A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy

M. Maemondo, N. Masuda, I. Sekine, K. Kubota, Y. Segawa, M. Shibuya, F. Imamura, N. Katakami, T. Hida, S. Takeo, Hiroshi Isobe, Yoshihiro Kikuchi, Masahiro Ando, Akira Yokoyama, Hiromi Miyao, Hirofumi Fujii, Hiroshi Sakai, Kouzou Yoshimori, Akihiko Genma, Yuichiro TakedaTsuboi Masahiro, Hiroharu Arai, Takashi Ogura, Wasaburo Koizumi, Kenji Eguchi, Chiyoe Kitagawa, Toshiyuki Sawa, Shinji Atagi, Mitsumasa Ogawara, Takashi Nishimura, Shunichi Negoro, Katsuyuki Kiura, Yasushi Shigeoka, Yukito Ichinose, Hiroshi Senba

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Abstract

Background: This is a randomized, double-blind, dose-ranging study in patients receiving highly emetogenic chemotherapy (HEC) to evaluate the safety, efficacy, and pharmacokinetics of palonosetron, in combination with dexamethasone. Materials and methods: We randomized 233 patients to receive palonosetron as a single i.v. bolus dose of 0.075, 0.25, or 0.75 mg before administration of HEC. Dexamethasone (12-16 mg i.v. on day 1, 8 mg i.v. on day 2, and 4-8 mg i.v. on day 3) was administered for prophylactic antiemesis. Pharmacokinetics of palonosetron was analyzed in 24 patients. Results: In this study, all patients were given ≥50 mg/m2 cisplatin, which was considered to be HEC. No significant differences in complete response (CR: no emesis and no rescue medication) rates were found in the first 24 h between the 0.075-, 0.25-, and 0.75-mg groups (77.6%, 81.8%, and 79.5%, respectively). In the 120-h period of overall observation, CR rates increased in a dose-dependent manner. In the 0.75-mg group, we observed a significantly longer time to treatment failure than in the 0.075-mg group (median time >120 versus 82.0 h, P = 0.038). Palonosetron was tolerated well and did not show any dose-related increase in adverse effects. Conclusions: Palonosetron at doses of 0.25 and 0.75 mg was shown to be effective in preventing chemotherapy-induced nausea and vomiting with high CR rates of patients treated with HEC in Japan. All tested doses of palonosetron were tolerated well.

Original languageEnglish
Pages (from-to)1860-1866
Number of pages7
JournalAnnals of Oncology
Volume20
Issue number11
DOIs
Publication statusPublished - 2009

Keywords

  • 5-HT receptor antagonist
  • CINV
  • Emesis
  • Palonosetron

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Maemondo, M., Masuda, N., Sekine, I., Kubota, K., Segawa, Y., Shibuya, M., Imamura, F., Katakami, N., Hida, T., Takeo, S., Isobe, H., Kikuchi, Y., Ando, M., Yokoyama, A., Miyao, H., Fujii, H., Sakai, H., Yoshimori, K., Genma, A., ... Senba, H. (2009). A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy. Annals of Oncology, 20(11), 1860-1866. https://doi.org/10.1093/annonc/mdp195