Pembrolizumab offered stable or improved measures of global health status and quality of life compared with chemotherapy in patients with previously treated advanced urothelial cancer.
Pembrolizumab offered stable or improved measures of global health status and quality of life compared with chemotherapy in a phase III trial of patients with previously treated advanced urothelial cancer. Along with previously reported improvements in efficacy, this confirms pembrolizumab as standard of care in this setting.
“Patients with urothelial cancer…report significant and clinically relevant decrements across all health-related quality of life [HRQOL] domains, with the greatest difficulties related to fatigue and social and role functioning,” wrote study authors led by David J. Vaughn, MD, of the Abramson Cancer Center at the University of Pennsylvania in Philadelphia.
The phase III KEYNOTE-045 trial previously showed that the immune checkpoint inhibitor pembrolizumab significantly prolongs overall survival compared with investigator’s choice of chemotherapy in patients with previously treated advanced urothelial cancer. The new analysis examined the HRQOL results from this same study.
The study included 542 patients, and the HRQOL analysis included 519 of those patients (266 pembrolizumab, 253 chemotherapy). HRQOL was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30. The results were published in the Journal of Clinical Oncology.
The median time to deterioration (TTD) in global health status/quality-of-life score was 3.5 months with pembrolizumab, compared with 2.3 months with chemotherapy, yielding a hazard ratio of 0.72 (95% CI, 0.56–0.92; P = .004).
The score was stable over time with pembrolizumab, while it worsened over time with chemotherapy. From baseline to week 15 with pembrolizumab, the mean change was 0.69 points, compared with a mean change of −8.36 points with chemotherapy.
Among patients who did not experience disease progression, the mean global health status/quality-of-life score rose by 5.94 points with pembrolizumab from baseline to week 15; it dropped by a mean of −4.65 points in chemotherapy patients. The score worsened regardless of treatment in patients who did experience disease progression, but pembrolizumab yielded a worsening of −3.62 points compared with −13.96 points with chemotherapy.
Taken along with the improvement in overall survival, “these data demonstrate the effectiveness of pembrolizumab in the three major areas that should be considered when selecting an optimal treatment-efficacy, safety, and quality of life,” the authors wrote. “These data support pembrolizumab as a new standard of care for platinum-refractory advanced urothelial cancer.”