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Observational Study
. 2022 Jul;198(7):612-621.
doi: 10.1007/s00066-022-01944-z. Epub 2022 May 2.

Whole breast radiotherapy in cN0 early breast cancer patients with pathological sentinel lymph nodes (pN1mic, pN1a) without axillary dissection: preliminary results of the observational LISEN trial

Lucia Anna Ursini  1 , Marianna Nuzzo  1 , Consuelo Rosa  2   3 , Marzia Borgia  1 , Luciana Caravatta  1 , Monica Di Tommaso  1 , Marianna Trignani  1 , Fiorella Cristina Di Guglielmo  1 , Giampiero Ausili Cefaro  1 , Domenico Angelucci  4 , Marzia Muzi  5 , Gianluigi Martino  6 , Ettore Cianchetti  7 , Simona Grossi  7 , Saveria Tavoletta  7 , Davide Brocco  8 , Antonino Grassadonia  9 , Nicola Tinari  9 , Simona Gildetti  10 , Nicola D'Ostilio  10 , Liborio Stuppia  11 , Annamaria Porreca  12 , Marta Di Nicola  13 , Domenico Genovesi  1   14
Affiliations
Observational Study

Whole breast radiotherapy in cN0 early breast cancer patients with pathological sentinel lymph nodes (pN1mic, pN1a) without axillary dissection: preliminary results of the observational LISEN trial

Lucia Anna Ursini et al. Strahlenther Onkol. 2022 Jul.

Abstract

Purpose: Axillary management remains unclear when sentinel lymph node (SLN) results are positive in cN0 patients with breast cancer (BC). The trial ACOSOG Z0011 represented a revolution with axillary lymph node dissection (ALND) omission in SLN+ patients, despite critiques regarding non-uniformity of radiation fields. We conducted an observational study (LISEN) where whole breast radiotherapy (WBRT) was planned with tangential fields without nodal irradiation in patients eligible for the Z0011 trial.

Methods: Inclusion criteria were female patients with histologically proven BC, cT1-2cN0, planned conservative surgery, no neoadjuvant therapy. Patients were stratified into two groups: micrometastatic (pN1mic, group 1) and macrometastatic (pN1a, group 2) lymph nodes. Tangential field WBRT was mandatory. Clinical outcomes were analysed, measured from surgery until the first event.

Results: In all, 199 patients underwent conservative surgery and SLN biopsy; 133 patients meeting criteria were analysed: 41 patients (30.8%) pN1mic and 92 (69.2%) pN1a. The 5‑year disease-free survival (DFS) was 95.0% (85.9-100%) in group 1 and 93.0% (86.3-100.0%) in group 2 (p = 0.78). Overall survival (OS) was 100% (100-100%) in group 1 and 97.4% (92.4-100%) in group 2 (p = 0.74). For the whole cohort DFS and OS were 93.6% (88.2-99.4%) and 96.9% (91.5-100.0%), respectively. For groups 1 and 2, the 5‑year outcomes were 5.0% (0.0-14.4%) and 2.3% (0.0-6.1%) for local recurrence (p = 0.51), and 6.2% (0.0-17.4%) and 7.0% (0.0-13.7%) for distant metastasis (p = 0.61), respectively. In group 1, regional recurrence (RR) and local regional recurrence (LRR) were 5.0% (0.0-14.1%; p = 0.13). In group 2, RR and LRR were 0.0% (0.0-0.0%).

Conclusion: Our results showed good regional control in patients who met the Z0011 trial criteria. WBRT, without nodal surgery or RT, avoiding axillary morbidity, seems to be a good choice.

Keywords: Axillary surgery omission; Breast cancer; Conservative surgery; Radiotherapy; Sentinel lymph node.

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Figures

Fig. 1
Fig. 1
Flowchart of patients of the LISEN trial. pts patients, RT radiotherapy
Fig. 2
Fig. 2
Kaplan–Meier curves adjusted for age for pN groups evaluated for overall survival (OS, a) and disease-free survival (DFS, b). P-values for difference between two groups of curves were calculated by the log rank test
See this image and copyright information in PMC

References

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