{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T13:59:57Z","timestamp":1772200797246,"version":"3.50.1"},"reference-count":27,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"13","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2024,5,1]]},"abstract":"<jats:sec><jats:title>PURPOSE<\/jats:title><jats:p> Literature evidence suggests that trabectedin monotherapy is effective in patients with recurrent ovarian cancer (OC) presenting BRCA mutation and\/or BRCAness phenotype. <\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p> A prospective, open-label, randomized phase III MITO-23 trial evaluated the activity and safety of trabectedin 1.3 mg\/m<jats:sup>2<\/jats:sup> given once every 3 weeks (arm A) in BRCA 1\/2 mutation carriers or patients with BRCAness phenotype (ie, patients who responded to \u2265two previous platinum-based treatments) with recurrent OC, primary peritoneal carcinoma, or fallopian tube cancer in comparison with physician's choice chemotherapy in the control arm (arm B; pegylated liposomal doxorubicin, topotecan, gemcitabine, once-weekly paclitaxel, or carboplatin). The primary end point was overall survival (OS) evaluated in the intention-to-treat population. <\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p> Overall, 244 patients from 21 MITO centers were randomly assigned (arm A = 122\/arm B = 122). More than 70% of patients received \u2265three previous chemotherapy lines and 35.7% had received a poly (ADP-ribose) polymerase inhibitor (PARPi) before enrollment. Median OS was not significantly different between the arms: arm A: 15.8 versus arm B: 17.9 months ( P = .304). Median progression-free survival was 4.9 months in arm A versus 4.4 months in arm B ( P = .897). Among 208 patients evaluable for efficacy, the objective response rate was 17.1% in arm A and 21.4% in arm B, with comparable median duration of response (5.62 v 5.66 months, respectively). No superior effect was observed for trabectedin in the prespecified subgroup analyses according to BRCA mutational status, chemotherapy type, and pretreatment with a PARPi and\/or platinum-free interval. Trabectedin showed a higher frequency of grade \u22653 adverse events (AEs), serious AEs, and serious adverse drug reactions compared with control chemotherapy. <\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSION<\/jats:title><jats:p> Trabectedin did not improve median OS and showed a worse safety profile in comparison with physician's choice control chemotherapy. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.23.01225","type":"journal-article","created":{"date-parts":[[2024,2,5]],"date-time":"2024-02-05T21:01:13Z","timestamp":1707166873000},"page":"1488-1498","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":3,"title":["Single-Agent Trabectedin Versus Physician's Choice Chemotherapy in Patients With Recurrent Ovarian Cancer With <i>BRCA<\/i>-Mutated and\/or BRCAness Phenotype: A Randomized Phase III Trial"],"prefix":"10.1200","volume":"42","clinical-trial-number":[{"clinical-trial-number":"nct02903004","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0981-0598","authenticated-orcid":false,"given":"Domenica","family":"Lorusso","sequence":"first","affiliation":[{"name":"Fondazione Policlinico Universitario A. 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