Neoadjuvant chemotherapy has become the standard treatment for stage III breast cancer. Gratifying results in these patients prompted this prospective, nonrandomized study of neoadjuvant chemotherapy in stage II breast cancer. This study presents our experience with neoadjuvant chemotherapy in 127 patients with stage II carcinoma of the breast.

Patients with stages IIA (T > 3.0 cm) and IIB carcinoma were considered for this study and underwent treatment with cyclic chemotherapy until a plateau of response was achieved. Responders underwent breast conservation or mastectomy according to conventional assessment. Chemotherapy was continued in the adjuvant setting. Survival data were compared with historic controls.

Between 1981 and 2001, 127 women between the ages of 22 and 80 years (mean age 52, median age 50), with stage II breast cancer were enrolled, with median followup of 60 months. One hundred twenty-two patients (96.1%) responded to chemotherapy. Of this group, 35 (29.2%) experienced complete pathologic responses or had only microscopic foci of disease after treatment. Sixty-two patients (52.5%) had negative lymph nodes at the time of the operation; 28 of these patients were previously considered N-1 clinically. Seventy-six patients (62%) underwent breast conservation. Overall survivals at 5 years for stage IIA and IIB disease were 94.7% and 88%, respectively. Disease-free survival at 5 years was 85.2% for stage IIA patients and 69.1% for stage IIB patients.

Neoadjuvant chemotherapy can be effectively applied to patients with stage II disease, and breast conservation becomes feasible in the majority of patients. When compared with historic controls, the current study suggests a statistically significant overall survival advantage (p < 0.007) at 5 years.