NEW YORK--Women facing mastectomy because of high-risk early breast
cancer may benefit from a new strategy that reduces tumor size,
allowing conservative surgery or eliminating the need for surgery,
Ian E. Smith, MD, said at the symposium of the Chemotherapy Foundation.
Studies conducted at the Royal Marsden Hospital and Institute
of Cancer Research, London, have achieved significant response
rates and complete remissions with a regimen of high-intensity
preoperative infusional chemotherapy, said Dr. Smith, head of
the Section of Medicine at Royal Marsden.
The current tendency to opt for lump-ectomy over mastectomy in
many breast cancer cases does not address the problems of women
with large tumors. Dr. Smith reported on several pilot studies
of women with poor prognosis, large breast cancers who received
long-term infusions of 5-fluorouracil (5-FU) plus conventional
epirubicin and cisplatin (ECF).
The infusional ECF regimen involved 5-FU delivered by ambulatory
pump and Hickman line in a continuous, 24-hour infusion of 200
mg/m² for 6 months, along with eight 3-week intravenous courses
of 50 mg/m² of epirubicin and 60 mg/m² of cisplatin.
A phase II pilot study treated 50 women with a median age of 44
years and median tumor diameter of 6 cm, all of whom were candidates
for mastectomy. Objective response was observed in 49 women, including
33 complete clinical remissions. Only 3 patients required mastectomy
after the trial; 31 had breast conserving surgery, and 15 (among
the group showing complete remission) received no excisional surgery,
proceeding instead to post-treatment radiotherapy.
Dr. Smith reported that treatment was generally well tolerated,
with severe grade 3-4 toxicity limited to emesis (20%), leukopenia
(2%), and alopecia (28%). The toxicity was similar to that seen
with conventional treatment, he said, even though there was a
fivefold increase in dose-intensity of 5-FU.
He added that the results, particularly complete response rates,
appear to be superior to those achieved with cyclophosphamide/methotrexate/5-FU
(CMF) and mitomycin/mitoxantrone/methotrexate (MMM) regimens.
On 2-year follow-up, local recurrences developed in 10% of patients,
a rate superior to that seen with conventional chemotherapy.