medwireNews: A phase II trial shows that the intravenous prodrug fosnetupitant in combination with palonosetron reduces chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy.
Reporting the findings in Cancer, the researchers write: “Fosnetupitant at a dose of 235 mg provided superior prevention of chemotherapy-induced nausea and vomiting among patients receiving cisplatin-based chemotherapy compared with the control group, and with a satisfactory safety profile.”
A total of 587 Japanese patients, with a confirmed malignant solid cancer, most commonly lung (95%), who were due to receive cisplatin at a dose of at least 70 mg/m2, were randomly assigned to one of three treatment groups.
Sixty minutes prior to receiving cisplatin, fosnetupitant, a neurokinin 1 receptor antagonist, was intravenously administered alongside palonosetron (0.75 mg) and dexamethasone (13.2 mg) to 392 patients at a dose of 81 mg (n=197) or 235 mg (n=195), while the remaining 195 patients received placebo plus palonosetron and dexamethasone.
Shunichi Sugawara (Sendai Kousei Hospital, Miyagi, Japan) and colleagues report that a complete response (CR; no vomiting and no rescue medication needed) was achieved by 76.8% of patients taking fosnetupitant 235 mg, 63.8% of those taking fosnetupitant 81 mg, and 54.7% of those taking placebo.
They acknowledge that while CR rates did not significantly differ between the fosnetupitant 81 mg and placebo groups, the rate was significantly higher in the fosnetupitant 235 mg dose group than the placebo group and therefore met the primary end point of the study.
In addition to the fosnetupitant 235 mg group significantly reducing nausea and the need for rescue drugs versus placebo, it was also associated with a comparable safety profile. And all three patient groups experienced a low incidence of infusion site reactions, at 1% or less, the researchers note.
Sugawara and team comment that intravenous fosnetupitant 235 mg in combination with palonosetron 0.25 mg is currently approved in the USA to treat CINV, and their results support this recommended dosage of fosnetupitant, but drawing conclusions from previous studies, the researchers suggest a higher efficacy of palonosetron, at 0.75 mg compared with 0.25 mg.
“A limitation of the current study was that the relative clinical efficacy of a fosnetupitant-based regimen was unclear because this study did not include an active comparator,” say the researchers. Going forward, the team plans to “conduct a confirmatory study to verify the efficacy and safety of fosnetupitant versus an existing active comparator regimen.”
By Hannah Kitt
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