84 patients with large operable breast cancer have been treated with p
rimary medical chemotherapy rather than mastectomy in three sequential
studies. 86% had tumours greater than 4 cm in diameter; median diamet
er was 6 cm (range 1-12). Median age was 46 years (range 23-66). In th
e first two studies 64 patients were treated with either CMF [cyclopho
sphamide 100 mg orally days 1-14, methotrexate 50 mg intravenously (i.
v.) days 1 and 8, and 5-fluorouracil 1 g i.v. days 1 and 8, repeating
at 28-day intervals for six courses] or MMM (mitozantrone 8 mg/m2 i.v.
once every 3 weeks, methotrexate 50 mg i.v. once every 3 weeks, mytom
ycin C 8 mg/m2 once every 6 weeks, for 8 courses). 69% achieved an ove
rall response including 17% complete remissions. 27% have had local re
lapse but only 3% uncontrolled local relapse. Only 14% have required m
astectomy. In the third study which is ongoing, 19 patients have been
treated with infusional FEC (5-fluorouracil 200 mg/m2 i.v. 24 hourly b
y continuous infusion via a Hickman line for 6 months, epirubicin 50 m
g/m2 i.v. bolus once every 3 weeks for 6 months, cisplatin 60 mg/m2 i.
V. once every 3 weeks for 6 months with appropriate intravenous hydrat
ion). Overall response rate so far is 84% with 58% complete remissions
. There have been no local relapses and no patient has required mastec
tomy. This study demonstrates that primary medical chemotherapy can be
used to avoid mastectomy in the great majority of patients presenting
with large operable primary breast cancer. Infusional FEC may be more
active than conventional chemotherapy in terms of overall response an
d complete remission rate, and infusional FEC chemotherapy now needs t
o be compared with conventional chemotherapy. The concept of primary m
edical therapy should also be compared with conventional mastectomy fo
llowed by adjuvant chemotherapy.