In an analysis from the phase III KEYNOTE-826 trial reported in The Lancet Oncology, Bradley J. Monk, MD, and colleagues found that the addition of pembrolizumab to chemotherapy with or without bevacizumab did not adversely affect health-related quality of life in patients with persistent, recurrent, or metastatic cervical cancer.
The trial supported the October 2021 approval of pembrolizumab in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score [CPS] ≥ 1).
Bradley J. Monk, MD
Study Details
In the double-blind trial, 617 patients who did not receive previous systemic chemotherapy were randomly assigned to receive pembrolizumab at 200 mg (n = 308) or placebo (n = 309) every 3 weeks for up to 35 cycles, in addition to paclitaxel and cisplatin or carboplatin, with or without bevacizumab. The primary analysis of the trial showed improved overall survival and progression-free survival in the pembrolizumab group vs the control group.
Change from baseline in EORTC Quality-of-Life-Core 30 (QLQ-C30) global health status quality of life (GHS-QOL) at week 30 was a prespecified secondary endpoint. It was assessed in the population of patients who received at least one dose of study treatment and completed at least one postbaseline QLQ-C30 assessment.
Key Findings
A total of 587 patients received at least one dose of study treatment and completed at least one postbaseline assessment, including 290 in the pembrolizumab group and 297 in the placebo group. Median follow-up was 22.0 months (interquartile range = 19.1–24.4 months).
The least squares mean change in QLQ-C30 GHS-QOL score from baseline to week 30 was −0.3 points (95% CI = −3.1 to 2.6 points) in the pembrolizumab group vs −1.3 points (95% CI = −4.2 to 1.7 points) in the control group (between-group difference in least squares mean change = 1.0 point, 95% CI = −2.7 to 4.7 points).
Median time to true deterioration in GHS-QOL (defined as time from baseline to first deterioration of ≥ 10 points, with confirmation by a second adjacent deterioration of ≥ 10 points or death) was not reached (95% CI = 13.4 months to not reached) in the pembrolizumab group vs 12.9 months (95% CI = 6.6 months to not reached) in the control group (hazard ratio = 0.84, 95% CI = 0.65–1.09).
Improvement in GHS-QOL at any time during the study (defined as a ≥ 10-point improvement in score at any time, confirmed on next visit) was observed in 122 (42%) of 290 patients in the pembrolizumab group vs 85 (29%) of 297 in the control group (P = .0003).
The investigators concluded, “[The] addition of pembrolizumab to chemotherapy with or without bevacizumab did not negatively affect health-related quality of life. Along with the efficacy and safety results already reported from KEYNOTE-826, these data support the benefit of pembrolizumab and the value of immunotherapy in patients with recurrent, persistent, or metastatic cervical cancer.”
Dr. Monk, of the University of Arizona College of Medicine, Creighton University School of Medicine, HonorHealth Research Institute, Phoenix, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by Merck Sharp & Dohme. For full disclosures of the study authors, visit thelancet.com.
