Steroid Receptors in Breast Cancer National Institutes of Health
Consensus Development Conference Statement
June 27-29, 1979
This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information on this and other health topics, we recommend consulting the National Institutes of Health's MedlinePlus http://www.nlm.nih.gov/medlineplus/.
This statement was originally published as: Steroid Receptors in Breast Cancer. NIH Consens Statement 1979 Jun 27-29;2(6):33-35.For making bibliographic reference to the statement in the electronic form displayed here, it is recommended that the following format be used: Steroid Receptors in Breast Cancer. NIH Consens Statement Online 1979 Jun 27-29 [cited year month day];2(6):33-35.
A Consensus Development Conference on Steroid Receptors in Breast Cancer was held at the National Institutes of Health June 27-29, 1979. The basic question asked at the meeting was:
What is the value of steroid receptor assays to the clinical management of breast cancer?
At NIH, consensus development conferences bring together biomedical research scientists, practicing physicians, consumers, and others as appropriate in an effort to reach general agreement on the efficacy and safety of a medical technology. That technology may be a drug, device, or a medical or surgical procedure.
Following is the list of conclusions drawn by the NIH consensus development panel:
The original results from the 1974 NCI-sponsored meeting on estrogen receptors and human breast cancer, showing the utility of estrogen receptor assays in the management of advanced breast cancer patients, have been confirmed and are found to be strengthened significantly by the studies over the last 5 years. Clearly, few patients whose breast cancers lack cytosol estrogen receptor respond to endocrine therapies, while more than half of patients whose tumors contain estrogen receptors obtain objective remissions from such treatments. Thus, results of estrogen receptor assays provide valuable information for making the clinical decisions on the type of the therapy to be employed.
For most early breast cancer patients sufficient primary tumor should be available for cytosol estrogen receptor assay. At time of recurrence, the metastatic lesions may be inaccessible or otherwise difficult to obtain. It is strongly recommended that each primary tumor be assayed for estrogen receptor so that the assay information will be available when needed at the time of disseminated disease. Current findings indicate that the cytosol estrogen receptor assay result on the primary tumor correlates well with response to endocrine therapy later, even though the time interval between assay and therapy may be more than several years.
It is evident that while almost all breast cancers which respond to endocrine therapy contain estrogen receptor, not all estrogen receptor containing breast cancers respond to endocrine therapy. To obtain additional confidence concerning the probability of patient response to endocrine therapy, one can determine actual quantitative amounts of estrogen receptor since it appears, in general, that patients with tumors containing higher concentrations of cytosol estrogen receptor have an increased likelihood of response to endocrine therapy. Furthermore, knowledge of whether the tumor contains cytosol progestin receptor seems to add appreciably to the ability to predict whether the patient will respond to endocrine therapy.
At the present time, there does not appear to be any histopathologic feature which can predict the estrogen receptor status of the cancer, although more highly differentiated tumors (i.e., histologic grade l) appear to have a higher proportion containing estrogen receptor than do the more poorly differentiated tumors.
There is no clear evidence that responses to chemotherapy correlate with the presence or absence of estrogen receptor. More basic laboratory and/or clinical studies are in order to understand how cancer cells are being affected by cytotoxic agents.
Stage II patients with tumors which lack estrogen receptors appear to recur earlier than those with estrogen receptor positive tumors, independent of the size of the tumor or nodal involvement. Regarding the length of survival or the prognosis for recurrence of Stage 1 patients, more data must be accumulated to determine whether the estrogen receptor status correlates in these cases.
The reliability of steroid receptor assays is paramount to their optimal use for the clinical management of breast cancer. The obtaining of the proper tissue sample is of extreme importance and requires the cooperation of the surgeon, pathologist, and the assay laboratory. The following recommendations are made to the people performing steroid receptor assays:
The tissue sample should be immediately chilled to ice temperature--and maintained at that temperature--and transported to the assay laboratory.
A piece of the tissue sample directly adjacent to the piece for receptor assay should be sent to pathology for evaluation to insure that the sample to be assayed consists of tumor tissue.
If the assay is not done on the same day, the tissue should be stored at -70� C or colder. Prolonged storage of tumor tissue prior to assay is to be discouraged.
Currently, the most reliable and reproducible methods for cytosol estrogen receptor assay appear to be sucrose density gradient sedimentation analysis and multiple point dextran coated charcoal assay analyzed by Scatchard plot. As other methods appear, they should be validated against these methods.
New techniques that localize receptor within tumor cells are desirable and may provide new or additional information. At the present time, no histochemical receptor assay can be considered validated and further work is needed to establish whether any such method has clinical usefulness.
There is a need for quality control of steroid receptor assays. In order to properly support the conduct of clinical trials in breast cancer, a quality control resource should be developed.
Consensus Development Panel
Eugene R. DeSombre, M.D., Chairman
University of Chicago
Paul P. Carbone, M.D.
Wisconsin Clinical Cancer Center
Elwood V. Jensen, M.D.
University of Chicago
Monmer B. Lipsett, M.D.
Clinical Center, National Institutes of Health
William L. McGuire, M.D.
University of Texas School of Medicine
San Antonio, Texas
Samuel A. Wells Jr., M.D.
Duke University Medical Center
Durham, North Carolina
James L. Wittliff, M.D.
University of Louisville
National Cancer Institute, Division of Cancer Biology and Diagnosis
Office of Medical Applications of Research