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The breast cancer medication anastrozole has now received approval as a preventive option for high-risk women in the UK.

Approximately 289,000 post-menopausal women, the majority of whom have a notable family history of breast cancer, may now qualify to utilize anastrozole as a preventive therapy. A trial that we financed demonstrated that it can reduce their risk by fifty percent.

Overall, studies indicate that approximately one in four eligible women using anastrozole could avert around 2,000 instances of breast cancer.

"Strategies aimed at reducing the risk of breast cancer in women who are at high risk are urgently required, making this announcement a positive development," stated Dr. David Crosby, the head of prevention and early detection at Cancer Research UK.

We conducted significant research in the development of these types of medications, referred to as 'aromatase inhibitors'. A decade ago, our clinical trial demonstrated that anastrozole could reduce the risk of certain women developing breast cancer by fifty percent, while presenting minimal side effects.

Historically, anastrozole was exclusively authorized by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of breast cancer. This limitation made it challenging to provide the medication to women who could gain from it as a preventive measure. It is the inaugural medication that the MHRA has reauthorized under NHS England’s Medicines Repurposing Programme.

One of the women at high risk who was prescribed anastrozole ‘off-label’ as a preventive medication is Lesley-Ann Woodhams. The 61-year-old finished the complete five-year regimen of one tablet daily in January 2023.

She stated: “Choosing to take anastrozole was a straightforward decision for me, as I had witnessed my mother fight against breast cancer and my risk level was significantly elevated.

"It truly was a blessing; it provided my family and me with peace of mind and, more significantly, a future to anticipate. I am thankful for each day I used this medication – it transformed my life. Anastrozole has enabled me to carry on with my life as I had envisioned."

Due to the fact that anastrozole is an older medication, it is currently off-patent, allowing multiple companies to manufacture it, resulting in a more affordable price. The complete five-year treatment regimen now amounts to only £78, which is approximately 4p per day. According to NHS England, preventing 2,000 instances of breast cancer is expected to save £15 million in treatment expenses.

"Repurposing therapeutic medications that have previously demonstrated safety for preventive purposes is a field rich with potential," stated Crosby. "Further research will be crucial in identifying additional opportunities of this nature, enhancing our understanding of individuals at elevated risk for developing cancer, and assisting in reducing that risk."

He continued: "If you possess a family history of breast cancer and have concerns regarding your cancer risk, consult your physician."

The decision made by the MHRA to approve anastrozole for use as a preventative treatment was founded on the findings of the IBIS-II trial.

During this trial, 3864 postmenopausal women who were at a heightened risk of developing breast cancer were enrolled and allocated to receive either anastrozole or a placebo daily for a duration of 5 years. Upon completion of their treatment, the research team conducted annual follow-ups to gather data regarding the incidence of breast cancer.

A 49% decrease in breast cancer incidence was observed among individuals treated with anastrozole compared to those who received a placebo (85 cases versus 165 cases) after a median follow-up period of 131 months.

Specifically, cases of invasive oestrogen receptor-positive breast cancer were reduced by 54%, while ductal carcinoma in situ saw a 59% reduction, particularly among participants identified as oestrogen receptor-positive.

These findings indicate that a 5-year course of anastrozole treatment has a sustained long-term impact on preventing breast cancer in these high-risk populations.

[stephenswoodd]

HOW DOES ANASTROZOLE WORK?

Anastrozole works by reducing the amount of oestrogen made in the body.

Some breast cancers use oestrogen in the body to help them to grow. These are known as oestrogen receptor positive or ER+ breast cancers.

Anastrozole will only be prescribed if your breast cancer is ER+.

Before the menopause, oestrogen is mainly produced in the ovaries. After the menopause, the ovaries no longer produce oestrogen, but some oestrogen is made in body fat. This process involves an enzyme (a type of protein) called aromatase.

Anastrozole belongs to a group of drugs called aromatase inhibitors. Aromatase inhibitors stop the aromatase enzyme from working. This means there’s less oestrogen in the body to help breast cancer cells to grow.

Invasive breast cancers are tested to see if they are ER+ using tissue from a biopsy or after surgery.

Tests may also be done to see if your breast cancer is progesterone receptor positive (PR+). Progesterone is another hormone. The benefits of hormone therapy are less clear for people whose breast cancer is only progesterone receptor positive (PR+ and ER-). Very few breast cancers fall into this category. However, if this is the case your specialist will discuss with you whether hormone therapy is appropriate.

[stephenswoodd]

Use of anastrozole in the chemoprevention and treatment of breast cancer: A literature review

Breast cancer is one of the most commonly diagnosed types of cancer in women, presenting high incidence rates in developed regions of the world compared with developing ones. Incidence rates of the disease range from 27 cases per 100,000 women in Eastern Africa to 96 cases per 100,000 women in Western Europe.1,2 Breast cancer is characterized as a multifactorial disease and its development has been reported as the result of complex interactions between an individual’s genoma and the environment.3 Prolonged exposure to estrogene plus progesterone plays a significant role in the etiology of breast carcinoma and biosynthesis pathway of estrogens is thus an important therapeutic target.

The main enzyme involved in estrogen biosynthesis is CYP19A1 or aromatase that belongs to the cytochrome P450 family and is predominantly located in the liver, adrenal glands and fatty tissue.5 However, the source of estrogen varies widely between premenopausal and postmenopausal women (Figure 1).6 In premenopausal women, the main source of estrogen is the ovary, while in postmenopausal women, estrogen is derived from the conversion of androgens into estrogens (through the aromatase enzyme). In particular, testosterone is converted into estradiol, androstenedione into estrone and 16-alpha-hydroxytestosterone into estriol (Figure 2), originating from the peripheral tissues, including the skin, fatty tissue and breast. Therefore, the aromatase enzyme directly affects estrogen biosynthesis in the breast and it is believed that this enzyme plays an important role in the progression of breast cancer.