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New ASCO Recommendation for Postmenopausal Women With Early Breast Cancer

London, November 15 (ots/PRNewswire)

- 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 @ 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.
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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
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Contact:

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