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Ref: NICE 2000/018 Issued: 16 June 2000.
The National Institute for Clinical Excellence has today
issued its guidance on the use of Taxanes in the treatment
breast cancer.
Andrew Dillon, Chief Executive of NICE, said,
“The Institute’s guidance is based on a very careful consideration
of the evidence and I believe that all those involved in cancer services
in the NHS will welcome it. This guidance is good news for women suffering
from breast cancer, wherever they live in England & Wales.”
The guidance,
which has been made available to the NHS in England and Wales, recommends
that as patients reach the appropriate stage in their treatment for advanced
breast cancer, they should be offered either docetaxel (Taxotere) or paclitaxel
(Taxol).
The decision as to which product should be used should be taken by the
responsible clinician in discussion with the patient taking into account
the clinical trial data set out in full in the guidance. To summarise:
• For docetaxel,
there are four RCTs (based on approximately 1000 patients), which show
significantly longer times before disease progression, compared to control
groups. On average it is 6 months before the cancer begins to progress.
• For paclitaxel,
there are two RCTs, (with a total of approximately 500 patients).
Paclitaxel shows that it delays the progression of breast cancer on average
by approximately 3.5 months, compared to a similar drug.
The Institute
also recommends that the use of Taxanes for adjuvant treatment of early
breast cancer, or for the first-line treatment of advanced breast cancer,
should be limited to clinical trials.
Ends
Notes for Editors:
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| 1. |
Copies of the full guidance, information for patients)
are available on the NICE web site (www.nice.org.uk). |
| 2. |
The full Guidance and patient notes are also available
from:
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| 3. |
Cancer is a disease of the body's cells. Normally,
all cells divide and reproduce themselves in an orderly and controlled
manner. In cancer, the cells multiply without proper control.
Breast cancer is the commonest cause of cancer death in women about
14,000 women die of breast cancer deaths each year in the UK.
The type of treatment given for a cancer depends on many factors.
These include: |
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- the type of cancer,
- where in the body it started,
- what the cancer cells look like under the
- how far they have spread, if at all
- the general health of the patient
The Taxanes are a type of anti-cancer
drugs known as cytotoxic drugs and they are used during chemotherapy.
Chemotherapy is the use of anti-cancer
drugs to destroy cancer cells.
Chemotherapy may be used on its own
to treat cancer or it may be used with other drugs, with surgery
and/or with radiotherapy.
- the number of patients whose tumour shrank by 50% or more (called
the response rate),
- the length of time between treatment and the disease developing
further (if this happened)
- the overall length of survival
- and the patients’ quality of life.
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| 4. |
The decision as to which product should be used should
be taken by the responsible clinician in discussion with the patient.
During this discussion they should take into account the following
randomised Controlled Trial (RCT) evidence for the use of the Taxanes
in advanced breast cancer which shows improved initial response to
the treatment and an increase in the time before the disease progresses:
• For docetaxel,
there are four RCTs (based on approximately 1000 patients), which
show significantly longer times before disease progression, compared
to control groups. On average it is 6 months before the cancer begins
to progress.
• For paclitaxel,
there are two RCTs, (with a total of approximately 500 patients).
Paclitaxel shows that it delays the progression of breast cancer
on average by approximately 3.5 months, compared to a similar drug.
No significant difference in the side effects has been demonstrated
between the two types Taxanes and the other comparison drugs used
in the trials.
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| 5. |
There are two Taxane drugs available in the UK, docetaxel
(Taxotere) and paclitaxel (Taxol). They both cost about £1,500 per
course of treatment and each patient may need up to six courses
It is estimated that the use of docetaxel and paclitaxel to treat
anthracycline-resistant advanced breast cancer will cost the NHS around
£20m each year, (assuming that 5,000 patients are treated at a cost
of around £4,000 per patient). It is estimated that approximately
1,000 patients are already receiving such treatment, thus the additional
cost to the NHS is likely to be of the order of £16m per year.
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| 6. |
This guidance means that no matter where they live
in England or Wales, both patients and health professionals, have
access to information on what the NHS considers to be best practice
in the use of Taxanes for breast cancer. |
| 7. |
Health professionals are expected to take the guidance
fully into account when exercising their clinical judgement about
the circumstances in which it is appropriate to use Taxanes to treat
breast cancer. This guidance does not, however, override the
individual responsibility of health professionals to make appropriate
decisions in the circumstances of the individual patient, in consultation
with the patient and/or guardian or carer.
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| 8. |
The National Institute for Clinical Excellence (NICE)
is a part of the NHS. Part of its work is technology appraisals. That
is we use a team of experts to produce guidance for both the NHS and
patients on medicines, medical equipment and clinical procedures based
on evidence of clinical and cost effectiveness. Each appraisal takes
around 12 months to complete and involves the manufacturers of the
technology, patient groups and professional organisations.
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| 9. |
NICE was asked to look at the use of Taxanes in the
treatment of ovarian and breast cancer and provide guidance to the
NHS. The guidance issued today is a result of the work on breast cancer. |
| 10. |
NICE had intended issuing guidance on the use of the
Taxanes in the treatment of both ovarian and breast cancer at the
same time. However, an appeal was made against the original guidance
specifically in relation to breast cancer. This appeal was heard on
the 3rd May, and was upheld. The full decision of the Appeal
Panel is published on the Institute’s web site, www.nice.org.uk.
Following the appeal the Appraisals committee considered their
original determination alongside the Appeal panel’s decision.
They released a Final Appraisal Determination to the Institute,
which prepared the guidance. This guidance was circulated to the
stakeholders, who had 10 working days to lodge an appeal. An appeal
was lodged against this guidance, and this appeal was heard on Wednesday
14 May. The appeal was not upheld and the guidance has been
issued to the NHS today.
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| 11. |
NICE follows an transparent and well structured process
for its technology appraisals, which gives appropriate groups (patients
professionals and manufacturers) with the opportunity to submit evidence,
to comment on draft conclusions and to appeal, if required, to a panel
of those independent of the original judgement. Its task is to assess
the evidence of all the clinical and other health related benefits
of an intervention. This will include impact on quality of life, relief
of pain or disability as well as any impact on likely length of life;
to estimate the associated costs and to reach a judgement as to whether,
on balance, the intervention can be recommended.
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| 12. |
At the end of the appraisal process the Appraisal Committee
produces a Final Appraisal Determination (FAD). The FAD is then considered
by the Institute's Guidance Executive who use it as the basis for
producing the Guidance to the NHS. The Institute then makes the Guidance
to the NHS available to all interested parties, initially on a confidential
basis, who, should they wish to, have 10 working days to lodge an
appeal against the guidance. The document Appeal Against Guidance
to the NHS on a New or Existing Technology - Guidance for Appellants
provides guidance appellants |
| 13. |
NICE promotes clinical and cost effectiveness through
its technology appraisals, clinical guidelines and audit tools. NICE
supports the work of those who make the complex treatment decisions
- doctors, nurses, and other health professionals. The needs of the
patient are central to NICE’s work, and the Institute has forged
strong links with patient groups and representatives. |
| 14. |
NICE appraises new and existing health technologies,
as selected by the Department of Health and the National Assembly
for Wales and advises the NHS on how these technologies can best be
used. It is also responsible for the production of national
clinical guidelines, promoting best practice throughout the NHS.
To support and assess the implementation of such guidelines, NICE
will produce audit tools for use in the clinical setting |
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