{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T22:31:35Z","timestamp":1784673095981,"version":"3.55.0"},"reference-count":15,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2023,1,30]],"date-time":"2023-01-30T00:00:00Z","timestamp":1675036800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,3,17]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Iniparib (BSI-201), a novel anticancer agent thought to have poly(ADP-ribose) polymerase (PARP) inhibitory activity and synergy with both gemcitabine and carboplatin (GC) was evaluated in 2 cohorts with GC.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Parallel multicenter, single-arm, phase II studies using a Simon two-stage design. Eligible patients had a histological diagnosis of epithelial ovarian carcinoma, fallopian tube cancer, or primary peritoneal carcinoma and demonstration of platinum-sensitive (\u22656 months [mo]) or -resistant disease (relapse 2-6 mo post-platinum). Carboplatin (AUC 4 IV day 1), gemcitabine (1000 mg\/m2 IV days 1 and 8), and iniparib (5.6 mg\/kg IV days 1, 4, 8, and 11) were given on a 21-day cycle.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The overall response rate (ORR RECIST 1.0) in platinum sensitive disease was 66% (95% CI, 49-80) with a higher response rate in the 15 pts with germline BRCA mutations (gBRCAmut) (73%). Median PFS was 9.9 (95% CI, 8.2-11.3) months. In the platinum resistant population the ORR was 26% (95% CI, 14-42), however in the 11 pts for whom BRCA mutation was present, the best overall response was PR in 5 (46%). Median PFS was 6.8 months (range, 5.7-7.7 months). Notably, among the 17 CA-125-response-evaluable patients who did not achieve tumor response, 7 (41.2%) patients had a CA125 response, and 93% has clinical benefit (CR + PR + SD). The GCI combination was generally well tolerated despite a high incidence of thrombocytopenia and neutropenia, with no new toxicities.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Given the subsequent lack of efficacy demonstrated for iniparib in breast cancer, these are studies of GC and demonstrate a higher than traditionally appreciated activity in patients with platinum-sensitive and -resistant recurrent ovarian cancer, especially in patients that harbor a BRCA mutation, resetting the benchmark for efficacy in phase II trials. (ClinicalTrials.gov Identifiers: NCT01033292 &amp; NCT01033123).<\/jats:p><\/jats:sec>","DOI":"10.1093\/oncolo\/oyac275","type":"journal-article","created":{"date-parts":[[2023,1,31]],"date-time":"2023-01-31T07:25:12Z","timestamp":1675149912000},"page":"252-257","source":"Crossref","is-referenced-by-count":6,"title":["Phase II Trials of Iniparib (BSI-201) in Combination with Gemcitabine and Carboplatin in Patients with Recurrent Ovarian Cancer"],"prefix":"10.1093","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8091-8588","authenticated-orcid":false,"given":"Richard T","family":"Penson","sequence":"first","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allison J","family":"Ambrosio","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christin A","family":"Whalen","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Dana-Farber Cancer Institute , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carolyn N","family":"Krasner","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Panagiotis A","family":"Konstantinopoulos","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Beth Israel Deaconess Medical Center , Boston, MA , USA"},{"name":"Department of Hematology Oncology, Dana-Farber Cancer Institute , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Bradley","sequence":"additional","affiliation":[{"name":"BiPar Sciences, Inc. , South San Francisco, CA , USA"},{"name":"Annexon, Inc. , Brisbane, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ursula A","family":"Matulonis","sequence":"additional","affiliation":[{"name":"Department of Hematology Oncology, Dana-Farber Cancer Institute , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J","family":"Birrer","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital , Boston, MA , USA"},{"name":"P. Rockefeller Cancer Institute , Little Rock, AR , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,1,30]]},"reference":[{"issue":"1","key":"2023041012084385300_","doi-asserted-by":"crossref","first-page":"7","DOI":"10.3322\/caac.21708","article-title":"Cancer statistics, 2022","volume":"72","author":"Siegel","year":"2022","journal-title":"CA Cancer J Clin"},{"issue":"1","key":"2023041012084385300_","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1038\/s43018-020-00166-5","article-title":"Advances in ovarian cancer, from biology to treatment","volume":"2","author":"McMullen","year":"2021","journal-title":"Nat Cancer"},{"issue":"2","key":"2023041012084385300_","doi-asserted-by":"crossref","first-page":"419","DOI":"10.1097\/IGC.0b013e3182070f17","article-title":"Definitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and CA 125 agreed by the Gynecological Cancer Intergroup 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