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Abstract
Purpose: The aim of this phase Ill study was to evaluate in a randomized way the efficacy of adding sequential half both irradiation (SHBI) to standard adjuvant chemotherapy for high-risk breast cancer with
-l0 positive lymph nodes.
Patients and Methods: Seventy patients with node positive (l0) breast cancer were randomly allocated to receive either 6 cycles of (FEC 100) cyclophospharnide 500 mg/rn2, 5FU 500 mg/rn2 and epirubicin 100 mg/rn2 followed by postoperative local irradiation (Arm A) versus the same adjuvant treatment plus consolidation SHBI staring with upper half 75OcGy /5 Fs/lw then one month gap followed by the lower half for the same dose (Arm B) Results: Arm A (n=35) and arm B (n=35) were almost comparable with the respect to different prognostic factors. There was apparent improvement in the disease free survival (DFS) at 3 years in arm B. The DFS was 578% in arm B while it was 26÷10% in arm A (P =0.0658). This difference reached statistical significance in 2 subgroups of patients with less potential metastatic burden, which are T2 cases and ER positive cases. In the subgroup of patients with T2 tumors (n=31), the DFS at 2 years was 66% in arm B and it was 46°c in arm A (P=0.03). In the subgroup of patients with ER positive tumors (n=51), the DFS at 2 years was 53% in arm B and it was 34% in arm A (P=0.02). The complications of the addition of SHBI were mild (grades 2 and 3) and mainly gastrointestinal (vomiting, diarrhea and colic). In both arms of the study there were no life-threatening complications or treatment-related mortality.