Title:
RENAL FUNCTION CHANGES AND NHS RESOURCE USE IN
BREAST CANCER PATIENTS WITH METASTATIC BONE
DISEASE TREATED WITH IV ZOLEDRONIC ACID OR ORAL
IBANDRONIC ACID: INTERIM RESULTS
Authors:
Stephen Houston
Sally Punter
Nicky Fisher
Elizabeth Hamilton
Name:
Nicky Fisher
Address:
pH Associates
47 Glade Road
Marlow
Bucks
SL7 1DQ
Tel:
01634 890428
Fax:
01634 890428
Email:
Nicky@phassociates.com
ABSTRACT
Abstract Title: RENAL FUNCTION CHANGES AND NHS RESOURCE USE
IN BREAST CANCER PATIENTS WITH METASTATIC BONE DISEASE
TREATED WITH IV ZOLEDRONIC ACID OR ORAL IBANDRONIC ACID:
INTERIM RESULTS
Authors: Stephen Houston (St Luke’s Cancer Centre, Royal Surrey County
Hospital NHS Trust, Guildford), Sally Punter (Pharmacy, St Luke’s Cancer
Centre, Royal Surrey County Hospital NHS Trust, Guildford), Nicky Fisher (pH
Associates, Marlow), Elizabeth Hamilton (Roche Products Ltd, Welwyn Garden
City)
Objectives
To describe how changes in renal function affect routine clinical practice in the
management of metastatic bone disease with IV zoledronic acid and oral ibandronic
acid and to describe the management pathways, adverse events and secondary care
NHS resources used.
Methods
This ongoing four centre study will involve retrospective review of medical
records of 200 patients with primary breast cancer and metastatic bone disease, from
the first dose of bisphosphonate until the end of therapy, focussing on renal function
and adjustment of the bisphosphonate dose. A prospective time and motion review of
resources involved in administering the bisphosphonates will also be conducted.
Results
Interim results from 129 patients treated with ibandronic acid (69) and zoledronic acid
(60) are presented:
Ibandronic acid
Zoledronic acid
(n=69) N(%)
(n=60) N(%)
Baseline creatinine clearance (CrCl)
0
25(41.7)
recorded in medical notes
Baseline CrCl could be calculated
7(10.1)
54(90.0)
from notes
Baseline CrCl >50ml/min
6(85.7)
46(85.1)
CrCl fell by at least one band during
1 /4 (25.0)
13 /43 (30.2)
treatment / patients for whom >1 CrCl
could be calculated
Serum creatinine (SCr) increased by
3(5.0)
4(6.7)
≥0.5mg/dl during treatment
SCr increased by ≥10% during
21(35.0)
31(51.7)
treatment
≥1 dose change
0
16(27%)
GI adverse events
7 in 7 patients
10 in 5 patients
Resource use data and results of the time and motion study are in analysis and will be
presented at the meeting.
Conclusion
These interim results show that in many patients, CrCl is not calculated before or
during treatment with bisphosphonates. Our data show that renal function deteriorated
in many patients during therapy. In view of the renal effects described here and
elsewhere, current practice may need to be reviewed to ensure appropriate dosing and
compliance with licence recommendations.