Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study

Autor: Federico Longo-Muñoz, Daniel Castellano, Jerome Alexandre, Sant P. Chawla, Cristian Fernández, Carmen Kahatt, Vicente Alfaro, Mariano Siguero, Ali Zeaiter, Victor Moreno, Enrique Sanz-García, Ahmad Awada, Ana Santaballa, Vivek Subbiah
Přispěvatelé: 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
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Cancer Research
neoplasias::neoplasias por tipo histológico::neoplasias de células germinales y embrionarias::tumores neuroectodérmicos::tumores neuroendocrinos [ENFERMEDADES]
Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores]
diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS
DIAGNÓSTICOS Y TERAPÉUTICOS]
Tumors neuroendocrins - Tractament
Other subheadings::Other subheadings::/drug therapy [Other subheadings]
Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL
DIAGNOSTIC AND THERAPEUTIC TECHNIQUES
AND EQUIPMENT]
Heterocyclic Compounds
4 or More Rings
Teràpia intravenosa
Neuroendocrine Tumors
Oncology
Neoplasms::Neoplasms by Histologic Type::Neoplasms
Germ Cell and Embryonal::Neuroectodermal Tumors::Neuroendocrine Tumors [DISEASES]
Avaluació de resultats (Assistència sanitària)
Humans
Therapeutics::Drug Therapy::Drug Administration Routes::Administration
Intravenous::Infusions
Intravenous [ANALYTICAL
DIAGNOSTIC AND THERAPEUTIC TECHNIQUES
AND EQUIPMENT]
Response Evaluation Criteria in Solid Tumors
Carbolines
terapéutica::farmacoterapia::vías de administración de medicamentos::administración intravenosa::infusiones intravenosas [TÉCNICAS Y EQUIPOS ANALÍTICOS
DIAGNÓSTICOS Y TERAPÉUTICOS]
Zdroj: Scientia
European journal of cancer (Oxford, England : 1990)
r-IIS La Fe. Repositorio Institucional de Producción Científica del Instituto de Investigación Sanitaria La Fe
instname
ISSN: 0959-8049
Popis: 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.
Databáze: OpenAIRE
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