Patient-reported outcomes (PROs) in pancreatic cancer clinical trials (CTs).

Abstract

534 Background: Incorporating PROs into CTs is critical for patients with pancreatic cancer, as these individuals often experience a high symptom burden and prioritize maximizing quality of life (QOL). Methods: We reviewed protocols of completed U.S. CTs listed on ClinicalTrials.gov that investigated curative/palliative interventions in pancreatic cancer from 1995-2020. We assessed up to August 2021 if CT publications reported PRO results through linked publications and an independent search through PubMed/MEDLINE. We extracted CT details (funding, eligibility, etc), and if PROs (outcome directly reported by patients) were listed as an endpoint (primary/secondary/exploratory). We classified interventions as cancer-directed (e.g. chemotherapy), supportive care (e.g. neurolysis), or other (e.g. curcumin). Results: We reviewed 619 protocols and included 379 in the analysis. Most CTs investigated cancer-directed interventions (317, 83.6%). Only 43 (11.4%) included PROs as endpoints (Table). In these, most of the PROs assessed QOL (34, 79.1%) and pain (15, 34.9%). For the 33/43 (76.7%) protocols that listed a specific PRO instrument, EORTC-QLQ C30 (11/33, 33.3%) was the most common. Only 6 (18.2%) protocols included pancreatic cancer-specific PROs, such as QLQ-PAN26. Supportive care CTs were more likely to assess PROs than cancer-directed CTs (odds ratio, OR= 62.6, 95% CI 16.7-234.3, p<0.0001). Protocols listed PROs as a primary, secondary, and exploratory endpoint in 15 (34.9%), 25 (58.1%), and 3 (6.9%) CTs respectively. Most CTs (13/15, 86.7%) with PROs as a primary endpoint evaluated supportive care interventions. Of 15 CTs with PROs as a primary endpoint, 10 (66.7%) had results published. Of 28 CTs assessing PROs as a secondary/exploratory outcome, 20 (71.4%) had published results and 12 (42.9%) included PRO data. Conclusions: From 1995-2020, only 11.4% of pancreatic cancer CTs incorporated PROs as endpoints. Supportive care CTs were more likely to include PROs than cancer-directed CTs. Our findings underscore the need to improve efforts to incorporate PROs into CTs for patients with pancreatic cancer. Data as number (%).[Table: see text]