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Multicenter Study
. 2025 Aug 26:226:115595.
doi: 10.1016/j.ejca.2025.115595. Epub 2025 Jul 3.

Outcome and safety of lurbinectedin as compassionate use in extensive stage small cell lung cancer: A multicentric international cohort

Daniela Scattolin  1 , Anne-Marie C Dingemans  2 , Alessandro Dal Maso  3 , Valentina Guarneri  4 , Joachim G J V Aerts  2 , Giulia Pasello  4 , Daphne W Dumoulin  5
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Free article
Multicenter Study

Outcome and safety of lurbinectedin as compassionate use in extensive stage small cell lung cancer: A multicentric international cohort

Daniela Scattolin et al. Eur J Cancer. .
Free article

Abstract

Introduction: Lurbinectedin has recently emerged in the treatment landscape of extensive stage (ES) small cell lung cancer (SCLC). Here we report the outcomes and safety of lurbinectedin within a named patient program in a multicentric, international cohort.

Methods: Clinical data of all patients with ES-SCLC treated with lurbinectedin at the Erasmus Medical Center (EMC, Rotterdam-The Netherlands) and the Veneto Institute of Oncology (IOV, Padua-Italy) were collected.

Results: A total of 238 patients receiving lurbinectedin as second- (37 %), third- (45 %) or further-line (18 %) were included. Median number of cycles was 3 (1-22). The objective response rate was 23.1 %, the disease control rate 45.5 %. The median progression free survival (PFS) 2.2 months (95 %CI 1.6-2.8) and the median overall survival (OS) 5.4 months (95 %CI 4.5-6.3). Patients with a chemotherapy-free interval (CFI) ≥ 90 days showed a longer PFS (3.1 vs 1.8 months, HR 0.46, 0.30-0.71, p < 0.001) and OS (6.8 vs 4.5 months, HR 0.56, 0.37-0.85, p = 0.006). Patients with ECOG performance status (PS) ≥ 2 at lurbinectedin start, brain or liver metastasis showed a worse outcome. Adverse events were recorded in 218 (92 %) patients, with 29 % grade 3-4 events.

Conclusion: Considering its safety profile and modest but consistent effectiveness, lurbinectedin represents a therapeutic option as compassionate use in patients with ES-SCLC, especially in those with a long CFI. Poor PS, CFI < 90 days, brain or liver metastases may affect the OS.

Keywords: Effectiveness; Lurbinectedin; Real-world; Small cell lung cancer.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Daniela Scattolin declares no conflict of interest; Anne-Marie C. Dingemans declares Consultant/Advisor/Speaker and or Travel fees, data monitoring: Sanofi, Amgen, Bayer, Roche, AstraZeneca, Boehringer Ingelheim, Daiichi, Jannsen, Pfizer, AstraZeneca, Takeda; Grants or contracts: Dutch Cancer Society, HANARTH, Amgen; Leadership: Chair EORTC lung cancer group; Alessandro Dal Maso declares no conflict of interest; Valentina Guarneri declares Consultant/Advisor/Speaker and or Travel fees and Advisory Board participation: AstraZeneca, Daiichi Sankyo, Eli Lilly, Novartis, Zentiva, Exact Sciences, Roche, Gilead, GSK, Menarini Stemline, Olema Oncology, Pierre Fabre; Joachim G.J.V. Aerts declares consultant/speaker fees: AstraZeneca, CureVac, Danone, MSD, BMS, Eli Lilly; research funding: AstraZeneca, Danone and Genmab; listed on patents relating to allogenic tumour cell lysates, combination immune-oncology drug regimens and biomarkers for immunotherapy; unpaid leadership roles as Treasurer of the IASLC; board member of IMIG; stock options holding in Amphera. Giulia Pasello declares consultant/Advisor/Speaker and or Travel fees and research support: AstraZeneca, Amgen, BMS, Merck, MSD, Eli Lilly, Johnson&Johnson, Novartis, Pfizer, Roche; Daphne W. Dumoulin declares Consultant/Advisor/Speaker and or Travel fees: MSD, BMs, Roche, AstraZeneca, Amgen Pfizer.

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