Posted: Monday, June 19, 2023
Changhoon Yoo, MD, PhD, of Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea, conducted the phase III KEYNOTE-966 study, which evaluated pembrolizumab plus gemcitabine and cisplatin versus placebo plus the chemotherapy doublet in patients with aggressive biliary tract cancer. During the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4003), the investigators presented the protocol-specified, patient-reported, health-related quality-of-life outcomes of this study.
“Health-related quality of life was maintained when pembrolizumab was added to gemcitabine and cisplatin,” the study authors noted. “Together with the efficacy and safety data, these results support pembrolizumab plus gemcitabine and cisplatin as a new first-line treatment option for advanced biliary tract cancer.”
The European Organisation for the Research and Treatment of Cancer Quality-of-Life Questionnaires (EORTC QLQ)-C30 and -BIL21 and the European Quality-of-Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaires were sent to patients undergoing treatment with pembrolizumab plus gemcitabine and cisplatin (n = 518) or placebo plus the chemotherapy doublet (n = 517). Evaluations included global health status, physical functioning, role functioning (EORTC QLQ-C30), jaundice, pain (EORTC QLQ-BIL21), and EQ-5D-5L visual analog scale. A stratified Cox proportional hazards model was used to assess between-arm difference in the time to deterioration of health-related quality of life from baseline.
In both arms, questionnaire compliance exceeded 87% from baseline to week 18. Of note, least squares mean changes from baseline to week 18 in global health status, physical and role functioning, jaundice, pain, and EQ-5D-5L visual analog scale were similar between the arms. Additionally, the time to deterioration of health-related quality-of-life scores was also similar between the arms: median not reached versus 21.2 months for global health status quality of life; not reached versus 12.0 months for physical functioning; 6.5 months versus 5.8 months for role functioning, and not reached for both jaundice and pain.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.