Aprepitant for prevention of nausea and vomiting secondary to high-dose cyclophosphamide administered to patients undergoing autologous peripheral blood stem cells mobilization: A phase II trial

Muneer H. Abidi, Nishant Tageja, Lois Ayash, Judith Abrams, Voravit Ratanatharathorn, Zaid Al-Kadhimi, Lawrence Lum, Simon Cronin, Marie Ventimiglia, Joseph Uberti

Research output: Contribution to journalArticle

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Abstract

This is a phase II trial evaluating efficacy and safety of aprepitant (AP) in combination with 5-HT3 antagonist and adjusted dose dexamethasone in patients receiving high-dose cyclophosphamide (CY) and filgrastim for stem cell mobilization. We used Simon's optimal two-stage design constrained to fewer than 40 patients with 10% type I error and 85% statistical power. The first stage of the study required accrual of 18 response-evaluable patients. The primary endpoint was the control of vomiting without the use of any rescue antiemetics at 24 h after the administration of high dose CY (4 g/m2). If emesis was controlled in ≥9 patients, an additional cohort of 17 patients would be enrolled. The null hypothesis would be rejected if there were ≥20 responses among 35 patients. Forty patients were enrolled, five of whom were not evaluable for response. Eighteen evaluable patients were enrolled in the first stage. Acute emesis was controlled in 10 patients; therefore, enrollment proceeded to stage 2. An additional 17 patients were enrolled; 20/35 response-evaluable patients (57%) did not develop acute vomiting or require rescue anti-emetics, thus achieving the goal of the study. A total of 22/35 response-evaluable patients (63%) met the secondary endpoint of delayed emesis control (days 2-5). Thirtythree out of 35 patients underwent successful stem cell mobilization. No≥grade 3 AP-related adverse events were noted. The AP regimen can effectively control acute and delayed emesis in the majority patients receiving high-dose CY.

Original languageEnglish (US)
Pages (from-to)2363-2369
Number of pages7
JournalSupportive Care in Cancer
Volume20
Issue number10
DOIs
StatePublished - Oct 1 2012

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aprepitant
Hematopoietic Stem Cell Mobilization
Cyclophosphamide
Nausea
Vomiting
Antiemetics
Peripheral Blood Stem Cells

Keywords

  • Aprepitant
  • High-dose cyclophosphamide
  • Nausea
  • Vomiting

ASJC Scopus subject areas

  • Oncology

Cite this

Aprepitant for prevention of nausea and vomiting secondary to high-dose cyclophosphamide administered to patients undergoing autologous peripheral blood stem cells mobilization : A phase II trial. / Abidi, Muneer H.; Tageja, Nishant; Ayash, Lois; Abrams, Judith; Ratanatharathorn, Voravit; Al-Kadhimi, Zaid; Lum, Lawrence; Cronin, Simon; Ventimiglia, Marie; Uberti, Joseph.

In: Supportive Care in Cancer, Vol. 20, No. 10, 01.10.2012, p. 2363-2369.

Research output: Contribution to journalArticle

Abidi, Muneer H. ; Tageja, Nishant ; Ayash, Lois ; Abrams, Judith ; Ratanatharathorn, Voravit ; Al-Kadhimi, Zaid ; Lum, Lawrence ; Cronin, Simon ; Ventimiglia, Marie ; Uberti, Joseph. / Aprepitant for prevention of nausea and vomiting secondary to high-dose cyclophosphamide administered to patients undergoing autologous peripheral blood stem cells mobilization : A phase II trial. In: Supportive Care in Cancer. 2012 ; Vol. 20, No. 10. pp. 2363-2369.
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AU - Tageja, Nishant

AU - Ayash, Lois

AU - Abrams, Judith

AU - Ratanatharathorn, Voravit

AU - Al-Kadhimi, Zaid

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AU - Cronin, Simon

AU - Ventimiglia, Marie

AU - Uberti, Joseph

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