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New ASCO Recommendation for Postmenopausal Women With Early
Breast Cancer
LONDON, November 15 /PRNewswire-FirstCall/ -- - Optimal Adjuvant Therapy
Should Now Include an AI Such as 'Arimidex' (anastrozole) in Order to Reduce
the Risk of Tumour Recurrence
Today, the American Society of Clinical Oncology (ASCO) Technology Assessment
Panel announced a fundamental change to its internationally recognised guidance
on the use of aromatase inhibitors (AIs) in the treatment of postmenopausal
women with early breast cancer.(1) For the first time, the ASCO Panel has
agreed that 5 years' tamoxifen is no longer the optimal treatment choice in
this setting and recommends that adjuvant therapy should include an AI, such as
anastrozole ('Arimidex'), as initial therapy or after treatment with tamoxifen,
in order to reduce risk of recurrence.
The ASCO Panel states that it is not known whether the AIs are interchangeable
in clinical practice and therefore favours using the agent with the most data
relevant to each individual clinical setting. Anastrozole is the most studied
of all the AIs and the only one with data to support its use as initial
adjuvant therapy; therefore, evidence-based medicine suggests that anastrozole
should be the preferred choice if an AI is to replace tamoxifen in this
setting.
This endorsement for anastrozole in the ASCO Technology Assessment, Use of
Aromatase Inhibitors in the Adjuvant Setting, is based on the compelling
evidence provided by the ATAC ('Arimidex', Tamoxifen, Alone or in Combination)
trial (2). The first five years following initial surgery is the period during
which women are most at risk of their disease returning and current data
demonstrate that anastrozole is significantly more effective than tamoxifen in
reducing this risk. Furthermore, the incidence of three life-threatening side
effects associated with tamoxifen - endometrial cancer, thromboembolic events
and stroke are also significantly reduced with anastrozole.
Commenting on this new recommendation, Professor Anthony Howell of Christie
Hospital, Manchester, UK said: "Although doctors have been aware of the
benefits that anastrozole offers over tamoxifen for some time, many have been
awaiting reassurance from guidelines committees such as ASCO before changing
their prescribing habits. This is a real milestone in the treatment of early
breast cancer. More women will now be able to benefit from the greater
protection that anastrozole provides against the cancer coming back, along with
a better tolerability profile."
In addition to replacing tamoxifen as an alternative initial adjuvant therapy,
the ASCO Panel also recognises that women who have already commenced a course
of adjuvant tamoxifen are more likely to remain free of the disease if they
have their therapy changed to an AI. Therefore the Panel recommends that women
on tamoxifen consider switching to an AI such as anastrozole.
Professor Howell continued: "I am pleased to see that ASCO have also recognised
the value in offering women the opportunity to change their therapy from
tamoxifen to an AI, to help improve their chances of remaining disease-free.
However, because the risk of recurrence is highest in the first five years,
it's important to remember that women gain the greatest benefit when the most
effective therapy is used as early as possible, preferably from the outset."
There is now little doubt that the AIs play an important role in the adjuvant
treatment of postmenopausal women with hormone receptor-positive early breast
cancer. The evidence shows that there is a clear and consistent improvement in
disease-free survival over tamoxifen for women who receive an AI and
differences in disease-free survival frequently lead to improvements in overall
survival with prolonged follow-up. Anastrozole remains the only AI to have
demonstrated superiority over tamoxifen as a primary adjuvant therapy in
postmenopausal women with early breast cancer and is the only AI approved for
use in this setting. With over 1 million patient-years experience, anastrozole
has the most mature efficacy and tolerability data available for any AI.
The ASCO Panel state that they are still awaiting further data, particularly
with respect to long-term toxicity before making their final recommendations on
the use of adjuvant AIs. The forthcoming data from the ATAC 5 year Completed
Treatment Analysis, due for presentation at the San Antonio Breast Cancer
Symposium in 3 week's time, will provide the first long-term data for any AI in
the early breast cancer setting.
'Arimidex' (anastrozole) is a trademark, property of the AstraZeneca Group of
Companies.
References
1. Winer EP, Hudis C, Burstein HJ et al .American Society of Clinical Oncology
Technology Assessment on the Use of Aromatase Inhibitors As Adjuvant Therapy
for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Status
Report 2004. Available on line @ http://www.jco.org/. To be published in the J
Clin Oncol, January 20, 2005.
2. The ATAC ('Arimidex', Tamoxifen, Alone or in Combination) Trialists' Group.
Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for
adjuvant treatment of postmenopausal women with early breast cancer: results of
the ATAC trial efficacy and safety update analyses. Cancer 2003; 98 (9):
1802-1810.
Notes to Editors:
Full Recommendations of the ASCO Technology Assessment Committee:
- Based on results from multiple large randomised trials, adjuvant therapy for
postmenopausal women with hormone receptor-positive breast cancer should
include an aromatase inhibitor in order to lower the risk of tumour recurrence.
Neither the optimal timing nor duration of aromatase inhibitor therapy is
established.
- Aromatase inhibitors are appropriate as initial treatment for women with
contraindications to tamoxifen. For all other postmenopausal women, treatment
options include 5 years of aromatase inhibitors treatment or sequential therapy
consisting of tamoxifen (for either 2 to 3 years or 5 years) followed by
aromatase inhibitors for 2 to 3, to 5 years.
- Patients intolerant of aromatase inhibitors should receive tamoxifen.
- There are no data on the use of tamoxifen after an aromatase inhibitor in the
adjuvant setting.
- Women with hormone receptor-negative tumours should not receive adjuvant
endocrine therapy.
- The role of other biomarkers such as progesterone receptor and HER2 status in
selecting optimal endocrine therapy remains controversial.
- Aromatase inhibitors are contraindicated in premenopausal women; there are
limited data concerning their role in women with treatment-related amenorrhoea.
- The side effect profiles of tamoxifen and aromatase inhibitors differ. The
late consequences of aromatase inhibitor therapy, including osteoporosis, are
not well characterised.
AstraZeneca continues its tradition of research excellence and innovation in
oncology that led to the development of its current anti-cancer therapies
including 'ARIMIDEX' (anastrozole), 'CASODEX' (bicalutamide), 'FASLODEX'
(fulvestrant), 'NOLVADEX' (tamoxifen), 'ZOLADEX' (goserelin), 'TOMUDEX'
(raltitrexed) and 'IRESSA' (gefitinib) as well as a range of novel targeted
products such as anti-proliferatives, anti-angiogenics, vascular targeting and
anti-invasive agents. AstraZeneca is also harnessing rational drug design
technologies to develop new compounds that offer advantages over current
cytotoxic and hormonal treatment options. The company has over 20 different
anti-cancer projects in research and development.
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the world's
leading pharmaceutical companies with healthcare sales of over $18.8 billion
and leading positions in sales of gastrointestinal, oncology, cardiovascular,
neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4Good Index.
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DATASOURCE: AstraZeneca
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