ESMO 2023: Pembrolizumab With Concurrent Chemoradiotherapy Improves Cervical Cancer Outcomes
Sixty-eight percent of patients who received the treatment were cancer-free after two years
FRIDAY, Oct. 27, 2023 (HealthDay News) -- Pembrolizumab (pembro) and concurrent chemoradiotherapy (CCRT) could become the new standard of care for patients with high-risk, locally advanced cervical cancer, according to a study presented at the annual meeting of the European Society for Medical Oncology, held from Oct. 20 to 24 in Madrid, Spain.
Domenica Lorusso, M.D., Ph.D., of the Catholic University of Rome, and colleagues evaluated data from the ENGOT-cx11/GOG-3047/KEYNOTE-A18 clinical trial to understand how the effect of chemoradiotherapy may be enhanced by immunotherapy.
“We registered so many advantages in cervical cancer treatment in advanced and recurrent disease in the last years with immunotherapy,” Lorusso told Elsevier’s PracticeUpdate. “Here we are in a potentially curative setting, and it is the first time since 1999 we [have seen an] advantage in [progression-free survival] in this setting.”
Eligible patients (1,060 patients) with newly diagnosed, previously untreated, high-risk, locally advanced cervical cancer were randomly assigned 1:1 to receive five cycles of pembro (200 mg) or placebo every three weeks with CCRT, followed by 15 cycles of pembro (400 mg) or placebo every six weeks. The CCRT regimen included five cycles, with an optional sixth dose of cisplatin 40 mg/m2 every week with external beam radiation therapy and then brachytherapy.
The researchers found treatment combining pembro and CCRT led to statistically significant and clinically meaningful improvement in progression-free survival and overall survival, with 68 percent of women who received pembro being cancer-free at two years compared with 57 percent who received placebo with CCRT.
Median progression-free survival was not reached in either the pembro group or the placebo group (hazard ratio [HR], 0.70; 95 percent confidence interval [CI], 0.55 to 0.89; P = 0.002). The addition of pembro to CCRT showed a favorable trend in overall survival, though this finding was not statistically significant (HR, 0.73; 95 percent CI, 0.49 to 1.07). The incidence of treatment-related adverse events that were grade 3 or worse was 67 percent in the pembro group versus 60 percent in the placebo.
“We are exploring different way[s] to combine radiotherapy plus immuno[therapy], in adjuvant or neoadjuvant survival setting[s] with different immunotherapy agents,” Lorusso told Elsevier’s PracticeUpdate. “But the new trials will have immuno-radiotherapy in the control arm according to [the] KEYNOTE-A18 scheme; otherwise, [they] will be inconclusive.”
This study received funding from Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
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