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Fulvestrant is a highly active systemic therapy in patients with metastatic hormone receptor positive breast cancer. Preclinical work suggested potential synergy of fulvestrant in combination with aromatase inhibitor therapy and delayed development of endocrine resistance. The purpose of this meta-analysis is to evaluate the effectiveness of fulvestrant plus anastrozole, compared to anastrozole alone, as first line treatment of postmenopausal stage IV hormone receptor positive, HER2-negative breast cancer. The literature search was performed using PubMed, Google Scholar, Embase, ASCO, and ESMO to search for abstracts published during the last 10 years using relevant keywords. Two prospective randomized clinical trials were found to fulfill the search criteria for combination of anastrozole plus fulvestrant versus anastrozole alone. Meta-estimates were calculated by combining study estimates using the DerSimonian and Laird random effects model. The linear mixed-effects model was used to generate 95 % prediction intervals (PIs) for study-specific hazard and odds ratios. Pooled hazard ratio for progression-free survival is 0.88 (95 % CI 0.72-1.09, 95 % PI 0.65-1.21), overall survival 0.88 (95 % CI 0.72-1.08, 95 % PI 0.68-1.14) and pooled odds ratio for response rate is 1.13 (95 % CI 0.79-1.63, 95 % PI 0.78-1.65). A non-significant trend was observed with anastrozole plus fulvestrant being only marginally better than anastrozole alone in the endpoints of: progression-free survival, overall survival, and response rates. Based on these data, there is not solid evidence that the addition of fulvestrant at a dose of 250 mg monthly is better than anastrozole alone as first line therapy in women with postmenopausal hormone receptor positive breast cancer.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

OBJECTIVE: Most patients with advanced breast cancer experience resistance to endocrine treatment and eventual disease progression. This meta-analysis was designed to compare the efficacy and tolerability of fulvestrant 250 mg with anastrozole 1mg in postmenopausal women with advanced breast cancer.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

This review concluded that participants who changed to anastrozole after 2 to 3 years' treatment with tamoxifen had significantly fewer disease recurrences than those remaining on tamoxifen for 5 years. Survival was also significantly improved. Poor reporting of review methodology and the lack of knowledge about the quality of the trials mean that the authors' conclusions should be interpreted with caution.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2006

This review found that anastrozole was more effective than tamoxifen in adjuvant hormonal treatment of early breast cancer in postmenopausal women, and that aromatase inhibitors should be the initial hormone therapy for its treatment. However, the review did not provide direct evidence for any treatment approach, and this, along with review methodological limitations, imply cautious interpretation of the results.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2008

In upfront therapy after breast surgery, aromatase inhibitors are taken for five years. The aromatase inhibitors anastrozole and letrozole have been approved for use in upfront therapy in Germany.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: July 27, 2017

In the "switch" treatment approach, the patient uses tamoxifen for two to three years, and then switches to an aromatase inhibitor. This anti-estrogen treatment lasts for five years in total. The decision regarding whether or not to switch to an aromatase inhibitor is made after the treatment with tamoxifen. The aromatase inhibitors anastrozole and exemestane have been approved for this treatment approach in Germany.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: July 27, 2017

Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.

National Academies Press (US).

Version: March 23, 2012

We reviewed the evidence concerning the effectiveness and safety of fulvestrant in prolonging time without further progression of cancer in women with advanced hormone‐sensitive breast cancer. We found nine studies testing whether or not fulvestrant is superior to other treatment options.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2017

Review question: Cochrane authors examined the evidence about aromatase inhibitors for subfertile women with polycystic ovary syndrome (PCOS).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Breast cancer is the most common cancer affecting women in the UK. Tamoxifen (TAM) is considered as the standard of care for many women with oestrogen receptor positive breast cancer. However, wide variability in the response of individuals to drugs at the same doses may occur, which may be a result of interindividual genetic differences (pharmacogenetics). TAM is known to be metabolised to its active metabolites N-desmethyl TAM and 4-hydroxytamoxifen by a number of CYP450 enzymes, including CYP2D6, CYP3A4, CYP2C9, CYP2C19 and CYP2B6. N-desmethyl TAM is further metabolised to endoxifen by CYP2D6. Endoxifen, which is also formed via the action of CYP2D6, is 30- to 100-fold more potent than TAM in suppressing oestrogen-dependent cell proliferation, and is considered an entity responsible for significant pharmacological effects of TAM. Thus, an association between the cytochrome P450 2D6 (CYP2D6) genotype and phenotype (expected drug effects) is believed to exist and it has been postulated that CYP2D6 testing may play a role in optimising an individual's adjuvant hormonal treatment.

Health Technology Assessment - NIHR Journals Library.

Version: September 2011

Breast cancer is the uncontrolled, abnormal growth of malignant breast tissue affecting predominantly women. Metastatic breast cancer (mBC) is an advanced stage of the disease when the disease has spread beyond the original organ. Hormone receptor status and human epidermal growth factor 2 (HER2) status are two predictive factors that are taken into consideration when estimating the prognosis of patients with breast cancer.

Health Technology Assessment - NIHR Journals Library.

Version: December 2011

Aromatase inhibitors (AIs) are proposed for the adjuvant treatment of oestrogen receptor-positive early breast cancer in postmenopausal women in three different indications: (1) instead of the current anti-oestrogen treatment, tamoxifen, for 5 years ('primary adjuvant'); (2) instead of tamoxifen for 2–3 years of an adjuvant programme, implemented opportunistically after a woman survives disease free for a period on tamoxifen ('unplanned switching strategy'), or planned from the time of surgery ('planned sequence strategy'); (3) for 3–5 years in women who are disease free following 5 years of tamoxifen: this is known as an 'extended adjuvant' strategy. The three AIs and their licensed indications are (1) anastrozole (primary adjuvant), (2) letrozole (primary adjuvant, extended adjuvant) and, (3) exemestane (unplanned switching).

NIHR Health Technology Assessment programme: Executive Summaries - NIHR Journals Library.

Version: 2007

Advanced (or metastatic) breast cancer is cancer that has spread beyond the breast and regional lymph node areas. Breast cancer can progress to metastatic disease despite the person undergoing a range of therapies given after initial treatment, such as surgery, chemotherapy or radiation therapy. Metastatic breast cancer is treatable but it is not curable. Most breast cancer is sensitive to the female hormone oestrogen. Sensitive cancer cells need oestrogen to stay alive and removal of oestrogen from the body, or stopping any circulating oestrogen getting to the cancer cells, is very effective treatment for hormone‐sensitive breast cancers. Endocrine (hormonal) therapy removes the influence of oestrogen on breast cancer cells. Hormonal treatments for advanced breast cancer include tamoxifen, the progestins megestrol acetate and medroxyprogesterone acetate, and aromatase inhibitors (AIs). AIs reduce the body's ability to make (synthesise) oestrogen and have tumour‐regressing effects. The AIs in current clinical use include anastrozole, exemestane, and letrozole.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Breast cancer is the most common cancer for women in England and Wales, with about 37,000 new cases diagnosed and 11,000 deaths recorded in England and Wales each year. In men breast cancer is rare, with about 270 cases diagnosed, and 70 deaths in England and Wales each year. Of these new cases in women and men, around 10% are diagnosed in the advanced stages, when the tumour has spread significantly within the breast or to other organs of the body. In addition, there is a significant number of women who have been previously treated with curative intent who subsequently develop either a local recurrence or metastases. Over recent years there have been important developments in the investigation and management of these patients including new chemotherapy, and biological and hormonal agents. There is some evidence of practice variation across the country and of patchy availability of certain treatments and procedures. A clinical guideline will help to address these issues and offer guidance on best practice.

NICE Clinical Guidelines - National Collaborating Centre for Cancer (UK).

Version: February 2009

In breast cancer, new, malignant tissue starts growing in a mammary gland. If the cancer remains within a limited area around the breast and doesn't spread to other parts of the body (metastasis), it is referred to as early-stage breast cancer. Some of the breast lymph nodes may also be affected.

Informed Health Online [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: July 27, 2017

Breast cancer is the uncontrolled, abnormal growth of malignant breast tissue affecting predominantly women. Metastatic breast cancer (mBC) is an advanced stage of the disease when the disease has spread beyond the original organ.

NIHR Health Technology Assessment programme: Executive Summaries - NIHR Journals Library.

Version: 2011

Expert-reviewed information summary about the treatment of ductal carcinoma in situ, lobular carcinoma in situ, and invasive breast cancer.

PDQ Cancer Information Summaries [Internet] - National Cancer Institute (US).

Version: October 13, 2017

This guideline offers best practice advice on assisting people of reproductive age who have problems conceiving.

NICE Clinical Guidelines - National Collaborating Centre for Women’s and Children’s Health (UK).

Version: February 2013

Tumours characterised by the presence of the HER2 protein are found in about one in five women with metastatic breast cancer. These tend to be more aggressive and the prognosis and choice of treatment are affected. Trastuzumab (Herceptin®) is a targeted biological drug (a monoclonal antibody) that attaches to the HER2 protein, blocking the growth of malignant cells.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2014

Expert-reviewed information summary about factors that may increase the risk of developing breast cancer and about research aimed at the prevention of this disease.

PDQ Cancer Information Summaries [Internet] - National Cancer Institute (US).

Version: August 18, 2017

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