Abstract 703P
Background
Lurbinectedin was FDA-approved in 2020 for metastatic SCLC on or after platinum-based chemotherapy. Its efficacy and safety in China clinical practice remain unknown. This real-world study evaluates Lurbinectedin in Chinese patients with pretreated ES-SCLC.
Methods
A retrospective study included 47 SCLC patients from two centers (29 from Ruijin Hainan Hospital and 18 from Boao Evergrande International Hospital). Patients aged ≥18 years with measurable lesions per RECIST v1.1 and who received at least two cycles of Lurbinectedin were included. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety.
Results
47 patients were included, median age 58 years (range 30-86), predominantly male (85.1%) and mostly non-smokers (53.2%). Most were in the extensive stage (93.6%) with ECOG PS 0-1 (91.7%), brain (33.3%) and liver metastases (41.7%). 12 patients received Lurbinectedin as second-line therapy (median age 57, 91.7% male, 66.7% with CTFI≥90 days), and 35 as third-line or beyond (median age 60, 82.9% male, 42.9% with CTFI≥90 days). The ORR was 29.8%, with 41.7% in the second-line group and 25.7% in the third-line. The DCR was 66% overall, with 75% in the second-line group and 62.8% in the third-line. The median PFS was 2.87 months (95% CI: 2.024-3.709) overall, 3.3 months (95% CI: 0.746-5.854) in the second-line group, and 2.6 months (95% CI: 2.152-3.048) in the third-line. The median OS was 9.2 months (95% CI: 7.642-10.758) overall, 9.2 months (95% CI: 6.945-11.455) in the second-line group, and 9.167 months (95% CI: 6.124-12.209) in the third-line. Common AEs in more than 10% of patients included gastrointestinal reactions (38.3%), thrombocytopenia (34%), fatigue (25.5%), leukopenia (23.4%), and anemia (19.1%). Grade 3 or higher AEs occurred in 17% of patients, with no treatment-related deaths.
Conclusions
This first RWS on Lurbinectedin in Chinese SCLC patients shows definite efficacy and acceptable safety in relapsed or refractory SCLC, with better outcomes in the second-line setting. Further studies are needed to confirm these results.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.