BY TIM BONFIELD
The Cincinnati Enquirer
Connie Wiles of Loveland plans to take tamoxifen in hopes that it will prevent her from getting breast cancer.
To her, it's worth risking the drug's potentially dangerous side effects because breast cancer killed her mother and her grandmother, and has attacked her sister.
But Brenda Kalkbrenner of Anderson Township wouldn't recommend the drug for her own daughters, even though she has had breast cancer and credits tamoxifen with helping save her life.
Such mixed opinions reflect the high degree of caution that doctors say women should have about taking tamoxifen, a drug that won reluctant federal approval Wednesday for use as preventive therapy in otherwise healthy women.
"There are still many unanswered questions about tamoxifen. The best thing to do is ask your doctor," said Dr. Elizabeth Shaughnessy, a breast cancer surgeon at the Barrett Cancer Center and one of the leading physicians monitoring local women involved in recent clinical trials of tamoxifen.
"We know that breast cancer occurrence was reduced for the five years that patients took the drug. What we don't know is whether the drug actually prevents breast cancer or simply delays its onset," Dr. Shaughnessy said.
Tamoxifen has been used for years in women with breast cancer to prevent tumors from recurring. It has been tested for several years in nationwide trials involving healthy women to see whether it helps prevent breast cancer from starting. In fact, more than 160 Tristate women have participated in those trials.
From these studies, doctors know that tamoxifen's beneficial effects come with increased risk of uterine cancer and of potentially dangerous blood clots. But these increased risks are rare. More commonly, tamoxifen can trigger early menopause, a serious consideration for women of child-bearing age.
"My daughters are 20 and 22," said Mrs. Kalkbrenner, 46. "They went through everything I went through during treatment. But neither of them are married and I know at least one of them wants to have children. I don't think I would advise either of them to do it (start taking tamoxifen)."
For Ms. Wiles, who has had a hysterectomy, the childbearing issue isn't a concern. Nor is the risk of uterine cancer.
"I feel really good about the drug," said Ms. Wiles, 45. "For me, breast cancer is like a time bomb. Even if it hasn't happened, it's always hanging over your head."
Tamoxifen also has helped Patti Feder, of Maineville, Ohio, who was diagnosed three years ago with breast cancer and lost her mother to the disease.
If Mrs. Feder had the chance, she would have taken the drug years ago. She still hopes to persuade her sister -- who does not have breast cancer -- to take a serious look at tamoxifen.
"It makes a lot of sense versus going through all this treatment (surgery, chemotherapy and radiation) and still having the distinct possibility of dying from it," Mrs. Feder said.
But doctors and patients still have questions about tamoxifen. They do not know whether the drug helps women who have the mutated BRCA1 or BRCA2 genes known to cause some breast cancers. They do not know whether the preventive effects of tamoxifen last after women stop taking the drug. They do not know whether the risk of side effects increase after taking the drug for more than five years. And they do not know whether other preventive drugs, with fewer side effects, may be just around the corner. Testing of one possible candidate -- raloxifine -- starts this fall.
Yet for some women, tamoxifen will have high value. Breast cancer -- the No. 2 cancer killer of women, behind lung cancer -- creates such fear that some women have had their breasts removed even before tests can detect any sign of the disease.
Knowing this, Dr. Shaughnessy said she would prescribe tamoxifen without hesitation to a woman with a strong family history and a high degree of anxiety.
"But if the family risk was not that high, I would be more cautious," Dr. Shaughnessy said.
