Raloxifene and Tamoxifen Offer Similar Quality of Life

Reviewed study: "Raloxifene and Tamoxifen Offer Similar Quality of Life for Post-menopausal Women at High Risk of Breast Cancer" by S. Land and others, American Society of Clinical Oncology Annual Meeting, June 2006, Abstract LBA561, and Journal of the American Medical Association, June 21, 2006

Is this for me? If you're a post-menopausal woman who has never had breast cancer but has a much higher-than-average risk, and you're considering taking medication to reduce your risk, you might want to read this article.

What question is the study trying to answer? The researchers wanted to know if women who take raloxifene (brand name: Evista) have a similar quality of life as women who take tamoxifen.

This research is part of the STAR (Study of Tamoxifen and Raloxifene) trial, which looked at whether raloxifene was as effective as tamoxifen in reducing the risk of invasive breast cancer. The study included post-menopausal women who were at high risk for breast cancer but had no personal history of the disease.

Study design: More than 19,700 post-menopausal women with an increased risk of breast cancer but with no personal history of the disease were randomly assigned to take either raloxifene or tamoxifen once a day in the STAR trial.

In the study reported here, researchers asked a subgroup of 1,983 women to fill out a questionnaire that asked about their quality of life. The questions covered:

  • general health
  • ability to function physically
  • emotional well-being
  • ability to function socially
  • mental health
  • sexual function and enjoyment

Both the 973 women who took tamoxifen and the 1,010 women who took raloxifene received the medication for 5 years. All the women were given the questionnaires several times:

  • before they began treatment
  • then every 6 months during the 5 years
  • then one last time, 6 years after they had started treatment

The average follow-up time was about 5 years.

The women's ages ranged from 35 to more than 75 years old (the average age was about 58). Most women (94%) were white.

Study results: Tamoxifen and raloxifene offered the women about the same overall quality of life. Women reported few differences in general health, emotional/mental health, sexual function, or physical functions.

But the two medications had different degrees of some side effects.

Women taking raloxifene reported more:

  • muscle and bone problems or pain
  • pain during sex
  • weight gain

Women taking tamoxifen reported more:

  • leg cramps
  • bladder problems
  • gynecological problems
  • hot flashes, night sweats, and other symptoms related to blood pressure

All these differences were statistically significant, which means they were likely due to the differences between the medications and not just to chance. Still, the difference in the severity of the symptoms in the two groups was small, usually about 0.2 on a scale of 0 to 4 (4 being the most severe).

 
End of Year 2008

What breastcancer.org says about this article…

Raloxifene and Tamoxifen Offer Similar Quality of Life

The results of the STAR trial seem to indicate that raloxifene offers the same protection as tamoxifen against breast cancer for post-menopausal women at high risk with no personal history of disease. This companion study shows that raloxifene offers the same quality of life as tamoxifen.

The list of side effects for each medication sounds like a pile of problems you'd want to avoid. You might be wondering, "Why would I ever want to take a medicine — tamoxifen OR raloxifene — that could screw up my quality of life with these kinds of symptoms?" Keep in mind that you are unique and your situation has to be considered with thought and sensitivity. A decision to take any medication involves weighing benefits and side effects and how they affect YOU. Most women in this study didn't have the side effects; some of the women did. Some of the women got the benefits of the medications; some didn't. Every woman's hope is to get the benefits and avoid the side effects.

If you are at increased risk for breast cancer, you will want to work with your doctor to find a plan that is best for you. Any plan has to include careful methods of early detection. At a minimum, this means yearly mammography, physical exam by your doctor, and regular breast self-examination. For women at especially increased risk (with a breast cancer gene abnormality or a very strong family history of breast cancer), it means a mammogram alternating with MRI scanning every year (so you get a screening every 6 months). You can also reduce your risk by making everyday lifestyle choices, which may be hard to stick to but are really important:

  • exercising 3 to 4 hours a week
  • limiting alcohol use (fewer than 5 alcohol drinks per week)
  • keeping your weight close to your ideal body weight
  • avoiding high-fat and fried foods

After these basic steps you may want to try to reduce your risk even further. You may consider medications such as those discussed in this study. And you might consider protective surgery.

When you're ready to consider taking another step to reduce your risk of breast cancer, talk to your doctor about raloxifene or tamoxifen. Either medicine is taken once a day for 5 years. But that's not an irreversible decision. While you're taking the medicine, you and your doctor will constantly evaluate your situation. If you have unpleasant side effects that don't improve after a few months, you can change your plan.

Stay tuned to Breastcancer.org for the latest information on medications and other options that can reduce your risk of breast cancer.

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