Clinical trial presented at the European Society of Medical Oncology and at the Society of Gynecologic Oncology Annual meeting and published in the New England Journal of Medicine, will change the standard of care for treating this aggressive cancer.
Approximately 66,000 cases of endometrial cancer are diagnosed each year in the United States, with 13,000 deaths. Patients diagnosed with stage 1 disease have an 80-90 percent survival rate, while for stage 2, it is 70 to 80 percent. Stages 3 and 4 have a larger range of 20 to 60 percent.
If detected early, uterine cancer is easy to treat, but new treatment options are needed for patients with advanced cases. The latest clinical trial led in part by Dr. Brian Slomovitz, Director of Gynecologic Oncology, Co-chair of the Cancer Research Committee and Professor of Obstetrics and Gynecology at Florida International University, shows great promise in the treatment of endometrial cancers with the use of immunotherapy. The trial was done in conjunction with the NCI-sponsored GOG (Gynecologic Oncology Group) Foundation where Dr. Slomovitz is the Clinical Trial Lead for all of the endometrial cancer clinical trials.
“In cancer, we know that the earlier you treat the better,” said Dr. Brian Slomovitz. “This study evaluated the use of immunotherapy in the newly diagnosed, recurrent, or advanced disease.”
The standard of care for advanced or recurrent endometrial cancer has always been chemotherapy. This study evaluated adding immunotherapy to the traditional therapy. Patients with primary advanced stage III or IV or first recurrent endometrial cancer, were randomized to receive chemotherapy alone vs. both chemotherapy with immunotherapy.
“What we found was that in a subset of women with a particular genetic makeup that accounts for up to 40% of the endometrial cancers, the addition of immunotherapy has a significant increase in progression-free survival, as well as overall survival,” explained Dr. Slomovitz.
When examining the results for the entire group, (not just the subset), there was a clinically meaningful improvement in progression-free survival.
The New England Journal of Medicine recently published a paper on the breakthrough trial, which Dr. Slomovitz co-authored, entitled “Dostarlimab for Primary Advanced or Recurrent Endometrial Cancer.”
To learn more about Dr. Slomovitz and Mount Sinai Medical center’s Comprehensive Cancer Center, please visit: Comprehensive Cancer Center – Mount Sinai Medical Center (msmc.com)
Clinical information on the trial:
TRIAL NAME: ENGOT-EN-6-NSGO/GOG-3031/RUBY trial (ClinicalTrials.gov: NCT03981796)
BACKGROUND: Dostarlimab is an immune checkpoint inhibitor targeting the PD-1 receptor. The combination of chemotherapy and immunotherapy may have synergistic effects in endometrial cancer.
METHODS: RUBY is a phase 3, global, randomized, double-blind, multicenter, placebo-controlled study. Eligible patients with primary advanced stage III or IV or first recurrent endometrial cancer were randomized 1:1 to receive dostarlimab 500 mg, or placebo, plus carboplatin AUC 5 mg/mL/min and paclitaxel 175 mg/m2 Q3W (6 cycles), followed by dostarlimab 1000 mg, or placebo, monotherapy Q6W for up to 3 years.
CONCLUSIONS: Dostarlimab plus carboplatin/paclitaxel significant increase in progression-free survival in primary advanced or recurrent endometrial cancer, with a substantial benefit in the dMMR/MSI-H population.
To view a recent interview about the trial with Dr. Slomovitz, please click here.
