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Anastrozole

A Review of its Use in Postmenopausal Women with Early-Stage Breast Cancer

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Summary

Abstract

Anastrozole (Arimidex®) is an aromatase inhibitor approved in the EU, the US and in other countries worldwide for use as an adjuvant treatment in postmenopausal women with early-stage, hormone receptor-positive breast cancer. It is also approved in the EU and other countries worldwide for continuing adjuvant treatment in women who have already had 2–3 years of adjuvant tamoxifen treatment for breast cancer.

Anastrozole is an effective primary adjuvant treatment for postmenopausal women with early-stage breast cancer. In patients with hormone receptor-positive tumours, 5 years of anastrozole treatment was more efficacious in reducing breast cancer recurrence than 5 years of tamoxifen, both in a head-to-head comparison and in switching trials when given after 2–3 years of tamoxifen treatment. The treatment benefits have now been shown to extend to 100 months following breast surgery. To date, overall survival was better in anastrozole than tamoxifen recipients in one switching trial and in a meta-analysis of three switching trials. There was no increased benefit in health-related quality of life with anastrozoleover tamoxifen. In women who had received 5 years of tamoxifen treatment, continuation of treatment with anastrozole further reduced the risk of breast cancer recurrence. Ongoing head-to-head trials against other third-generation aromatase inhibitors will provide data as to its relative efficacy against these agents.

Anastrozole is a generally well tolerated treatment for early-stage breast cancer. Like other aromatase inhibitors, its most important adverse effect was an increased risk of bone fractures, which for anastrozole was restricted to the treatment period. It is still unclear whether primary adjuvant treatment extended beyond 5 years is of benefit and whether primary adjuvant treatment with anastrozole for 5 years is preferable to switching to anastrozole after 2–3 years of tamoxifen treatment. However, the evidence to date establishes anastrozole as a valuable adjuvant and extended adjuvant treatment for postmenopausal women with hormone receptor-positive, early-stage breast cancer.

Pharmacological Properties

Anastrozole is a benzyltriazole derivative that reduces estrogen synthesis by binding competitively to the haem group of the cytochrome P450 unit of aromatase. It is a potent, selective aromatase inhibitor and has minimal or no effects on adrenal steroid hormones. In healthy postmenopausal women, multiple doses of anastrozole 1 mg/day led to prolonged suppression of plasma estradiol by ≥80% from baseline levels. In postmenopausal women with advanced breast cancer, plasma and tumour tissue estradiol levels were reduced from baseline levels by ≈90%. In a large clinical trial, after 12 and 24 months of follow-up, anastrozole was associated with decreased hip and lumbar spine bone mineral density, and an increase in serum cholesterol levels. In contrast with tamoxifen, after 5 years’ treatment there was no increase in endometrial thickening with anastrozole.

Anastrozole has linear pharmacokinetics. It is metabolized primarily in the liver, with a plasma elimination half-life of 40–50 hours, indicating that once-daily administration is adequate. In vitro and clinical studies indicate that drug-drug interactions are unlikely to occur between anastrozole and drugs metabolized by hepatic cytochrome P450 enzymes. In patients with breast cancer, there were no clinically important interactions between anastrozole and tamoxifen or its metabolite, N-desmethyltamoxifen.

Therapeutic Efficacy

The ATAC (Arimidex®, Tamoxifen, Alone or in Combination) randomized, double-blind trial compared the efficacy of anastrozole as a primary adjuvant treatment for early-stage breast cancer in postmenopausal women with that of tamoxifen. Anastrozole was consistently more efficacious than tamoxifen according to both primary and secondary endpoints at 3-year, 5-year and 100-month (median) follow-ups. At the 100-month follow-up, for disease-free survival (primary endpoint), the hazard ratio for anastrozole versus tamoxifen was 0.85 (95% CI 0.76, 0.94) in the hormone receptor-positive population, representing a 4.1% absolute difference in the event rate. Three randomized, open-label, multicentre trials evaluated continuous adjuvant tamoxifen treatment for 5 years versus switching from tamoxifen to anastrozole after 2–3 years of tamoxifen treatment. In patients who were switched to anastrozole, the odds of experiencing breast cancer recurrence, cancer in the contralateral breast or death were approximately one-third lower than for those continuing tamoxifen. In a separate trial designed to evaluate 5 years of tamoxifen treatment followed by extended treatment with anastrozole 1 mg/day versus no extended treatment, patients receiving extended anastrozole treatment had fewer recurrences than patients who received no extended treatment. The greatest benefit was a significant reduction in the incidence of distant recurrences (4.1% vs 7.5%).

Tolerability

In the ATAC trial, anastrozole was generally well tolerated when used as the primary adjuvant treatment in early-stage breast cancer. Patients in the anastrozole group had significantly fewer treatment-related adverse events, serious treatment-related adverse events and withdrawals from treatment because of adverse events than tamoxifen recipients. In anastrozole recipients, osteopenia/osteoporosis, arthralgia, fractures, hypertension, hypercholesterolaemia, diarrhoea and paraesthesiae were significantly more common than in tamoxifen recipients. Gynaecological events, such as hot flushes, vaginal discharge, vaginal bleeding, endometrial cancer and hysterectomy, were significantly more common with tamoxifen, as were urinary tract infections, muscle cramps, anaemia, venous thrombosis, deep vein thrombosis and ischaemic cerebrovascular events. Tolerability findings from the switching trials were consistent with these findings from the ATAC trial.

Pharmacoeconomic Considerations

Several studies have used the ATAC trial data to estimate the cost utility of anastrozole. When compared with tamoxifen, from the perspective of the health-funding systems from four countries, anastrozole was a cost-effective treatment for early-stage, hormone receptor-positive breast cancer. Incremental costs per quality-adjusted life-year gained were well below accepted cost-effectiveness thresholds for each economic environment when costs and outcomes were modelled over ≥20-year time horizons.

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Notes

  1. The use of trade names is for product identification purposes only and does not imply endorsement.

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Authors and Affiliations

  1. Wolters Kluwer Health ¦ Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, Auckland, 0754, New Zealand

    Mark Sanford & Greg L. Plosker

  2. Wolters Kluwer Health, Conshohocken, Pennsylvania, USA

    Mark Sanford & Greg L. Plosker

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Correspondence to Mark Sanford.

Additional information

Various sections of the manuscript reviewed by: M. Baum, Department of Surgery, University College London, London, UK; J. Cuzick, Cancer Research UK, Centre for Epidemiology, Mathematics and Statistics, Wolfson Institute of Preventive Medicine, London, UK; A. Howell, Cancer Research UK Department of Medical Oncology, Christie Hospital National Health Service Foundation Trust, Manchester, UK; Y. Hozumi, Division of Breast and General Surgery, Jichi Medical University, Tochigi, Japan; P. Lonning, Department of Oncology, Institute of Medicine, University of Bergen, Bergen, Norway; N. McCarthy, Division of Medical Oncology, Royal Brisbane and Women’s Hospital, Brisbane, Queensland, Australia.

Data Selection

Sources: Medical literature published in any language since 1980 on ‘anastrozole’, identified using MEDLINE and EMBASE, supplemented by AdisBase (a proprietary database of Wolters Kluwer Health | Adis). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: MEDLINE, EMBASE and AdisBase search terms were ‘anastrozole’ and (‘early breast cancer’ or ‘early-stage breast cancer’). Searches were last updated 26 May 2008.

Selection: Studies in postmenopausal women with early-stage breast cancer who received treatment with anastrozole. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Anastrozole, aromatase inhibitors, early-stage breast cancer, hormone receptor-positive breast cancer, pharmacological properties, therapeutic use, tolerability, pharmacoeconomics.

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Sanford, M., Plosker, G.L. Anastrozole. Drugs 68, 1319–1340 (2008). https://doi.org/10.2165/00003495-200868090-00007

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