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We would like to express our concern regarding the recently published
NICE final appraisal determination document for Herceptin which states the
requirement for an absolute left ventricular ejection fraction (LVEF) of
55% as an eligibility criterion for the adjuvant or neoadjuvant use of
Herceptin in early stage breast carcinoma.1
In our opinion the reliance on an absolute ejection fraction values
creates significant difficulties in the clinic. Firstly the value of LVEF
depends very much on the measurement technique. In the UK three non-
invasive methods are used to assess LVEF; nuclear techniques,
echocardiography or cardiovascular magnetic resonance imaging (CMRI). The
preferred option used depends very much on local availability. Previous
studies have demonstrated these techniques to show considerable
variability in methodology, reproducibility and accuracy.2 Therefore, LVEF
measured by one method cannot be directly compared with one measured by
another.
Secondly there is no consensus about the definition of a normal LVEF.
In echocardiography the normal values range from 50 to 80%.3. The normal
value measured by nuclear techniques varies by department, the important
issue being the normal value for that department and its reproducibility.
Echocardiography tends to give the highest LVEF, followed by CMRI, with
nuclear techniques giving the lowest results. There can be up to 15%
difference in the measured LVEF dependent upon the methods used.2
This has important implications when it comes to the decision process
as to which patients are eligible for adjuvant Herceptin. It could result
in a postcode lottery scenario where the same patient would be eligible
for Herceptin in one institution and refused Herceptin in another
depending on the method used to assess LV ejection fraction. This has
been highlighted by several clinical cases in our own institution, where a
patient was deemed to have a “normal” LVEF when measured by a nuclear
technique but with a result lower than the required 55% stated in the NICE
guidance.
We therefore think that a national consensus, agreed by cardiologists
and oncologists is needed on the definition of an acceptable LVEF in the
eligibility criteria for Herceptin. In particular this needs to embrace
the considerable variability both between centres and in the methods used
to measure LVEF. This is important to maintain consistent, effective, and
safe implementation of the NICE guidance on the use of adjuvant Herceptin
throughout the UK.
Dr D Schlosshan, Specialist Registrar in Cardiology, Leeds General
Infirmary, Leeds
Dr R Sapsford, Consultant Cardiologist, St James’s University Hospital,
Leeds
Dr C Dickinson, British Nuclear Cardiology Society Secretary and
Consultant Cardiologist, Leeds General Infirmary
Dr David Dodwell, Consultant Clinical Oncologist, St James’s University
Hospital, Leeds
Dr T Perren, Consultant Clinical Oncologist, St James’s University
Hospital, Leeds
References
1 National Institute for Health and Clinical Excellence. Final
Appraisal Determination – Trastuzumab for the adjuvant treatment of early-
stage HER2-positive breast cancer.Issue date: June 2006. http://www.nice.org.uk.
2 Bellenger NG, Burgess MI, Ray SG, Lahiri A, Coats AJ, Cleland JG,
Pennel DJ. Comparison of left ventricular ejection fraction and volumes in
heart failure by echocardiography, radionuclide ventriculography and
cardiovascular magnetic resonance; are they interchangeable? Eur Heart J.
2000 Aug;21(16):1387-96.
3 Rimington H. In Echocardiography: A practical guide for
Reporting.1998. Page 3. Parthenon Publishing. London
Competing interests:
None declared
Competing interests:
No competing interests
18 September 2006
Dominik Schlosshan
SpR Cardiology
Robert Sapsford,Catherine Dickinson, David Dodwell,Tim Perren
Use of an absolute left ventricular ejection fraction (LVEF) of 55% as an eligibility criterion for the adjuvant or neoadjuvant use of Herceptin in early stage breast carcinoma
Dear editors,
We would like to express our concern regarding the recently published
NICE final appraisal determination document for Herceptin which states the
requirement for an absolute left ventricular ejection fraction (LVEF) of
55% as an eligibility criterion for the adjuvant or neoadjuvant use of
Herceptin in early stage breast carcinoma.1
In our opinion the reliance on an absolute ejection fraction values
creates significant difficulties in the clinic. Firstly the value of LVEF
depends very much on the measurement technique. In the UK three non-
invasive methods are used to assess LVEF; nuclear techniques,
echocardiography or cardiovascular magnetic resonance imaging (CMRI). The
preferred option used depends very much on local availability. Previous
studies have demonstrated these techniques to show considerable
variability in methodology, reproducibility and accuracy.2 Therefore, LVEF
measured by one method cannot be directly compared with one measured by
another.
Secondly there is no consensus about the definition of a normal LVEF.
In echocardiography the normal values range from 50 to 80%.3. The normal
value measured by nuclear techniques varies by department, the important
issue being the normal value for that department and its reproducibility.
Echocardiography tends to give the highest LVEF, followed by CMRI, with
nuclear techniques giving the lowest results. There can be up to 15%
difference in the measured LVEF dependent upon the methods used.2
This has important implications when it comes to the decision process
as to which patients are eligible for adjuvant Herceptin. It could result
in a postcode lottery scenario where the same patient would be eligible
for Herceptin in one institution and refused Herceptin in another
depending on the method used to assess LV ejection fraction. This has
been highlighted by several clinical cases in our own institution, where a
patient was deemed to have a “normal” LVEF when measured by a nuclear
technique but with a result lower than the required 55% stated in the NICE
guidance.
We therefore think that a national consensus, agreed by cardiologists
and oncologists is needed on the definition of an acceptable LVEF in the
eligibility criteria for Herceptin. In particular this needs to embrace
the considerable variability both between centres and in the methods used
to measure LVEF. This is important to maintain consistent, effective, and
safe implementation of the NICE guidance on the use of adjuvant Herceptin
throughout the UK.
Dr D Schlosshan, Specialist Registrar in Cardiology, Leeds General
Infirmary, Leeds
Dr R Sapsford, Consultant Cardiologist, St James’s University Hospital,
Leeds
Dr C Dickinson, British Nuclear Cardiology Society Secretary and
Consultant Cardiologist, Leeds General Infirmary
Dr David Dodwell, Consultant Clinical Oncologist, St James’s University
Hospital, Leeds
Dr T Perren, Consultant Clinical Oncologist, St James’s University
Hospital, Leeds
References
1 National Institute for Health and Clinical Excellence. Final
Appraisal Determination – Trastuzumab for the adjuvant treatment of early-
stage HER2-positive breast cancer.Issue date: June 2006.
http://www.nice.org.uk.
2 Bellenger NG, Burgess MI, Ray SG, Lahiri A, Coats AJ, Cleland JG,
Pennel DJ. Comparison of left ventricular ejection fraction and volumes in
heart failure by echocardiography, radionuclide ventriculography and
cardiovascular magnetic resonance; are they interchangeable? Eur Heart J.
2000 Aug;21(16):1387-96.
3 Rimington H. In Echocardiography: A practical guide for
Reporting.1998. Page 3. Parthenon Publishing. London
Competing interests:
None declared
Competing interests: No competing interests