Journal of Clinical Oncology, Vol 13, 424-429, Copyright © 1995 by American Society of Clinical Oncology
High complete remission rates with primary neoadjuvant infusional chemotherapy for large early breast cancer
IE Smith, G Walsh, A Jones, J Prendiville, S Johnston, B Gusterson, F Ramage, H Robertshaw, N Sacks and S Ebbs
Breast Unit, Royal Marsden Hospital, London, England.
PURPOSE: To investigate the efficacy of continuous infusion fluorouracil
(5FU) with every-3-week epirubicin and cisplatin (ECF) as primary
chemotherapy instead of immediate mastectomy for patients with large,
potentially operable, breast cancer. PATIENTS AND METHODS: Fifty patients
with large operable breast cancer, median tumor diameter 6 cm (range, 3 to
12), were treated with 5FU 200 mg/m2/d via a Hickman line using an
ambulatory pump for 6 months with epirubicin 50 mg/m2 intravenously (IV)
and cisplatin 60 mg/m2 IV every 3 weeks for eight courses. Subsequent
surgery and/or radiotherapy was determined by clinical response. RESULTS:
Forty-nine patients achieved an overall response (98%; 95% confidence
interval [CI], 94% to 100%), including 33 complete clinical remissions
(CRs) (66%; 95% CI, 53% to 79%). Only three patients (6%) still required
mastectomy. Tumor cellularity was markedly reduced on repeat needle biopsy
following 3 weeks of treatment in 81% of patients versus only 36% in
similar patients after conventional chemotherapy (P < .002). Severe
(World Health Organization [WHO] grade 3 to 4) toxicity was rare, with
nausea/vomiting being the most common, occurring in 20% of patients.
CONCLUSION: Primary infusional ECF appears to be more active on clinical
and histopathologic grounds than conventional chemotherapy for large
operable breast cancer and is well tolerated. This approach now merits
randomized comparison to determine if high CR rates may translate into
improved survival.
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