'SPEED UP' CANCER DRUG ASSESSMENT
Campaigners have called for a fast-track
assessment of a new breast cancer drug which may help save
A global study found Femara (letrozole) was of most benefit
to women at highest risk of the cancer returning, the New
England Journal of Medicine reported.
In women whose cancer had spread to the
lymph nodes, the drug cut the risk of a recurrence of disease
by 29% compared to 'gold standard' tamoxifen treatment.
The study involved 8,000 women, including
more than 400 from the UK.
The findings contributed to a decision earlier
this month by the Medicines and Healthcare products
Regulatory Agency (MHRA) to approve a licence for
the use of the drug for postmenopausal women with
early breast cancer straight after surgery.
However, the NHS drug watchdog is not due to rule
on whether the drug should be made widely available
until late next year.
are fantastic news and give hope to women with
The study, co-ordinated by the Senology
Center of Eastern Switzerland in Kantonsspital, looked at
which drug women in the study were initially treated with.
They found Femara cut the risk of disease
returning in women who had already undergone chemotherapy
by 28%, compared to tamoxifen therapy.
Among all women taking Femara there was
a 27% reduction in the risk of cancer spreading to other
parts of the body compared to those taking tamoxifen, and
a 19% drop in the risk of breast cancer returning.
Femara is a type of drug called an aromatase
inhibitor which stops the natural production of oestrogen
- the hormone that is responsible for the growth and recurrence
of many breast cancers.
There has been concern recently that cancer
patients in some areas are being denied access to the newest
drugs because of financial concerns of NHS trusts.
This has led some to take legal action
to make their health authority fund the treatment.
The National Institute for Health and Clinical
Excellence (NICE) is due to rule on the use of aromatase
inhibitors by the NHS next autumn. However, pressure is
building for the process to be speeded up.
The drug has already been approved in Scotland
for post-menopausal patients - but only after they have
been treated with tamoxifen.
Nigel Bundred, a professor in surgical
oncology at Wythenshawe Hospital, Manchester, said: "These
results are fantastic news and give hope to women with breast
cancer - especially those at high risk of their cancer recurring.
"They show that Femara is more effective
than tamoxifen when given to women after surgery and offers
even greater advantages to these particularly vulnerable
Liz Caroll, from charity Breast Cancer
Care, said: "These results further suggest the benefits
of using aromatase inhibitors over tamoxifen in treating
early invasive breast cancer and indicate that many more
lives could be saved.
"Many women, like those we support,
with breast cancer will welcome the news that they might
benefit from this new treatment option, as will the healthcare
professionals treating them."
However, Professor Karol Sikora, an expert
in cancer medicine at Hammersmith Hospital, London, said:
"What we need is to see a really slick version of NICE
that can approve a drug within two days.
"There is going to be no more data
when they finally approve it than they have got now - and
that is the tragedy."
Treatment with tamoxifen was associated
with higher rates of blood clots, endometrial cancer, and
On the other hand, Femara therapy was tied
to higher rates of skeletal and heart problems, as well
as high cholesterol levels.
Story from BBC NEWS: http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/4566112.stm
Published: 2005/12/29 09:52:32 GMT
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