Supportive Care in Cancer

, Volume 20, Issue 10, pp 2363–2369 | Cite as

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
Original Article
First Online:
Received:
Accepted:

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 anti-emetics 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). Thirty-three 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.

Keywords

Aprepitant Nausea Vomiting High-dose cyclophosphamide 
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Notes

Disclosure/conflicts

This study was supported in part by a research grant from the investigator-initiated studies program of Merck Sharp & Dohme Corp. The opinions expressed in this paper are those of the authors and do not represent those of Merck Sharp & Dohme Corp.

LL is supported in part by R01 092344 from the NCI, NIH, Translational Grants from the Leukemia and Lymphoma Society Translational Grants #6092-09 and #6066-06, and Susan G. Komen Foundation BCTR0707125.

MA receives research funding from Amgen and Merck, serves as a consultant for Genzyme and Millennium, and is on the speaker’s bureau of Millennium.

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Copyright information

© Springer-Verlag 2011

Authors and Affiliations

  • Muneer H Abidi
    • 1
    • 2
  • Nishant Tageja
    • 1
  • Lois Ayash
    • 1
    • 2
  • Judith Abrams
    • 1
    • 2
  • Voravit Ratanatharathorn
    • 1
    • 2
  • Zaid Al-Kadhimi
    • 1
    • 2
  • Lawrence Lum
    • 1
    • 2
  • Simon Cronin
    • 2
  • Marie Ventimiglia
    • 2
  • Joseph Uberti
    • 1
    • 2
  1. 1.Wayne State University School of MedicineDetroitUSA
  2. 2.Department of Bone Marrow Transplantation, Division of Blood and Marrow TransplantationBarbara Ann Karmanos Cancer InstituteDetroitUSA

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