TY - JOUR
T1 - Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment
AU - Subbiah, Vivek
AU - Paz-Ares, Luis
AU - Besse, Benjamin
AU - Moreno, Victor
AU - Peters, Solange
AU - Sala, María Angeles
AU - López-Vilariño, José Antonio
AU - Fernández, Cristian
AU - Kahatt, Carmen
AU - Alfaro, Vicente
AU - Siguero, Mariano
AU - Zeaiter, Ali
AU - Zaman, Khalil
AU - López, Rafael
AU - Ponce, Santiago
AU - Boni, Valentina
AU - Arrondeau, Jennifer
AU - Delord, Jean Pierre
AU - Martínez, Maite
AU - Wannesson, Luciano
AU - Antón, Antonio
AU - Valdivia, Javier
AU - Awada, Ahmad
AU - Kristeleit, Rebecca
AU - Olmedo, Maria Eugenia
AU - Rubio, María Jesús
AU - Sarantopoulos, John
AU - Chawla, Sant P.
AU - Mosquera-Martinez, Joaquín
AU - D’ Arcangelo, Manolo
AU - Santoro, Armando
AU - Villalobos, Victor M.
AU - Sands, Jacob
AU - Trigo, José
N1 - Publisher Copyright:
© 2020 The Authors
PY - 2020/12/1
Y1 - 2020/12/1
N2 - 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/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. 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.
AB - 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/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. 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.
KW - Chemotherapy-free interval
KW - Lurbinectedin
KW - NCCN guidelines
KW - Platinum re-challenge
UR - http://www.scopus.com/inward/record.url?scp=85092925317&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2020.10.003
DO - 10.1016/j.lungcan.2020.10.003
M3 - Article
C2 - 33096421
AN - SCOPUS:85092925317
SN - 0169-5002
VL - 150
SP - 90
EP - 96
JO - Lung Cancer
JF - Lung Cancer
ER -