The National Cancer Institute audit of National Surgical Adjuvant Breast and Bowel Project Protocol B-06

Article Abstract:

An audit of a clinical trial that demonstrated the effectiveness of lumpectomy and irradiation in treating breast cancer found most of the data to be reliable. Protocol B-06 was a multicenter clinical trial that recommended the treatment of early breast cancer with lumpectomy plus radiation, rather than mastectomy or lumpectomy alone. Researchers checked data in the study records against personal medical records for 1,554 of the 2,163 patients in the trial. The auditors attempted to check 7770 data items, including number of positive nodes before treatment, treatment characteristics, tumor relapse in the same breast, and survival. Of these audited data items, 97.5% were found to be accurate, 1.6% could not be checked, and 0.9% were found to be inaccurate. The data was sufficiently accurate for a reanalysis which was conducted.

Investigations, Accounting and auditing, Clinical trials, Fraud in science, Science fraud

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Paradigmatic shifts in the management of breast cancer

Article Abstract:

Recent studies comparing different modes of treatment for breast cancer seem to support the shift in attitudes about the disease. Up until the 1960's, physicians believed that surgery alone would be effective in treating breast cancer. But researchers have now shown that systemic chemotherapy following mastectomy or lumpectomy can prolong survival. This is based on the belief that the tumor may spread to other organs even before the cancer is diagnosed. It is not known whether chemotherapy is directly toxic to cancer cells or whether it suppresses ovarian hormones that can stimulate breast cancer. The important finding from many of the studies of surgery alone or surgery with chemotherapy is how long many treated women survive. In some studies, over 70% are still alive after 10 years, and 25% to 34% are alive after 20 years.

Analysis, Paradigm (Theory of knowledge)

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Ductal carcinoma in situ -- the focus for prevention, screening, and breast conservation in breast cancer

Article Abstract:

Ductal carcinoma in situ is a precursor of invasive breast cancer but it can be cured by breast-conserving surgery without the need for radiation. When surgeons remove the tumor, they usually also remove tissue that extends beyond the tumor to make sure they have removed all of the tumor. This tissue around the tumor is called the margin. A 1999 study of women with ductal carcinoma in situ found that radiation treatment was not needed as long as the width of the margin was at least one millimeter.

Carcinoma in situ

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