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13 percent of women stop taking breast cancer drug because of side effects, U-M study finds
September 06, 2007Aromatase inhibitors cause musculoskeletal issues in nearly half of patients
ANN ARBOR, Mich. - More than 10 percent of women with breast cancer stopped taking a commonly prescribed drug because of joint and muscle pain, according to a new study from researchers at the University of Michigan Comprehensive Cancer Center.
The women in the study were taking aromatase inhibitors, a type of drug designed to block the production of estrogen, which fuels some breast cancers. The treatment is generally given after surgery, chemotherapy or radiation therapy to prevent the cancer from returning. It's typically prescribed as one pill each day for five years. Use of these drugs has increased because they have been shown to be more effective than tamoxifen, the previous standard of care.
"We know 25 percent to 30 percent of women taking aromatase inhibitors have aches and pains. What was surprising here was the number of people who actually discontinued the drugs because of the side effects. Up to 15 percent of patients in previously reported studies stopped taking aromatase inhibitors for a variety of reasons, but in our study, we had 13 percent drop out just because of musculoskeletal problems," says N. Lynn Henry, M.D., Ph.D., lecturer in internal medicine at the U-M Medical School.
Henry will present the findings Sept. 8 in San Francisco at the 2007 Breast Cancer Symposium, a scientific meeting sponsored by five leading cancer care societies.
The study looked at the first 100 women enrolled in a trial to study how genetics play a role in the way individuals metabolize drugs and experience side effects. The women in this analysis were all post-menopausal following treatment for hormone-responsive breast cancer. They were assigned to take one of two aromatase inhibitors, exemestane or letrozole, and were followed for at least six months.
Study participants completed questionnaires about their health and side effects. If their reported joint and muscle concerns scored above a certain threshold on these questionnaires, the women were referred to a rheumatologist. Referrals were based on worsened pain or a change in function from the start of the study that resulted in more difficulty performing tasks such as rising from a chair, climbing out of a car or opening a jar.
In women who developed symptoms while taking the medication, the symptoms typically came on soon after starting treatment, at a median just under two months. The specific symptoms varied among the study participants, including tendonitis in the shoulder or wrist, inflammation in the knees or arthritis-type symptoms in the hands or hips. Some women reported joint pain while others had muscle pain.
The researchers are looking at interventions to determine how to manage the musculoskeletal side effects of these drugs. Symptoms almost always improve after stopping the drug. Researchers are trying to determine if switching to a different aromatase inhibitor will prevent the side effects in women who are affected, and they're testing interventions to manage the side effects. Another option is to switch from an aromatase inhibitor to tamoxifen, which also blocks estrogen but which is not known to cause as much joint and muscle pain.
Large randomized studies have shown aromatase inhibitors work better than tamoxifen in post-menopausal women to prevent breast cancer from recurring. But, Henry points out, given the risks and side effects an individual woman might face, tamoxifen might be the better choice for some women.
"Tamoxifen has been around 20-30 years and has a long track record. We know about its benefits and its risks. Aromatase inhibitors are new, and we don't have as much experience with them. We have to see in the long term which one ends up being better," Henry says.
The goal of the larger study, which is led by the Consortium on Breast Cancer Pharmacogenomics, is to determine if breast cancer treatment can be personalized based on an individual woman's genetic make-up. At this point, the sample size is not large enough to determine any genetic markers. Eventually, the researchers hope to enroll 500 women in the study. Finding a marker that predisposes a woman to more severe side effects could help doctors make personalized treatment decisions.
University of Michigan Health System
"We know 25 percent to 30 percent of women taking aromatase inhibitors have aches and pains. What was surprising here was the number of people who actually discontinued the drugs because of the side effects. Up to 15 percent of patients in previously reported studies stopped taking aromatase inhibitors for a variety of reasons, but in our study, we had 13 percent drop out just because of musculoskeletal problems," says N. Lynn Henry, M.D., Ph.D., lecturer in internal medicine at the U-M Medical School.
Henry will present the findings Sept. 8 in San Francisco at the 2007 Breast Cancer Symposium, a scientific meeting sponsored by five leading cancer care societies.
The study looked at the first 100 women enrolled in a trial to study how genetics play a role in the way individuals metabolize drugs and experience side effects. The women in this analysis were all post-menopausal following treatment for hormone-responsive breast cancer. They were assigned to take one of two aromatase inhibitors, exemestane or letrozole, and were followed for at least six months.
Study participants completed questionnaires about their health and side effects. If their reported joint and muscle concerns scored above a certain threshold on these questionnaires, the women were referred to a rheumatologist. Referrals were based on worsened pain or a change in function from the start of the study that resulted in more difficulty performing tasks such as rising from a chair, climbing out of a car or opening a jar.
In women who developed symptoms while taking the medication, the symptoms typically came on soon after starting treatment, at a median just under two months. The specific symptoms varied among the study participants, including tendonitis in the shoulder or wrist, inflammation in the knees or arthritis-type symptoms in the hands or hips. Some women reported joint pain while others had muscle pain.
The researchers are looking at interventions to determine how to manage the musculoskeletal side effects of these drugs. Symptoms almost always improve after stopping the drug. Researchers are trying to determine if switching to a different aromatase inhibitor will prevent the side effects in women who are affected, and they're testing interventions to manage the side effects. Another option is to switch from an aromatase inhibitor to tamoxifen, which also blocks estrogen but which is not known to cause as much joint and muscle pain.
Large randomized studies have shown aromatase inhibitors work better than tamoxifen in post-menopausal women to prevent breast cancer from recurring. But, Henry points out, given the risks and side effects an individual woman might face, tamoxifen might be the better choice for some women.
"Tamoxifen has been around 20-30 years and has a long track record. We know about its benefits and its risks. Aromatase inhibitors are new, and we don't have as much experience with them. We have to see in the long term which one ends up being better," Henry says.
The goal of the larger study, which is led by the Consortium on Breast Cancer Pharmacogenomics, is to determine if breast cancer treatment can be personalized based on an individual woman's genetic make-up. At this point, the sample size is not large enough to determine any genetic markers. Eventually, the researchers hope to enroll 500 women in the study. Finding a marker that predisposes a woman to more severe side effects could help doctors make personalized treatment decisions.
University of Michigan Health System
Aromatase Current Events and Aromatase News RSSEstrogen therapy likely must be given soon after menopause to provide stroke protection
For estrogen replacement to provide stroke protection, it likely must be given soon after levels drop because of menopause or surgical removal of the ovaries, scientists report in the Journal of Neuroscience.
Penn studies point to strategies for reducing painful breast cancer drug side effects
Aromatase inhibitors, the same drugs that have buoyed long-term survival rates among breast cancer patients, also carry side effects including joint pain so severe that many patients discontinue these lifesaving medicines.
Study of adjuvant endocrine treatment for breast cancer reveals cost of noncompliance
The largest study in the world of treatments for post menopausal, hormone positive breast cancer has shown that patients who continue to take exemestane or tamoxifen do significantly better than patients who start to take one or other drug (or tamoxifen followed exemestane) but then stop.
Low-dose estrogen shown safe and effective for metastatic breast cancer
When estrogen-lowering drugs no longer control metastatic breast cancer, the opposite strategy might work. Raising estrogen levels benefited 30 percent of women whose metastatic breast cancer no longer responded to standard anti-estrogen treatment.
Uterine cells produce their own estrogen during pregnancy
For decades, scientists assumed that the ovary alone produced steroid hormones during pregnancy.
Newly appreciated membrane estrogen receptor important therapeutic target for breast cancer
New research at Rhode Island Hospital has uncovered the biological effects of a novel membrane estrogen receptor, a finding that has potential implications for hormonal therapy for breast cancer.
PET scan can non invasively measure early assessment of treatment for common type of breast cancer
Non-invasive imaging can measure how well patients with the most common form of breast cancer - estrogen receptor positive type - respond to standard aromatase inhibitor therapy after only two weeks and shows similar findings that more invasive needle sampling identifies, according to a poster presentation to be presented at the ASCO annual meeting next week.
Mayo Clinic researchers say agent provides treatment option for women with hot flashes
A pill used for nerve pain offers women relief from hot flashes, Mayo Clinic researchers report at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO).
Progress made in understanding causes and treatment of endometriosis
Endometriosis is a poorly understood chronic disease characterized by infertility and chronic pelvic pain during intercourse. It affects between 5 to 10 million women in the U.S.
Meta-analyses of global trials finds in favor of aromatase inhibitors
Two separate meta-analyses of clinical trials from around the world that tested tamoxifen against aromatase inhibitor drugs in postmenopausal women with early breast cancer have each reached the same conclusion: aromatase inhibitors are more effective in preventing breast cancer from coming back.
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