Asia PR News

MACCLESFIELD, Oct. 31 /PRNewswire-AsiaNet/ –

New data presented at ECCO* shows ‘Faslodex’ (fulvestrant) works as quickly
as the gold-standard Arimidex(TM)(anastrozole) in advanced breast cancer
patients recurring or progressing on prior tamoxifen therapy.

Data presented today at ECCO 13 may open the door to more women being able
to benefit from ‘Faslodex’ (fulvestrant), an effective treatment for advanced
breast cancer after recurrence or progression on hormonal therapy. Conclusive
evidence has already demonstrated that fulvestrant, which is administered as a
once-monthly intra-muscular (IM) injection, is at least as effective as the
gold-standard aromatase inhibitor (AI), ‘Arimidex’ (anastrozole) in this
setting, as well as being better tolerated (1-2). However, new data presented
today at a key European Cancer Congress in Paris, France, confirm that
fulvestrant is also rapidly controls cancer progression, a key consideration
for physicians in determining which treatment option to chose for women with
this devastating disease. The results are of key importance for the physician
and the patient because they show that not only is fulvestrant an effective
treatment for advanced breast cancer, but also that women can start to
experience the clinically recognised benefits of this therapy within three
months of commencing treatment.

A retrospective analysis of the combined data from over 850 women involved
in Studies 20 and 21 demonstrated that for fulvestrant, the median Time To
Response (TTR), a measure of how quickly a drug begins to have effect on the
cancer, was comparable to that of anastrozole (3.1 months and 2.99 months
respectively)(3). An additional comparison from a separate phase III clinical
trial, Study 25, showed that TTR was also comparable between fulvestrant and
tamoxifen(4). These data reinforce fulvestrant as a suitable therapy for
patients recurring or progressing on prior hormonal therapy for early or
advanced breast cancer.

The lead investigator of the retrospective analysis, Dr. David Dodwell,
Clinical Oncologist at the Cookridge Hospital, Leeds, clarified, "These data
mean that there is no suggestion that ‘Faslodex’ takes longer to work than
‘Arimidex.’ Therefore, clinicians can feel confident in prescribing the drug,
which is both highly effective and comparatively fast-acting, allowing women
with advanced breast cancer to benefit rapidly from this recently introduced
therapy."

The data from the two pivotal phase III trials analysed, Studies 20 and 21,
also formed the basis for fulvestrant approvals to date. Studies 20 and 21
compared the efficacy and tolerability of fulvestrant to anastrozole in the
treatment of hormone sensitive advanced breast cancer in postmenopausal women
who had previously been treated with anti-oestrogen therapy. The results of the
studies showed that:

- Fulvestrant was at least as effective as anastrozole with respect to Time
To Progression (TTP), Overall Response Rate (ORR) and Overall Survival
(OS).(1-2)

- Fulvestrant showed a durable response. The median Duration of Response
(DoR) was 16.7 months for fulvestrant and 13.7 months for anastrozole.(5)

- Fulvestrant is an effective and well-tolerated treatment without any of
the side effects commonly associated with chemotherapy, and is better tolerated
than anastrozole and tamoxifen.(1-2)

- Fulvestrant was associated with significantly fewer joint disorders
compared to anastrozole.(1-2)

With these data confirming fulvestrant as being as effective and as
rapidly-acting as anastrozole, which proved its superiority over tamoxifen in
both the adjuvant setting and in the first-line treatment of advanced breast
cancer, the treatment paradigm can be seen to be shifting significantly.
Physicians and patients now have an important novel treatment that is both
effective and well tolerated in their battle with breast cancer.

Professor Kurt Possinger, Head of the Oncology Department at Humboldt
University of Berlin, Germany confirmed, "For patients who recur after initial
diagnosis, efficacy, tolerability and assured compliance are key factors in
treatment choice. Taking these new data into consideration with what we already
knew about this unique therapy, it is clear that physicians should be
considering the use of ‘Faslodex’ as early as possible in the treatment of
advanced breast cancer. Having a treatment in your armoury against breast
cancer that is both fast acting and effective, but without the sometimes harsh
side-effects of other commonly used therapies, should provide physicians and
patients alike with the confidence that they have a strong ally in their fight
against this disease."

Further data from a recent survey of breast cancer patients has
demonstrated that fulvestrant’s unique form of administration - through a once
monthly 250mg intra-muscular injection - is popular among patients compared to
taking a once-a-day tablet. Nearly three quarters (74.5%) of patients surveyed
stated that they would prefer to receive their treatment through a monthly
injection if it resulted in greater efficacy and almost two thirds (61%) of
breast cancer patients would prefer this method of administration for their
treatment if it resulted in fewer hot flushes(6). Additionally, one third of
women (32%) said that they would be prepared to have a monthly injection if it
meant that they were more likely to comply with their treatment(6).

References

* The European Cancer Congress, Paris, France

1. C.K. Osborne, et al. Double-Blind, Randomized Trial Comparing the
Efficacy and Tolerability of Fulvestrant Versus Anastrozole in Postmenopausal
Women With Advanced Breast Cancer Progressing on Prior Endocrine Therapy:
Results of a North American Trial. Journal of Clinical Oncology 2002; 20(16)
3386-3395.

2. A. Howell, et al. Fulvestrant, Formerly ICI 182,780, Is as Effective as
Anastrozole in Postmenopausal Women With Advanced Breast Cancer Progressing
After Prior Endocrine Treatment. Journal of Clinical Oncology 2002; 20(16)
3396-3403.

3. D. Dodwell. Time to response - A comparison of fulvestrant with
anastrozole. ECCO 2005, Abs. 280

4. A. Howell et al. Comparison of fulvestrant versus tamoxifen for the
treatment of advanced breast cancer in postmenopausal women previously
untreated with endocrine therapy: a multinational, double-blind, randomized
trial. Journal of Clinical Oncology 2004;22:1605-1613.

5. J.F.R. Robertson, et al. Fulvestrant versus anastrozole for the
treatment of advanced breast carcinoma in postmenopausal women; A prospective
combined analysis of two multicentre trials. Cancer 2003; 98: 229-238

6. L. Fallowfield. Routes of administration in breast cancer: Preliminary
results from a patient survey. St. Gallen, 2005.

Notes to Editors

‘Faslodex’ is a trademark, the property of the AstraZeneca group of
companies.

‘Faslodex’ is indicated for the treatment of postmenopausal women with
receptor-positive locally advanced or metastatic breast cancer, for disease
recurrence or progression on or after therapy with an anti-oestrogen such as
tamoxifen. It has been launched in the USA since May 2002, and is also now
available in Brazil and over 25 countries in Europe.

‘Faslodex’ works differently to other anti-oestrogen agents for breast
cancer, in that it binds to the oestrogen receptor in the breast cancer cell,
and this interaction results in loss of the cellular oestrogen receptor
(down-regulation). ‘Faslodex’ attacks cancer cells that have grown resistant to
current anti-oestrogen treatment options. Thousands of women are diagnosed with
advanced breast cancer each year - advanced breast cancer is diagnosed when
cancer that is originally confined to the breast is found in other parts of the
body. More specifically, a woman is considered to have advanced disease when
breast cancer cells also form a tumour in places such as the lungs, liver or
bones. In locally advanced disease, the cancer involves spread to the tissues
surrounding the breast, such as underlying muscles or skin, but not to distant
organs. Extensive lymph node involvement is also counted as locally advanced
disease.

AstraZeneca continues its tradition of research excellence and innovation
in oncology that led to the development of its current anti-cancer therapies
including anastrozole (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.

‘ARIMIDEX’, ‘CASODEX’, ‘FASLODEX’, ‘NOLVADEX’, ‘ZOLADEX’, ‘TOMUDEX’, and
‘IRESSA’ are trademarks, the property of the AstraZeneca group of companies.

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 $21.4 billion
and leading positions in sales of gastrointestinal, cardiovascular,
respiratory, oncology, and neuroscience products. AstraZeneca is listed in the
Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information, please visit http://www.astrazenecapressoffice.com

SOURCE: AstraZeneca

CONTACT: Lynn Grant,
AstraZeneca,
Global PR Director,
+44-1625-517-406,
Lynn.Grant@Astrazeneca.com

Web site: http://www.astrazenecapressoffice.com