Antitumor Activity of Lurbinectedin in Second-line Small Cell Lung Cancer Patients Who Are Candidates for Re-challenge with the First-line Treatment
Mené sur 20 patients atteints d’un cancer du poumon à petites cellules sensible aux sels de platine et récidivant, cet essai de phase II évalue l’efficacité, du point de vue du taux de réponse globale, et la toxicité de la lurbinectédine en traitement de deuxième ligne, plus de 180 jours après le traitement de première ligne
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/m 2 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.
Lung Cancer 2020