Abstract 4471: Patient-reported outcomes and emergency department (ED) visits among gastrointestinal (GI) cancer patients prescribed anti-CTLA4/PD-1/L-1 antibody immunotherapy
Authors: McCleary Nadine J. , Cleveland Jessica , Zhang Sunyi , Upadhyay Vivek , Hassett Michael 
Published: September 2020

Introduction: Leveraging electronic Patient Reported Outcomes (ePRO) improves cancer care delivery by reducing ED visits/hospitalizations and increasing overall survival. Yet little is known patient-reported outcomes or association with ED visits outcomes following immunotherapy. Here, we describe systematic ePRO collection using 15 core symptoms via the validated Patient Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) tool among pts prescribed anti-CTLA4/PD-1/L-1 antibody immunotherapy for GI cancer.

Methods: We previously demonstrated feasibility of an electronic health record (EHR)-embedded ePRO collection via iPads for nearly 70% of new and established patients across Dana-Farber Cancer Institute ambulatory oncology practices. ePRO is deployed once weekly to established patients at home via the EHR patient portal or in clinic via tablet. Patient responses are scored using an algorithm, scaled 0-3, with scores of 3 indicating moderate/severe symptomatic adverse events (SAEs; equivalent to CTCAE grade 3+). We examined pt/disease/immunotherapy treatment characteristics, symptom burden at baseline, SAEs for pts prescribed Pembrolizumab, Nivolumab, Atezolizumab, Ipilimumab, Durvalumab, or Avelumab between January 2018 - August 2019. Exploratory analysis include frequency of ED visits at 30/60/90/120 days from immunotherapy start among subset reporting moderate/severe SAEs.

Findings: Fifty-one (12.98%) of the 393 eligible pts prescribed immunotherapy used ePRO to report SAEs with median followup of 105 days (interquartile range 43-189). The summary distribution of SAEs across 15 PRO-CTCAE domains shows that moderate/severe SAEs reported were fatigue (19.61%), insomnia (11.76%), and general pain (21.57%); least frequently reported SAEs were fever/rash/vomiting (0%), and nausea (1.96%). In exploratory analysis, 111 (28%) patients had an ED visit, 37(9.40%) occurred within the first 90 days of treatment.

Conclusions: We demonstrate proof-of-principle that ePRO implementation in routine practice is feasible, describes the distribution of patient-reported SAEs, and can be evaluated relative to key clinical outcomes such as ED utilization following immunotherapy. Further analysis will examine pt/disease/treatment characteristics predicting moderate/severe SAEs and inferior clinical outcomes. With increased response rates, we will leverage ePRO to develop targeted population health management interventions for patients prescribed immunotherapy in ambulatory oncology practice.

Citation Format: Nadine J. McCleary, Jessica Cleveland, Sunyi Zhang, Vivek Upadhyay, Michael Hassett. Patient-reported outcomes and emergency department (ED) visits among gastrointestinal (GI) cancer patients prescribed anti-CTLA4/PD-1/L-1 antibody immunotherapy [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 4471.