Shannon N. Westin, MD, MPH, FACOG, discusses the endometrial cancer patient population enrolled in the phase 3 DUO-E trial.
Shannon N. Westin, MD, MPH, FACOG, an associate professor, Department of Gynecologic Oncology and Reproductive Medicine, Division of Surgery at the University of Texas MD Anderson Cancer Center, discusses the endometrial cancer patient population enrolled in the phase 3 DUO-E trial (NCT04269200).
The randomized, multicenter, double-blind, placebo-controlled study examines the efficacy and safety of durvalumab in combination with platinum-based chemotherapy, paclitaxel plus carboplatin, followed by maintenance durvalumab (Imfinzi) with or without olaparib (Lynparza) as treatment for patients with newly-diagnosed advanced or recurrent endometrial cancer.
Enrolled patients are females aged 18 and older with histologically confirmed epithelial endometrial carcinoma, excluding sarcomas. Requirements also include having systemic anti-cancer agents, an ECOG performance status of 0 or 1, and a tumor sample available for testing.
The primary end point of the study is progression-free survival with secondary end points including overall survival, second progression, objective response rate, duration of response, safety, as well as other efficacy end points.
0:08 | One of the things that we made sure of is to include several patients that are even at higher risk. Many of these types of trials will exclude patients who have carcinosarcoma, which is one of the more aggressive subtypes. But we are including that in our trials. So, we're excited to see if we can get benefit for that patient population.
0:28 | In addition, we are allowing patients to have prior chemotherapy, so those patients that have recurrent endometrial cancer can have had prior chemotherapy if it's been more than a year. So that's a few of the unique pieces of this trial that will hopefully expand eligibility, and also, give us an idea of the activity and all these different populations.