Adjuvant chemo(immuno-)-therapy of primary breast cancer with adriamycin-cyclophosphamide (and levamisole)--six-year evaluation.

In a phase II-type study 52 patients with no signs of metastases but with a high risk of recurrence were treated with 6 courses of adriamycin-cyclophosphamide as adjuvant systemic therapy following modified radical mastectomy of primary breast cancer. Half of the patients were randomized to receive additional immunotherapy with levamisole for 2 yr. The scheduled dose and time regimen could be achieved in over 90% of patients. A comparison of the actuarial disease-free and overall survival with data reported in the literature indicates a similar positive effect of adjuvant systemic therapy as described in adjuvant studies using polychemotherapy regimens. Immunotherapy with levamisole has no effect on disease-free and overall survival but added to general toxicity. Particular attention was paid to psychological consequences of adjuvant systemic therapy; consistent attention by one specifically trained physician during the whole therapy and follow-up period was effective in coping with the emotional problems. The difficulties in treating recurrences after adjuvant therapy became apparent. A high rate of loco-regional recurrences and of cerebral metastases was noted.