High-dose mitoxantrone-vinblastine-cyclophosphamide and autologous stem cell transplantation for stage III breast cancer: final results of a prospective multicentre study.
BACKGROUND
Stage III breast cancer patients continue to suffer high relapse and death rates despite standard chemotherapy regimens. High-dose alkylator chemotherapy does not further improve outcome. This phase II study evaluated a novel high-dose chemotherapy regimen which combined active breast cancer agents with differing mechanisms of action.


METHODS
Eligibility included at least seven involved axillary nodes (AxLNs) for tumours <5 cm, at least four AxLNs for tumours >5 cm or locally advanced breast cancer (LABC). Patients received four cycles of fluorouracil-adriamycin-cyclophosphamide (FAC) followed by one cycle of mitoxantrone 63 mg/m(2)-vinblastine 12.5 mg/m(2)-cyclophosphamide 6 g/m(2) (MVC) with autologous blood stem cell transplantation (ASCT).


RESULTS
Between April 1995 and December 1998, 92 patients aged 21-65 years (median 45 years) were enrolled, of whom 25 were treated preoperatively for LABC and 67 were treated postoperatively. Although there was no early treatment-related mortality, one late death occurred from secondary acute myeloid leukaemia. The 7-year event-free and overall survival rates were 53% (95% confidence interval 42-64%) and 62% (95% CI 52-73%), respectively, with no significant difference between pre- and postoperative groups.


CONCLUSIONS
FAC followed by MVC-ASCT is feasible and reasonably well tolerated, but does not result in improved survival rates compared with other conventional or high-dose regimens for stage III breast cancer.
Stewart
D A
DA
Department of Medical Oncology, University of Calgary, Canada. douglast@cancerboard.ab.ca
Paterson
A H G
AH
Ruether
J D
JD
Russell
J
J
Craighead
P
P
Smylie
M
M
Mackey
J
J
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008942:Mitoxantrone / Q000008:administration & dosage; D011446:Prospective Studies; D033581:Stem Cell Transplantation; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage
D014747:Vinblastine; D004317:Doxorubicin; D003520:Cyclophosphamide; D008942:Mitoxantrone; D005472:Fluorouracil