HIGH COMPLETE REMISSION RATES WITH PRIMARY NEOADJUVANT INFUSIONAL CHEMOTHERAPY FOR LARGE EARLY BREAST-CANCER

Purpose: To investigate the efficacy of continuous infusion fluorourac il (5FU) with every-3-week epirubicin and cisplatin (ECF) as primary c hemotherapy instead of immediate mastectomy for patients with large, p otentially operable, breast cancer. Patients and Methods: Fifty patien ts with large operable breast cancer, tumor diameter 6 cm (range, 3 to 12), were treated with 5FU 200 mg/m(2)/d via a Hickman line using an ambulatory pump for 6 months with epirubicin 50 mg/m(2) intravenously (IV) and cisplatin 60 mg/m(2) IV every 3 weeks for eight courses. Subs equent 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 r epeat 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) toxici ty 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 chem otherapy for large operable breast cancer and is well tolerated. This approach now merits randomized comparison to determine if high CR rate s may translate into improved survival.