Molina Casabán C1, Sancho Artés A1, Moya-Gil A1, Martín Ureste M2, Maestu Maiques I2, Climente Martí M1
1 Servicio de Farmacia
2 Servicio de Oncología Médica
Hospital Universitario Dr. Peset. Valencia (España)
Fecha de recepción: 04/07/2018 – Fecha de aceptación: 24/07/2018
Correspondencia: Carlos Molina Casabán w Hospital Universitario Dr. Peset (Servicio de Farmacia) w Avda. Gaspar Aguilar, 90 w 46017 Valencia (España)
Purpose: To assess the effectiveness and safety of nivolumab in real-life, as well as defining clinical predictors of treatment effectiveness.
Methods: Retrospective and observational study of non-small cell lung cancer diagnosed patients treated with nivolumab as second line or later between August 2015 and August 2017. Response was evaluated with RECIST v1.1 criteria. Effectiveness primary end-points were overall response rate (ORR) and overall survival (OS). Secondary efficacy end points included progression-free survival (PFS), best overall response (BOR), duration of response (DR) and time to response. The possible predictive factors (age, sex, stage, histology, ECOG-PS and number of prior treatments) of better response were analyzed by a Cox proportional-hazards regression model. For safety analysis, adverse events (AE) were categorized by CTCEA v4.3.
Results: 29 patients included, median age 67 years, (range 37-78), men (59%), ECOG-PS 0-1(93%) and disease stage IV (83%). ORR was 21% (95% CI 10-38). Median OS was 12,1 months (95% IC 4,7-19,5) and PFS 4,2 months (95% IC 1,4-10,5). BOR was partial response (PR) in six patients (21%), median DR was 3,6 (range 4,2-16,2+) and median time to response was 4,4 months (range 1,3-4,7). No baseline characteristics were founded as clinical predictors of effectiveness. Eleven patients (38%) had at least one AE G3-G4 what caused treatment interruption in three patients (10%).
Conclusions: Nivolumab had similar effectiveness results than clinical trials, not identifying predictors of better response. The safety of the treatament was reasonable although it had a clinical significant percentage (10%) of AE related discontinuations.
Key words: Nivolumab, real-life data, effectiveness, clinical predictors, safety.