乌鸦传媒

PHOENIX -- The addition of pembrolizumab (Keytruda) to chemotherapy, with or without bevacizumab (Avastin), in women with persistent, recurrent, or metastatic cervical cancer was linked with better quality of life (QoL), a researcher reported.

Patient-reported outcomes (PRO) from the KEYNOTE-826 trial showed that changes from baseline in QLQ-C30 global health status (GHS)/QoL scores -- a secondary endpoint of the trial -- were similar between the pembrolizumab-chemotherapy and placebo groups (1.01 difference in mean changes), with some metrics showing a numerical improvement with pembrolizumab, reported Bradley J. Monk, MD, of the University of Arizona College of Medicine in Phoenix, and Creighton University School of Medicine in Omaha, Nebraska.

These results are "building a case" that there's a favorable benefit-risk ratio when pembrolizumab is added to chemotherapy-bevacizumab in this disease setting, and support the regimen as a new standard of care, Monk said at the Society of Gynecologic Oncology (SGO) meeting.

KEYNOTE-826 efficacy and safety results were presented at the 2021 European Society for Medical Oncology meeting, and demonstrated that add-on pembrolizumab provided a statistically significant improvement in overall survival (OS, median 24.4 vs 16.5 months) and progression-free survival (PFS, 10.4 vs 8.2 months).

Monk pointed out that the regimen tested in KEYNOTE-826 is for the treatment of patients with persistent, recurrent, or metastatic cervical cancer whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test. The SGO presentation included data for patients with any level of PD-L1 expression, he noted.

While the trial survival outcomes were laudable, "it is all about the patient experience," Monk said. "We have to contextualize this clinical benefit to see if it satisfies the risk-benefit ratio in the clinic."

The current analysis used three PRO instruments:

• EORTC Quality of-Life-Core 30 (QLQ-C30)
• EORTC Cervical Cancer module (QLQ-CX24)
• EuroQol (EQ)-5D-5L visual analog scale (VAS)

These questionnaires were administered before treatment at cycles 1-14, at every other cycle thereafter, at the end of treatment, and at a safety follow-up visit.

Of 617 patients randomized, 566 were in the PRO analyses (281 with in the pembrolizumab-chemotherapy arm and 285 in in the placebo-chemotherapy arm).

Monk and colleagues found that the hazard ratio for time to deterioration was 0.84 (95% CI 0.65-1.09), with 12-month estimates of patients free from deterioration of 57.3% in the pembrolizumab arm and 51.1% in the placebo arm.

"You can see that pembrolizumab was numerically better," Monk said. "Not statistically significant, but it adds confidence to our impression that there was no detriment in KEYNOTE-826 associated with the improvement of OS and PFS."

In addition, Monk reported there were no meaningful differences in changes in physical functioning between the groups, and that more patients with pembrolizumab-chemotherapy had an improved GHS/QoL compared with placebo/chemotherapy (42.1% vs 28.6%), as well as improved EQ-5D-5L VAS (42.8% vs 36.4%).

SGO discussant Leslie Randall, MD, MAS, of Virginia Commonwealth University Massey Cancer Center in Richmond, said the study provided "very important data that this [regimen] improved QoL."

She noted that an analysis of the provided further evidence that immunotherapy boosts PFS and OS in cervical cancer patients who are PD-L1 positive, along with improving QoL. EMPOWER evaluated cemiplimab (Libtayo) versus chemotherapy among patients with recurrent cervical cancer.

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