Patients with advanced or recurrent endometrial cancer treated with Keytruda plus chemotherapy had improved progression-free survival compared with chemotherapy alone.
Adding Keytruda (pembrolizumab) to chemotherapy to treat patients with advanced or recurrent endometrial cancer significantly prolonged survival compared with chemotherapy alone, recent study findings demonstrated.
“These data suggest that the incorporation of immunotherapy into the first-line treatment of patients with advanced or recurrent endometrial cancer translates into improved oncologic outcomes, regardless of (mismatch repair) status or histologic findings,” the researchers wrote in the study published in The New England Journal of Medicine.
According to the National Cancer Institute, mismatch repair deficiency refers to cells with changes (or mutations) in certain genes involved in correcting errors when DNA is copied in a cell. Cells that are considered mismatch repair deficient have many DNA mutations that may lead to cancer. Knowing whether a tumor if mismatch repair deficient may help patients and their care teams plan treatment or possibly predict how a tumor will respond to a particular treatment.
In this phase 3 trial, researchers analyzed data from 816 women with advanced (stages 3, 4A or 4B) or recurrent endometrial cancer who were randomly assigned Keytruda or placebo. Both groups of patients underwent combination chemotherapy, which included paclitaxel plus carboplatin.
Of note, patients were grouped based on their mismatch repair status; 225 patients were considered mismatch repair deficient, and 591 patients were mismatch repair proficient. In addition, patients who previously received adjuvant chemotherapy were allowed in this study if they did not receive the treatment in the past 12 months.
The main focus of this study was to assess progression-free survival, defined as the time during and after treatment when a patient with cancer is alive without disease worsening. Researchers also monitored for side effects in both groups.
Patients with endometiral cancer who added Keytruda to their chemotherapy regimen saw improved progression-free survival than those who did not, according to recent research.
At 12 months, the risk for disease progression or death in patients with mismatch repair deficient disease was 70% lower in the Keytruda plus chemotherapy group compared with the placebo plus chemotherapy group. In particular, progression-free survival at the 12-month mark was observed in 74% of patients assigned Keytruda versus 38% of those assigned placebo.
For patients with mismatch repair proficient disease, median progression-free survival was 13.1 months for the Keytruda group and 8.7 months for the placebo group.
Side effects were as expected, according to the researchers, for patients assigned Keytruda or placebo plus chemotherapy. The most common side effects, which occurred in at least 15% of patients in the trial, included fatigue, peripheral sensory neuropathy, anemia, nausea, constipation, diarrhea, thrombocytopenia (low platelet count), joint pain, shortness of breath, muscle pain, neutropenia, vomiting, weight loss and rash.