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Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment

2020; Elsevier BV; Volume: 150; Linguagem: Inglês

10.1016/j.lungcan.2020.10.003

1872-8332

Vivek Subbiah, Luis Paz‐Ares, Benjamin Besse, Víctor Moreno, Solange Peters, María Ángeles Sala, José Antonio López-Vilariño, Cristian Fernández, Carmen Kahatt, Vicente Alfaro, Mariano Siguero, Ali Zeaiter, Khalil Zaman, Rafael López‐López, Santiago Ponce, Valentina Boni, Jennifer Arrondeau, Jean‐Pierre Delord, Maite Martínez, Luciano Wannesson, Antonio Antón, Javier Valdivia, Ahmad Awada, Rebecca Kristeleit, M.E. Olmedo, María Jesús Rubio, John Sarantopoulos, Sant P. Chawla, Joaquín Mosquera, Manolo D’ Arcangelo, Armando Santoro, Víctor M. Villalobos, Jacob Sands, José Trigo,

Peptidase Inhibition and Analysis

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.