HER2

1
HER2

• Human Epidermal growth factor Receptor 2
• Excess HER2 gene leads to over expression of HER2
  protein
• 20-30 Of breast cancers over express HER2

2
Her2 and breast cancer

• Prognostic marker Poor clinical outcomes
• Predictive marker Response to Transtuzumab
  Herceptin
• Tamoxifen resistance
• Anthracyclines

3
Which patients?

• All patients with metastases.
• All newly diagnosed patients.

4
How?

• Immunocytochemistry
• antibody to HER2 protein gene product
• 0/1 Negative
• 2 Equivocal
• 3 Positive

5

• In Situ Hybridisation ISH
• F.I.S.H. Fluorescent ISH
• quantifies the gene amplification

6
Herceptin in early breast cancer

• ASCO 2005
• HERA and NSABP B-31
• October 2005 DoH SEHD

7
WoSCAN

• Testing All newly diagnosed
  patients All metastatic cases
• I.H.C Ayrshire and Arran
  2002 Glasgow 2004 Lanarkshire, Argyll and
  Clyde, Forth Valley . Dumfries and Galloway
• FISH Glasgow

8
SCAN

• Testing All metastatic cases All
  high risk new diagnoses
• IHC FISH Edinburgh Lothian, Fife and
  the Borders

9
NoSCAN

• Grampian Testing All newly diagnosed
  cases All metastatic cases
• Aberdeen IHC Pathology FISH
  Cytogenetics

10

• Inverness Testing Metastatic cases
  only
• IHC FISH Pathlore

11

• Tayside Testing All new
  cases All metastatic cases
• Dundee IHC Pathology FISH Cytogeneti
  cs

12
Strengths

• Substantial numbers of new patients already
  tested.
• NEQAS participation
• Innovative approach
• Utilising regional MCNs

13
Challenges

• Not all new patients being tested
• Backlog
• Funding
• Quality assurance
• Turnaround times
• Numbers
• IHC which antibody?

14
HER2 Service

• All pertinent patients
• Quality Assurance Standards
• Results available in clinically relevant
  timescales.

15
Molecular Diagnostics

• Comprehensive
• Infrastructure
• Versatile