Few studies have evaluated HRQoL in patients with ESPC (resectable or borderline resectable) who received A/NAC. This SLR aimed to summarize the available evidence on HRQoL in this population.
Key electronic databases (all years), conference abstracts (2013-2017), and clinical trial registries were searched according to PRISMA guidance to identify relevant studies reporting HRQoL as assessed by patient-reported outcomes measures (PROMs) in A/NAC for ESPC. HRQoL scores were compared with reference values (ie, norms) and assessed longitudinally when possible. Minimally important difference (MID) estimates for the most frequently used PROMs were also assessed.
Of 645 identified records, 37 PROMs and HRQoL outcomes studies were retained. The EORTC QLQ-C30 and/or QLQ-PAN26 were used in 31 studies; other PROMs were used in 11 studies, including the Functional Assessment of Cancer Therapy (n = 4), 36-Item Short Form Survey (n = 2), and the Center for Epidemiologic Studies Depression Scale (n = 2). At baseline (before and/or immediately after surgery), EORTC QLQ-C30 global health status/QoL scores for patients with ESPC were similar to reference values for PC but lower than those for all cancers. Among studies that reported QoL over time, longitudinal QoL trends varied: 4 studies reported improvement from baseline, whereas 4 studies reported initial declines, upon which QoL increased to or above baseline (n = 3) or below baseline (n = 1) within 3 to 6 months. An MID of 10 was identified for EORTC QLQ-C30. An MID for QLQ-PAN26 does not seem to have been comprehensively assessed to date.
The EORTC QLQ-C30 and QLQ-PAN26 are the most commonly used HRQoL PROMs for studies of A/NAC in ESPC. Poor HRQoL was reported by EORTC QLQ-C30 global health status/QoL scores, indicating a high unmet need. Some studies indicated improved HRQoL over time; however, this may reflect survivor selection bias. The MID for QLQ-C30 may be useful in understanding the clinically relevant impact of ESPC treatment on HRQoL. Future research should validate the QLQ-PAN26 and establish its MID in A/NAC for ESPC.
Clinical trial identification
Legal entity responsible for the study
Medical writing assistance was provided by Narender Dhingra, MBBS, PhD, MediTech Media, Ltd, funded by Celgene Corporation. All listed authors were fully responsible for all content and editorial decisions for this abstract.
M. Reni: Grants, Personal fees, Non-financial support: Celgene; Grants and personal fees: Baxalta, Merck, Serono, Helsinn; Personal fees: Lilly, Pfizer, Baxalta, Merck, Serono, Astra Zeneca, Novocure, Halozyme, Novartis, Shire, during the conduct of the study. H. Riess: Personal fees: Celgene, Roche, Shire, outside the submitted work. M.A. Tempero: Consultant: AbbVie, Advance Medical, BioPharm Communications, BMS, Celgene, Eisai, Ignyta, Pharmacyslics, Pharmcyte Biotech, Tocagen, Inc.; Ad Boards: AstraZeneca, CPRIT, Immunovia; Research contract: Halozyme. M.F. Botteman: Grants, Personal fees: Celgene, during the conduct of the study; Grants, Personal fees: Pharmaceutical and device manufacturers, outside the submitted work. C. Deshpande: Employee: Pharmerit International, which received research funding from Celgene corporation for this study. E. Lucas: Grants: Celgene, during the conduct of the study; Grants: Pharmaceutical and device manufacturers, outside the submitted work. All other authors have declared no conflicts of interest.