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This analysis of the KEYNOTE-826 trial focused on health-related quality of life in patients with persistent, recurrent or metastatic cervical cancer.
Health-related quality of life was not negatively affected in patients with persistent, recurrent or metastatic cervical cancer who were treated with Keytruda (pembrolizumab) plus chemotherapy, regardless of whether Avastin (bevacizumab) was added, according to findings from a recent study.
Researchers assessed several factors of quality of life related to physical, cognitive, emotional and social functioning, in addition to symptoms related to treatment.
“The addition of (Keytruda) to chemotherapy in patients with persistent, recurrent or metastatic cervical cancer did not negatively affect (health-related quality of life),” the researchers wrote in the study published in The Lancet Oncology. “Along with the efficacy and safety observed in KEYNOTE-826, these (health-related quality of life) data support the benefit of (Keytruda) and the value of immunotherapy in a diverse population of women diagnosed with persistent, recurrent or metastatic cervical cancer.”
In the phase 3 KEYNOTE-826 trial, researchers analyzed data from 587 patients with persistent, recurrent or metastatic cervical cancer who were not previously treated with systemic chemotherapy and did not respond to curative treatment. Patients in this study also had an Eastern Cooperative Oncology Group performance status of 0 (meaning that they are fully active) or 1 (restricted in strenuous activity).
Patients were randomly assigned either Keytruda (290 patients) or placebo (297 patients). Both treatment groups received chemotherapy with or without Avastin. Researchers used several scores to measure outcomes related to quality of life, as reported by patients at intervals throughout the trial.
Several factors were assessed throughout the trial including overall survival (the time from the start of treatment when a patient with cancer is still alive) and progression-free survival (the time during and after treatment when a patient with cancer lives with the disease without worsening. Researchers also monitored changes in quality-of-life scores at the beginning of the trial and throughout follow-up, which was conducted for a median of 22 months.
At week 30, the average change in scores for several measures, compared with the start of the trial, was minimal between both groups.
The average time to true deterioration, or the time from the beginning of the trial to when a patient’s quality of life worsened by a certain measurement, was not reached in the Keytruda group. In other words, more than half of patients treated with Keytruda plus chemotherapy did not experience a significant deterioration in quality of life. For patients assigned placebo plus chemotherapy, the average time to true deterioration of quality of life was 12.9 months.
At any time during the study, quality of life scores improved in 42% of patients in the Keytruda group and 29% of those in the placebo group.
In October 2021, the Food and Drug Administration approved Keytruda for use with chemotherapy, with or without Avastin, for the treatment of persistent, recurrent or metastatic cervical cancer with tumors that express PD-L1. The approval was based on the findings focused on outcomes from the KEYNOTE-826 trial.
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