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STAR research unveils new, better breast cancer prevention drug

Thirteen years ago, Lauren Newcomer lost her sister after a seven-year battle with breast cancer. That placed Newcomer in the high-risk category for developing the same disease.

The Harrison Medical Center nurse was friends with her sister’s oncologist, Dr. Joseph Johnson of Olympic Hematology & Oncology Associates, a Bremerton clinic. When Johnson recommended that Newcomer sign up for the Study of Tamoxifen and Raloxifene (STAR) she did not hesitate.

Newcomer was one of the last women to join the study, which enrolled nearly 50 women from Kitsap, east Jefferson and North Mason counties.

“I felt like I was doing something that might help somebody else because of my sister,” Newcomer said. “I’m hoping that this study ... can have a big impact on preventing breast cancer, not just treating it.”

STAR compared the effectiveness of raloxifene (Evista) and tamoxifen (Nolvadex) for reducing the occurrence of breast cancer in postmenopausal women at high risk for that type of cancer.

Newcomer’s family history of breast cancer put her at that elevated risk and a hysterectomy she had in early 2004 satisfied the postmenopausal requirement.

At the end of that year, at the age of 48, she enrolled in the clinical study and was assigned to take one of the two drugs. None of the women in the seven-year study were told which pill they were assigned.

“I was absolutely convinced that I was taking raloxifene,” Newcomer said.

Raloxifene, used for prevention and treatment of osteoporosis in postmenopausal women, was expected to have fewer side effects. Tamoxifen, which has a 30-year track record as a breast cancer treatment medication, has since 1998 been approved as a prevention drug as well. It was the first medication ever approved as a preventative measure for any type of cancer.

Last month STAR was ceased and the results were made public, revealing that both pills had the same success rate in preventing breast cancer for postmenopausal women of high risk, but raloxifene won out with fewer side effects.

All of the nearly 20,000 women enrolled in the study in the United States, Canada and Puerto Rico, were told which drug they had been placed on and given the option to switch.

Newcomer is thinking about it since she found out she was actually on tamoxifen. She and her husband travel often and airplane flights increase the risk of blood clots in the legs. Because tamoxifen carries a higher risk of blood clots, it is not the most tempting option for Newcomer.

According to the study, when the data collected revealed the conclusions, both drugs reduce the risk of developing breast cancer by about 50 percent. Raloxifene also carries a lower incidence of uterine cancers and blood clots.

“The side effects from both drugs are very mild and well tolerated,” said Maggie Hill, a nurse at Olympic Hematology & Oncology Associates who has been collecting data on STAR since the study began about six years ago.

In most medical studies, one group of participants take the drug tested and another take a placebo — a blank pill or shot. Then the results for each group are compared, while the participants themselves have no idea whether they are taking the real deal.

STAR was different. The women enrolled would not know which pill they are taking, but they all knew they were taking medication that had one benefit or another.

“This was a unique thing,” said Dr. Ronald Reimer of Olympic Hematology & Oncology Assoc-iates. “It was hard for me to imagine every patient not benefitting from this.”

Raloxifene and tamoxifen both fall into a class of prescription drugs, called selective estrogen receptor modulators. That means they may act as estrogen in helping with osteoporosis, but at the same time may have anti-estrogen effects like helping with breast cancer.

“It doesn’t replace everything estrogen does,” Reimer said about the newly discovered cancer-preventing role of raloxifene. “But it does a lot for people with very little downside.”

Reimer says in the last 10-15 years there have been significant advances in breast cancer screening, treatment and now prevention, thanks to tamoxifen’s use and this latest study revealing raloxifene’s powers.

Olympic Hematology & Oncology Associates participated in STAR through its link with Fred Hutchinson Cancer Research Center in Seattle. The roughly 50 volunteers who fit the requirement criteria and participated in the study through the Bremerton office are a significant number for a community of the size the clinic serves, Reimer said.

“You always have a special spot in your heart for people who participate in medical studies,” he added. “Because they know the people who come after them will benefit the most.”

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