{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T07:15:30Z","timestamp":1790234130993,"version":"4.1.0"},"reference-count":16,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"31","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2018,11,1]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> This multicenter phase II trial evaluated lurbinectedin (PM01183), a selective inhibitor of active transcription of protein-coding genes, in patients with metastatic breast cancer. A unicenter translational substudy assessed potential mechanisms of lurbinectedin resistance. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Two arms were evaluated according to germline BRCA1\/2 status: BRCA1\/2 mutated (arm A; n = 54) and unselected ( BRCA1\/2 wild-type or unknown status; arm B; n = 35). Lurbinectedin starting dose was a 7-mg flat dose and later, 3.5 mg\/m<jats:sup>2<\/jats:sup> in arm A. The primary end point was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST). The translational substudy of resistance mechanisms included exome sequencing (n = 13) and in vivo experiments with patient-derived xenografts (n = 11) from BRCA1\/2-mutated tumors. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> ORR was 41% (95% CI, 28% to 55%) in arm A and 9% (95% CI, 2% to 24%) in arm B. In arm A, median progression-free survival was 4.6 months (95% CI, 3.0 to 6.0 months), and median overall survival was 20.0 months (95% CI, 11.8 to 26.6 months). Patients with BRCA2 mutations showed an ORR of 61%, median progression-free survival of 5.9 months, and median overall survival of 26.6 months. The safety profile improved with lurbinectedin dose adjustment to body surface area. The most common nonhematologic adverse events seen at 3.5 mg\/m<jats:sup>2<\/jats:sup> were nausea (74%; grade 3, 5%) and fatigue (74%; grade 3, 21%). Neutropenia was the most common severe hematologic adverse event (grade 3, 47%; grade 4, 10%). Exome sequencing showed mutations in genes related to the nucleotide excision repair pathway in four of seven tumors at primary or acquired resistance and in one patient with short-term stable disease. In vivo, sensitivity to cisplatin and lurbinectedin was evidenced in lurbinectedin-resistant (one of two) and cisplatin-resistant (two of three) patient-derived xenografts. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Lurbinectedin showed noteworthy activity in patients with BRCA1\/2 mutations. Response and survival was notable in those with BRCA2 mutations. Additional clinical development in this subset of patients with metastatic breast cancer is warranted. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2018.78.6558","type":"journal-article","created":{"date-parts":[[2018,9,21]],"date-time":"2018-09-21T19:59:41Z","timestamp":1537559981000},"page":"3134-3143","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":44,"title":["Multicenter Phase II Study of Lurbinectedin in <i>BRCA<\/i>-Mutated and Unselected Metastatic Advanced Breast Cancer and Biomarker Assessment Substudy"],"prefix":"10.1200","volume":"36","author":[{"given":"Cristina","family":"Cruz","sequence":"first","affiliation":[{"name":"Cristina Cruz and Judith Balma\u00f1a, Vall d\u2019Hebron Hospital; Cristina Cruz, Alba Llop-Guevara, Joaqu\u00edn Arribas, Ana Vivancos, Violeta Serra, and Judith Balma\u00f1a, Vall d\u2019Hebron Institute of Oncology; Jos\u00e9 A. P\u00e9rez Fidalgo, Ana Lluch, Joaqu\u00edn Arribas, and Violeta Serra, Centro de Investigaci\u00f3n Biom\u00e9dica en Red; Joaqu\u00edn Arribas, Instituci\u00f3 Catalana de Recerca i Estudis Avan\u00e7ats, Barcelona; Jos\u00e9 A. P\u00e9rez Fidalgo and Ana Lluch, Hospital Cl\u00ednico de Valencia, Valencia; Cristian Fern\u00e1ndez, Carmen Kahatt, Carlos M...."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alba","family":"Llop-Guevara","sequence":"additional","affiliation":[{"name":"Cristina Cruz and Judith Balma\u00f1a, Vall d\u2019Hebron Hospital; Cristina Cruz, Alba Llop-Guevara, Joaqu\u00edn Arribas, Ana Vivancos, Violeta Serra, and Judith Balma\u00f1a, Vall d\u2019Hebron Institute of Oncology; Jos\u00e9 A. P\u00e9rez Fidalgo, Ana Lluch, Joaqu\u00edn Arribas, and Violeta Serra, Centro de Investigaci\u00f3n Biom\u00e9dica en Red; Joaqu\u00edn Arribas, Instituci\u00f3 Catalana de Recerca i Estudis Avan\u00e7ats, Barcelona; Jos\u00e9 A. P\u00e9rez Fidalgo and Ana Lluch, Hospital Cl\u00ednico de Valencia, Valencia; Cristian Fern\u00e1ndez, Carmen Kahatt, Carlos M...."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judy E.","family":"Garber","sequence":"additional","affiliation":[{"name":"Cristina Cruz and Judith Balma\u00f1a, Vall d\u2019Hebron Hospital; Cristina Cruz, Alba Llop-Guevara, Joaqu\u00edn Arribas, Ana Vivancos, Violeta Serra, and Judith Balma\u00f1a, Vall d\u2019Hebron Institute of Oncology; Jos\u00e9 A. P\u00e9rez Fidalgo, Ana Lluch, Joaqu\u00edn Arribas, and Violeta Serra, Centro de Investigaci\u00f3n Biom\u00e9dica en Red; Joaqu\u00edn Arribas, Instituci\u00f3 Catalana de Recerca i Estudis Avan\u00e7ats, Barcelona; Jos\u00e9 A. 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