For several years, patients have been filing a large number of lawsuits because they believe their physicians did not do enough testing to follow up early-stage breast cancer. "We all have friends and colleagues who have been sued because they didnt get a bone scan in a patient who now has metastatic disease," said Cliff A. Hudis, M.D.
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To back up his claim, Hudis, who is from Memorial Sloan-Kettering Cancer Center, New York, cited a 1994 study in the Journal of Clinical Oncology in which Charles L. Loprinzi, M.D., from the Mayo Clinic in Rochester, Minn., and his colleagues looked at a large series of breast cancer patients with early-stage cancer.
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Two reports on the value of chest x-rays suggest a limited value to this test. A study published in 1989 in the European Journal of Cancer Clinical Oncology involved 263 patients with early breast disease. From the 1,600 chest x-rays performed over 7 years, 4 patients (0.25%) with asymptomatic metastases were discovered. An equal number of false positives were found. Researchers found in a second study published in 1983 in the Italian journal Tumori that a mere 0.02% of the 11,000 exams performed on 1,700 patients over 9 years revealed previously undetected metastatic disease.
Randomized Trials
Even more convincing data to show inadequacy of follow-up tests came from two randomized trials where Italian researchers examined whether there was any benefit of intensive versus routine follow-up testing of early-stage breast cancer patients. Both were reported in the Journal of the American Medical Association in 1994.
The first involved 1,243 patients, all of whom received yearly mammograms and a history and physical exam at 3-month intervals for 2 years, followed by 6-month intervals for the next 3 years. In addition, half of the patients were randomly assigned to receive a chest x-ray and bone scan twice a year. Although more metastases were detected in the intensive follow-up group, there was no difference in 5-year survival or local/regional recurrences between the two groups.
In the second multicenter randomized trial carried out by GIVIO investigators (Interdisciplinary Group for Cancer Care Evaluation in Milan, Italy), the 1,300 patients with stages I through III breast disease were randomly assigned to either routine screening or intensive follow-up. The routine screening tests received by both groups were the same in both trials.
Intensive surveillance in this case, however, consisted of a chest x-ray every 6 months and a yearly bone scan, liver ultrasound, and a serum liver function test. After 6 years, the two groups showed no difference in survival or time to detection of recurrence and there was no statistically significant difference between the two groups in perceptions related to quality of life. However, more than 70% of respondents stated their preference to be seen frequently by a physician and undergo diagnostic tests postoperatively, even if free of symptoms.
A Big Frustration
What this means is that no matter what patients are told, a majority "have a fundamental core unshakable belief that if they get screened and followed, they may be able to get a better outcome than if they dont. Thats a big frustration in many ways," said Hudis.
Loprinzi agreed. "If you ask patients whether they would like to get tests to detect whether their breast cancer is recurring, most patients reply in the affirmative." Loprinzi, writing in a recent article in the Journal of Clinical Oncology, said he believes that this is because of a number of false assumptions that many people have.
The first false assumption is that the American Cancer Society recommends frequent follow-up test. "The American Cancer Society recommends evaluation for early detection of primary curable cancers, not tests to detect recurrent widely metastatic disease," said Loprinzi.
"Another false assumption is that if we can catch recurrent cancer early we can cure it," he continued. "It does not seem to be true for established metastatic disease."
Hudis agreed. "The key thing is that there is no early detection for metastatic breast cancer. Its not early when you find it."
Recommendations
Besides ACS, organizations like the American Society of Clinical Oncology recommend minimal follow-up exams: a monthly breast self-exam, annual mammography, a careful history and physical examination every 3 to 6 months for 3 years, then every 6 to 12 months for 2 years, then annually. The 1998 guidelines state: "Data are not sufficient to recommend routine bone scans, chest radiographs, hemotologic blood counts, tumor markers (carcinoembryonic antigen, cancer antigen [CA] 15-5, and CA 27.29), liver ultrasonograms, or computed tomography scans." Similarly, the National Comprehensive Cancer Network recommends only history and physical exam and mammography for breast cancer surveillance.
Not only are there no data to suggest that tests other than history, examination, and mammograms can improve survival, but Loprinzi pointed out that follow-up tests may impact negatively on the quality of life. Surveillance tests are only reassuring if all of the tests are completely normal every time. But if the liver test is a little elevated, then it will have to be rechecked a couple of months later and if it is two points higher then, a computed tomography scan might have to be done. These waiting times between tests are generally not reassuring to the patient.
The result is that many clinicians are testing less. "We have backed away over the last few years from requiring any sort of routine follow-up, other than physical exam," said Hudis. "We collect blood samples for clinical trials, but we allow clinicians to decide whether to do chest x-rays or not, and have eliminated bone scans entirely."
That the decision to test less is correct seems to be borne out by a preliminary analysis of the tests used in managing 786 breast cancer patients at Memorial Sloan-Kettering conducted by Arti Hurria, M.D. Out of the 502 x-rays and 160 CAT scans received by 297 patients, two metastases were detectedone by chest-x-ray and the other by CAT scan. And only one patient was asymptomatic. This means that 0.3% of these two tests revealed metastases. However, 19 patients had abnormal chest x-rays that led to repeat chest x-rays, CAT scans, bone scans, and even electrocardiograms. All 19 eventually proved to be false positives.
The Tamoxifen Issue
Two recent reports suggest a lack of benefit for another testultrasound screening for uterine cancer for women with breast cancer who are taking tamoxifen, which is recommended by NCCN. An article in last years Journal of Clinical Oncology showed that although time on tamoxifen was related to endometrial thickness, in the 134 patients who had a hysteroscopy, no uterine cancer was detected, and the false positive rate was 46%.
Recent data also from Memorial Sloan-Kettering appearing in the October 15 issue of the same journal corroborates this finding. Of the 111 women who had biopsies every 6 months over a 5-year period, none had evidence of endometrial cancer. The authors concluded that the utility of routine endometrial biopsies for screening in tamoxifen-treated women is limited.
From his own examination of the data, Hudis concluded that a history and physical exam several times a year is justified, "if for nothing else than to remind people to check their blood pressure." And a mammogram once a year can be justified, although he pointed out that there are no randomized trials looking at mammography for post-treatment of breast cancer. From the recent data, ultrasound screening for uterine cancer appears to have no benefit, and nothing else can be justified.
In a discussion of these data, Daniel Goodenberger, M.D., from Washington University School of Medicine, St. Louis, said, "Despite our almost ineradicable urge to do something for our patients, it may well be that, after definitive initial therapy, the best approach for breast cancer is dont just do something, stand there. "
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