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

Subbiah, V. ; Paz-Ares, L. ; Besse, B. ; Moreno, V. ; Peters, S. ; Sala, M.A. ; López-Vilariño, J.A. ; Fernández, C. ; Kahatt, C. ; Alfaro, V. ; Siguero, M. ; Zeaiter, A. ; Zaman, K. ; López, R. ; Ponce, S. ; Boni, V. ; Arrondeau, J. ; Delord, J.P. ; Martínez, M. ; Wannesson, L. ; Antón, A. (Universidad de Zaragoza) ; Valdivia, J. ; Awada, A. ; Kristeleit, R. ; Olmedo, M.E. ; Rubio, M.J. ; Sarantopoulos, J. ; Chawla, S.P. ; Mosquera-Martinez, J. ; D’ Arcangelo, M. ; Santoro, A. ; Villalobos, V.M. ; Sands, J. ; Trigo, J.

Resumen: 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.

Idioma: Inglés

DOI: 10.1016/j.lungcan.2020.10.003

Año: 2020

Publicado en: LUNG CANCER 150 (2020), 90-96
ISSN: 0169-5002

Factor impacto JCR: 5.705 (2020)

Categ. JCR: RESPIRATORY SYSTEM rank: 13 / 64 = 0.203 (2020) - Q1 - T1
Categ. JCR: ONCOLOGY rank: 73 / 242 = 0.302 (2020) - Q2 - T1

Factor impacto SCIMAGO: 1.989 - Cancer Research (Q1) - Pulmonary and Respiratory Medicine (Q1) - Oncology (Q1)

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)