Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment
Vivek Subbiah, Luis Paz-Ares, Benjamin Besse, Victor Moreno, Solange Peters, María Angeles Sala, José Antonio López-Vilariño, Cristian Fernández, Carmen Kahatt, Vicente Alfaro, Mariano Siguero, Ali Zeaiter, Khalil Zaman, Rafael López, Santiago Ponce, Valentina Boni, Jennifer Arrondeau, Jean-Pierre Delord, Maite Martínez, Luciano Wannesson, Antonio Antón, Javier Valdivia, Ahmad Awada, Rebecca Kristeleit, Maria Eugenia Olmedo, María Jesús Rubio, John Sarantopoulos, Sant P Chawla, Joaquín Mosquera-Martinez, Manolo D' Arcangelo, Armando Santoro, Victor M Villalobos, Jacob Sands, José Trigo, Vivek Subbiah, Luis Paz-Ares, Benjamin Besse, Victor Moreno, Solange Peters, María Angeles Sala, José Antonio López-Vilariño, Cristian Fernández, Carmen Kahatt, Vicente Alfaro, Mariano Siguero, Ali Zeaiter, Khalil Zaman, Rafael López, Santiago Ponce, Valentina Boni, Jennifer Arrondeau, Jean-Pierre Delord, Maite Martínez, Luciano Wannesson, Antonio Antón, Javier Valdivia, Ahmad Awada, Rebecca Kristeleit, Maria Eugenia Olmedo, María Jesús Rubio, John Sarantopoulos, Sant P Chawla, Joaquín Mosquera-Martinez, Manolo D' Arcangelo, Armando Santoro, Victor M Villalobos, Jacob Sands, José Trigo
Abstract
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.
Keywords: Chemotherapy-free interval; Lurbinectedin; NCCN guidelines; Platinum re-challenge.
Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.
Source: PubMed