{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T14:41:02Z","timestamp":1791211262216,"version":"4.1.0"},"reference-count":22,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"19","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2022,7,1]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>PATIENTS AND METHODS<\/jats:title><jats:p> 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). <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> 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, \u20132.0 to \u20130.2, P = .0063) versus chemotherapy; no difference between olaparib and chemotherapy was observed. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> 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. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.21.02011","type":"journal-article","created":{"date-parts":[[2022,3,15]],"date-time":"2022-03-15T19:59:27Z","timestamp":1647374367000},"page":"2138-2147","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":87,"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"],"prefix":"10.1200","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3888-3972","authenticated-orcid":false,"given":"Joyce F.","family":"Liu","sequence":"first","affiliation":[{"name":"Medical Oncology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6700-2981","authenticated-orcid":false,"given":"Mark F.","family":"Brady","sequence":"additional","affiliation":[{"name":"NRG Oncology; 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