Mastectomy with axillary clearance versus mastectomy without it. Late results of a trial in which patients had no adjuvant chemo-, radio- or endocrine therapy.

OBJECTIVE: Long-term outcome of comparison of mastectomy with axillary clearance to mastectomy without it. DESIGN: Second analysis of a terminated prospective randomised trial. SETTING: The Breast Clinic, Groote Schuur Hospital, Cape Town. PATIENTS: Ninety-five women aged under 76 years with stages 1 and 2 (T1-2 NO-1 MO) breast cancer. INTERVENTIONS: Radical mastectomy (mastectomy and formal axillary dissection with pectoral muscle excision) or simple mastectomy (mastectomy without axillary dissection if nodes were not clinically palpable, or local excision of the nodes if they were). OUTCOME MEASURES: Loco-regional recurrence and survival. RESULTS: Whereas initial analysis at 40 months had showed more axillary recurrences (P = 0.056) in the simple mastectomy group (leading to the termination of the trial), this difference has disappeared at 10 years (P = 0.113). There was no difference in rate of recurrence at all other sites, time to recurrence, or survival rates at 40 months or at 10 or 25 years. CONCLUSIONS: Full axillary clearance offered no better long-term loco-regional control or survival. Early analysis and marginally significant differences in axillary recurrence prompted premature termination of this trial.

A re-evaluation of isotope screening for skeletal metastases in node-negative breast cancer.

OBJECTIVE: To determine the accuracy and cost-effectiveness of skeletal scintigraphy in women with early, node-negative (T1-2N0M0) breast cancer. DESIGN: Retrospective, where scintigraphic prediction of metastases was compared with the criterion standard of radiological confirmation during a follow-up of 5 - 10 years. SETTING: Tertiary referral breast clinic at Groote Schuur Hospital. PATIENTS: Six hundred and seventy-three women with clinical T1-2N0M0 breast cancer who had skeletal scintigraphy between 1974 and 1987, and who had been followed up for more than 5 years. INTERVENTIONS: Initial skeletal scintigraphy, annual follow-up with radiological examination of symptomatic areas. MAIN OUTCOME MEASURES: Correlation of the sites indicated by scintigraphy with the initial presence or later development of metastases at 1 - 10 years, and the cost. RESULTS: Five hundred and sixty-one (83.4%) scans were normal, 35 (5.2%) indicated benign processes, and 77 (11.4%) were suggestive or diagnostic of metastatic disease, with radiological confirmation in 3 (initial detection rate 3/673, 0.44%; accuracy rate 3/77, 3.9%). Of the remaining 74 abnormal scans without radiological confirmation of metastases, 62 has a focus at a single site, and 45 were of low intensity and equivocal, with no apparent explanation. The cumulative sensitivity for predicting site of metastases at 1 year was 33% (3/9) and the positive predictive value 4.0% (3/75). At 10 years the sensitivity was 5.0% (3/60) and the positive predictive value 5.0% (3/65). The total cost of screening was calculated to be R323 460.00, suggesting that the cost for each patient in whom metastases were detected was R64 629.00. CONCLUSION: While scintigraphy may be of value in symptomatic or more advanced disease, screening of node-negative women had a minimal detection rate, was expensive and cannot be supported.

Combined assessment (aspiration cytology and mammography) of clinically suspicious breast masses.

We examined the safety and utility of the combined assessment of aspiration cytology and mammography in 705 women who had clinically suspicious or malignant palpable breast masses. Histological assessment confirmed 176 benign and 529 malignant lesions. There were no incorrect (false positive) diagnoses made in the 176 benign masses when combined assessment was used (specificity 1.0; predictive value 0.86); in isolation, however, there was a false positive cytological diagnosis ('papillary carcinoma') and 3 false positive mammographic diagnoses. Benign disease (false negative) was incorrectly diagnosed by combined assessment in 4 of the 529 malignant masses (sensitivity 0.99; predictive value 0.98): cytological diagnoses were of fat necrosis (2) and benign cells on cytospin (1) and aspiration biopsy (1); mammographic diagnoses were of benign disease (2) and normality (2). Indeterminate ('atypical', 'suspicious') diagnoses were problematic and frequent (overall 223 (31.6%), malignant masses 137 (25.9%), benign masses 86 (48.9%); cytology 117 (16.6%), mammography 141 (20%). Thus, with the combined assessment of mammography and cytology in clinically suspicious breast masses, a decisive diagnosis was made in about two-thirds of cases allowing the safe commencement of therapy; the balance of patients required core or excision biopsy.

Survival after local treatment for early breast cancer.

A 10-year survival rate of 82% was found in 517 women with early localized breast cancer (pathological stage T1-2N0M0) who had been treated with local therapy alone (total mastectomy and axillary clearance). Factors influencing survival were tumour size (T1 versus T2) and age; patients older than 50 years fared better than younger patients at 5 years but this advantage had disappeared at 10 years. Receptor status influenced disease-free survival, but not survival. Recurrence developed in 93 patients--systemic in 46 and local in 47. Support for the contention that all breast cancer is systemic was thus not found at 10 years, and the value of local therapy alone in node-negative women was endorsed.

Malignant tumours of the breast. Frequency distribution by age, race and stage at Groote Schuur Hospital, Cape Town, 1971-1981.

During the 11-year period 1971 - 1981, 2215 new female patients with breast cancer were seen at the Groote Schuur Hospital Breast Clinic, Cape Town. The mean age at presentation of White patients was similar to that in most Western countries, but the disease was seen at an earlier age in Coloured and Black patients. Coloured and Black patients also presented with more advanced disease than White patients. There was, however, a progressive overall trend over the 11 years towards presentation at an earlier stage of the disease.