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Sixty-five patients with operable breast cancer were studied to assess the reliability of immunocytochemical analysis of oestrogen receptor (ER-ICA) in specimens obtained by percutaneous fine needle aspiration. Results obtained with the commercially available ER-ICA kit were compared with those obtained by the routine biochemical radioligand assay of oestrogen receptor (ER) on excised tumour specimens. Fifty-two of 65 percutaneous aspirates were evaluable. Of these, thirty-five (67%) were ER positive by the radioligand method. ER-ICA was found to be a reliable method for oestrogen receptor assay, with a high concordance (90.4%) between it and the radioligand essay. The ER-ICA assay had a sensitivity of 89%, specificity of 94%, positive predictive value of 97% and negative predictive value of 80%. ER-ICA assay performed on material obtained by fine-needle aspiration is a reliable method of ER assay. It can replace formal biopsy for patients with inoperable primary tumours or accessible metastases.

Survival data for 2006 women who had oestrogen receptor assay carried out on primary breast cancer tissue between 1976 and 1982 are presented. There was a significant trend to shorter survival in patients with low ER levels than in those with high ER levels (P less than 0.01). This trend was evident in both pre- and post-menopausal women. The point of maximum discrimination between prognostic groups occurred at 8 fm in premenopausal women and the four year survival rates of patients above and below this level were 84% and 48%, respectively. In post-menopausal women, maximum discrimination occurred at 90 fm, and the four year survival rates above and below this level were 82% and 64%, respectively.

The validation of a prognostic index for patients with primary breast cancer is described. The actual survival data in a group of 383 patients was compared with expected survival predicted by an index based on axillary lymph node status, oestrogen receptor, progesterone receptor and age. There was no significant difference between actual and predicted deaths for five ranges of index value at 2 years and for the three highest ranges of index value at 5 years. However, in the two lowest ranges, the index significantly underpredicted deaths at 5 years. The Cox proportional hazards model was used to determine if there was any significantly better combination of coefficients and covariates to predict survival in the test group. The original index--1 = N + E + P + A, where N = 0 if no nodes are involved, 13 if one to three nodes are involved, and 31 if more than three nodes are involved; E = 15 if oestrogen receptor value is less than 10 fmol/mg cytosol protein and 0 otherwise; P = 12.5 if progesterone receptor value is less than 10 fmol/mg cytosol protein and 0 otherwise; and A = number of years over age 65--was as good as any competing model in ranking survival prospects in the test group. However, it was a less sensitive predictor in this group than in the original set of patients. A second index based on tumour size, hormone receptor status and age, for use when lymph node status was unavailable, was tested by the same method and validated.(ABSTRACT TRUNCATED AT 250 WORDS)

Eighty-one women who had received hormonal therapy for advanced disease were assessed for objective response to treatment. Another 73 patients who had received chemotherapy were similarly studied. Patients with ER - tumours had a significantly poorer response rate to hormonal therapy than those with ER + tumours (P less than 0.05) and a significant trend toward an increasing rate of response occurred with increasing quantitative levels of receptor (P less than 0.01). This trend was even more significant when the assay had been performed on recurrent tumour (P less than 0.001), suggesting that this provides a more accurate index of response to hormonal treatment than assays performed on the primary lesion. These results suggest that whilst the quantitative receptor level used to discriminate between 'negative' or 'positive' assays is appropriate, this division is an over-simplification. Oestrogen receptor was not helpful in predicting response to chemotherapy.

Sixty-six women who had received hormonal therapy for advanced disease were assessed for objective response to treatment. Another 51 patients who had received chemotherapy were similarly studied. Progesterone receptor was of no value as a predictor of patients unlikely to respond to hormone therapy, though it may have a role in predicting patients likely to respond favourably. The addition of progesterone receptor data to oestrogen receptor data may increase prediction of response in the ER+ range but clinicians should be cautious in their interpretation of progesterone receptor results in the ER- range. Progesterone receptor was of no value in predicting response to chemotherapy in this series. Analysis of survival data of 1731 women with primary breast cancer showed a highly significant trend toward longer survival in patients with progesterone receptor positive tumours than in those with receptor negative tumours (P less than 0.001). This trend was evident in both pre- and post-menopausal women. Even though the prognostic discrimination provided by progesterone receptor was correlated with that of oestrogen receptor, the addition of progesterone receptor data to oestrogen receptor data significantly improved prediction of survival (P less than 0.05).