Sistema de Salut de Catalunya
Institut Català de la Salut
[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
Vall d'Hebron Barcelona Hospital Campus
2024-02-09T10:28:12Z
2024-02-09T10:28:12Z
2024-02
Chemotherapy-free interval; Lurbinectedin; Response rate
Interval lliure de quimioteràpia; Lurbinectedina; Taxa de resposta
Intervalo libre de quimioterapia; Lurbinectedina; Tasa de respuesta
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.
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.
Article
Published version
English
Medicaments antineoplàstics - Ús terapèutic; Pulmons - Càncer - Tractament; DISEASES::Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell Lung; Other subheadings::Other subheadings::Other subheadings::/drug therapy; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents; Other subheadings::Other subheadings::/therapeutic use; 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; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos; Otros calificadores::Otros calificadores::/uso terapéutico
Elsevier
Lung Cancer;188
https://doi.org/10.1016/j.lungcan.2023.107448
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
