Original Article

Supportive Care in Cancer

, Volume 20, Issue 10, pp 2363-2369

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 AbidiAffiliated withWayne State University School of MedicineDepartment of Bone Marrow Transplantation, Division of Blood and Marrow Transplantation, Barbara Ann Karmanos Cancer Institute Email author 
  • , Nishant TagejaAffiliated withWayne State University School of Medicine
  • , Lois AyashAffiliated withWayne State University School of MedicineDepartment of Bone Marrow Transplantation, Division of Blood and Marrow Transplantation, Barbara Ann Karmanos Cancer Institute
  • , Judith AbramsAffiliated withWayne State University School of MedicineDepartment of Bone Marrow Transplantation, Division of Blood and Marrow Transplantation, Barbara Ann Karmanos Cancer Institute
  • , Voravit RatanatharathornAffiliated withWayne State University School of MedicineDepartment of Bone Marrow Transplantation, Division of Blood and Marrow Transplantation, Barbara Ann Karmanos Cancer Institute
  • , Zaid Al-KadhimiAffiliated withWayne State University School of MedicineDepartment of Bone Marrow Transplantation, Division of Blood and Marrow Transplantation, Barbara Ann Karmanos Cancer Institute
  • , Lawrence LumAffiliated withWayne State University School of MedicineDepartment of Bone Marrow Transplantation, Division of Blood and Marrow Transplantation, Barbara Ann Karmanos Cancer Institute
  • , Simon CroninAffiliated withDepartment of Bone Marrow Transplantation, Division of Blood and Marrow Transplantation, Barbara Ann Karmanos Cancer Institute
  • , Marie VentimigliaAffiliated withDepartment of Bone Marrow Transplantation, Division of Blood and Marrow Transplantation, Barbara Ann Karmanos Cancer Institute
    • , Joseph UbertiAffiliated withWayne State University School of MedicineDepartment of Bone Marrow Transplantation, Division of Blood and Marrow Transplantation, Barbara Ann Karmanos Cancer Institute

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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 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