2026-04-17T03:36:09Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/81982024-12-13T10:31:47Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Longo-Muñoz, Federico
author
Castellano, D.
author
Alexandre, Jerome
author
Chawla, Sant P.
author
Fernández, Cristian
author
Kahatt, Carmen
author
Sanz Garcia, Enrique
2023-11-08T10:20:20Z
2023-11-08T10:20:20Z
2022-09-15T08:13:53Z2022-09-15T08:13:53Z2022-09
http://hdl.handle.net/11351/8198
Lurbinectedin; Neuroendocrine tumours; Small cellLurbinectedina; Tumores neuroendocrinos; Célula pequeñaLurbinectedina; Tumors neuroendocrins; Cèl·lula petitaBackground
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.
Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess
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 in patients with pretreated neuroendocrine tumours: Results from a phase II basket study
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion