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(Drug information on epirubicin) and cisplatin(Drug information on 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(Drug information on cyclophosphamide)/methotrexate/5-FU (CMF) and mitomycin(Drug information on 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.