Lurbinectedin in extensive-stage small-cell lung cancer: a brief report of the IFCT-2105 LURBICLIN study

ESMO Open. 2024 Dec;9(12):103968. doi: 10.1016/j.esmoop.2024.103968. Epub 2024 Nov 27.

Abstract

Background: Small-cell lung cancer (SCLC) is a highly aggressive type of lung cancer. Lurbinectedin is recommended as second-/third-line treatment for advanced, previously treated SCLC.

Materials and methods: LURBICLIN is a nationwide, non-interventional, retrospective chart review study, based on the cohort of consecutive patients enrolled in the named patient use for lurbinectedin in France.

Results: A total of 312 patients were included. Lurbinectedin was delivered as second-line therapy in 138 (44%) patients. Grade 3-4 treatment-related adverse events were observed in 28 (9%) and 15 (5%) patients, respectively. Objective response rate (ORR) to lurbinectedin was 22% in the intention-to-treat population. After a median follow-up of 20.8 months, median progression-free survival (PFS) was 1.9 months [95% confidence interval (CI) 1.8-2.0 months]. At multivariate analysis, chemotherapy-free interval (CTFI) ≥ 90 days was an independent predictor of higher PFS [hazard ratio (HR) = 0.64, 95% CI 0.50-0.84, P < 0.0001]. The median overall survival (OS) was 4.7 months (95% CI 4.0-5.4 months). At multivariate analysis, performance status < 2 and CTFI ≥ 90 days were independent predictors of higher OS (HR = 0.71, 95% CI 0.53-0.95, P = 0.03; and HR = 0.58, 95% CI 0.44-0.76, P < 0.0001, respectively). Overall, 147 (47%) patients had initiated subsequent systemic treatments.

Conclusions: LURBICLIN confirms the activity of lurbinectedin in patients with SCLC with a manageable safety profile. Lurbinectedin monotherapy provides an alternative option for SCLC patients.

Keywords: chemotherapy; compassionate use trials; immunotherapy; lurbinectedin; small-cell lung cancer.

Publication types

  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / pharmacology
  • Antineoplastic Agents / therapeutic use
  • Carbolines* / therapeutic use
  • Female
  • France
  • Heterocyclic Compounds, 4 or More Rings* / pharmacology
  • Heterocyclic Compounds, 4 or More Rings* / therapeutic use
  • Humans
  • Lung Neoplasms* / drug therapy
  • Lung Neoplasms* / pathology
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Progression-Free Survival
  • Retrospective Studies
  • Small Cell Lung Carcinoma* / drug therapy
  • Small Cell Lung Carcinoma* / pathology
  • Treatment Outcome

Substances

  • Carbolines
  • PM 01183
  • Heterocyclic Compounds, 4 or More Rings
  • Antineoplastic Agents