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Scott Gottlieb No advantage exists in routine endometrial screening for patients
with breast cancer who are being treated with tamoxifen, according to
two new studies.
Although tamoxifen cuts the risk of breast cancer in some women, it
also raises the risk of endometrial cancer. As a result, patients
taking the drug often undergo invasive and somewhat painful biopsies
and ultrasound examination of the uterine lining.
The new studies report that these commonly used screening methods are
no more effective at diagnosing early endometrial cancer in these
patients than watching for abnormal vaginal bleeding. Researchers found
that with high rates of false positive results, the risks from both
endometrial biopsy and transvaginal ultrasonography far outweigh the
benefits (Journal of Clinical Oncology 2000;18:3459-63, 3464-70).
In the first study, led by Dr Richard Barakat, associate chief of
gynaecology at Memorial Sloan-Kettering Cancer Center in New York, the
researchers prospectively followed 159 premenopausal and postmenopausal
patients with stage I or stage II breast cancer who were starting
tamoxifen therapy.
The women, with a median age of 50, had an endometrial biopsy every six
months for two years, then annually for three years. At a median three
years, the patients had undergone 635 endometrial biopsies, 13% of
which were insufficient for diagnosis. In total, 26% of the women
underwent dilation and curettage for abnormal endometrial biopsies,
persistent bleeding, or adnexal masses. Results were negative in three cases.
The remaining diagnoses were polyps, progesterone decidualisation,
complex hyperplasia, abnormal histiocytes, and simple hyperplasia. Of
the three hysterectomies performed, only one (from a patient with
abnormal bleeding) showed malignant pathology.
The authors wrote: "Breast cancer patients on tamoxifen are anxious
about developing a second cancer. While it may seem beneficial to order
a battery of screening tests, if these screening tests do not have
proven records of efficacy, then they might feed, rather than
alleviate, these anxieties and lead to unnecessary procedures."
In the second study, Dr Bernd Gerber and colleagues at University of
Rostock, Germany, compared 247 postmenopausal patients with breast
cancer who were being treated with tamoxifen with 98 controls. Patients
underwent transvaginal ultrasonography every six months for up to five
years. Those found to have homogeneous endometrium thickening greater
than 10 mm were screened with ultrasonography every three months.
Endometrial thickness grew significantly in the treated women, compared
with the controls. Of the asymptomatic patients with suspect
endometrial tissue, 52 underwent hysteroscopy and dilation and
curettage, with four resulting in uterine perforation. Diagnoses were
atrophy, polyps, hyperplasia, and cancer.
Diagnoses were statistically indistinguishable for the 20 patients who
reported bleeding. There was one asymptomatic polyp and one case of
symptomatic hyperplasia in the control group.
About 0.002% of women who are taking tamoxifen will develop
endometrial cancer, and about 15% of these cancers results in early
death. The studies show that routine biopsy or ultrasonography is no
more effective at signalling early signs of cancer than abnormal
vaginal bleeding is.
"I think many, many doctors in this country subject their patients to
these screening tests, but the problem is that it often leads to
unnecessary procedures," Dr Barakat said.
What can you learn from this BMJ paper? Read Leanne Tite's Paper+