A national study to find out whether a drug used to treat breast cancer could also prevent the disease from developing hit close to home for three Southeast Missouri sisters.
Martha Nothdurft, Cheryl Crouch and Sharon Wendel all participated in the national Breast Cancer Prevention Trial, which studied the effectiveness of the drug tamoxifen as a preventive measure against breast cancer in women at high risk of developing the disease.
As the study winds up, the news is good: Tamoxifen seems to be the first drug that prevents breast cancer from developing in the first place.
Nothdurft, Crouch and Wendel had good reason to participate: They lost their mother and a sister to breast cancer, and each showed other risk factors for developing the disease.
Tamoxifen has been used for two decades to treat breast cancer.
The national trial results show that breast cancer incidence was 45 percent lower among women who were given tamoxifen than among those who received a placebo.
In the tamoxifen group, 85 women developed invasive breast cancer versus 154 women in the placebo group.
Now medical experts say the women who received the placebo and others at risk of developing breast cancer should consider tamoxifen therapy as a preventive measure.
"I think the weight of this evidence is that women should consider taking tamoxifen who are in those groups that are considered high-risk," said Dr. Stanley Sides, who headed up the tamoxifen study locally.
The results were so clear that the agencies conducting the study -- the National Surgical Adjutant Breast and Bowel project and the National Cancer Institute -- recommended releasing the results 14 months early. Women began signing up for the study in 1992.
Southeast Missouri Hospital and St. Francis Medical Center both participated in the study.
The women who participated are being notified of whether they received the drug or the placebo.
Nothdurft, who participated in through Southeast Missouri Hospital, received tamoxifen. She will be taking the drug for another year to complete her five-year trial.
Her sisters received placebos. Crouch participated through Southeast while Wendel participated through St. Francis Medical Center.
"It was kind of a twofold reason to participate, one being, if it would help, that's good. The other was a purely selfish reason, because you hoped you got the drug," Wendel said.
Nothdurft lives in Delta and teaches computer classes at Scott City. Wendel is a bookkeeper for the Cape Girardeau School District and lives in Whitewater. Crouch teaches learning disabled children at Clippard School in Cape Girardeau and lives near Burfordville.
Both Crouch and Wendel are seriously considering taking tamoxifen and will be talking to their physicians about the treatment.
"My general practitioner has talked with me several times," Crouch said. "He was hoping I was on tamoxifen to begin with, and I was too."
Crouch said she thinks tamoxifen "is something I need to diminish my chances" of developing breast cancer.
Wendel said the study's results convinced her to consider tamoxifen therapy. "I probably wouldn't be asking about it if the study hadn't been so conclusive," she said.
Wendel, 52, completed her five-year participation in October. When she applied for the study, she had already had to have biopsies to test for possible breast cancer.
When Nothdurft, 43, and Crouch, 45, applied for the study, they didn't qualify. Both were too young and didn't show any of the other risk factors.
But when their sister, Carol LaRue, was diagnosed with the disease, Nothdurft and Crouch both became eligible for the study. LaRue was 48 when she died in 1996. Their mother was 62 when she died of breast cancer 17 years ago.
A strong family history -- more than one first-degree relative with breast cancer -- was among criteria.
"My risk went from 16 percent to 40 percent," said Nothdurft, who since signing up for the study has had to undergo biopsies to check for breast cancer.
The study won't end with the release of the results, said Sides.
"They all need to be followed much further, much longer to understand how these benefits play out and how much long-term benefits they may achieve," Sides said. "We still have a bunch of women who are still being monitored."
Crouch and her sisters still worry about their own risk of developing breast cancer, and they worry about what might happen to their daughters. But the tamoxifen results give them hope that those fears may never become reality.
"Maybe this study will help them," Wendel said. "Maybe if they're high risk the doctors will say, `You'll take this,' and that will be it."
"If it helps one person that's one less person that has to go through what we've gone through twice," Nothdurft said.
Each of the women in the study signed up for five years. Several haven't completed that five-year commitment yet.
Sides pointed out the drug wasn't 100 percent effective, but the results are still "excellent."
Women at high risk for breast cancer "still have concerns," Sides said. "They still need their mammograms and their checkups."
Sides said he would "absolutely" recommend tamoxifen therapy to women at risk of developing breast cancer.
But the drug has its downside, he pointed out. For one thing, tamoxifen is expensive: Treatment costs about $130 to $140 a month.
"For a young girl who's in her 30s who's going to be taking tamoxifen for the long term, that's a major expense," Sides said.
And the study found tamoxifen increased women's risk of developing three potentially life-threatening conditions.
Thirty-three women in the tamoxifen group developed endometrial cancer, or cancer of the lining of the uterus, versus 14 cases in the placebo group.
But the risk of endometrial cancer in pre-menopausal "seems extremely low," Sides said.
"The potential benefit is much, much greater by this study," he said.
Another 17 women in the tamoxifen group were diagnosed with pulmonary embolism, or blood clots in the lung, compared to six in the placebo group.
And 30 women in the tamoxifen group developed deep vein thrombosis -- blood clots in major veins -- as compared to 19 in the placebo group.
TAMOXIFEN TRIAL RESULTS
Nationally, 13,388 women are participating in a study to determine whether the tamoxifen, currently used to treat breast cancer, can also prevent the disease from developing. Results of the study:
-- Occurrence of breast cancer was 45 percent lower in women who received tamoxifen than in women who received a placebo: 85 cases versus 154.
-- Women who received tamoxifen showed higher risk of developing three potentially life-threatening diseases: endometrial cancer (33 cases versus 14 in the placebo group); pulmonary embolism (17 cases versus six in the placebo group); and deep vein thrombosis (30 cases versus 19).
-- Medical experts recommend that women in the study who received the placebo and all women at high risk of developing breast cancer consider taking tamoxifen therapy to help prevent breast cancer.
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