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1784P Activity of lurbinectedin in second-line SCLC patients candidates for platinum re-challenge

2020; Elsevier BV; Volume: 31; Linguagem: Inglês

10.1016/j.annonc.2020.08.1545

1569-8041

Vivek Subbiah, Luis Paz‐Ares, Benjamin Besse, Víctor Moreno, Khalil Zaman, M.Á. Sala González, José Antonio López-Vilariño, Cristian Marcelo Fernandez, Carmen Kahatt, Mariano Siguero, Ali Zeaiter, Rafael López‐López, Santiago Ponce Aix, V. Boni, Jennifer Arrondeau, J.P. Delord, Maite Martínez-Aguillo, L. Wannesson De Nicola, A. Antón Torres, J.M. Trigo Perez,

Peptidase Inhibition and Analysis

Remarkable activity was observed with lurbinectedin in patients (pts) with relapsed small-cell lung cancer (SCLC) in a phase II Basket trial (Trigo et al. 2020). NCCN guidelines recommend platinum re-challenge if chemotherapy-free interval (CTFI) >180 days (d) based on small clinical trials mostly conducted in the 1980s. Recent data on re-challenge with CTFI >90 d showed overall response rate (ORR) of 45-49% and median overall survival (OS) of 7.5-7.9 months (mo) (Genestreti et al. 2015; Monnet et al. 2019). In the SCLC cohort of the Basket trial, 60 pts with CTFI >90 d (20 pts with CTFI >180 d) pretreated with one prior platinum-based line were treated with lurbinectedin 3.2 mg/m2 1-hour i.v. infusion q3wk. Median (range) age was 59 (44-78) years; 56.7% were males; ECOG PS 0/1/2 was 45/50/5%; 31.7% had liver metastases; 58% extensive disease at diagnosis; all received prior platinum; 8.3% received prior immunotherapy; and best response to prior platinum-based chemotherapy was CR (13.3%), PR (71.7%), and SD (13.3%). Median (range) CTFI was 4.7 mo (2.9-16.1) mo. Median (range) number of lurbinectedin cycles was 6 (1-24).Table: 1784PCTFI >90 d (n=60)CTFI >180 d (n=20)IAIRCIAIRCORR (95% CI), % (confirmed responses)45.0 (32.1-58.4)43.3 (30.6-56.8)60.0 (36.1-86.9)50.0 (27.2-72.8)Disease Control Rate at 8 wks, %81.7 (69.6-90.5)73.3 (60.3-83.9)95.0 (75.1-99.9)80.0 (56.3-94.3)Median Duration of Response (95% CI), mo6.2 (3.5-7.3)5.3 (4.9-7.0)5.5 (2.9-11.2)5.5 (2.8-8.5)Median OS (95% CI), mo11.9 (9.7-16.2)16.2 (9.6-NR)OS at 12 mo (95% CI), %48.3 (32.5-64.1)60.9 (35.7-86.2)OS at 24 mo (95% CI), %21.0 (8.2-33.8)27.1 (5.4-48.8)CI: confidence interval; d: days; IA: Investigator's assessment; IRC: Independent Review Committee; NR: not reached; wks: weeks. Open table in a new tab CI: confidence interval; d: days; IA: Investigator's assessment; IRC: Independent Review Committee; NR: not reached; wks: weeks. Main adverse events were hematological (grade 3/4 neutropenia: 25%; febrile neutropenia, 1.7%; grade 3/4 anemia: 10%) and grade 3 fatigue (10%). Further treatment after lurbinectedin was mainly platinum-based chemotherapy (55%) and immunotherapy (20.5%). Lurbinectedin is effective and well-tolerated in platinum-sensitive relapsed SCLC, especially when CTFI >180 d. Lurbinectedin is an alternative to platinum re-challenge.