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Microarray Testing in
Breast Cancer Treatment
Willem H. van Harten, Jolien M. Bueno de Mesquita,
Marjan Hummel, Kim Karsenberg, Valesca P. Retèl
Constructive Technology Assessment in
Early Stage Clinical Implementation
Sauter, G. et. al. N Engl J Med 2002;347:1995-1996
Gene-Expression Profiling
70-Gene Microarray testing in
Node Negative Breast Cancer
• Based on validated retrospective series
(van ’t Veer, Nature 2002, van de Vijver,
NEJM 2002)
• Confirmed by independent retrospective
validation series (Buyse, 2006)
• Dutch Health Care Insurance Board
sponsored controlled introduction study
Constructive Technology Assessment
• Mutual influence of technology & environment
(especially early stage)
• Lack of impact many HTA-studies
• -Delay study draft and implementation of
results.
• - Scientific and practice developments
interfering
• -Cost-effectiveness focus
Constructive Technology Assessment
• Based on Technology dynamics & Public
policy
• Combination of assessment and influence
• Broad evaluation
– IOM aspects of quality
– Ethical & juridical aspects
– Scenario drafting and revision
• Int Journal HTA 2007 Douma et.al.
CTA 70-Gene Microarray
• 16 Dutch hospitals
• 812 Breast cancer patients enrolled
• 427 70-Gene tested
• Clinical;Logistic;Patient;Scenario’s.
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CTA 70-Gene Microarray
Clinical Results
High risk
profile
Low risk profile
427
(100%)
208
(49%)
219
(51%)
Total
184
(43%)
132
(31%)
52
(12%)
Clinical (CBO) High risk
profile
243
(57%)
76
(18%)
167
(39%)
Clinical (CBO) Low risk
profile
Total
70-gene signature risk profile
N = 427
CTA 70-Gene Microarray
Clinical Results
In 19% of patients the adjuvant systemic
treatment advice was changed based on
the 70-gene signature profile:
– in 5% the treating physician refrained from
adjuvant systemic treatment
– in 14% adjuvant systemic treatment was
added
CTA 70-Gene Microarray
Logistic Analysis
• Change of work routine for OR-
tissue handling and Pathologist
• Mean duration of implementation of
logistics 2,2 months (0,2 – 9,4)