title: [Primary high-dose chemotherapy with hematopoietic growth factors followed by surgery and radiotherapy in stage III breast carcinoma; a Phase II study in 15 patients].
abstract: 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.
  
  
  METHODS
  Phase II study.
  
  
  METHODS
  University Hospital Free University, Amsterdam.
  
  
  METHODS
  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 micrograms/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 < or = 1 cm. The haematological toxicity was mild. Grade III-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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Afd. Geneeskundige Oncologie, Academisch Ziekenhuis Vrije Universiteit, Amsterdam.
authors.forename: K
authors.initials: K
authors.lastname: Hoekman
authors.forename: J
authors.initials: J
authors.lastname: Wagstaff
authors.forename: J B
authors.initials: JB
authors.lastname: Vermorken
authors.forename: S
authors.initials: S
authors.lastname: Meijer
authors.forename: O W
authors.initials: OW
authors.lastname: Meijer
authors.forename: H M
authors.initials: HM
authors.lastname: Pinedo
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D015411:Mastectomy, Modified Radical; D008875:Middle Aged; D010198:Pancytopenia / Q000139:chemically induced / Q000517:prevention & control; D011379:Prognosis; D011879:Radiotherapy Dosage; D015996:Survival Rate
chemical_list: D004317:Doxorubicin; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D003520:Cyclophosphamide
vernacular_title: Primaire hoog gedoseerde chemotherapie met hematopoëtische groeifactoren gevolgd door chirurgie en radiotherapie bij stadium III-mammacarcinoom; een fase II-onderzoek bij 15 patiënten.