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oai:recercat.cat:11351/81982024-12-13T10:31:47Zcom_2072_378070com_2072_378040col_2072_378092

Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study Longo-Muñoz, Federico Castellano, D. Alexandre, Jerome Chawla, Sant P. Fernández, Cristian Kahatt, Carmen Sanz Garcia, Enrique Institut Català de la Salut [Longo-Muñoz F] Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain. [Castellano D] Medical Oncology, Hospital Universitario 12 de Octubre, Madrid, Spain. [Alexandre J] Medical Oncology, Cochin Hospital, AP-HP, Paris, France. [Chawla SP] Medical Oncology, Sarcoma Oncology Center, Santa Monica CA 90403, USA. [Fernández C, Kahatt C] Clinical R&D, PharmaMar, Colmenar Viejo, Spain. [Sanz-García E] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain Vall d'Hebron Barcelona Hospital Campus Tumors neuroendocrins - Tractament Teràpia intravenosa Avaluació de resultats (Assistència sanitària) DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Germ Cell and Embryonal::Neuroectodermal Tumors::Neuroendocrine Tumors Other subheadings::Other subheadings::Other subheadings::/drug therapy ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Drug Administration Routes::Administration, Intravenous::Infusions, Intravenous ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias de células germinales y embrionarias::tumores neuroectodérmicos::tumores neuroendocrinos Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::vías de administración de medicamentos::administración intravenosa::infusiones intravenosas TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento Lurbinectedin; Neuroendocrine tumours; Small cell Lurbinectedina; Tumores neuroendocrinos; Célula pequeña Lurbinectedina; Tumors neuroendocrins; Cèl·lula petita Background Patients with neuroendocrine tumours (NETs) need alternative therapies after failure of first-line therapy. Patients and methods This phase II trial evaluated lurbinectedin, a selective inhibitor of oncogenic transcription, at 3.2 mg/m2 as a 1-h intravenous infusion every 3 weeks in 32 NETs patients treated in the second- or third-line setting. The primary efficacy endpoint was overall response rate (ORR) according to RECIST v1.1 assessed by the investigators. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), overall survival (OS) and safety. Results Two of 31 evaluable patients had confirmed partial responses (ORR = 6.5%; 95%CI, 0.8–21.4%). Median DoR was 4.7 months (95% CI, 4.0–5.4 months), median PFS was 1.4 months (95% CI, 1.2–3.0 months) and median OS was 7.4 months (95% CI, 3.4–16.2 months). Lurbinectedin showed an acceptable, predictable and manageable safety profile. The most common grade 3/4 toxicity was neutropenia (40.6%; grade 4, 12.4%; febrile neutropenia, 3.1%). Conclusions Considering the exploratory aim of this trial that evaluated a heterogeneous population of NETs patients, and the signs of antitumour activity observed (two confirmed partial responses and seven long disease stabilisations), further development of lurbinectedin is warranted in a more selected NETs population. 2022-09-15T08:13:53Z 2022-09-15T08:13:53Z 2022-09 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Longo-Muñoz F, Castellano D, Alexandre J, Chawla SP, Fernández C, Kahatt C, et al. Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study. Eur J Cancer. 2022 Sep;172:340–8. 0959-8049 https://hdl.handle.net/11351/8198 10.1016/j.ejca.2022.06.024 35830841 000829363200011 http://hdl.handle.net/11351/8198 eng European Journal of Cancer;172 https://doi.org/10.1016/j.ejca.2022.06.024 Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess application/pdf Elsevier Scientia