Publication:
Atezolizumab, bevacizumab, and chemotherapy for newly diagnosed stage III or IV ovarian cancer: placebo-controlled randomized phase III trial (IMagyn050/GOG 3015/ENGOT-OV39)

dc.contributor.coauthorMoore, K. N.
dc.contributor.coauthorBookman, M.
dc.contributor.coauthorSehouli, J.
dc.contributor.coauthorMiller, A.
dc.contributor.coauthorAnderson, C.
dc.contributor.coauthorScambia, G.
dc.contributor.coauthorMyers, T.
dc.contributor.coauthorRobison, K.
dc.contributor.coauthorMäenpää, J.
dc.contributor.coauthorWillmott, L.
dc.contributor.coauthorColombo, N.
dc.contributor.coauthorThomes-Pepin, J.
dc.contributor.coauthorLiontos, M.
dc.contributor.coauthorGold, M. A.
dc.contributor.coauthorGarcia, Y.
dc.contributor.coauthorSharma, S. K.
dc.contributor.coauthorDarus, C. J.
dc.contributor.coauthorAghajanian, C.
dc.contributor.coauthorOkamoto, A.
dc.contributor.coauthorWu, X.
dc.contributor.coauthorSafin, R.
dc.contributor.coauthorWu, F.
dc.contributor.coauthorMolinero, L.
dc.contributor.coauthorMaiya, V.
dc.contributor.coauthorKhor, V. K.
dc.contributor.coauthorLin, Y. G.
dc.contributor.coauthorPignata, S.
dc.contributor.kuauthorTaşkıran, Çağatay
dc.contributor.kuprofileFaculty Member
dc.contributor.schoolcollegeinstituteSchool of Medicine
dc.contributor.yokid134190
dc.date.accessioned2024-11-09T13:53:07Z
dc.date.issued2021
dc.description.abstractPurpose: to evaluate the addition of the humanized monoclonal antiprogrammed death ligand-1 (PD-L1) antibody, atezolizumab, to platinum-based chemotherapy and bevacizumab in newly diagnosed stage III or IV ovarian cancer (OC). Methods: this multicenter placebo-controlled double-blind randomized phase III trial (ClinicalTrials.gov identifier: NCT03038100) enrolled patients with newly diagnosed untreated International Federation of Gynecology and Obstetrics (FIGO) stage III or IV OC who either had undergone primary cytoreductive surgery with macroscopic residual disease or were planned to receive neoadjuvant chemotherapy and interval surgery. Patients were stratified by FIGO stage, Eastern Cooperative Oncology Group performance status, tumor immune cell PD-L1 staining, and treatment strategy and randomly assigned 1:1 to receive 3-weekly cycles of atezolizumab 1,200 mg or placebo (day 1, cycles 1-22), with paclitaxel plus carboplatin (day 1, cycles 1-6) plus bevacizumab 15 mg/kg (day 1, cycles 2-22), omitting perioperative bevacizumab in neoadjuvant patients. The co-primary end points were investigator-assessed progression-free survival and overall survival in the intention-to-treat and PD-L1-positive populations. Results: between March 8, 2017, and March 26, 2019, 1,301 patients were enrolled. The median progression-free survival was 19.5 versus 18.4 months with atezolizumab versus placebo, respectively (hazard ratio, 0.92; 95% CI, 0.79 to 1.07; stratified log-rank P = .28), in the intention-to-treat population and 20.8 versus 18.5 months, respectively (hazard ratio, 0.80; 95% CI, 0.65 to 0.99; P = .038), in the PD-L1-positive population. The interim (immature) overall survival results showed no significant benefit from atezolizumab. The most common grade 3 or 4 adverse events were neutropenia (21% with atezolizumab v 21% with placebo), hypertension (18% v 20%, respectively), and anemia (12% v 12%). Conclusion: current evidence does not support the use of immune checkpoint inhibitors in newly diagnosed OC. Insight from this trial should inform further evaluation of immunotherapy in OC.
dc.description.fulltextYES
dc.description.indexedbyScopus
dc.description.indexedbyPubMed
dc.description.issue17
dc.description.openaccessYES
dc.description.publisherscopeInternational
dc.description.sponsoredbyTubitakEuN/A
dc.description.sponsorshipNIH/NCI Cancer Center Support Grant
dc.description.versionPublisher version
dc.description.volume39
dc.formatpdf
dc.identifier.doi10.1200/JCO.21.00306
dc.identifier.eissn1527-7755
dc.identifier.embargoNO
dc.identifier.filenameinventorynoIR02866
dc.identifier.issn0732-183X
dc.identifier.linkhttps://doi.org/10.1200/JCO.21.00306
dc.identifier.quartileQ1
dc.identifier.scopus2-s2.0-85107415850
dc.identifier.urihttps://hdl.handle.net/20.500.14288/4003
dc.keywordsOvarian cancer
dc.languageEnglish
dc.publisherWolters Kluwer
dc.relation.grantnoP30 CA008748
dc.relation.urihttp://cdm21054.contentdm.oclc.org/cdm/ref/collection/IR/id/9513
dc.sourceJournal of Clinical Oncology
dc.subjectOncology
dc.titleAtezolizumab, bevacizumab, and chemotherapy for newly diagnosed stage III or IV ovarian cancer: placebo-controlled randomized phase III trial (IMagyn050/GOG 3015/ENGOT-OV39)
dc.typeJournal Article
dspace.entity.typePublication
local.contributor.authorid0000-0002-0936-552X
local.contributor.kuauthorTaşkıran, Çağatay

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