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Overall Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer. We previously reported prolonged progression-free survival and marginally prolonged overall survival among postmenopausal patients with hormone receptor-positive metastatic breast cancer who had been randomly assigned to receive the aromatase inhibitor anastrozole plus the selective estrogen-receptor down-regulator fulvestrant, as compared with anastrozole alone, as first-line therapy. We now report final survival (...) outcomes.We randomly assigned patients to receive either anastrozole or fulvestrant plus anastrozole. Randomization was stratified according to adjuvant tamoxifen use. Analysis of survival was performed by means of two-sided stratified log-rank tests and Cox regression. Efficacy and safety were compared between the two groups, both overall and in subgroups.Of 707 patients who had undergone randomization, 694 had data available for analysis. The combination-therapy group had 247 deaths among 349 women (71
evidence and guidance to answer their clinical questions. We have a large collection of systematic reviews, clinical guidelines, regulatory 2018 7. Prevention of repeated benign endometrial pathology in postmenopausal women with breast cancer and tamoxifen-induced endometrial pathology: A randomized trial comparing anastrozole and tamoxifen. 2016 8. Impact of age on the gynecologic adverse event (AE) profile of anastrozole (A) or tamoxifen (T) in the ATAC ('Arimidex', Tamoxifen, Alone or in Combination (...) premenopausal women: a Phase 1 randomized controlled trial. STUDY QUESTION: What are suitable doses of the aromatase inhibitor anastrozole (ATZ) and the progestin levonorgestrel (LNG), when delivered to the systemic circulation by an intravaginal ring (IVR), for further clinical development as a potential new therapy for the treatment of endometriosis? SUMMARY 2016 14. A randomised trial comparing two doses of the new selective aromatase inhibitor anastrozole (Arimidex) with megestrol acetate
Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant (...) disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised
Tualang honey adjunct with anastrozole improve parenchyma enhancement of breast tissue in breast cancer patients: A randomized controlled trial. To investigate whether the combination of anastrozole and Tualang honey (T honey) influences background parenchymal enhancement (BPE) in breast magnetic resonance imaging (MRI) of postmenopausal women with breast cancer.A total of 30 patients were recruited and randomly divided into control (anastrozole 1 mg daily) and intervention (anastrozole 1 mg (...) + T honey 20 g daily). The BPE of the contralateral breast before and six months following treatment was compared using the sign test.There was a decrease in BPE in 10% of the women (p = 0.317) who received only anastrozole, which resulted in a change of BPE category from moderate to mild. However, the combination of anastrozole and T honey evoked a decrease in BPE in 42% of the patients (p = 0.034).The combination of T honey and anastrozole maybe more efficacious than anastrozole alone
Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Aromatase inhibitors are a standard of care for hormone receptor-positive locally advanced or metastatic breast cancer. We investigated whether the selective oestrogen receptor degrader fulvestrant could improve progression-free survival compared with anastrozole in postmenopausal patients who had not received previous endocrine (...) intramuscular injection; on days 0, 14, 28, then every 28 days thereafter) or anastrozole (1 mg orally daily) using a computer-generated randomisation scheme. The primary endpoint was progression-free survival, determined by Response Evaluation Criteria in Solid Tumors version 1·1, intervention by surgery or radiotherapy because of disease deterioration, or death from any cause, assessed in the intention-to-treat population. Safety outcomes were assessed in all patients who received at least one dose
2016LancetControlled trial quality: predicted high
Fulvestrant 500 mg Versus Anastrozole 1 mg for the First-Line Treatment of Advanced Breast Cancer: Overall Survival Analysis From the Phase II FIRST Study To compare overall survival (OS) for fulvestrant 500 mg versus anastrozole as first-line endocrine therapy for advanced breast cancer.The Fulvestrant First-Line Study Comparing Endocrine Treatments (FIRST) was a phase II, randomized, open-label, multicenter trial. Postmenopausal women with estrogen receptor-positive, locally advanced (...) /metastatic breast cancer who had no previous therapy for advanced disease received either fulvestrant 500 mg (days 0, 14, 28, and every 28 days thereafter) or anastrozole 1 mg (daily). The primary end point (clinical benefit rate [72.5% and 67.0%]) and a follow-up analysis (median time to progression [23.4 months and 13.1 months]) have been reported previously for fulvestrant 500 mg and anastrozole, respectively. Subsequently, the protocol was amended to assess OS by unadjusted log-rank test after
Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial. Aromatase inhibitors effectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women. We assessed the efficacy and safety of the aromatase inhibitor anastrozole for prevention of breast cancer in postmenopausal women who are at high risk of the disease.Between Feb 2, 2003, and Jan 31, 2012 (...) , we recruited postmenopausal women aged 40-70 years from 18 countries into an international, double-blind, randomised placebo-controlled trial. To be eligible, women had to be at increased risk of breast cancer (judged on the basis of specific criteria). Eligible women were randomly assigned (1:1) by central computer allocation to receive 1 mg oral anastrozole or matching placebo every day for 5 years. Randomisation was stratified by country and was done with blocks (size six, eight, or ten). All
2014LancetControlled trial quality: predicted high
Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentr The optimum endocrine treatment for postmenopausal women with advanced hormone-receptor-positive breast cancer that has progressed on non-steroidal aromatase inhibitors (NSAIs) is unclear. The aim of the SoFEA trial was to assess a maximum (...) for at least 12 months or as first-line treatment for at least 6 months). Additionally, patients had to have adequate organ function and a WHO performance status of 0-2. Participants were randomly assigned (1:1:1) to receive fulvestrant (500 mg intramuscular injection on day 1, followed by 250 mg doses on days 15 and 29, and then every 28 days) plus daily oral anastrozole (1 mg); fulvestrant plus anastrozole-matched placebo; or daily oral exemestane (25 mg). Randomisation was done with computer-generated
Everolimus (Afinitor® or Votubia®) in combination with exemestane in postmenopausal women with oestrogen receptor positive, HER2- negative locally advanced or metastatic breast cancer who are refractory to letrozole or anastrozole Everolimus (Afinitor® or Votubia®) in combination with exemestane in postmenopausal women with oestrogen receptor positive, HER2- negative locally advanced or metastatic breast cancer who are refractory to letrozole or anastrozole Everolimus (Afinitor® or Votubia® (...) ) in combination with exemestane in postmenopausal women with oestrogen receptor positive, HER2- negative locally advanced or metastatic breast cancer who are refractory to letrozole or anastrozole Jeitler K, Semlitsch T, Nachtnebel A, von Minckwitz G Record Status This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database. Citation Jeitler K, Semlitsch T, Nachtnebel A, von Minckwitz G
Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial Aromatase inhibitors have shown increased efficacy compared with tamoxifen in postmenopausal early breast cancer. We aimed to assess the efficacy and safety of anastrozole versus tamoxifen in premenopausal women receiving goserelin for early breast cancer in the neoadjuvant setting.In this phase 3, randomised, double-blind, parallel-group (...) , multicentre study, we enrolled premenopausal women with oestrogen receptor (ER)-positive, HER2-negative, operable breast cancer with WHO performance status of 2 or lower. Patients were randomly assigned (1:1) to receive goserelin 3·6 mg/month plus either anastrozole 1 mg per day and tamoxifen placebo or tamoxifen 20 mg per day and anastrozole placebo for 24 weeks before surgery. Patients were randomised sequentially, stratified by centre, with randomisation codes. All study personnel were masked to study
Tamoxifen and anastrozole as a sequencing strategy: a randomized controlled trial in postmenopausal patients with endocrine-responsive early breast cancer from the Austrian Breast and Colorectal Cancer Study Group Anastrozole (ANA) alone delivers significant disease-free survival benefits over tamoxifen (TAM) monotherapy in postmenopausal women with early estrogen receptor-positive breast cancer. The ABCSG-8 (Austrian Breast and Colorectal Cancer Study Group 8) study is a large phase III
Cost-effectiveness study of clomiphene citrate versus anastrozole for inducing ovulation in infertile adult patients in a public hospital, La Raza in Mexico City Cost-effectiveness study of clomiphene citrate versus anastrozole for inducing ovulation in infertile adult patients in a public hospital, La Raza in Mexico City Cost-effectiveness study of clomiphene citrate versus anastrozole for inducing ovulation in infertile adult patients in a public hospital, La Raza in Mexico City Martinez (...) Nunez JM, Altagracia Martinez M, Rios C, Kravzov Jinich J, Hinojosa Cruz JC, Vital Reyes VS Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. CRD summary The objective was to evaluate the cost-effectiveness of clomiphene citrate versus anastrozole
Economic evaluation of anastrozole versus tamoxifen for early stage breast cancer in Singapore Economic evaluation of anastrozole versus tamoxifen for early stage breast cancer in Singapore Economic evaluation of anastrozole versus tamoxifen for early stage breast cancer in Singapore Shih V, Chan A, Xie F, Ko Y Record Status This is an economic evaluation that meets the criteria for inclusion on NHS EED. CRD summary The study estimated the cost-effectiveness postmenopausal women with early (...) stage breast cancer. The authors concluded that, although anastrozole had a higher drug acquisition cost, it was cost-effective for treating early stage breast cancer in Singapore based on effectiveness and utility data. The quality of the study methodology was good, with methods and results reported in detail. Given the scope of the study, the authors’ conclusions appear to be appropriate. Type of economic evaluation Cost-effectiveness analysis, cost-utility analysis Study objective The study
Combination anastrozole and fulvestrant in metastatic breast cancer. The aromatase inhibitor anastrozole inhibits estrogen synthesis. Fulvestrant binds and accelerates degradation of estrogen receptors. We hypothesized that these two agents in combination might be more effective than anastrozole alone in patients with hormone-receptor (HR)-positive metastatic breast cancer.Postmenopausal women with previously untreated metastatic disease were randomly assigned, in a 1:1 ratio, to receive either (...) 1 mg of anastrozole orally every day (group 1), with crossover to fulvestrant alone strongly encouraged if the disease progressed, or anastrozole and fulvestrant in combination (group 2). Patients were stratified according to prior or no prior receipt of adjuvant tamoxifen therapy. Fulvestrant was administered intramuscularly at a dose of 500 mg on day 1 and 250 mg on days 14 and 28 and monthly thereafter. The primary end point was progression-free survival, with overall survival designated
Trastuzumab plus anastrozole versus anastrozole alone for the treatment of postmenopausal women with human epidermal growth factor receptor 2-positive, hormone receptor-positive metastatic breast cancer TAnDEM is the first randomized phase III study to combine a hormonal agent and trastuzumab without chemotherapy as treatment for human epidermal growth factor receptor 2 (HER2)/hormone receptor-copositive metastatic breast cancer (MBC).Postmenopausal women with HER2/hormone receptor-copositive (...) MBC were randomly assigned to anastrozole (1 mg/d orally) with or without trastuzumab (4 mg/kg intravenous infusion on day 1, then 2 mg/kg every week) until progression. The primary end point was progression-free survival (PFS) in the intent-to-treat population. Results Overall, 103 patients received trastuzumab plus anastrozole; 104 received anastrozole alone. Patients in the trastuzumab plus anastrozole arm experienced significant improvements in PFS compared with patients receiving anastrozole
Comparing the cost of adjuvant anastrozole with the benefits of managing less patients with relapsed breast cancer Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.
Effects of anastrozole on cognitive performance in postmenopausal women: a randomised, double-blind chemoprevention trial (IBIS II) Mild cognitive impairments have been recorded in cross-sectional studies of women with breast cancer receiving endocrine treatment. More comprehensive studies were warranted because aromatase inhibitors are being used increasingly in both chemoprevention and adjuvant settings. We report findings from the cognitive subprotocol of the International Breast (...) Intervention Study (IBIS II), a double-blind placebo-controlled trial of anastrozole in postmenopausal women at high risk of developing breast cancer. We aimed to study and compare the effect of anastrozole versus placebo on memory and attention in these women.Between Jan 3, 2003, and Dec 21, 2005, participants were recruited into the cognitive subprotocol from five UK centres. Cognitive assessments were done before randomisation, at 6 months, and at 24 months. 227 of 249 women approached completed
Meta-analysis of trials comparing anastrozole and tamoxifen for adjuvant treatment of postmenopausal women with early breast cancer Untitled Document The CRD Databases will not be available from 08:00 BST on Friday 4th October until 08:00 BST on Monday 7th October for essential maintenance. We apologise for any inconvenience.
Cost utility analysis of early adjuvant letrozole or anastrozole versus tamoxifen in postmenopausal women with early invasive breast cancer: the UK perspective Cost utility analysis of early adjuvant letrozole or anastrozole versus tamoxifen in postmenopausal women with early invasive breast cancer: the UK perspective Cost utility analysis of early adjuvant letrozole or anastrozole versus tamoxifen in postmenopausal women with early invasive breast cancer: the UK perspective Karnon J, Delea T (...) in order to select the most cost-effective alternative. Concluding remarks: This study was adequately conducted, and, on the whole, was clearly and transparently reported. The conclusions reached by the authors reflected the scope of their analysis. Funding Funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. Bibliographic details Karnon J, Delea T, Barghout V. Cost utility analysis of early adjuvant letrozole or anastrozole versus tamoxifen in postmenopausal women with early invasive
Cost-utility of adjuvant hormone therapies with aromatase inhibitors in post-menopausal women with breast cancer: upfront anastrozole, sequential tamoxifen-exemestane and extended tamoxifen-letrozole Cost-utility of adjuvant hormone therapies with aromatase inhibitors in post-menopausal women with breast cancer: upfront anastrozole, sequential tamoxifen-exemestane and extended tamoxifen-letrozole Cost-utility of adjuvant hormone therapies with aromatase inhibitors in post-menopausal women (...) with breast cancer: upfront anastrozole, sequential tamoxifen-exemestane and extended tamoxifen-letrozole Skedgel C, Rayson D, Dewar R, Younis T Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The study examined three adjuvant hormonal