Audit and Research Proposal

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Multicentre Audit of Patients Progressing on
Trastuzumab (Herceptin) for Metastatic Breast Cancer
Penny Gamble and Steve Williamson
Senior Clinical Pharmacist – Adult Cancer Services
Pharmacy Department, Northern Centre for Cancer Care
Newcastle Hospitals NHS Foundation Trust
Steve Williamson
Consultant Pharmacist for Cancer Services
Northumbria Healthcare Trust and North of England Cancer Network
Address for Correspondence
Clinical Trials Pharmacy
Northern Centre for Cancer Care
Freeman Hospital
High Heaton
Newcastle upon Tyne NE7 7DN
0191 2139269
Email: Penny.Gamble@nuth.nhs.uk
106741615
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Multicentre Audit of Patients Progressing on
Trastuzumab (Herceptin) for Metastatic Breast Cancer
Penny Gamble and Steve Williamson
Background
Herceptin (trastuzumab) is been an established therapy for metastatic breast cancer for patients
whose tumours over-express human epidermal growth factor receptor 2 (HER2).1 Recently there has
been much interest in the use of herceptin ‘beyond progression’ as there is emerging evidence that
this is clinically acceptable. However NICE recommend ‘For patients who are receiving treatment
with trastuzumab for advanced breast cancer, discontinue treatment with trastuzumab at the time of
disease progression outside the central nervous system. 3
Aims
1. To audit patients who progress when receiving herceptin for metastatic breast cancer.
2. To see where and when disease progression occurs
3. To see what the local survival is post progression for use of metastatic herceptin.
4. To audit the incidence of cardiac toxicity and evaluate if toxicity contributes to stopping treatment
5. To evaluate if there is local use of herceptin beyond progression.
Methods
Patients treated at the Newcastle Hospitals and Northumbria Trust (North of Tyne) with Trastuzumab
(Herceptin) for Metastatic Breast Cancer from 2003 to present day. A Retrospective study
Electronic data on drug issues from pharmacy system use to populate patient database.
Patient medical records audited to identify the reasons for progression.
Results
32 patients received herceptin in the study period. Full results to be presented in poster: Preliminary
data shows
 7 patients ongoing, 4 patients progressed in CNS, t he remainder had mixed progression, bone,
liver, local tissue.
 Survival data analysis ongoing.
 Two patients were stopped due to cardiac toxicity.
 At least one patient has continued beyond progression.
Note the data is subject to independent review (complete before poster submitted)
Discussion
The use of herceptin in metastatic disease is well established; adjuvant use highlighted the cardiac
risk of the drug. There was concern that the cardiac toxicities in metastatic disease may be
underreported. The audit looked at local use and compared with expected outcomes. The audit also
demonstrated that pharmacists can successfully lead a multicentre clinical audit. Further discussion
in poster.
Note: Full results including; further in depth analysis of the data will be included poster.
References
1. Slamon D, Leyland-Jones B, Shak S, Paton V et al. Addition of Herceptin™ (humanized anti-HER2
antibody) to first line chemotherapy for HER2 overexpressing metastatic breast cancer (HER2 +/MBC)
markedly increases anticancer activity: a randomized, multinational controlled phase III trial. Proc Am Soc
Clin Oncol 1998;17:98a
2. Minckwitz et la. Trastuzumab Beyond Progression in Human Epidermal Growth Factor Receptor 2–Positive
Advanced Breast Cancer: A German Breast Group 26/Breast International Group 03-05 Study. Mar 16
2009 Journal of Clinical Oncology
3. NICE Clinical Guidelines CG81, ‘Advanced breast cancer: diagnosis and treatment Issued: February 2009
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