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Chemotherapy-induced nausea and vomiting (CINV) are common toxic reactions after chemotherapy for malignant tumors
.
This is a phase 3 clinical study that compared two different neurokinin-1 receptor antagonists, Fosnetupitant (FosNTP) vs.
Chemo-induced nausea and vomiting (CINV) prevention
Patients receiving cisplatin-based chemotherapy were randomly divided into two groups, receiving FosNTP 235 mg or FosAPR 150 mg combined with palonosetron 0.
75 mg and dexamethasone
.
The primary endpoint is the rate of overall complete remission (CR; no vomiting events and no emergency medications), stratified according to gender and age (non-inferiority threshold: overall CR rate difference -10%)
In total, 795 patients were randomized, of which 785 received the study drug (392 in the FosNTP group vs.
393 in FosAPR) and were included in the efficacy and safety analysis
.
The overall CR rate of FosNTP group and FosAPR group was 75.
The overall CR rates of the FosNTP and FosAPR groups were 75.
The incidence of nausea and vomiting caused by chemotherapy
The incidence of nausea and vomiting caused by chemotherapyThe total CR rates of the acute phase (0-24 hours), delayed phase (24-120 hours), ultra-delayed phase (120-168 hours), and 0-168 hours in the FosNTP and FosAPR groups were 93.
9% vs 92.
6% and 76.
8, respectively % vs 72.
8%, 86.
5% vs 81.
4% and 73.
2% vs 66.
9%
.
9% vs 92.
6% and 76.
8, respectively % vs 72.
8%, 86.
5% vs 81.
4% and 73.
2% vs 66.
9%
.
The total CR rates of the acute phase (0-24 hours), delayed phase (24-120 hours), ultra-delayed phase (120-168 hours), and 0-168 hours in the FosNTP and FosAPR groups were 93.
In summary, the study proves that FosNTP (Fonatopitant) is not inferior to FosAPR (Fosapitan) in preventing nausea and vomiting caused by highly emetic chemotherapy , and it has good safety and low efficiency.
The risk of injection site reactions
.
Therefore, FosNTP is valuable in preventing nausea and vomiting caused by acute, delayed and ultra-delayed chemotherapy
FosNTP (fornetupitant) is not inferior to FosAPR ( fosapitant) in preventing nausea and vomiting caused by hyperemetic chemotherapy.
Original source:
Akito Hata, et al.
Randomized, Double-Blind, Phase III Study of Fosnetupitant Versus Fosaprepitant for Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: CONSOLE in this message