The first-line treatment for endometrial cancer to date is the combination chemotherapy paclitaxel plus carboplatin. In the phase III study NRG-Gy018, the addition of pembrolizumab to standard chemotherapy was investigated in patients with advanced or recurrent endometrial cancer. The results have been published in the prestigious New England Journal of Medicine The publication and reference to pembrolizumab as a new beacon of hope.
A total of 816 patients with advanced endometrial cancer (stage III, IVA or IVB) or recurrence were included in the randomized, double-blind, placebo-controlled Phase III study. They were assigned to the two groups (pembrolizumab vs placebo) in a 1:1 ratio. The groups received pembrolizumab (200 mg) or placebo with combination therapy paclitaxel plus carboplatin every three weeks for a total of six cycles, followed by 14 maintenance cycles of pembrolizumab (400 mg) every six weeks. Stratification into two groups was also performed, depending on whether patients had mismatch-repair-deficient (dMMR; n = 225) or mismatch-repair-competent (pMMR; n = 591). In the dMMR group, 112 patients received pembrolizumab plus chemotherapy and 113 patients received placebo, while in the pMMR group 295 patients received plus chemotherapy and 296 received placebo. Previous adjuvant chemotherapy was also tolerated if the treatment-free time period was at least twelve months. The primary endpoint was progression-free survival.