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; Marianna Nuzzo; Consuelo Rosa; Marzia Borgia; Luciana Caravatta; Monica Di Tommaso; Marianna Trignani; Fiorella Cristina Di Guglielmo; Giampiero Ausili Cefaro; Domenico Angelucci; Marzia Muzi; Gianluigi Martino; Ettore Cianchetti; Simona Grossi; Saveria Tavoletta; Davide Brocco; Antonino Grassadonia; Nicola Tinari; Simona Gildetti; Nicola D'Ostilio; Liborio Stuppia; Annamaria Porreca; Marta Di Nicola; Domenico Genovesi

doi:10.1007/s00066-022-01944-z

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

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

Authors

Lucia Anna Ursini¹, Marianna Nuzzo¹, Consuelo Rosa^{2

3}, Marzia Borgia¹, Luciana Caravatta¹, Monica Di Tommaso¹, Marianna Trignani¹, Fiorella Cristina Di Guglielmo¹, Giampiero Ausili Cefaro¹, Domenico Angelucci⁴, Marzia Muzi⁵, Gianluigi Martino⁶, Ettore Cianchetti⁷, Simona Grossi⁷, Saveria Tavoletta⁷, Davide Brocco⁸, Antonino Grassadonia⁹, Nicola Tinari⁹, Simona Gildetti¹⁰, Nicola D'Ostilio¹⁰, Liborio Stuppia¹¹, Annamaria Porreca¹², Marta Di Nicola¹³, Domenico Genovesi^{1

14}

Affiliations

¹ Department of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
² Department of Radiation Oncology, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy. c.rosa155@gmail.com.
³ Department of Neuroscience, Imaging and Clinical Sciences, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy. c.rosa155@gmail.com.
⁴ Department of Pathological Anatomy, ASL 02 Lanciano-Vasto-Chieti, Via dei Vestini, 66100, Chieti, Italy.
⁵ Division of Breast Radiology, Department of Radiology, G. Bernabeo Hospital, Contrada Santa Liberata, 66026, Ortona, Chieti, Italy.
⁶ Department of Radiological Sciences, Institute of Nuclear Medicine, SS. Annunziata Hospital, Via dei Vestini, 66100, Chieti, Italy.
⁷ Division of Surgical Senology, G. Bernabeo Hospital, Contrada Santa Liberata, 66026, Ortona, Chieti, Italy.
⁸ Clinical Oncology Unit, SS. Annunziata Hospital, Via dei Vestini, 66100, Chieti, Italy.
⁹ Department of Medical, Oral and Biotechnological Sciences and CeSI-MeT, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
¹⁰ Department of Oncology, Floraspe Renzetti Hospital, Via per Fossacesia 1, Lanciano, 66034, Chieti, Italy.
¹¹ Center for Advanced Studies and Technology (CAST), "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
¹² Department of Economics, "G. D'Annunzio" University of Chieti-Pescara, Pescara, Italy.
¹³ Laboratory of Biostatistics, Department of Medical, Oral and Biotechnological Sciences, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.
¹⁴ Department of Neuroscience, Imaging and Clinical Sciences, "G. D'Annunzio" University of Chieti, Via dei Vestini, 66100, Chieti, Italy.

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.

Publication types

Observational Study

MeSH terms

Axilla / pathology
Breast Neoplasms* / radiotherapy
Breast Neoplasms* / surgery
Female
Humans
Lymph Node Excision / methods
Lymph Nodes / pathology
Lymphatic Metastasis / pathology
Lymphatic Metastasis / radiotherapy
Male
Sentinel Lymph Node Biopsy / methods
Sentinel Lymph Node* / pathology