Will molecular diagnostics become part of routine clinical practice

1
Will molecular diagnostics become part of routine
clinical practice?  

• Moderation
• Monica Castiglione

2
How do we proceed?

• Introduction
• Audience vote
• YES argument
• NO argument
• Discussion
• Summary of YES argument
• Summary of NO argument
• Audience vote and conclusion

3
The issue
Kaplan-Meier Survival Curves for pre, N-
And we cannot distinguish
4
The issue

• We need
• Prognostic and
• Predictive factors
• Helping us to determine
• Which patients need treatment
• What treatment has to be given
• For improving outcome and reducing over-treatment

5
Up to now we have

• Prognostic factors
• Nodal Status
• Tumor size
• Tumor grade
• Hormone receptors
• HER2/neu
• Age
• Menopausal status
• .

• Predictive factors
• Hormone receptors
• HER2/neu
• .

6
Adjuvant!
http//www.adjuvantonline.com
7
Today technologies available (gene expression)

• Gene chip with 25000 genes
• 70 genes (MammaPrint)
• 21 genes
• (OncoType DX)

8
Gene expression shows better discrimination than
St. Gallen criteria in node-negative BC
van de Vijver, M. et al. N Engl J Med
20023471999-2009
9
but use seems to be controversial!
10
Question to the audience

• Will molecular diagnostics become part of routine
  clinical practice?
• YES? NO?
• --gt Hands up!  

11
The disputants or discussants

• Prof. José Baselga,
• Spain
• Prof. Robert Leonard, United Kingdom

12
YES

• ? Prof. José Baselga

13
NO

• ? Prof. Robert Leonard

14
Summary YES

• ? Prof. José Baselga

15
Summary NO

• ? Prof. Roberto Leonard

16
Question to the audience

• Will molecular diagnostics become part of routine
  clinical practice?
• Did you change your mind?
• YES? NO?
• ? Hands up!  

17
Are profiles ready for the clinic?

• Reproducibility
• Independent retrospective validation
• Concordance with other profiles
• Retrospective vs Prospective

• Central vs Local testing
• Costs/Reimbursement
• Regulatory
• Guidelines

18
Thank you!