Abstract 538P
Background
Chemotherapy induced nausea and vomiting (CINV) is the most common adverse event of chemotherapy, and its out-of-hospital incidence remains high. Previous studies have focused on acute and delayed CINV, and there are relatively few studies on long-delayed CINV (>120 hours), whose incidence, mechanisms, and effective antiemetic regimens still need to be thoroughly investigated. This study investigated the efficacy and safety of adding NEPA (netupitant/palonosetron) capsules on the fifth day of chemotherapy for prevention of long-delayed CINV in patients treated with highly emetogenic chemotherapy (HEC).
Methods
This study was designed to compare the efficacy and adverse effects (AEs) of NEPA 300mg used on day 1,5 (prolonged group) versus on day 1 (regular group) in patients receiving highly emetogenic chemotherapy (HEC) regimens. All patients also received dexamethasone (DEX) on day 1-4 of chemotherapy. The primary endpoint were incidence of long-delayed nausea and vomiting (6 days to 14 days after chemotherapy). The second endpoint was treatment related AEs. All the endpoints above were defined according to CTCAE5.0.
Results
Twenty patients were randomly assigned in prolonged group and twenty in regular group. The incidence of long-delayed vomiting was significant lower in the prolonged group as compared with the regular group (overall: 2.78% vs 13.89%, p=0.0001; grade 1: 1.11% vs 9.44%, p=0.0004; grade 2 and above: 1.67% vs 4.44%, p=0.1257). The incidence of long-delayed nausea was slightly lower in prolonged group as compared with regular group (overall: 12.78% vs. 18.89%, p=0.1123; grade 1 10.56% vs. 13.89%, p=0.3343; grade 2 and above 2.22% vs 5.00%, p=0.1578) . No significant difference was found between the two groups regarding constipation, diarrhea, hiccough, fatigue, palpitation and headache in long-delayed phase.
Conclusions
Prolonged usage of NEPA was effective and safe in preventing long-delayed CINV in patients receiving HEC regimens.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
National Natural Science Foundation of China Young Scientist Fund; Beijing Xisike Clinical Oncology Research Foundation.
Disclosure
All authors have declared no conflicts of interest.