10.1200/JCO.22.01010
• Languages: English
• ISSNs: 0732-183X

Abstract

Abstract : 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/m 2 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.