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Abstract
Introduction. There are differing opinions regarding the appropriateness of routine irradiation of supraclavicular lymph nodes (LNs) during adjuvant radiotherapy (RT) to areas of regional lymph drainage in patients with early breast cancer (BC).
Aim. To evaluate the possibility of safely avoiding adjuvant radiotherapy in patients with early BC and limited axillary LNs (1-3 metastatic nodes) or 1-2 signaling LNs involvement and no additional risk factors.
Materials and methods. A prospective randomized trial from February 2022 to October 2024 included 121 patients with early BC. All patients were randomized in 2 groups to determine the volume of postoperative radiotherapy. In the control group, postoperative RT was performed in the standard volume - irradiation of the remaining breast tissue or anterior chest soft tissue with axillary level I, II, III LNs and supraclavicular LNs. In the study group, axillary level III LNs and supraclavicular LNs were excluded from the RT volume.
Results. At the time of the interim analysis, 121 patients were enrolled in the study. In 52 women follow-up exceeded 24 months. In this group, the comparative analysis of loco-regional control parameters was performed in 44 patients of the study group (without irradiation of supraclavicular LNs) and 8 patients of the control group who received postoperative standard volume radiotherapy. Two-year survival without evidence of loco-regional recurrence, including in the ipsilateral supra-subclavicular region, was 100% in both groups. The two-year relapse-free survival rate was 97.7% in the study group and 100% in the control group [p>0.2]. One woman in the study group had generalized BC with bone lesions.
Conclusion. De-escalation of adjuvant RT in patients with early BC with lesions of no more than 3 axillary LNs in the first two years of follow-up does not decrease RFS and does not increase the risk of BC recurrence in the supraclavicular region.
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