AIM OF THE STUDY: The aim of this randomised trial was to determine advantages and drawbacks of neo-adjuvant chemotherapy in patients with operable breast cancers > 3 cm. MATERIAL AND METHODS: Two hundred and seventy-two women (age 70) with operable breast cancers larger than 3 cm (T2-3/N0-1/M0) were included in a randomised trial from January 1, 1985 to April 30, 1989. Patients in group A (n = 138) were treated by mastectomy and axillary node dissection. Adjuvant chemotherapy was indicated for 104 patients with axillary node involvement (n = 82) or negative oestrogen and progesterone receptors (EPR-) (n = 22). Patients in group B (n = 134) were treated by initial chemotherapy (identical as in group A) followed by locoregional treatment according to the response. Before treatment, the average of clinical tumoural diameter was 43 mm. RESULTS: The median follow-up was 124 months. In group B, 49 patients (36.5%) were resistant to chemotherapy; a conservative breast surgical treatment was performed in the other 84 patients sensitive to chemotherapy (62.6%). In this last subgroup, 19 (22.6%) needed a secondary mastectomy because of locoregional recurrence. Survival rates were not different in groups A and B, but loco-regional recurrences were frequent in group B. At 10 years, the overall survival rate was 60% and half of living patients in group B were free of cancer and with their breast. CONCLUSION:Neoadjuvant chemotherapy permitted in two-thirds of cases breast conservation treatment, initially considered to be impossible. Locoregional recurrences are more frequent than after mastectomy and adjuvant chemotherapy.
RCT Entities:
AIM OF THE STUDY: The aim of this randomised trial was to determine advantages and drawbacks of neo-adjuvant chemotherapy in patients with operable breast cancers > 3 cm. MATERIAL AND METHODS: Two hundred and seventy-two women (age 70) with operable breast cancers larger than 3 cm (T2-3/N0-1/M0) were included in a randomised trial from January 1, 1985 to April 30, 1989. Patients in group A (n = 138) were treated by mastectomy and axillary node dissection. Adjuvant chemotherapy was indicated for 104 patients with axillary node involvement (n = 82) or negative oestrogen and progesterone receptors (EPR-) (n = 22). Patients in group B (n = 134) were treated by initial chemotherapy (identical as in group A) followed by locoregional treatment according to the response. Before treatment, the average of clinical tumoural diameter was 43 mm. RESULTS: The median follow-up was 124 months. In group B, 49 patients (36.5%) were resistant to chemotherapy; a conservative breast surgical treatment was performed in the other 84 patients sensitive to chemotherapy (62.6%). In this last subgroup, 19 (22.6%) needed a secondary mastectomy because of locoregional recurrence. Survival rates were not different in groups A and B, but loco-regional recurrences were frequent in group B. At 10 years, the overall survival rate was 60% and half of living patients in group B were free of cancer and with their breast. CONCLUSION: Neoadjuvant chemotherapy permitted in two-thirds of cases breast conservation treatment, initially considered to be impossible. Locoregional recurrences are more frequent than after mastectomy and adjuvant chemotherapy.