Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following moderately emetogenic chemotherapy: A randomized, multicenter, phase III trial

Luigi Celio, Sergio Frustaci, Angela Denaro, Angela Buonadonna, Antonio Ardizzoia, Elena Piazza, Alessandra Fabi, Alba Maria Capobianco, Luciano Isa, Luigi Cavanna, Alessandro Bertolini, Ettore Bichisao, Emilio Bajetta

Research output: Contribution to journalArticle

Abstract

Purpose: A phase III trial assessed the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following a broad range of moderately emetogenic chemotherapy (MEC) regimens. Methods: This multicentre, randomized, open-label, non-inferiority trial evaluated two different treatment groups. One group received palonosetron (0.25 mg intravenously) and dexamethasone (8 mg intravenously) before chemotherapy, while the other was administered the same regimen on day 1 followed by dexamethasone 8 mg orally on days 2 and 3. The primary endpoint was complete response (CR; defined as no emetic episodes and no rescue medication) during the overall phase (days 1-5 after chemotherapy initiation). The non-inferiority margin was predefined as a 15% difference between groups in the primary endpoint. Results: Of 332 chemotherapy-naïve patients included in the intention-to-treat analysis, 65.1% were female, and 35.2% received anthracycline plus cyclophosphamide (AC)-based regimens. Overall CR rates were 67.5% for those administered dexamethasone only on day 1 (n=166), and 71.1% for those also administered dexamethasone on days 2 and 3 (n=166; difference -3.6% (95% confidence interval, -13.5 to 6.3)). CR rates were not significantly different between groups during the acute (0-24 h post-chemotherapy; 88.6% versus 84.3%; P=0.262) and delayed phases (days 2-5; 68.7% versus 77.7%; P=0.116). Conclusions: Palonosetron plus single-dose dexamethasone administered before common MEC regimens provide protection against acute and delayed CINV which is non-inferior to that of palonosetron plus dexamethasone for 3 days. However, the major benefit of the single-day regimen occurs in patients receiving non-AC MEC regimens.

Original languageEnglish
Pages (from-to)1217-1225
Number of pages9
JournalSupportive Care in Cancer
Volume19
Issue number8
DOIs
Publication statusPublished - Aug 2011

Fingerprint

Nausea
Dexamethasone
Vomiting
Drug Therapy
Cyclophosphamide
Emetics
palonosetron
Intention to Treat Analysis
Anthracyclines
Confidence Intervals

Keywords

  • Dexamethasone
  • Moderately emetogenic chemotherapy
  • Nausea
  • Palonosetron
  • Serotonin antagonists
  • Vomiting

ASJC Scopus subject areas

  • Oncology

Cite this

Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following moderately emetogenic chemotherapy : A randomized, multicenter, phase III trial. / Celio, Luigi; Frustaci, Sergio; Denaro, Angela; Buonadonna, Angela; Ardizzoia, Antonio; Piazza, Elena; Fabi, Alessandra; Capobianco, Alba Maria; Isa, Luciano; Cavanna, Luigi; Bertolini, Alessandro; Bichisao, Ettore; Bajetta, Emilio.

In: Supportive Care in Cancer, Vol. 19, No. 8, 08.2011, p. 1217-1225.

Research output: Contribution to journalArticle

Celio, Luigi ; Frustaci, Sergio ; Denaro, Angela ; Buonadonna, Angela ; Ardizzoia, Antonio ; Piazza, Elena ; Fabi, Alessandra ; Capobianco, Alba Maria ; Isa, Luciano ; Cavanna, Luigi ; Bertolini, Alessandro ; Bichisao, Ettore ; Bajetta, Emilio. / Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following moderately emetogenic chemotherapy : A randomized, multicenter, phase III trial. In: Supportive Care in Cancer. 2011 ; Vol. 19, No. 8. pp. 1217-1225.
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abstract = "Purpose: A phase III trial assessed the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following a broad range of moderately emetogenic chemotherapy (MEC) regimens. Methods: This multicentre, randomized, open-label, non-inferiority trial evaluated two different treatment groups. One group received palonosetron (0.25 mg intravenously) and dexamethasone (8 mg intravenously) before chemotherapy, while the other was administered the same regimen on day 1 followed by dexamethasone 8 mg orally on days 2 and 3. The primary endpoint was complete response (CR; defined as no emetic episodes and no rescue medication) during the overall phase (days 1-5 after chemotherapy initiation). The non-inferiority margin was predefined as a 15{\%} difference between groups in the primary endpoint. Results: Of 332 chemotherapy-na{\"i}ve patients included in the intention-to-treat analysis, 65.1{\%} were female, and 35.2{\%} received anthracycline plus cyclophosphamide (AC)-based regimens. Overall CR rates were 67.5{\%} for those administered dexamethasone only on day 1 (n=166), and 71.1{\%} for those also administered dexamethasone on days 2 and 3 (n=166; difference -3.6{\%} (95{\%} confidence interval, -13.5 to 6.3)). CR rates were not significantly different between groups during the acute (0-24 h post-chemotherapy; 88.6{\%} versus 84.3{\%}; P=0.262) and delayed phases (days 2-5; 68.7{\%} versus 77.7{\%}; P=0.116). Conclusions: Palonosetron plus single-dose dexamethasone administered before common MEC regimens provide protection against acute and delayed CINV which is non-inferior to that of palonosetron plus dexamethasone for 3 days. However, the major benefit of the single-day regimen occurs in patients receiving non-AC MEC regimens.",
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T2 - A randomized, multicenter, phase III trial

AU - Celio, Luigi

AU - Frustaci, Sergio

AU - Denaro, Angela

AU - Buonadonna, Angela

AU - Ardizzoia, Antonio

AU - Piazza, Elena

AU - Fabi, Alessandra

AU - Capobianco, Alba Maria

AU - Isa, Luciano

AU - Cavanna, Luigi

AU - Bertolini, Alessandro

AU - Bichisao, Ettore

AU - Bajetta, Emilio

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N2 - Purpose: A phase III trial assessed the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following a broad range of moderately emetogenic chemotherapy (MEC) regimens. Methods: This multicentre, randomized, open-label, non-inferiority trial evaluated two different treatment groups. One group received palonosetron (0.25 mg intravenously) and dexamethasone (8 mg intravenously) before chemotherapy, while the other was administered the same regimen on day 1 followed by dexamethasone 8 mg orally on days 2 and 3. The primary endpoint was complete response (CR; defined as no emetic episodes and no rescue medication) during the overall phase (days 1-5 after chemotherapy initiation). The non-inferiority margin was predefined as a 15% difference between groups in the primary endpoint. Results: Of 332 chemotherapy-naïve patients included in the intention-to-treat analysis, 65.1% were female, and 35.2% received anthracycline plus cyclophosphamide (AC)-based regimens. Overall CR rates were 67.5% for those administered dexamethasone only on day 1 (n=166), and 71.1% for those also administered dexamethasone on days 2 and 3 (n=166; difference -3.6% (95% confidence interval, -13.5 to 6.3)). CR rates were not significantly different between groups during the acute (0-24 h post-chemotherapy; 88.6% versus 84.3%; P=0.262) and delayed phases (days 2-5; 68.7% versus 77.7%; P=0.116). Conclusions: Palonosetron plus single-dose dexamethasone administered before common MEC regimens provide protection against acute and delayed CINV which is non-inferior to that of palonosetron plus dexamethasone for 3 days. However, the major benefit of the single-day regimen occurs in patients receiving non-AC MEC regimens.

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KW - Moderately emetogenic chemotherapy

KW - Nausea

KW - Palonosetron

KW - Serotonin antagonists

KW - Vomiting

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