WILMINGTON, Del., Dec. 10 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)
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"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:
Presented at oral session 2 on Thursday 10th December 2009 at 3:30 CST. Abstract 23.
Presented at oral session 2 on Thursday 10th December 2009 at 3:45 CST. Abstract 24.
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.
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(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.
-- 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)