000096089 001__ 96089
000096089 005__ 20221004075833.0
000096089 0247_ $$2doi$$a10.1016/j.lungcan.2020.10.003
000096089 0248_ $$2sideral$$a120753
000096089 037__ $$aART-2020-120753
000096089 041__ $$aeng
000096089 100__ $$aSubbiah, V.
000096089 245__ $$aAntitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment
000096089 260__ $$c2020
000096089 5060_ $$aAccess copy available to the general public$$fUnrestricted
000096089 5203_ $$aIntroduction: 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.
000096089 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/
000096089 590__ $$a5.705$$b2020
000096089 591__ $$aRESPIRATORY SYSTEM$$b13 / 64 = 0.203$$c2020$$dQ1$$eT1
000096089 591__ $$aONCOLOGY$$b73 / 242 = 0.302$$c2020$$dQ2$$eT1
000096089 592__ $$a1.989$$b2020
000096089 593__ $$aCancer Research$$c2020$$dQ1
000096089 593__ $$aPulmonary and Respiratory Medicine$$c2020$$dQ1
000096089 593__ $$aOncology$$c2020$$dQ1
000096089 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000096089 700__ $$aPaz-Ares, L.
000096089 700__ $$aBesse, B.
000096089 700__ $$aMoreno, V.
000096089 700__ $$aPeters, S.
000096089 700__ $$aSala, M.A.
000096089 700__ $$aLópez-Vilariño, J.A.
000096089 700__ $$aFernández, C.
000096089 700__ $$aKahatt, C.
000096089 700__ $$aAlfaro, V.
000096089 700__ $$aSiguero, M.
000096089 700__ $$aZeaiter, A.
000096089 700__ $$aZaman, K.
000096089 700__ $$aLópez, R.
000096089 700__ $$aPonce, S.
000096089 700__ $$aBoni, V.
000096089 700__ $$aArrondeau, J.
000096089 700__ $$aDelord, J.P.
000096089 700__ $$aMartínez, M.
000096089 700__ $$aWannesson, L.
000096089 700__ $$0(orcid)0000-0002-9159-4988$$aAntón, A.$$uUniversidad de Zaragoza
000096089 700__ $$aValdivia, J.
000096089 700__ $$aAwada, A.
000096089 700__ $$aKristeleit, R.
000096089 700__ $$aOlmedo, M.E.
000096089 700__ $$aRubio, M.J.
000096089 700__ $$aSarantopoulos, J.
000096089 700__ $$aChawla, S.P.
000096089 700__ $$aMosquera-Martinez, J.
000096089 700__ $$aD’ Arcangelo, M.
000096089 700__ $$aSantoro, A.
000096089 700__ $$aVillalobos, V.M.
000096089 700__ $$aSands, J.
000096089 700__ $$aTrigo, J.
000096089 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000096089 773__ $$g150 (2020), 90-96$$pLung cancer$$tLUNG CANCER$$x0169-5002
000096089 8564_ $$s313555$$uhttps://zaguan.unizar.es/record/96089/files/texto_completo.pdf$$yVersión publicada
000096089 8564_ $$s367513$$uhttps://zaguan.unizar.es/record/96089/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000096089 909CO $$ooai:zaguan.unizar.es:96089$$particulos$$pdriver
000096089 951__ $$a2022-10-03-13:19:11
000096089 980__ $$aARTICLE