Summary More accurate criteria are required for the selection of patients with node-negative breast cancer for systemic adjuvant therapy. Expression of epidermal growth factor receptor (EGFr) has been shown previously to be inversely related to oestrogen receptor (ER) in patients with operable breast cancer and to be associated with a poorer prognosis. Analysis of EGFr and ER was performed on tumour samples from 231 patients with operable breast cancer followed for up to 6 years after surgery. The median duration of follow-up in patients still alive at the time of analysis was 45 months. Thirty-five percent of patients (82) The histological status of the axillary lymph nodes, specifically the absolute number of nodes involved, remains the most potent prognostic marker for patients with operable breast cancer (Valagussa et al., 1978;Fisher et al., 1983). Tumour recurrence and death due to breast cancer, however, affects a significant proportion of patients with node-negative disease (Fisher et al., 1989c). Recurrence rates of up to 43% and mortality at 10 years of 32% have been reported (Fisher et al., 1989b), suggesting a need for effective adjuvant systemic therapy for selected patients in this supposedly good prognostic subgroup.It is now recognised that there is a need for a marker (or markers) capable of discriminating patients with axillary node-negative disease at high risk of recurrence and death. Tumour oestrogen receptor (ER) content has been proposed but there is disagreement about its value (Cooke et al., 1979;Fisher et al., 1988 Valagussa, 1987).There have been several reports describing the presence of specific, high affinity receptors for epidermal growth factor (EGFr) on membranes prepared from primary human breast carcinoma (Sainsbury et al., 1985;Perez et al., 1984). These studies showed a marked inverse relationship between expression of EGFr and ER. Tumours which overexpressed EGFr were associated with a poor overall prognosis (Sainsbury et al., 1987;Rios et al., 1988) but short follow-up precluded close examination of patient subgroups in particular nodenegative patients. Continued prospective patient follow-up and increased patient numbers now allows examination of the prognostic value of EGFr, particularly in node-negative patients.
Patients and methodsTwo hundred and thirty-one consecutive patients with operatable breast cancer and without biochemical or radiological evidence of distant metastases were treated by simple mastectomy (n = 181) or wide local excision and post-operative radiotherapy by external beam and iridium wire implants (n = 50). Level I axillary nodes (behind pectoralis major) were sampled if palpable at surgery (n = 129, 56%). An average of four nodes were sampled and for those with positive nodes an average of three contained metastatic tumour (range 1-8). In patients treated by mastectomy adjuvant radiotherapy was given to the ipsilateral axilla if the nodes were involved. No patient received adjuvant chemotherapy in this study. Forty patients towards the end of the s...