Nivolumab shows modest antitumour activity in advanced adrenocortical carcinoma
Patients with metastatic adrenocortical carcinoma (ACC) appear to achieve modest benefits from treatment with nivolumab, as shown by results of a phase II trial. The safety profile of nivolumab is consistent with previous clinical experience with no unforeseen adverse events (AEs).
Ten patients with advanced ACC were included in the study between March and December 2016. They were administered a median of two doses of nivolumab. Three patients received only one treatment: one died of disease progression, one stopped due to AEs, and one withdrew after treatment initiation.
Over a median follow-up of 4.5 months (range, 0.1–25.6 months), two patients achieved stable disease for 48 and 11 weeks, respectively, and one patient had an unconfirmed partial response but discontinued the study due to an AE.
Majority of the AEs were mild (grade 1/2). Grade 3/4 treatment-related AEs were also reported, including mucositis, odynophagia, and aspartate aminotransferase and alanine aminotransferase elevations.
This single-arm, multicentre, phase II clinical trial with two-stage design conducted in a comprehensive cancer centre enrolled 10 adult patients with metastatic ACC previously treated with platinum-based chemotherapy or mitotane and those who declined front-line chemotherapy. Patients received nivolumab 240 mg intravenously every 2 weeks.
Objective response rate according to the response evaluation criteria in solid tumours was the primary endpoint. Progression-free survival, overall survival and safety were the secondary endpoints.
“Systemic treatment of metastatic ACC remains limited to chemotherapy and mitotane,” the authors said. “Preliminary evidence suggesting that antitumour immune responses can be elicited in ACC has fostered interest in checkpoint inhibitors such as anti–PD-1 nivolumab.”