In a secondary analysis of the KEYNOTE-204 clinical trial, researchers reported that patients receiving pembrolizumab for relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL) experienced improved health-related quality of life (HRQoL). The study results were reported in the journal Blood Advances.
The study investigators noted in their report that patients with R/R cHL face a poor prognosis, especially in circumstances of either having failed autologous stem cell transplantation (ASCT) or being ineligible for ASCT. HRQoL in patients with cHL who require further treatment may also be impacted, they explained.
The trial was the phase 3 KEYNOTE-204 study (ClinicalTrials.gov Identifier: NCT02684292). In this trial, patients with relapsed/refractory cHL were randomized to receive either pembrolizumab or brentuximab vedotin (BV). Included patients had either had R/R disease following ASCT or they were ineligible for ASCT. The current study was a secondary analysis of this trial with a focus on HRQoL outcomes.
HRQoL was assessed through analyses of patient-reported outcomes (PROs) as reported through 2 questionnaires: the EuroQoL EQ-5D-3L (EQ-5D) and the European Organization for Research and Treatment of Cancer (EORTC) QoL Questionnaire Core 30 (QLQ-C30). The PRO-analysis population consisted of patients who received 1 or more doses of study treatment and completed at least 1 item from 1 of the PRO questionnaires. PRO assessments were completed at baseline, every 6 weeks until week 24, and every 12 weeks after that time. Prespecified endpoints were least squares mean (LSM) changes between baseline and week 24 and the time to true deterioration (TTD), defined as a ≥10-point reduction from baseline.
Of patients from the trial, 146 patients from the pembrolizumab arm and 150 patients from the BV arm were included in this analysis of HRQoL. The global health status (GHS)/QoL scores on the EORTC QLQ-C30 showed a 24-week LSM difference of 8.60 points (95% CI, 3.89-13.31; P =.0004) in favor of pembrolizumab. Significant improvements were reported with pembrolizumab across EORTC QLQ-C30 domains, but significant differences were not seen in the emotional and cognitive functioning domains. The TTD in GHS/QoL was also reported to be longer with pembrolizumab, with a hazard ratio of 0.40 (95% CI, 0.22-0.74; P =.003).
With the EQ-5D questionnaire, visual analog scores showed an LSM difference in favor of pembrolizumab of 6.12 points (95% CI, 1.91-10.34; P =.0046), and the utility score reportedly showed an LSM difference in favor of pembrolizumab of 0.09 points (95% CI, 0.04-0.14; P =.0004).
“The results presented here support the usefulness of PROs in determining clinically meaningful differences in patients with R/R cHL and suggest that pembrolizumab treatment is associated with better HRQoL than BV treatment,” the researchers wrote in their report.
Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
Zinzani PL, Ramchandren R, Santoro A, et al. Quality-of-life analysis of pembrolizumab vs brentuximab vedotin for relapsed/refractory classical Hodgkin lymphoma. Blood Adv. 2022;6(2):590-599. doi:10.1182/bloodadvances.2021004970