American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Statement in Response to the Clinical Alert from the National Cancer Institute

A clinical alert from the National Cancer Institute (NCI) was released on May 16, 1988, to a selected group of physicians in the United States. This NCI document described the three-to-four-year follow-up of three prospectively randomized clinical trials investigating adjuvant hormonal or cytotoxic chemotherapy for Stage I, node-negative, breast cancer patients. Based on the NCI's analysis of these unpublished data, the statement concluded: "Outside of a trial setting, the hormonal and chemotherapy treatments described represent credible therapeutic options worthy of careful attention."

The American College of Surgeons recognizes the importance and appropriateness of clinical trials and the desire of the National Cancer Institute "...to inform practicing physicians in advance of publication."

However, release of information about enhanced disease-free survival before practicing physicians have had the opportunity to examine detailed data in relevant scientific publication has resulted in certain physicians' hearing of the clinical alert after patients have read it in their newspapers. The resultant pressure for adjuvant therapy by patients with Stage I breast cancer can place physicians in an untenable position.

The public health implications of treating all Stage I breast cancer patients with adjuvant hormonal or cytotoxic chemotherapy are enormous. Until these clinical trials are published and widely analyzed, the American College of Surgeons believes that practicing surgeons should continue to use their own clinical judgment in recommending for their individual patients any form of adjuvant therapy for Stage I breast cancer.


Reprinted from Bulletin of the American College of Surgeons 
Vol. 73, No. 7, Page 17, July 1988