Pembrolizumab patient reported benefits: A perspective based on multiple tumors.

Abstract

2650 Background: Pembrolizumab is a programmed death ligand receptor-1 (PD-L1) treatment indicated for multiple tumors. Patient-reported outcomes (PRO) benefit has only been reported at the tumor level, while a holistic review of PRO effects across tumor types has been missing. We performed a systematic review of PRO to assess the overall health-related quality of life (HRQoL) among cancer patients treated with pembrolizumab across multiple tumors. Methods: We systematically searched PRO evidence published from January 2014 to April 2020 across approved pembrolizumab indications using Embase, MEDLINE, and CENTRAL. Eligible studies were required to assess cancer patients treated with pembrolizumab (200 mg or 2mg/kg Q3W) and report PROs and/or HRQoL. The PRO evidence was summarized into three categories: short-term (≤Week 12), mid-term (Week 13-Week 24), and long-term (Week 25-Week 52). A clinically meaningful difference in HRQoL is defined as at least a 10 points improvement or deterioration relative to baseline; a change between ± 10 points is defined as stable. Results: We screened 1,262 citations, of which 16 publications reported EORTC QLQ-C30 data; 10 (9 trial-based studies; 1 observational study) of 16 publications reported global health status (GHS) mean change from baseline (CFB) across six indications. Within trial based studies in first-line setting (n=3 studies), the short-term, mid-term, and long-term GHS changes from baseline vary from 0.5 to 2.1, 1.2 to 8.4, and 1.6 to 2.5, respectively. For second-line plus setting (n=6 studies), GHS changes vary from -3.3 to 8.6, -1.0 to 10.9, and -0.9 to 9.2, respectively. Eight trial-based publications reported EORTC QLQ-C30 domain data as CFB. Short- or mid-term mean changes in functioning domain data showed improvement or stability in emotional, cognitive, role, and social functioning. Short-term deterioration in physical functioning was observed for 1 study, whereas physical functioning remained stable for other studies. For symptom domains, deterioration was not observed in any studies; mid-term improvement was reported by one study each in fatigue, dyspnea, and appetite loss; 2 studies reported mid-term improvement in pain. Conclusions: This is the first study that presented pembrolizumab PRO evidence at the product level. This study suggests that most pembrolizumab-treated patients maintained or improved HRQoL relative to baseline at pre-defined timepoints. This review s limitations include potential publication bias and lack of meta-analytic methods in reporting results. Nevertheless, these findings provide additional information about pembrolizumab s benefits to physicians and patients from a patient-centric perspective.