New Data on HRQOL for Patients With Hepatocellular Carcinoma From the KEYNOTE-240 Trial

Health-related quality of life (HRQOL) was found to be similar in patients with advanced hepatocellular carcinoma (HCC) treated with pembrolizumab compared with those receiving best supportive care (BSC), according to data presented at ESMO Congress 2019 in Barcelona, Spain.

Researchers presented the latest findings from the KEYNOTE-240 Trial (ClinicalTrials.gov: NCT02702401), a double-blind, randomized, placebo-controlled, phase 3 trial comparing pembrolizumab 200 mg every 3 weeks with BSC. All the patients in the trial had advanced HCC that was previously treated systemically.

The KEYNOTE-240 trial showed that pembrolizumab reduced the risk of death by 22% and improved progression-free survival (PFS) compared with BSC. However, clinical significance was not reached for prespecified statistical criteria, so results presented at this meeting are those of prespecified exploratory HRQOL analyses.

The HRQOL cohort included 398 patients (271 in the pembrolizumab arm and 127 in the BSC arm). Participants completed questionnaires administered electronically at baseline and at weeks 3, 6, 9, 12, and 18. After week 18, the questionnaires were completed every 9 weeks for up to 1 year or until the end of treatment. The researchers compared least squares mean (LSM) score changes from baseline to week 12 (prespecified) using a constrained longitudinal data analysis model. It included treatment by study visit interaction and employed stratification factors as covariates.

The researchers found compliance with HRQOL questionnaires at week 12 was 90.0% for the pembrolizumab arm and 89.3% for the BSC arm. The study showed no statistically significant differences in LSM between the 2 arms for global health status (GHS)/QOL score (–1.19) from baseline to week 12. The researchers reported that GHS/QOL scores in both arms remained stable over time, and the time to deterioration (TTD) for prespecified symptoms of abdominal swelling (HR, 1.08), fatigue (HR, 0.98), and pain (HR, 0.97) were similar between the two arms.

Reference

Merle P, Kulkarni AS, Ryoo BY, et al. Health-related quality of life (HRQoL) impact of pembrolizumab (pembro) versus best supportive care (BSC) in previously systemically treated patients (pts) with advanced hepatocellular carcinoma (HCC): KEYNOTE-240. Presented at: ESMO Congress 2019; September 27-October 1, 2019; Barcelona, Spain. Abstract 676PD.