4CPS-303 Efficacy and safety of monotherapy with pembrolizumab in non-microcytic metastatic lung cancer in clinical practice

Abstract

Material and methods An observational, retrospective, descriptive study was conducted between January 2018 and October 2020. Age, sex, Barcelona Clinic Liver Cancer (BCLC) staging, adverse events (AEs), need for dose reduction or discontinuation, and time to progression or death were collected from our electronic records. None of the patients had received previous systemic therapy. The analysis was performed using R 4.0.3. Results 47 patients with metastatic HCC were treated with sorafenib. Patient characteristics are shown in table 1. Median overall survival (mOS) was 17.9 months (range 0.5-24.0; 95% CI 15.5 to not reached). The main AEs observed were: fatigue (42.5%), hand-foot skin reactions (42.5%), anorexia (40.4%), diarrhoea (38.3%), hypertension (14.9%), abdominal pain (14.9%), digestive bleeding (12.7%) and pruritus (10.6%). The most common reasons for treatment discontinuation were AEs (14 patients) and progression (22 patients). The rate of discontinuation due to AEs was 29.8%. 34 patients (72.3%) required dose reduction. Conclusion and relevance In our setting, mOS was superior to that reported in the pivotal clinical trial even though baseline characteristics were similar. Some of the AEs were more frequent, such as fatigue, hand-foot skin reactions, hypertension and anorexia, although the rate of discontinuation due to AEs was lower than reported in the SHARP trial. Sex M/F (n (%)) 42 (91.5)/5 (8.5) BCLC stage (n (%)) B (intermediate): 2 (4.3