THE EFFECTIVENESS OF HYDROCORTISONE PREMEDICATION ON DRUG
DELIVERY REACTIONS FOLLOWING ABELCET: A PROSPECTIVE AUDIT
Anne Borley1, Nigel O’Connor,1 Barry Rodgers-Gray2, Zahid Bashir3
1
Royal Shrewsbury Hospital, Shrewsbury, UK; 2 Strategen Ltd., Basingstoke, UK;
3
Cephalon Ltd, Welwyn Garden City, UK.
Invasive fungal infections are a serious cause of morbidity and mortality in cancer
patients. Abelcet, a lipid formulation of amphotericin B, is an effective treatment of
fungal infections; however, it is associated with mild to moderate drug delivery reactions
(DDRs), such as fever and chills, in some immunocompromised patients. The objective
of this audit was to assess the effect of hydrocortisone premedication on the incidence of
DDRs following Abelcet.
All cancer patients treated with Abelcet at The Royal Shrewsbury Hospital were
audited prospectively over an 18 month period. Each patient received 100 mg of
intravenous hydrocortisone 15-30 minutes prior to each Abelcet Infusion. Abelcet was
administered at an initial dose of 100 mg for prophylaxis and 200-400 mg as treatment
for suspected or proven fungal infection, depending on disease severity.
275 cycles of Abelcet were administered (mean dosage 930.6±50.0 mg), 16.0%
of which were associated with a DDR. The majority of reactions occurred following the
initial infusion of a cycle (15.3% vs. 2.9% following subsequent infusions). The most
common reactions were rigor, which occurred in all patients with a DDR, and fever.
There was no significant difference in the DDR rate between Abelcet naïve (n=99) and
previously treated patients (17.2% vs. 15.5%, P=0.734). In addition, the DDR rate did not
significantly differ between prophylactic and treatment use (16.2% vs. 14.6%; P=0.735).
The dosage of Abelcet also had no significant effect on the DDR rate (100 mg: 15.8%,
200 mg: 12.8%, or ≥300 mg: 21.1%; P=0.7759). Female gender, neutropaenia and
younger age were found to be associated with having a DDR in Abelcet-naïve patients.
These results represent a substantial decrease compared to DDR rates published in
clinical trials of >50%.1,2 It can be concluded that premedication with hydrocortisone
results in a low incidence of DDRs following Abelcet.
References:
1. Wingard JR, White MH, Anaissie E, Raffalli J, Goodman J, Arrieta A. A randomised,
double blind comparative trial evaluating the safety of liposomal
amphotericin B versus amphotericin B lipid complex in the empirical
treatment of febrile neutropaenia. Clin Infect Dis 2000;31:1155-1163.
2. Subira M, Martino R, Gomez L et al. Low dose amphotericin B lipid complex vs
conventional amphotericin B for empirical antifungal therapy of neutropenic
fever in patients with haematologic malignancies – a randomised, controlled
trial. Eur J Haematol 2004;72:342-34
Further Information
Title:
THE EFFECTIVENESS OF HYDROCORTISONE PREMEDICATION ON
DRUG
DELIVERY
REACTIONS
FOLLOWING
ABELCET:
PROSPECTIVE AUDIT
Authors: Anne Borley, Nigel O’Connor, Barry Rodgers-Gray, Zahid Bashir
Name: Dr Zahid Bashir
Postal Address:
Cephalon Ltd.
1 Albany Place
Hyde Way
Welwyn Garden City
Herts AL7 3BT
Telephone: 01707 385800
Fax: 01707 385802
Email: zbashir@cephalon.com
A