PRIMAIRE HOOG GEDOSEERDE CHEMOTHERAPIE MET HEMATOPOETISCHE GROEIFACTOREN GEVOLGD DOOR CHIRURGIE EN RADIOTHERAPIE BIJ STADIUM III-MAMMACARCINOOM; EEN FASE II-ONDERZOEK BIJ 15 PATIENTEN

Objective. To establish if the prognosis of a stage III breast carcinoma is improved by primary high-dose chemotherapy in combination with haemopoietic growth factors, followed by radical surgery and radiotherapy. Design. Phase II study. Setting. University Hospital Free University, Amsterdam. Method. Fifteen patients with a locally advanced breast carcinoma (stages IIIA or IIIB) were treated every three weeks with doxorubicin 90 mg'sq.m. and cyclophosphamide 1000 mg/sq.m., followed by granulocyte-macrophage colony-stimulating factor (GM-CSF) 250 μg/sq.m. from day 2 up to and including day 12. After 4-6 of these courses the treatment in principle was continued with a modified radical mastectomy, followed by radiotherapy. Median duration of follow-up was 18 months. Results. All tumours were reduced by over 50%. 10/15 Patients went into clinical complete remission; in 6/9 of these, pathological examination revealed only microscopical tumour rests, in the other three the rest diameter was ≤ 1 cm. The haematological toxicity was mild. Grade IIV-IV bone marrow suppression was followed by rapid return to normal of the numbers of neutrophil granulocytes and thrombocytes under the influence of GM-CSF. The non-haematological toxicity manifested itself with nausea and vomiting, stomatitis and mild side effects attributable to GM-CSF. Conclusion. It appears justified in the treatment of locally advanced breast carcinoma to start with chemotherapy. Dose escalation of efficacious chemotherapeutics resulted in a large number of complete remissions.