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 Takeda & 15 others Tsuboi 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

Fingerprint

Nausea
Dexamethasone
Vomiting
Drug Therapy
Pharmacokinetics
Treatment Failure
Cisplatin
palonosetron
Japan
Observation
Safety

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy. / Maemondo, M.; Masuda, N.; Sekine, I.; Kubota, K.; Segawa, Y.; Shibuya, M.; Imamura, F.; Katakami, N.; Hida, T.; Takeo, S.; Isobe, Hiroshi; Kikuchi, Yoshihiro; Ando, Masahiro; Yokoyama, Akira; Miyao, Hiromi; Fujii, Hirofumi; Sakai, Hiroshi; Yoshimori, Kouzou; Genma, Akihiko; Takeda, Yuichiro; Masahiro, Tsuboi; Arai, Hiroharu; Ogura, Takashi; Koizumi, Wasaburo; Eguchi, Kenji; Kitagawa, Chiyoe; Sawa, Toshiyuki; Atagi, Shinji; Ogawara, Mitsumasa; Nishimura, Takashi; Negoro, Shunichi; Kiura, Katsuyuki; Shigeoka, Yasushi; Ichinose, Yukito; Senba, Hiroshi.

In: Annals of Oncology, Vol. 20, No. 11, 2009, p. 1860-1866.

Research output: Contribution to journalArticle

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, Takeda, Y, Masahiro, T, Arai, H, Ogura, T, Koizumi, W, Eguchi, K, Kitagawa, C, Sawa, T, Atagi, S, Ogawara, M, Nishimura, T, Negoro, S, Kiura, K, Shigeoka, Y, Ichinose, Y & 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, vol. 20, no. 11, pp. 1860-1866. https://doi.org/10.1093/annonc/mdp195
Maemondo, M. ; Masuda, N. ; Sekine, I. ; Kubota, K. ; Segawa, Y. ; Shibuya, M. ; Imamura, F. ; Katakami, N. ; Hida, T. ; Takeo, S. ; Isobe, Hiroshi ; Kikuchi, Yoshihiro ; Ando, Masahiro ; Yokoyama, Akira ; Miyao, Hiromi ; Fujii, Hirofumi ; Sakai, Hiroshi ; Yoshimori, Kouzou ; Genma, Akihiko ; Takeda, Yuichiro ; Masahiro, Tsuboi ; Arai, Hiroharu ; Ogura, Takashi ; Koizumi, Wasaburo ; Eguchi, Kenji ; Kitagawa, Chiyoe ; Sawa, Toshiyuki ; Atagi, Shinji ; Ogawara, Mitsumasa ; Nishimura, Takashi ; Negoro, Shunichi ; Kiura, Katsuyuki ; Shigeoka, Yasushi ; Ichinose, Yukito ; Senba, Hiroshi. / A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy. In: Annals of Oncology. 2009 ; Vol. 20, No. 11. pp. 1860-1866.
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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.",
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T1 - A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy

AU - Maemondo, M.

AU - Masuda, N.

AU - Sekine, I.

AU - Kubota, K.

AU - Segawa, Y.

AU - Shibuya, M.

AU - Imamura, F.

AU - Katakami, N.

AU - Hida, T.

AU - Takeo, S.

AU - Isobe, Hiroshi

AU - Kikuchi, Yoshihiro

AU - Ando, Masahiro

AU - Yokoyama, Akira

AU - Miyao, Hiromi

AU - Fujii, Hirofumi

AU - Sakai, Hiroshi

AU - Yoshimori, Kouzou

AU - Genma, Akihiko

AU - Takeda, Yuichiro

AU - Masahiro, Tsuboi

AU - Arai, Hiroharu

AU - Ogura, Takashi

AU - Koizumi, Wasaburo

AU - Eguchi, Kenji

AU - Kitagawa, Chiyoe

AU - Sawa, Toshiyuki

AU - Atagi, Shinji

AU - Ogawara, Mitsumasa

AU - Nishimura, Takashi

AU - Negoro, Shunichi

AU - Kiura, Katsuyuki

AU - Shigeoka, Yasushi

AU - Ichinose, Yukito

AU - Senba, Hiroshi

PY - 2009

Y1 - 2009

N2 - 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.

AB - 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.

KW - 5-HT receptor antagonist

KW - CINV

KW - Emesis

KW - Palonosetron

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