Penrose Cancer Center participates in drug trials

Filed under: Health Care |

The Penrose Cancer Center participated in one of the largest breast cancer prevention trials conducted in the United States.

The study showed that raloxifene, used to prevent and treat osteoporosis in postmenopausal women, reduces breast cancer risk for women who are at increased risk of the disease.

The study compared raloxifene to tamoxifen, which also is used to reduce breast cancer risk for postmenopausal women.

Both drugs reduced the risk of developing invasive breast cancer by 50 percent. In addition, women who were randomly assigned to take raloxifene daily, and who were followed for an average of four years, had 36 percent fewer uterine cancers and 29 percent fewer blood clots than the women assigned to take tamoxifen.

Uterine cancers, especially endometrial cancers, are a rare but serious side effect of tamoxifen. Both are known to increase a woman’s risk of blood clots.

The study enrolled 19,747 postmenopausal women who were at increased risk of breast cancer. At the Penrose Cancer Center 53 women were enrolled, and in Colorado, 349 were enrolled.

Participants were randomly assigned to receive either 60 mg of raloxifene or 20 mg of tamoxifen daily for five years. The trial was coordinated by the National Surgical Adjuvant Breast and Bowel Project, a network of cancer research professionals and was sponsored by the National Cancer Institute, part of the National Institutes of Health.

“In 1998, the landmark breast cancer prevention trial showed that tamoxifen could reduce the risk of invasive breast cancer in pre-menopausal and postmenopausal women by nearly 50 percent,” said Norman Wolmark, NSABP chairman. “Today, we can tell you that for postmenopausal women at increased risk of breast cancer, raloxifene is just as effective, without some of the serious side effects known to occur with tamoxifen.”

Women taking either drug had equivalent numbers of strokes, heart attacks and bone fractures. Raloxifene and tamoxifen have been shown to protect bone health, and it is estimated that half a million postmenopausal women are taking raloxifene to prevent or treat osteoporosis.

The initial results from the study suggest that raloxifene does not increase the risk of developing a cataract, as tamoxifen does.

“Although no drugs are without side effects, tamoxifen and raloxifene are vital options for women who are at increased risk of breast cancer and want to take action,” said Dr. Leslie Ford, associate director for clinical research in NCI’s Division of Cancer Prevention. “For many women, raloxifene’s benefits will outweigh its risks in a way that tamoxifen’s benefits do not.”

Researchers also tracked known menopausal side effects that occur with both drugs and monitored the participants’ quality of life. The data shows that side effects of both drugs were mild to moderate in severity, and quality of life was the same.

Participants are receiving information about which drug they were taking. Women assigned to raloxifene will continue to be provided with the drug until they have completed five years of treatment. Women assigned to tamoxifen can choose to continue taking tamoxifen or to receive raloxifene to complete their five years of treatment.

Caring for Colorado awards grants

Caring for Colorado Foundation has awarded grants to three health care programs that provide services to El Paso County.

The El Paso County Department of Health and Environment received $15,000 to support a youth suicide prevention program in the county.

Falcon School District 49/Falcon Career Academy Programs received $75,000 to support the Health Care Academy, which prepares high school students for health professions.

Westside CARES received $11,283 to support the Pastoral Nursing Program.

Since 2001, Caring for Colorado has awarded more than $30 million statewide to increase access to care for underserved populations.

JCAHO announces new accreditation process

Beginning this year, the Joint Commission on Accreditation of Healthcare Organizations will conduct on-site accreditation surveys and certification reviews on an unannounced basis. This change applies to the more than 15,000 health care organizations it accredits or certifies.

“The joint commission’s accreditation process should create an impetus for each organization to be in compliance with 100 percent of the standards 100 percent of the time,” said Dennis S. O’Leary, president of the joint commission. “Making on-site evaluations less predictable and more focused on potential performance issues is intended to satisfy both public demand for greater organization accountability and organization demand for greater value in undergoing these outside evaluations.”

The transition to unannounced surveys is a facet of the new accreditation process which was launched in January 2004, and designed to promote continuing organization compliance with the accreditation standards. The new accreditation process provides periodic self-assessments which, as of this year, are required on an annual basis. In addition, organizations periodically receive performance data and information gathered by the joint commission.

The decision to institute unannounced surveys was driven in large part by leaders in the health care field who felt that their organizations are always performing at a high level and should always be prepared for a joint commission survey.

Amy Gillentine covers health care for the Colorado Springs Business Journal.