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PURPOSE: Primary chemotherapy was administered to patients with tumors that measured > or = 2.5 cm in largest diameter to decrease the size of the primary tumor and allow for effective local and distant control while avoiding mastectomy. PATIENTS AND METHODS: Two prospective nonrandomized studies were performed that used different regimens of primary chemotherapy followed by breast-sparing surgery in the presence of objective tumor remission. Additional postoperative chemotherapy was given to women at high risk of disease relapse. The median follow-up duration was 65 months. RESULTS: A total of 536 assessable patients were enrolled, and the main characteristics were fairly comparable between the two trials. Following primary chemotherapy, 85% of patients could be subjected to breast-sparing surgery; in 14 patients (3%), surgical specimens failed to show any residual neoplastic cell. In the final multivariate analysis, the histologically assessed extent of axillary node involvement (P 5.0 cm) and can allow breast-sparing surgery in a high fraction of patients (62%). However, to assess effectively the worthiness of this approach on long-term results, properlyconceived large randomized studies with newer and more effective drug regimens are warranted.
Bonadonna et al. (Thu,) studied this question.