Highlights
- The NCCN recommends first-line re-challenge for relapsed SCLC with CTFI ≥ 180 days.
- •This recommendation is based on data from small trials from the 1980s.
- •Lurbinectedin has remarkable activity and acceptable safety in second-line SCLC.
- •ORR was 60.0% in a preplanned subset of patients with CTFI ≥ 180 days.
- •Lurbinectedin can be a valuable alternative to re-treatment with first-line therapy.
Abstract
Introduction
The National Comprehensive Cancer Network guidelines recommend re-challenge with the first-line treatment for relapsed small cell lung cancer (SCLC) with chemotherapy-free interval (CTFI)≥180 days. A phase II study (NCT02454972) showed remarkable antitumor activity in SCLC patients treated with lurbinectedin 3.2 mg/m2 1 -h intravenous infusion every 3 weeks as second-line therapy. We report results for the pre-planned subset of patients with CTFI ≥ 180 days.
Material and Methods
Twenty patients aged ≥18 years with pathologically proven SCLC diagnosis, pretreated with only one prior platinum-containing line, no CNS metastases, and with CTFI ≥ 180 days were evaluated. The primary efficacy endpoint was the overall response rate (ORR) assessed by the Investigators according to RECIST v1.1.
Results
ORR was 60.0% (95%CI, 36.1-86.9), with a median duration of response of 5.5 months (95%CI, 2.9-11.2) and disease control rate of 95.0% (95%CI, 75.1-99.9). Median progression-free survival was 4.6 months (95%CI, 2.6-7.3). With a censoring of 55.0%, the median overall survival was 16.2 months (95%CI, 9.6-upper level not reached). Of note, 60.9% and 27.1% of patients were alive at 1 and 2 years, respectively. The most common grade 3/4 adverse events and laboratory abnormalities were hematological disorders (neutropenia, 55.0%; anemia; 10.0% thrombocytopenia, 10.0%), fatigue (10.0%) and increased liver function tests (GGT, 10%; ALT and AP, 5.0% each). No febrile neutropenia was reported.
Conclusion
Lurbinectedin is an effective treatment for platinum-sensitive relapsed SCLC, especially in patients with CTFI ≥ 180 days, with acceptable safety and tolerability. These encouraging results suggest that lurbinectedin can be another valuable therapeutic option rather than platinum re-challenge.
