{"doi":"10.1200/jco.21.02011","title":"Olaparib With or Without Cediranib Versus Platinum-Based Chemotherapy in Recurrent Platinum-Sensitive Ovarian Cancer (NRG-GY004): A Randomized, Open-Label, Phase III Trial","abstract":"PURPOSE Platinum-based chemotherapy is the standard of care for platinum-sensitive ovarian cancer, but complications from repeated platinum therapy occur. We assessed the activity of two all-oral nonplatinum alternatives, olaparib or olaparib/cediranib, versus platinum-based chemotherapy. PATIENTS AND METHODS NRG-GY004 is an open-label, randomized, phase III trial conducted in the United States and Canada. Eligible patients had high-grade serous or endometrioid platinum-sensitive ovarian cancer. Patients were randomly assigned 1:1:1 to platinum-based chemotherapy, olaparib, or olaparib/cediranib. The primary end point was progression-free survival (PFS) in the intention-to-treat population. Secondary end points included activity within germline BRCA-mutated or wild-type subgroups and patient-reported outcomes (PROs). RESULTS Between February 04, 2016, and November 13, 2017, 565 eligible patients were randomly assigned. Median PFS was 10.3 (95% CI, 8.7 to 11.2), 8.2 (95% CI, 6.6 to 8.7), and 10.4 (95% CI, 8.5 to 12.5) months with chemotherapy, olaparib, and olaparib/cediranib, respectively. Olaparib/cediranib did not improve PFS versus chemotherapy (hazard ratio [HR] 0.86; 95% CI, 0.66 to 1.10; P = .077). In women with germline BRCA mutation, the PFS HR versus chemotherapy was 0.55 (95% CI, 0.32 to 0.94) for olaparib/cediranib and 0.63 (95% CI, 0.37 to 1.07) for olaparib. In women without a germline BRCA mutation, the PFS HR versus chemotherapy was 0.97 (95% CI, 0.73 to 1.30) for olaparib/cediranib and 1.41 (95% CI, 1.07 to 1.86) for olaparib. Hematologic adverse events occurred more commonly with chemotherapy; however, nonhematologic adverse events were higher with olaparib/cediranib. In 489 patients evaluable for PROs, patients receiving olaparib/cediranib scored on average 1.1 points worse on the NFOSI-DRS-P subscale (97.5% CI, –2.0 to –0.2, P = .0063) versus chemotherapy; no difference between olaparib and chemotherapy was observed. CONCLUSION Combination olaparib/cediranib did not improve PFS compared with chemotherapy and resulted in reduced PROs. Notably, in patients with a germline BRCA mutation, both olaparib and olaparib/cediranib had significant clinical activity.","journal":"Journal of Clinical Oncology","year":2022,"id":234943,"datarank":2.561527665179527,"base_score":4.48863636973214,"endowment":4.48863636973214,"self_citation_contribution":0.6732954554598211,"citation_network_contribution":1.888232209719706,"self_endowment_contribution":0.6732954554598211,"citer_contribution":1.888232209719706,"corpus_percentile":null,"corpus_rank":null,"citation_count":88,"citer_count":84,"citers_with_citation_signal":72,"citers_with_endowment":72,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9096,"is_data_producer":true,"deposit_databanks":{"ClinicalTrials.gov":["NCT02446600"]},"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2022-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":50711,"name":"Mark F. Brady","orcid":"0000-0001-6700-2981","position":1,"is_corresponding":false},{"id":91541,"name":"Ursula A. Matulonis","orcid":"0000-0002-3103-6992","position":2,"is_corresponding":false},{"id":259919,"name":"Austin Miller","orcid":"0000-0001-9739-8462","position":3,"is_corresponding":false},{"id":230686,"name":"Elise C. Kohn","orcid":"0000-0002-8631-9762","position":4,"is_corresponding":false},{"id":70261,"name":"Elizabeth M. Swisher","orcid":"0000-0003-2331-0434","position":5,"is_corresponding":false},{"id":232516,"name":"David Cella","orcid":"0000-0002-9881-4541","position":6,"is_corresponding":false},{"id":233752,"name":"William P. Tew","orcid":"0000-0001-5115-4470","position":7,"is_corresponding":false},{"id":852317,"name":"Noelle G. Cloven","orcid":null,"position":8,"is_corresponding":false},{"id":234722,"name":"Carolyn Y. Muller","orcid":null,"position":9,"is_corresponding":false},{"id":852318,"name":"David P. Bender","orcid":null,"position":10,"is_corresponding":false},{"id":471674,"name":"Richard G. Moore","orcid":"0000-0001-5598-5263","position":11,"is_corresponding":false},{"id":552906,"name":"David P. Michelin","orcid":null,"position":12,"is_corresponding":false},{"id":66137,"name":"Steven E. Waggoner","orcid":null,"position":13,"is_corresponding":false},{"id":302947,"name":"Melissa A. Geller","orcid":"0000-0003-4591-620X","position":14,"is_corresponding":false},{"id":346845,"name":"Keiichi Fujiwara","orcid":"0000-0002-7388-0243","position":15,"is_corresponding":false},{"id":852319,"name":"Stacy D. D'Andre","orcid":null,"position":16,"is_corresponding":false},{"id":33566,"name":"Michael E. Carney","orcid":"0000-0002-5497-405X","position":17,"is_corresponding":false},{"id":70189,"name":"Angeles Alvarez Secord","orcid":"0000-0003-0946-7662","position":18,"is_corresponding":false},{"id":852320,"name":"Katherine M. Moxley","orcid":null,"position":19,"is_corresponding":false},{"id":50710,"name":"Michael A. Bookman","orcid":"0000-0002-4255-7814","position":20,"is_corresponding":false},{"id":96397,"name":"Joyce F. Liu","orcid":"0000-0003-3888-3972","position":0,"is_corresponding":true}],"reference_count":22,"raw_metadata":null,"created_at":"2026-07-19T00:21:42.662304Z","pmid":"35290101","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}