Although the clinical relevance of quality of life (QOL) is increasingly being acknowledged, it is rarely included as a clinical study end point in biliary tract cancers (BTCs). A systematic review was conducted to characterize the assessment and reporting of QOL in phase 2 and 3 clinical trials conducted in patients with BTC. These results were presented at the 2022 ESMO GI congress.
A literature search was performed of primary publications of phase 2 and 3 clinical trials evaluating anticancer drugs in patients with BTC published between 2010 and 2021 by 7 relevant scientific journals. The authors extracted data concerning QOL from primary, secondary, or exploratory end points; presence of QOL results; and methodology of QOL analyses from papers and study protocols.
A total of 49 publications were identified. Of these, 2 were in the adjuvant setting, 27 in first-line, 3 in first-line and beyond, 8 in second-line, and 9 in second-line and beyond. All studies included intrahepatic and extrahepatic cancers; 41/42 included gallbladder cancers, and ampullary neoplasms were rarely included (6/42).
The majority of publications (71.4%) did not list QOL among the end points. This trend was consistent over time (ie, between 2010 and 2015 and between 2016 and 2021). Trials conducted in Western populations were more likely to include QOL as a primary end point. In the metastatic setting, QOL was a secondary end point in 21.3% of trials and an exploratory end point in 4.3% of trials. Of the 14 primary publications of trials reporting QOL as a primary, secondary, or exploratory end point, QOL results were published in less than half of the papers (42.8%). The most common QOL tools used were EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire; 57.1%) and EuroQoL-5D (European Quality of Life Five Dimension, and EuroQol five-dimensional; 21.4%).
The findings of this systematic review indicate that phase 2 and 3 clinical trials conducted in the past decade did not routinely include QOL assessments as a trial outcome. The investigators noted that this was true “even in metastatic setting where QOL data should be fundamental for the optimal management of patients.”
Source: Tober N, Fillipini DM, Pagani R, et al. Quality of life assessment in biliary tract cancer: a systematic review of phase 2 and 3 clinical trials published between 2010 and 2021. European Society for Medical Oncology World Congress on Gastrointestinal Cancer 2022. Abstract P-144.