dc.contributor
Institut Català de la Salut
dc.contributor
[Peters S] Department of Oncology, University Hospital CHUV, Lausanne, Switzerland. [Trigo J] Department of Medical Oncology, Hospital Universitario Virgen de la Victoria, Málaga, Spain. [Besse B] Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France. [Moreno V] Department of Medical Oncology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Olmedo ME] Department of Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid, Spain
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Peters, Solange
dc.contributor.author
Trigo, José
dc.contributor.author
Besse, Benjamin
dc.contributor.author
NAVARRO, ALEJANDRO
dc.contributor.author
Moreno, Victor
dc.contributor.author
Olmedo García, María Eugenia
dc.date.accessioned
2025-10-25T05:39:28Z
dc.date.available
2025-10-25T05:39:28Z
dc.date.issued
2024-02-09T10:28:12Z
dc.date.issued
2024-02-09T10:28:12Z
dc.identifier
Peters S, Trigo J, Besse B, Moreno V, Navarro A, Eugenia Olmedo M, et al. Lurbinectedin in patients with small cell lung cancer with chemotherapy-free interval ≥30 days and without central nervous metastases. Lung Cancer. 2024 Feb;188:107448.
dc.identifier
https://hdl.handle.net/11351/11009
dc.identifier
10.1016/j.lungcan.2023.107448
dc.identifier.uri
http://hdl.handle.net/11351/11009
dc.description.abstract
Chemotherapy-free interval; Lurbinectedin; Response rate
dc.description.abstract
Interval lliure de quimioteràpia; Lurbinectedina; Taxa de resposta
dc.description.abstract
Intervalo libre de quimioterapia; Lurbinectedina; Tasa de respuesta
dc.description.abstract
Objectives
This report focuses on lurbinectedin activity and safety in a subgroup of small cell lung cancer (SCLC) patients from a Basket phase 2 study (Trigo et al. Lancet Oncology 2020;21:645–654) with chemotherapy-free interval (CTFI) ≥ 30 days. This pre-planned analysis was requested for obtaining regulatory approval of lurbinectedin in Switzerland.
Materials and methods
Patients with extensive-stage SCLC, no central nervous system (CNS) metastases, and disease progression after platinum-containing therapy were included. Topotecan data from a contemporary, randomized, controlled phase 3 study (ATLANTIS) were used as indirect external control in a matched patient population (n = 98 patients).
Results
Lurbinectedin showed a statistically significant higher overall response rate (ORR) by investigator assessment (IA) compared to topotecan subgroup (41.0 % vs. 25.5 %; p = 0.0382); higher ORR by Independent Review Committee (IRC) (33.7 % vs. 25.5 %); longer median duration of response (IA: 5.3 vs. 3.9 months; IRC: 5.1 vs. 4.3 months), and longer median overall survival (10.2 vs. 7.6 months). Grade ≥ 3 hematological abnormalities were remarkably lower with lurbinectedin: anemia 12.0 % vs. 54.1 %; leukopenia 30.1 % vs. 68.4 %; neutropenia 47.0 % vs. 75.5 %, and thrombocytopenia 6.0 % vs. 52.0 %. Febrile neutropenia was observed at a higher incidence with topotecan (6.1 % vs. 2.4 % with lurbinectedin) despite that the use of growth-colony stimulating factors was mandatory with topotecan.
Conclusion
With the limitations of an indirect comparison, however using recent and comparable SCLC datasets, this post hoc analysis shows that SCLC patients with CTFI ≥ 30 days and no CNS metastases have a positive benefit/risk ratio with lurbinectedin, superior to that observed with topotecan.
dc.description.abstract
The study was funded by Pharma Mar S.A with grants from the Centro para el Desarrollo Tecnológico Industrial (CDTI) during the conduct of the study.
dc.format
application/pdf
dc.relation
Lung Cancer;188
dc.relation
https://doi.org/10.1016/j.lungcan.2023.107448
dc.rights
Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Medicaments antineoplàstics - Ús terapèutic
dc.subject
Pulmons - Càncer - Tractament
dc.subject
DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell Lung
dc.subject
Other subheadings::Other subheadings::Other subheadings::/drug therapy
dc.subject
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents
dc.subject
Other subheadings::Other subheadings::/therapeutic use
dc.subject
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas
dc.subject
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
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COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos
dc.subject
Otros calificadores::Otros calificadores::/uso terapéutico
dc.title
Lurbinectedin in patients with small cell lung cancer with chemotherapy-free interval ≥30 days and without central nervous metastases
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
