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帕洛诺司琼对比昂丹司琼在儿科癌症患者中的应用:一项随机 III 期研究的多周期分析。

Palonosetron compared with ondansetron in pediatric cancer patients: multicycle analysis of a randomized Phase III study.

机构信息

Second Department of Pediatrics, Semmelweis University, Budapest, Hungary.

Department of Pediatrics, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.

出版信息

Future Oncol. 2017 Aug;13(19):1685-1698. doi: 10.2217/fon-2017-0189. Epub 2017 Jun 1.

Abstract

AIM

To investigate across multiple cycles the efficacy and safety of palonosetron in the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients receiving highly or moderately emetogenic chemotherapy (HEC/MEC).

PATIENTS & METHODS: Patients were randomly assigned to 10, 20 μg/kg palonosetron or 3 × 150 μg/kg ondansetron for up to four cycles of HEC/MEC.

RESULTS

In all on-study chemotherapy cycles, complete response rates were higher in patients in the 20 μg/kg palonosetron group than the ondansetron group. Treatment-emergent adverse events were comparable between the palonosetron 20 μg/kg and ondansetron groups.

CONCLUSION

Over four cycles of HEC/MEC, 20 μg/kg palonosetron was an efficacious and safe treatment for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients.

摘要

目的

在多个周期内研究帕洛诺司琼预防接受高致吐性化疗(HEC)/中度致吐性化疗(MEC)的儿科癌症患者化疗引起的恶心和呕吐的疗效和安全性。

患者和方法

患者被随机分配至 10、20μg/kg 帕洛诺司琼或 3×150μg/kg 昂丹司琼组,接受最多四个 HEC/MEC 周期的治疗。

结果

在所有研究化疗周期中,20μg/kg 帕洛诺司琼组患者的完全缓解率均高于昂丹司琼组。帕洛诺司琼 20μg/kg 组与昂丹司琼组的治疗后出现的不良事件相当。

结论

在四个 HEC/MEC 周期中,20μg/kg 帕洛诺司琼是预防儿科癌症患者化疗引起的恶心和呕吐的有效且安全的治疗方法。

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