Phase III study of palonosetron for prevention of chemotherapy-induced nausea and vomiting in pediatric patients

Junichi Hara, Yoshiyuki Kosaka, Katsuyoshi Koh, Kimikazu Matsumoto, Tadashi Kumamoto, Hiroyuki Fujisaki, Yuji Ishida, Ryoko Suzuki, Shinji Mochizuki, Hiroaki Goto, Yuki Yuza, Yuhki Koga

研究成果: Contribution to journalArticle査読

抄録

Background: Palonosetron has demonstrated non-inferiority to ondansetron for prevention of chemotherapy-induced nausea and vomiting in pediatric patients in the United States and Europe. We conducted a single-arm registration study to evaluate the efficacy, safety and pharmacokinetics of palonosetron in pediatric patients in Japan. Methods: Key inclusion criteria were age of 28 days to 18 years and malignant disease for which initial highly emetogenic chemotherapy or moderately emetogenic chemotherapy was planned. Patients received palonosetron at 20 μg/kg over at least 30 s intravenously before the start of highly emetogenic chemotherapy or moderately emetogenic chemotherapy and received dexamethasone on Days 1-3. The primary endpoint was the proportion of patients achieving a complete response in the overall phase (0-120 h) in Course 1, and its threshold was set at 30%. Results: From December 2016 to June 2019, 60 patients were enrolled, and 58 received at least one dose of palonosetron. The proportion of patients achieving a complete response during the overall phase was 58.6% (95% confidence interval, 44.9%-71.4%), showing the primary endpoint was met (P < 0.0001). Treatment-related adverse events occurred in two patients (3.4%). Regarding the pharmacokinetics of palonosetron, neither the plasma concentration immediately after administration nor the area under the plasma concentration-time curve from time 0 to infinity differed significantly among the age groups. Conclusion: We demonstrated the efficacy of palonosetron in pediatric patients receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy and confirmed the appropriateness of the 20 μg/kg dose, regardless of age, considering the safety and pharmacokinetic profiles. Trial registration: JapicCTI-163305, registered 6 June 2016.

本文言語英語
ページ(範囲)1204-1211
ページ数8
ジャーナルJapanese journal of clinical oncology
51
8
DOI
出版ステータス出版済み - 8 1 2021

All Science Journal Classification (ASJC) codes

  • 腫瘍学
  • 放射線学、核医学およびイメージング
  • 癌研究

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