San Antonio Breast Cancer Symposium, California (ots/PRNewswire) -
- New Results From Two Phase II Trials Demonstrate Efficacy and
Tolerability for 'Faslodex' Following Progression on aromatase
Inhibitor Therapy - Webcast of Data Available on
Important new data from two studies presented at the 27th Annual
San Antonio Breast Cancer Symposium (SABCS) in the USA, suggest that
'Faslodex' (fulvestrant) is an effective and well tolerated treatment
for postmenopausal women with advanced breast cancer who have
experienced disease progression on aromatase inhibitor therapy.
The first of the two studies (1) was conducted by Dr Lucien Perey,
from The Swiss Group for Clinical Cancer Research (SAKK), in Bern,
Switzerland. In this phase II trial, 67 postmenopausal women with
advanced breast cancer whose disease had progressed after previous
treatment with both tamoxifen and then an aromatase inhibitor were
assessed. The results showed 28% of patients achieved a clinical
benefit (PR+SD>/= 24 weeks (NOTE A)).
(NOTE A) PR+SD>/=24 weeks is defined as where the clinician has
observed a clinical response to treatment (i.e. the tumour has been
shrunk in size - a partial response [PR]) and where the disease has
been stabilised for at least 24 weeks [SD>/=24 weeks]
This finding is further supported by data from the second study
(2), conducted by Dr James Ingle, from the Mayo Clinic in Minnesota,
USA. In this phase II trial, 77 postmenopausal women with advanced
breast cancer whose disease progressed following treatment with an
aromatase inhibitor and, at most, one additional hormonal agent, were
assessed. These data showed that a similar clinical benefit rate
(PR+SD>/= 24 weeks (NOTE A)) was observed in almost one third (29%)
of the patients in the trial. These data also showed that 'Faslodex'
was well tolerated, with only mild-to-moderate side effects being
reported and no patients withdrawing due to adverse events.
"The data from these two studies represent an important finding
since they suggest that patients with advanced breast cancer who have
progressed on aromatase inhibitor therapy have an additional
effective and well tolerated hormonal treatment option at their
disposal, which further delays the need to use chemotherapy."
commented Dr Perey. "Significantly, what is also key here is the fact
that both studies have shown a similar level of efficacy and
tolerability for patients who have received prior aromatase inhibitor
therapy and who were then treated with 'Faslodex'."
Previous data, which form the basis of its current approved
indication, have confirmed that 'Faslodex' is effective and well
tolerated in postmenopausal women with advanced breast cancer whose
disease has progressed following treatment with tamoxifen (3).
However, as aromatase inhibitors such as 'Arimidex' (anastrozole)
have now demonstrated their superiority over tamoxifen in both the
adjuvant setting and as first line therapy for advanced breast
cancer, the changing treatment paradigm means that the efficacy and
tolerability of 'Faslodex' following aromatase inhibitor therapy has
become an important question for clinicians and patients alike. These
new data therefore represent an important development that will be
eagerly welcomed by the oncology community, since they suggest that
women who have received prior non-steroidal aromatase inhibitor
therapy now have an additional effective and well-tolerated hormonal
therapy with which to fight their disease, extending the benefits of
hormonal therapy and delaying the need for the more aggressive
In order to confirm findings from studies such as these,
AstraZeneca are undertaking two large-scale international, randomised
controlled trials of 'Faslodex' following aromatase inhibitor
therapy, known as the EFECT trial (Evaluation of Fulvestrant versus
Exemestane Clinical Trial) and the SOFEA trial (Study of 'Faslodex',
Exemestane and 'Arimidex'), both of which are expected to confirm the
efficacy and tolerability of 'Faslodex' in this important setting.
The possibility of extending the benefits of 'Faslodex' treatment
to all women with advanced disease at the first opportunity is also
being explored in more detail. Additional data presented at the SABCS
congress have shown efficacy for 'Faslodex' as a first-line therapy
for postmenopausal patients with advanced breast cancer. These data
come from a study conducted by Professor John Robertson at Nottingham
City Hospital in the UK (4), which assessed 30 patients with
previously untreated advanced breast cancer who received 'Faslodex'
as their initial treatment. The results show continued and maintained
downregulation of oestrogen receptor levels for a sustained period
(six months). Patients treated with 'Faslodex' who had evaluable
disease at six months had a clinical benefit rate of 79% (PR+SD>/= 24
weeks (NOTE A)). Importantly, the data from the study also showed
that the oestrogen receptor was present at the time of disease
progression in all patients, supporting the use of further hormonal
therapies following 'Faslodex' treatment. This is significant since
it means that the benefits of well-tolerated hormonal therapy may be
extended, delaying the need to resort to chemotherapy with its well
recognised side effects.
"These data from this phase II trial highlight the potential of
Faslodex as an effective first line treatment for postmenopausal
women with locally advanced and advanced breast cancer." commented
Professor Robertson. "These data add to the increasingly extensive
data base which suggest that 'Faslodex' is both a very effective and
arguably the best tolerated hormonal therapy available."
For further details on this and other key breast cancer data from
SABCS, please visit www.astrazenecapressoffice.com from 07.00 hrs CST
/ 13.00 hrs GMT on Saturday December 11th to view webcast
presentations from leading breast cancer specialists.
'Faslodex' and 'Arimidex' are trademarks, the properties of the
AstraZeneca group of companies.
Notes to editors
'Faslodex' is a novel therapy, the first of a new type, with a
unique mode of action. 'Faslodex' has a long duration of response and
does not limit subsequent treatment options, therefore extending the
benefits of well tolerated hormonal therapy. In clinical trials,
'Faslodex' was well tolerated and was associated with significantly
less joint pains (arthralgia) than the aromatase inhibitor
anastrazole3 - arthralgia being a side effect associated with the
aromatase inhibitor class of drugs. In a separate trial, 'Faslodex'
was associated with fewer hot flushes than tamoxifen (5).
'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' is a sustained release formulation that is administered
once monthly as an intramuscular injection, which may offer
compliance benefits and since it is an hormonal treatment, it does
not cause the side effects commonly associated with chemotherapy.
'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
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
Since AstraZeneca released its first anti-cancer drug, 'Nolvadex'
(tamoxifen), more than 25 years ago, investment in research has led
to the discovery of new anti-cancer agents and other innovative
therapeutic strategies which give AstraZeneca an extensive portfolio
of developmental agents to complement the established product range.
AstraZeneca's product range for breast cancer, include the following:
- 1973: Tamoxifen (NOLVADEX (TM)): a well-tolerated, oral
anti-oestrogen. Now the most widely prescribed agent for the
treatment of all stages of breast cancer worldwide.
- 1990: Goserelin (ZOLADEX (TM)): a well-tolerated and
widely-prescribed LHRH analogue, administered by sub-cutaneous
injection every 28 days, which reduces sex hormone production.
Goserelin is now used in the treatment of early and advanced breast
cancer in pre-menopausal women with hormone-sensitive disease.
- 1995: Anastrozole (ARIMIDEX (TM)): the first of a new class of
drugs - selective 'aromatase inhibitors' - now widely used in the
treatment of early and advanced breast cancer in post-menopausal
women with hormone sensitive disease.
- 2002: Fulvestrant (FASLODEX (TM)): a new type of breast cancer
therapy (an oestrogen receptor antagonist without known agonist
effects). It is now available in the USA and Brazil for the treatment
of hormone receptor positive metastatic breast cancer in
postmenopausal women with disease progression following antioestrogen
therapy such as tamoxifen. Approved in Europe in 2004.
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 US$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.
1) Perey LR et al. Fulvestrant as hormonal treatment in
postmenopausal patients with advanced breast cancer progressing after
treatment with tamoxifen and aromatase inhibitors: update of a phase
II SAKK trial. SABCS 2004, abs.
2) Ingle JN et al. Evaluation of fulvestrant in women with
advanced breast cancer progression on prior aromatase inhibitor
therapy: a phase II trial of the North Central Cancer Treatment
Group. SABCS 2004, abs.
3) Robertson JFR 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;
4) Robertson JFR et al. Clinical efficacy of fulvestrant and
effects on estrogen receptor levels during first-line endocrine
treatment of patients with advanced breast cancer. SABCS 2004, abs.
5) 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, randomised trial. J Clin Oncol. 2004 May
ots Originaltext: AstraZeneca
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