Subbiah, VivekPaz-Ares, LuisBesse, BenjaminMoreno, VictorPeters, SolangeSala, María AngelesLópez-Vilariño, José AntonioFernández, CristianKahatt, CarmenAlfaro, VicenteSiguero, MarianoZeaiter, AliZaman, KhalilLópez, RafaelPonce, SantiagoBoni, ValentinaArrondeau, JenniferDelord, Jean-PierreMartínez, MaiteWannesson, LucianoAntón, AntonioValdivia, JavierAwada, AhmadKristeleit, RebeccaOlmedo, Maria EugeniaRubio, María JesúsSarantopoulos, JohnChawla, Sant PMosquera-Martinez, JoaquínD' Arcangelo, ManoloSantoro, ArmandoVillalobos, Victor MSands, JacobTrigo, José2023-02-092023-02-092020-10-10http://hdl.handle.net/10668/16466The 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. 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. 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. 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.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/Chemotherapy-free intervalLurbinectedinNCCN guidelinesPlatinum re-challengeAdolescentAdultAntineoplastic Combined Chemotherapy ProtocolsCarbolinesHeterocyclic Compounds, 4 or More RingsHumansLung NeoplasmsNeoplasm Recurrence, LocalSmall Cell Lung Carcinomaresearch article33096421open access10.1016/j.lungcan.2020.10.0031872-8332http://www.lungcancerjournal.info/article/S0169500220306401/pdf