We treated 20 women with locally advanced breast cancer between January 199
1 and September 1996. The treatment regimen included 4 cycles of intensive
doxorubicin (30 mg/m(2)/d on 3 consecutive days every 2 weeks with G-CSF su
pport), followed by appropriate surgery, followed by high dose therapy with
cyclophosphamide, carboplatin and thiotepa (STAMP V, CTCb), Of the 20 pati
ents, seven presented with inflammatory breast cancer, three with Stage III
B, seven with stage IIIA, one with multifocal Stage IIB and two with Stage
IV M1 (ipsilateral supraclavicular lymph node involvement) (including one w
ho had an inflammatory primary) disease, Six patients had not undergone mas
tectomy at the time of entering the protocol, These six received the doxoru
bicin in a neoadjuvant fashion and were thus evaluable for tumor response,
The remaining 14 received doxorubicin as adjuvant therapy prior to intensif
ication and transplantation. All patients underwent local-regional radiatio
n therapy and were placed on oral tamoxifen, Doxorubicin was well tolerated
in this schedule with all but three patients receiving all their cycles on
schedule, Both BM and PBPC were easily collected after this regimen and, w
hen reinfused, resulted in the prompt recovery of granulocytes (median 11 d
ays to 500 absolute granulocyte count) and platelets (median 13 days to 200
00 platelets). The six patients who received doxorubicin prior to mastectom
y all had major clinical responses, but were found to have microscopic foci
i of breast cancer in the mastectomy specimens, The overall treatment was w
ell tolerated with the exception of one treatment-related death (5%). The o
verall and relapse free survival are 70% and 58% respectively with a median
follow-up of 40 months (range 12-74 months), When the Stage IV patients ar
e censored, the relapse-free survival rate is 69%, In the bone marrow trans
plant phase of treatment, the major nonhematologic toxicities were stomatit
is (70%) and anorexia requiring parental nutrition (75%).