TY - JOUR
T1 - Optimal Treatment Duration of Bevacizumab as Front-Line Therapy for Advanced Ovarian Cancer
T2 - AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15 Open-Label Randomized Phase III Trial
AU - Pfisterer, Jacobus
AU - Joly, Florence
AU - Kristensen, Gunnar
AU - Rau, Joern
AU - Mahner, Sven
AU - Pautier, Patricia
AU - El-Balat, Ahmed
AU - Kurtz, Jean-Emmanuel
AU - Canzler, Ulrich
AU - Sehouli, Jalid
AU - Heubner, Martin L
AU - Hartkopf, Andreas D
AU - Baumann, Klaus
AU - Hasenburg, Annette
AU - Hanker, Lars C
AU - Belau, Antje
AU - Schmalfeldt, Barbara
AU - Denschlag, Dominik
AU - Park-Simon, Tjoung-Won
AU - Selle, Frédéric
AU - Jackisch, Christian
AU - Burges, Alexander
AU - Lück, Hans-Joachim
AU - Emons, Günter
AU - Meier, Werner
AU - Gropp-Meier, Martina
AU - Schröder, Willibald
AU - de Gregorio, Nikolaus
AU - Hilpert, Felix
AU - Harter, Philipp
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/2/1
Y1 - 2023/2/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85147092420&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/8ec099d7-f931-3a1a-8253-52ac1f58367b/
U2 - 10.1200/JCO.22.01010
DO - 10.1200/JCO.22.01010
M3 - Journal articles
C2 - 36332161
SN - 0732-183X
VL - 41
SP - 893
EP - 902
JO - Journal of clinical oncology : official journal of the American Society of Clinical Oncology
JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology
IS - 4
ER -
