RT Journal Article
T1 Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment.
A1 Subbiah, Vivek
A1 Paz-Ares, Luis
A1 Besse, Benjamin
A1 Moreno, Victor
A1 Peters, Solange
A1 Sala, María Angeles
A1 López-Vilariño, José Antonio
A1 Fernández, Cristian
A1 Kahatt, Carmen
A1 Alfaro, Vicente
A1 Siguero, Mariano
A1 Zeaiter, Ali
A1 Zaman, Khalil
A1 López, Rafael
A1 Ponce, Santiago
A1 Boni, Valentina
A1 Arrondeau, Jennifer
A1 Delord, Jean-Pierre
A1 Martínez, Maite
A1 Wannesson, Luciano
A1 Antón, Antonio
A1 Valdivia, Javier
A1 Awada, Ahmad
A1 Kristeleit, Rebecca
A1 Olmedo, Maria Eugenia
A1 Rubio, María Jesús
A1 Sarantopoulos, John
A1 Chawla, Sant P
A1 Mosquera-Martinez, Joaquín
A1 D' Arcangelo, Manolo
A1 Santoro, Armando
A1 Villalobos, Victor M
A1 Sands, Jacob
A1 Trigo, José
K1 Chemotherapy-free interval
K1 Lurbinectedin
K1 NCCN guidelines
K1 Platinum re-challenge
AB 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.
YR 2020
FD 2020-10-10
LK http://hdl.handle.net/10668/16466
UL http://hdl.handle.net/10668/16466
LA en
DS RISalud
RD Apr 6, 2025