title: Phase II study of intensive chemotherapy with autologous bone marrow transplantation in patients in complete remission of disseminated breast cancer.
abstract: BACKGROUND
  This trial studied the disease-free survival after high-dose chemotherapy in patients in complete remission of metastatic breast cancer.
  
  
  METHODS
  Thirty women, mean age 42.2 years (range 33-55) with metastatic breast cancer, received high-dose chemotherapy in a phase II study. Patients were eligible if they were < or = 55 years of age, had achieved complete remission within 6 months of the initiation of chemotherapy, and had a WHO performance scale of 0 or 1. The high-dose regimen consisted of melphalan 180 mg/m2 and mitoxantrone 60 mg/m2 both divided over 3 days. On day 7 bone marrow and/or peripheral stem cells were infused. After bone marrow recovery, external beam radiation was administered to sites of previous metastatic disease in 15 patients.
  
  
  RESULTS
  Apart from leuko- and thrombocytopenia, mucositis was the major side effect. One patient died during the bone marrow transplant period due to an aspergillus infection. The median follow-up since high-dose chemotherapy is 25 months (range 13 to 56 months). The median disease-free survival since high-dose chemotherapy is 27 months and the disease free survival is still 43% with an overall survival of 53% at 3 years. In two patients tumor relapse occurred only in the brain; in one patient the only relapse sign was a meningeal carcinosis. At the moment 17 patients are disease-free (13(+)-56+) months after high-dose chemotherapy.
  
  
  CONCLUSIONS
  Until now this high-dose regimen in selected patients with complete remission after induction chemotherapy for metastatic breast cancer has a promising disease free survival.
authors.affiliation: Dutch Working Party on ABMT in Solid Tumors, Department of Medical Oncology, University Hospital Groningen, The Netherlands.
authors.forename: E G
authors.initials: EG
authors.lastname: de Vries
authors.forename: S
authors.initials: S
authors.lastname: Rodenhuis
authors.forename: H C
authors.initials: HC
authors.lastname: Schouten
authors.forename: P S
authors.initials: PS
authors.lastname: Hupperets
authors.forename: W V
authors.initials: WV
authors.lastname: Dolsma
authors.forename: J V
authors.initials: JV
authors.lastname: Lebesque
authors.forename: G H
authors.initials: GH
authors.lastname: Blijham
authors.forename: M
authors.initials: M
authors.lastname: Bontenbal
authors.forename: N H
authors.initials: NH
authors.lastname: Mulder
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016026:Bone Marrow Transplantation; D001943:Breast Neoplasms / Q000401:mortality / Q000628:therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D015996:Survival Rate; D014182:Transplantation, Autologous