Netupitant-palonosetron combo + dexamethasone may prevent chemo-induced nausea, vomiting
A single administration of the fixed-dose combination consisting of netupitant plus palonosetron (NEPA) in addition to dexamethasone may be an effective strategy for preventing chemotherapy-induced nausea and vomiting (CINV) among breast cancer patients receiving combination chemotherapy consisting of anthracycline and cyclophosphamide (AC), according to results from the GIM15-NEPA* trial presented at EBCC 2018.
A triple-drug combination consisting of an NK1RA**, a 5-HT3RA***, and dexamethasone is particularly recommended for breast cancer patients receiving AC-based chemotherapy to prevent CINV, which is likely to occur following chemotherapy due to the highly emetogenic nature of the agents used, noted the researchers.
NEPA is the first oral combination antiemetic that fulfils this requirement for the prevention of acute and delayed CINV as it consists of the highly selective NK1RA netupitant, and the 5-HT3RA palonosetron, said the researchers.
This open-label, multicentre study evaluated the efficacy of oral NEPA and dexamethasone 12 mg on 146 breast cancer patients undergoing AC-based chemotherapy. The antiemetic agents were administered on day 1 before each AC chemotherapy commenced, for a maximum of four cycles. The primary endpoint was the achievement of a complete response (CR), which pertains to the lack of emetic episode as well as the nonuse of rescue medication during the overall phase (0–120 hours) after the four cycles of chemotherapy. [EBCC-11, abstract PB-110]
The primary endpoint was achieved throughout all cycles (overall CR, 0.705, 90 percent confidence limit [CL], 0.641–0.769 for the first and second cycles; 0.724, 90 percent CL, 0.662–0.787 and 0.705, 90 percent CL, 0.642–0.770 for the third and fourth cycles, respectively).
NEPA was also well-tolerated, and most adverse events (AEs) were mild to moderate in intensity, which is consistent with the SmPC#-documented safety profile of NEPA, noted the researchers. The most common drug-related AE was fatigue (3.4 percent), followed by anaemia (2.7 percent), headache (2.1 percent), and reduction in neutrophil count (1.4 percent).
“[T]his study [demonstrated] a clinically relevant efficacy of one-day NEPA plus dexamethasone in preventing [CINV] during the entire period of … AC-based chemotherapy,” said the researchers.
These findings are consistent with evidence highlighting NEPA as a convenient, safe, and effective prophylactic antiemetic therapy for CINV, given its potential to target two antiemetic pathways with only a single dose. [Support Care Cancer 2018;26:1151-1159]