Phase III CONFIRM Study Shows Faslodex (fulvestrant) Injection 500 mg May Delay Time of Disease Progression Over 250-mg Dose in Postmenopausal Women With Hormone Receptor-Positive Advanced Breast Cancer
WILMINGTON, Del., Dec. 10 /PRNewswire-FirstCall/ -- AstraZeneca
(NYSE: AZN) today announced that data from a
Phase III study of postmenopausal women with hormone
receptor-positive advanced breast cancer presented at the San
Antonio Breast Cancer Symposium (Abstract 25) showed treatment with
fulvestrant (FASLODEX) 500 mg reduced the risk of disease
progression (assessed as time to progression (TTP)) by 20% (HR
0.80; 95% CI 0.68-0.94, p=0.006) when compared with fulvestrant 250
mg, the dose currently approved by the Food and Drug Administration
(FDA). CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic
breast cancer) a double-blind, double-dummy study, evaluated the
efficacy of fulvestrant 500 mg/month (n=362) compared with
fulvestrant 250 mg/month (n=374) to treat postmenopausal women with
hormone receptor-positive metastatic breast cancer who have
progressed or recurred following prior endocrine therapy.(i)
(Logo: http://www.newscom.com/cgi-bin/prnh/20091027/PH99766LOGO
)
"Findings from CONFIRM provide additional data showing that
increasing the dose of fulvestrant from 250 mg to 500 mg may
improve the effectiveness of a currently available treatment option
to help maintain disease control longer -- a primary objective of
treatment for women with metastatic breast cancer," said Dr. Angelo
Di Leo, M.D., Ph.D, Head of Sandro Pitigliani Medical Oncology
Unit, Hospital of Prato, Italy, and CONFIRM principal
investigator.
Patients were randomized to receive either fulvestrant 500 mg (2
x 250 mg intramuscular injections) or fulvestrant 250 mg/month on
days 0, 14 and 28, followed by 500 mg every 28 days thereafter. The
primary objective was to compare the efficacy, as measured by TTP,
of fulvestrant 500 mg with the approved 250-mg regimen. Secondary
objectives included: objective response rate, clinical benefit rate
(complete or partial response or stable disease lasting greater
than or equal to 24 weeks), duration of clinical benefit, overall
survival and quality of life. Safety and tolerability were also
assessed.(i)
The CONFIRM Study showed fulvestrant 500 mg significantly
prolonged time to progression compared to fulvestrant 250 mg, with
a median TTP of 6.5 months at 500 mg dose vs. a median TTP of 5.5
months with 250 mg dose (HR 0.80; p=0.006). The study also showed a
non-significant 16% reduction in the risk of death for patients
receiving fulvestrant 500 mg compared with fulvestrant 250 mg (HR
0.84; 95% CI: 0.69, 1.03, p=0.091). The objective response rates
were similar, 13.8% at 500 mg and 14.6% at 250 mg (p= 0.795).
Clinical benefit rate was 45.6% vs. 39.6% for the 500 mg versus 250
mg arms; odds ratio 1.28 [95% CI 0.95, 1.71]; p=0.1). Median
duration of clinical benefit was 16.6 months for fulvestrant 500 mg
compared with 13.9 months for fulvestrant 250 mg. The safety
profile was comparable between the two groups: no new safety
concerns were identified with the 500 mg dose. The most common side
effects included nausea, bone pain, back pain and injection site
pain.(i)
About FASLODEX® (fulvestrant) at SABCS 2009
Two other abstracts for FASLODEX were presented at SABCS 2009:
-- First Results from FACT - An Open-Label, Randomized Phase III Study
Investigating Loading Dose of Fulvestrant Combined with Anastrozole
Versus Anastrozole at First Relapse in Hormone Receptor Positive
Breast Cancer.(ii)
Presented at oral session 2 on Thursday 10th December 2009 at
3:30 CST. Abstract 23.
-- Tumor Biomarker Changes Following Pre-Surgical Treatment with 500 mg
Fulvestrant Plus Anastrozole Versus 500 mg Fulvestrant alone and 1 mg
Anastrozole alone.(iii)
Presented at oral session 2 on Thursday 10th December 2009 at
3:45 CST. Abstract 24.
About CONFIRM
CONFIRM (COmparisoN of FASLODEX In Recurrent or Metastatic
breast cancer) is a Phase III, randomized, double-blind,
parallel-group, multi-center trial comparing fulvestrant 500 mg
(n=362) and 250 mg (n=374) in postmenopausal women with estrogen
receptor-positive advanced breast cancer, failing on prior
endocrine therapy (antiestrogen or aromatase inhibitor). Eligible
patients were randomized 1:1 to fulvestrant 500 mg or 250 mg, and
assessed for tumor progression every 12 weeks. The primary
objective was to compare the efficacy of both treatment groups in
terms of time to progression (TTP). Secondary objectives included:
objective response rate (ORR), clinical benefit rate (CBR; complete
or partial response or stable disease lasting greater than or equal
to 24 weeks), duration of clinical benefit (DoCB), overall survival
and quality of life (QoL). Safety and tolerability were also
assessed.(i)
Important Information About FASLODEX® (fulvestrant)
Injection
FASLODEX is indicated for the treatment of hormone
receptor-positive metastatic breast cancer in postmenopausal women
whose disease has returned or progressed following antiestrogen
therapy.
Important Safety Information About FASLODEX
Prescription FASLODEX is only for postmenopausal women. Do not
take FASLODEX if you are pregnant and do not become pregnant while
taking FASLODEX because it may harm your unborn child. (See
WARNINGS and CONTRAINDICATIONS sections of full Prescribing
Information.)
Because FASLODEX is administered intramuscularly, it should not
be used in patients with certain blood disorders or in patients
receiving anticoagulants (sometimes called blood thinners, for
example, warfarin).
In clinical studies, the most commonly reported side effects
were nausea, vomiting, constipation, diarrhea, abdominal pain,
headache, back pain, hot flashes, sore throat, and injection site
reactions with mild, transient pain and inflammation.
Please see full Prescribing Information. For more information,
visit FASLODEX.com.
Important Information About ARIMIDEX® Tablets
ARIMIDEX is approved for adjuvant treatment (treatment following
surgery with or without radiation) of postmenopausal women with
hormone receptor-positive early breast cancer.
ARIMIDEX is approved for the initial treatment of postmenopausal
women with hormone receptor-positive or hormone receptor-unknown
locally advanced or metastatic breast cancer and for the treatment
of postmenopausal women with advanced breast cancer that has
progressed following treatment with tamoxifen. Patients with
hormone receptor-negative disease and patients who did not
previously respond to tamoxifen therapy rarely responded to
ARIMIDEX.
Important Safety Information About ARIMIDEX
Prescription ARIMIDEX is only for postmenopausal women. ARIMIDEX
should not be taken if you are pregnant because it may harm your
unborn child. Based on information from a study in patients with
early breast cancer, women with a history of blockages in heart
arteries (ischemic heart disease) who take ARIMIDEX may have a
slight increase in this type of heart disease compared to similar
patients who take tamoxifen.
ARIMIDEX can cause bone softening/weakening (osteoporosis)
increasing the chance of fractures. In a clinical study in early
breast cancer, there were more fractures (including fractures of
the spine, hip, and wrist) with ARIMIDEX (10%) than with tamoxifen
(7%).
In a clinical study in early breast cancer, some patients taking
ARIMIDEX had an increase in cholesterol. Skin reactions, allergic
reactions, and changes in blood tests of liver function have also
been reported.
In the early breast cancer clinical trial, the most common side
effects seen with ARIMIDEX include hot flashes, joint symptoms
(including arthritis and arthralgia), weakness, mood changes, pain,
back pain, sore throat, nausea and vomiting, rash, depression, high
blood pressure, osteoporosis, fractures, swelling of arms/legs,
insomnia, and headache.
In advanced breast cancer trials, the most common side effects
seen with ARIMIDEX versus tamoxifen include hot flashes, nausea,
decreased energy and weakness, pain, back pain, headache, bone
pain, increased cough, shortness of breath, sore throat, and
swelling of arms and legs. Joint pain/stiffness has been reported
in association with the use of ARIMIDEX.
ARIMIDEX should not be taken with tamoxifen or
estrogen-containing therapies.
Please see full Prescribing Information. For more information,
visit ARIMIDEX.com.
About AstraZeneca
AstraZeneca is engaged in the research, development,
manufacturing and marketing of meaningful prescription medicines
and in the supply of healthcare services. AstraZeneca is one of the
world's leading pharmaceutical companies with global healthcare
sales of $31.6 billion and is a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory, oncology, and infectious
disease medicines. In the United States, AstraZeneca is a $13.5
billion dollar healthcare business.
For more information about AstraZeneca in the US or our
AZ&Me(TM) Prescription Savings programs, please visit:
www.astrazeneca-us.com.
(i) Di Leo A, Jerusalem G, Petruzelka L et al. CONFIRM: Phase
III, randomized, parallel-group trial comparing fulvestrant 250 mg
vs. fulvestrant 500 mg in postmenopausal women with oestrogen
receptor-positive advanced breast cancer. San Antonio Breast Cancer
Symposium 2009. Oral session 2 on Thursday 10th December 2009 at
16.00 PST. Abstract 25.
(ii) Bergh J, Jonsson PE, Lidbrink E et al. First results from
FACT -- An open-label, randomized phase III study investigating
loading dose of fulvestrant combined with anastrozole versus
anastrozole at first relapse in hormone receptor positive breast
cancer. San Antonio Breast Cancer Symposium 2009. Oral session 2 on
Thursday 10th December 2009 at 15.30 PST. Abstract 23.
(iii) Robertson JFR, Dixon JM, Sibbering DM et al. Tumor
Biomarker Changes Following Pre-Surgical Treatment with 500Mg
Fulvestrant Plus Anastrozole Versus 500Mg Fulvestrant alone and 1Mg
Anastrozole alone. San Antonio Breast Cancer Symposium 2009. Oral
session 2 on Thursday 10th December 2009 at 15.45 PST. Abstract
23.
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Source: AstraZeneca
CONTACT: Media Inquiries, Blair Hains of AstraZeneca,
office,
+1-302-885-1813, or mobile, +1-302-252-1586
Web Site: http://www.astrazeneca-us.com/
Posted: December 2009
