Health-Related Quality-of-Life Analysis of Anti–PD-1 Therapy vs Chemotherapy in Advanced Urothelial Cancer


Key Points

  • Pembrolizumab was associated with prolonged time to deterioration vs chemotherapy.
  • Pembrolizumab was associated with significantly improved global health status/quality-of-life score vs chemotherapy.

As reported by Vaughn et al in the Journal of Clinical Oncology, a health-related quality-of-life analysis from the phase III KEYNOTE-045 trial in previously treated advanced urothelial cancer showed that patients treated with the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) had improved time to deterioration and global health status/quality of life vs patients treated with chemotherapy. In the trial, pembrolizumab was associated with significantly prolonged overall survival vs chemotherapy.

Study Details

In the trial, 542 patients with progression on or after a platinum-based regimen were randomized to receive pembrolizumab 200 mg (n = 270) or investigator’s choice of docetaxel 75 mg/m2, paclitaxel 175 mg/m2, or vinflunine 320 mg/m2 (n = 272) given every 3 weeks. Key prespecified health-related quality-of-life analyses were time to deterioration (defined as a ≥ 10-point decrease from baseline), and mean change from baseline to week 15 in the EORTC Quality of Life Questionnaire C30 global health status/quality-of-life score.

Health-Related Quality-of-Life Outcomes

Of the total of 542 randomized patients, 519 (266 pembrolizumab patients, 253 chemotherapy patients) completed at least one health-related quality-of-life questionnaire and were included in the health-related quality-of-life analysis. Compliance with health-related quality-of-life assessment was 95% at baseline and approximately 88% at week 15 for both groups. Pembrolizumab patients exhibited a prolonged time to deterioration in global health status/quality-of-life score vs chemotherapy patients (median = 3.5 months vs 2.3 months, hazard ratio = 0.72, P = .004). The mean change from baseline to week 15 in global health status/quality-of-life score was +0.69 (95% confidence interval [CI] = -2.40 to 3.77) in the pembrolizumab group vs -8.36 (-11.84 to -4.89) in the chemotherapy group (mean difference = 9.05 points, P < .001).

The investigators concluded, “Pembrolizumab prolonged [time to deterioration] in [health-related quality of life] compared with chemotherapy. Patients who were treated with pembrolizumab had stable or improved global health status/quality of life, whereas those who were treated with investigator’s choice of chemotherapy experienced declines in global health status/quality of life. Combined with efficacy and safety outcomes, these data support pembrolizumab as standard of care for patients with platinum-refractory advanced urothelial cancer.”

The study was funded by Merck & Co, Inc.

David J. Vaughn, MD, of Abramson Cancer Center, University of Pennsylvania, is the corresponding author for the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.