Purpose: To investigate the tolerability and impact on progression-fre
e and overall survival of two consecutive cycles of high-dose chemothe
rapy (HDC) with autologous bone marrow transplantation (ABMT) in patie
nts with previously untreated metastatic breast cancer. Patients and M
ethods: Twenty-eight patients received conventional-dose induction the
rapy (ITx) followed by a planned two cycles of HDC with ABMT. Median a
ge was 45 years (range, 34 to 60 years). Sites of disease were bone (s
even patients), visceral (three), soft tissue (11), multiple (six), an
d CNS (one). The ITx regimens of cyclophosphamide, Adriamycin (doxorub
icin; Adria Laboratories, Columbus, OH), methotrexate, fluorouracil, p
rednisone, and tamoxifen (CAMFTP) (three patients); fluorouracil, doxo
rubicin, and cyclophosphamide (FAG; 11 patients); cyclophosphamide, me
thotrexate, and fluorouracil (CMF; four patients); or doxorubicin or m
itoxantrone/cyclophosphamide (10 patients) were given to maximum respo
nse (three to five cycles). HDC was cyclophosphamide 6 g/m(2), carbopl
atin 2 g/m(2), and etoposide 625 mg/m(2) with ABMT. Results: Of 28 pat
ients, 24 received two (86%) cycles of HDC. Four received only one cyc
le due to persistent toxicity from course 1 (one patient), no response
to course 1 (two), and death on course 1 (one). Grade 3 to 4 nonhemat
ologic toxicities included mucositis (in one or both cycles in 21 of 2
8 patients; 75%), diarrhea, nausea, and vomiting. Reversible periphera
l neuropathy wets seen in 15 of 28 patients and was severe in one. Doc
umented infections were seen in 19 of 52 cycles. There was one transpl
ant-related death. Six patients were converted from partial remission
(PR) to complete remission (CR) with HDC; two of 24 patients (8%) were
converted from PR to CR with the second cycle of HDC. Progression-fre
e survival rate is nine of 28 patients (32%) with median follow-up of
23 months (range, 13 to 36+ months). Eighteen of 28 patients (64%) hav
e progressed at I to 17 months from ABMT. Conclusion: Two cycles of HD
C with ABMT wets well tolerated with ct high response rate in patients
with metastatic breast cancer. The importance of the second cycle of
HDC in this population is unclear. (C) 1995 by American society of Cli
nical Oncology.