ASCO Patient Guide: Bisphosphonates for Breast Cancer

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ASCO Patient Guide: Bisphosphonates for Breast Cancer

Introduction

August 2003

To help doctors give their patients the best possible care, the American Society of Clinical Oncology (ASCO) asks its medical experts to review the latest research on issues in cancer care and develop recommendations called clinical practice guidelines.

To help patients understand their cancer care, ASCO created this patient guide, based on the guidelines ASCO's experts developed to help people with breast cancer.

As you read this guide, please keep in mind:

Every person treated for cancer is different. These recommendations are not meant to replace your or your doctors' judgment. The final decisions you and your doctors make will be based on your individual circumstances.

These recommendations do not apply to clinical trials (research studies). Many of the drugs here continue to be studied in clinical trials. If ASCO does not recommend a drug or practice, it is often because there is not enough information to provide such recommendations, not because they are useless or harmful.

All guides are available in print or in PDF format. To order copies of ASCO Patient Guides, call ASCO customer service at 888-273-3508 or visit ASCO's publications shopping cart.

Last Updated: August 01, 2003

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What is breast cancer?

Breast cancer is a disease in which cells become abnormal, grow and divide without the regulations on normal cells, and form a mass called a tumor. Most breast tumors are benign (not cancer), but those that have the ability to spread to the lymph nodes and other parts of the body are called malignant (cancer).

Breast cancer is the most common type of cancer in women (excluding cancers of the skin), and the second leading cause of cancer death in women (after lung cancer). Although rare, breast cancer is also found in men. When detected at an early stage, breast cancer is very treatable. Sometimes, however, breast cancer is found at a more advanced stage, when the cancer has already spread (metastasized). Breast cancer first spreads to the lymph nodes and then on to other parts of the body such as the liver, brain, or bone. Of the sites that breast cancer has been shown to spread, metastasis to the bone is the most common and the majority of women with advanced breast cancer will experience bone complications. When cancer spreads to the bone, significant pain and loss of movement can occur. Because advanced breast cancer is more difficult to treat and cure, efforts have been made to develop drugs that help to reduce the effects of breast cancer on the bones.

This guide discusses a type of drug called bisphosphonates that may be offered to people with advanced (metastatic) breast cancer. These drugs have been shown, in many cases, to reduce the negative effects that breast cancer has on bone. These drugs have not, however, been shown to extend life or slow the growth of cancer.

If breast cancer spreads to the bones, it causes increasing damage to the bones and bone marrow. Normally, people have balanced levels of cells called osteoclasts and osteoblasts that work together to shape and maintain healthy bones. Osteoclasts destroy old bone, and osteoblasts help to build new bone in its place.

People with bone metastases have abnormally high levels of osteoclasts. When osteoclasts break down and absorb old bone faster than new bone is formed, fractures (breaks), bone pain, osteoporosis (thinning of the bones), and hypercalcemia (high levels of calcium in the blood) can result.

Last Updated: August 01, 2003

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What are the recommendations?

Who may receive bisphosphonates?

The two bisphosphonates given to women with breast cancer are pamidronate and zoledronic acid. They have been found in research studies to be equally effective, but differ in cost (pamidronate is less expensive) and amount of time required to administer each dosage.

Pamidronate: Given every three to four weeks; each infusion takes two hours to administer.

Zoledronic acid: Given every three to four weeks; each infusion takes 15 minutes to administer.

Both are given intravenously (IV) in a chemotherapy infusion room at a doctor's office or hospital.

Through results of clinical trials, these drugs have been found to be appropriate for women in these situations:

Women whose x-rays show bone metastases
Women whose x-rays are normal, but whose bone scans, computed tomography (CT) scans, or magnetic resonance imaging (MRI) scans show evidence of bone metastases
Bisphosphonates are not recommended for women who have an abnormal bone scan but normal x-rays, CT scans, and MRI scans.

What will your doctor watch for when you are taking bisphosphonates?

Based on current research, bisphosphonates are best monitored using these guidelines:

Women with pre-existing renal (kidney) disease and a blood creatinine level less than 3.0 mg/dL may safely take bisphosphonates. Creatinine is a type of protein in the blood that may indicate kidney damage if found at levels above 3.0 mg/dL.
Infusion times should be at least two hours for pamidronate and at least 15 minutes for zoledronic acid.
According to the FDA, blood creatinine levels should be tested before each infusion of any bisphosphonate. Blood tests for calcium, electrolytes, phosphate, magnesium, and hematocrit/hemoglobin should also be monitored regularly.

Can biochemical markers tell if bone damage has already occurred?

For some types of cancer, doctors can test a person's blood for higher than normal levels of certain substances that might indicate that a tumor is spreading, has come back, or has stayed the same. These substances are called biochemical markers, biomarkers, or tumor markers. Based on available research, there are no biochemical markers that may help doctors monitor how bisphosphonates are working in women with breast cancer.

How long should bisphosphonates be used?

How long bisphosphonates are used should be decided according to each woman's overall health and preference. Bisphosphonates are safe to use as long as a woman remains able to perform her normal daily activities (called performance status).

Can bisphosphonates help control pain?

There are many ways to help control pain for women who have bone damage from breast cancer. These include painkillers, nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, certain surgical procedures, and radiation therapy.

Radiation therapy may be effective at helping to control pain for women who have bone damage from breast cancer. However, there is not enough evidence to suggest bisphosphonates be given along with radiation therapy unless chemotherapy and/or hormonal therapy is also being used.

Can bisphosphonates be used to prevent or slow bone metastases?

Research is ongoing to determine if bisphosphonates can be used to prevent or slow bone metastases. At this time, women in these situations should take bisphosphonates only as part of a clinical trial:

Women who have not developed detectable bone metastases
Women who have breast cancer that has spread to other areas of the body but not the bones
Women with breast cancer who are at high risk of bone metastases

What is the risk of developing osteoporosis?

Most women with breast cancer are at risk of developing osteoporosis. Risk of both breast cancer and osteoporosis increases with age. Also, many cancer treatments can lead to osteoporosis, so it is important for women and their doctors to try to detect osteoporosis as early as possible. There are many ways to treat or slow down osteoporosis.

Taking calcium and vitamin D supplements
Exercising
Avoiding smoking
Using bisphosphonates alendronate and risedronate
Taking raloxifene may help some women, but it is not recommended for women who have already taken tamoxifen for five years. Raloxifene is a kind of selective estrogen receptor modulator (SERM) that behaves in some ways like estrogen.

Hormone treatments (such as estrogen and progesterone) are frequently given to women who have not been diagnosed with breast cancer. Hormone treatments are not safe for women with breast cancer.

Last Updated: August 01, 2003

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