Netupitant/Palonosetron Combination Effective in Preventing CINV

July 6, 2017

A combination of netupitant and palonosetron was non-inferior to aprepitant plus granisetron in preventing chemotherapy-induced nausea and vomiting.

A combination of netupitant and palonosetron (NEPA) was non-inferior to aprepitant plus granisetron (APR/GRAN) in preventing chemotherapy-induced nausea and vomiting (CINV) associated with highly emetogenic chemotherapy (HEC), according to a randomized phase III trial. The NEPA regimen required only one administration, vs 3 days with the APR/GRAN regimen.

Coadministration of antiemetics that can inhibit multiple pathways is needed to help control CINV in patients receiving HEC, according to Li Zhang, MD, of Sun Yat-Sen University Cancer Center in Guangzhou, China. Oral NEPA is the first antiemetic that combines a highly selective NK1 receptor agonist (netupitant) with a 5-HT3 receptor agonist (palonosetron); previously, no studies had directly compared regimens containing NK1 receptor agonists.

Zhang presented results of the new study, comparing NEPA with APR/GRAN, at the Multinational Association of Supportive Care in Cancer’s Annual Meeting, which was held June 22–24 in Washington, DC. The study included 829 patients undergoing cisplatin-based chemotherapy randomized to either NEPA (413 patients) or APR/GRAN (416 patients); the NEPA patients received the medication on day 1 of chemotherapy treatment, while those receiving APR/GRAN received APR on days 1, 2, and 3 and GRAN on day 1. All patients received oral dexamethasone on days 1–4.

Most patients were male (> 70% in each group), and the most common cancer type was lung, followed by head and neck malignancies.

A complete response (CR) was defined as no emesis, and no need for rescue medication during the overall phase (hours 0 to 120). The CR rate was 73.8% with NEPA, compared with 72.4% with APR/GRAN, which met the criteria for non-inferiority. In the acute period (0–24 hours), the CR rate was 84.5% with NEPA and 87.0% with APR/GRAN; in the delayed period (25–120 hours), those rates were 77.9% and 74.3%, respectively.

Zhang noted that though the overall CR rates were similar, the daily rates of patients experiencing CINV remained steady between 13% and 15% for APR/GRAN, while it declined from 16% to 8% over 5 days with NEPA. At day 5, this difference was significant (P = .0063).

The toxicity profiles of the regimens were similar; 58.1% of NEPA patients experienced at least one treatment-emergent adverse event, compared with 57.5% of APR/GRAN patients. Severe events occurred in 8.7% and 10.8% of those groups, respectively.

Zhang concluded that NEPA is at least as effective as APR/GRAN in cancer patients receiving HEC, and it carries the added convenience of a single capsule targeting multiple molecular pathways that can be administered only once per cycle.