帕洛诺司琼(netupitant)止吐效果好吗

Palonosetron (netupitant) has a very good antiemetic effect and can be used to prevent nausea and vomiting caused by chemotherapy. It is a third-generation 5-hydroxytryptamine receptor blocker and has a strong therapeutic effect. It is enough to treat the symptoms of nausea and vomiting in the body, and can also prevent and treat vomiting caused by tumor surgery. Palonosetron can block H receptors in the nerve center, thereby inhibiting the vomiting center, and can improve severe vomiting symptoms caused by chemotherapy, radiotherapy, etc.

Palonosetron (netupitant) antiemetic test

In a phase III multicenter, randomized, double-blind, double-sham, stratified, parallel-group, active comparison trial (NCT00359567), the efficacy and safety of palonosetron versus granisetron for the treatment of chemotherapy-induced nausea and vomiting were evaluated, both drugs being used with dexamethasone in patients receiving highly emetogenic chemotherapy.

research methods

1143 cancer patients receiving highly emetogenic chemotherapy (i.e., cisplatin or anthracycline and cyclophosphamide combination [AC/EC]) were recruited from 75 institutions in Japan and randomly assigned to receive a single dose of palonosetron (0. 75 mg) or granisetron (40 mcg/kg) and given concomitantly with dexamethasone (16 mg IV) 30 minutes before chemotherapy on Day 1, followed by a booster dose on Days 2 and 3 (8 mg IV for patients with cisplatin, 4 mg orally for AC/EC patients).

The primary endpoints were the proportion of patients with a complete response (defined as the absence of emetic episodes and the need for rescue medications) in the acute phase (0 to 24 hours after chemotherapy; noninferiority comparison with granisetron) and the proportion of patients with a complete response in the delayed phase (24 to 120 hours after chemotherapy; superiority comparison with granisetron). The prespecified noninferiority margin in the study protocol was a 10% difference in the proportion of patients with complete responses between the two groups. Palonosetron at 0.75 mg was selected based on two dose-determination trials in Japanese patients. All patients who received study treatment and highly emetogenic chemotherapy were included in the efficacy analysis (modified intention-to-treat).

Research results

1114 patients were included in the efficacy analysis: 555 in the palonosetron group and 559 in the granisetron group. Complete responses in the acute phase were seen in 418 of 555 patients (75.3%) in the palonosetron group and in 410 of 559 patients (73.3%) in the granisetron group (mean difference, 2.9% [95% CI -2.70-7.27]). During the delayed phase, 315 of 555 patients (56.8%) in the palonosetron-treated group had a complete response, compared with 249 of 559 patients (44.5%) in the granisetron-treated group (P<0.0001).

Test conclusion

When combined with dexamethasone before highly emetogenic chemotherapy, palonosetron was noninferior to granisetron in the acute phase and superior to granisetron in the delayed phase for the treatment of chemotherapy-induced nausea and vomiting, and the two treatments were comparable.

Palonosetron is a second-generation 5-hydroxytryptamine 3 (5-HT(3)) receptor antagonist. Compared with ondansetron and dolasetron, it has better efficacy in preventing chemotherapy-induced nausea and vomiting (CINV) in patients with moderately emetogenic chemotherapy, and is similar to ondansetron in preventing CINV in patients with highly emetogenic chemotherapy.

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References

Saito M, Aogi K, Sekine I, Yoshizawa H, Yanagita Y, Sakai H, Inoue K, Kitagawa C, Ogura T, Mitsuhashi S. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomized, comparative phase III trial. Lancet Oncol. 2009 Feb;10(2):115-24. doi: 10.1016/S1470-2045(08)70313-9. Epub 2009 Jan 8. Erratum in: Lancet Oncol. 2010 Mar;11(3)226. PMID: 19135415.