%0 Journal Article
%A Subbiah, Vivek
%A Paz-Ares, Luis
%A Besse, Benjamin
%A Moreno, Victor
%A Peters, Solange
%A Sala, María Angeles
%A López-Vilariño, José Antonio
%A Fernández, Cristian
%A Kahatt, Carmen
%A Alfaro, Vicente
%A Siguero, Mariano
%A Zeaiter, Ali
%A Zaman, Khalil
%A López, Rafael
%A Ponce, Santiago
%A Boni, Valentina
%A Arrondeau, Jennifer
%A Delord, Jean-Pierre
%A Martínez, Maite
%A Wannesson, Luciano
%A Antón, Antonio
%A Valdivia, Javier
%A Awada, Ahmad
%A Kristeleit, Rebecca
%A Olmedo, Maria Eugenia
%A Rubio, María Jesús
%A Sarantopoulos, John
%A Chawla, Sant P
%A Mosquera-Martinez, Joaquín
%A D' Arcangelo, Manolo
%A Santoro, Armando
%A Villalobos, Victor M
%A Sands, Jacob
%A Trigo, José
%T Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment.
%D 2020
%U http://hdl.handle.net/10668/16466
%X 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. 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.
%K Chemotherapy-free interval
%K Lurbinectedin
%K NCCN guidelines
%K Platinum re-challenge
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