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Geburtshilfe Frauenheilkd 2017; 77(02): 149-157
DOI: 10.1055/s-0042-122853
GebFra Science
Original Article/Originalarbeit
Georg Thieme Verlag KG Stuttgart · New York

Restricted Axillary Staging in Clinically and Sonographically Node-Negative Early Invasive Breast Cancer (c/iT1–2) in the Context of Breast Conserving Therapy: First Results Following Commencement of the Intergroup-Sentinel-Mamma (INSEMA) Trial

Article in several languages: English | deutsch
T. Reimer
1   Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany
,
A. Stachs
1   Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany
,
V. Nekljudova
2   German Breast Group, Neu-Isenburg, Germany
,
S. Loibl
2   German Breast Group, Neu-Isenburg, Germany
,
S. Hartmann
1   Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany
,
K. Wolter
3   Department of Radiotherapy, University of Rostock, Rostock, Germany
,
G. Hildebrandt
3   Department of Radiotherapy, University of Rostock, Rostock, Germany
,
B. Gerber
1   Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany
› Author Affiliations
Further Information

Publication History

received 22 September 2016
revised 26 November 2016

accepted 03 December 2016

Publication Date:
17 March 2017 (online)

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Abstract

Axillary lymph node status remains an important prognostic factor in early breast cancer. It is regarded as an indicator for (neo)adjuvant systemic treatment and postoperative radiotherapy of the regional lymphatics. Commenced in September 2015, the INSEMA trial is investigating whether operative determination of nodal status as part of breast conserving therapy (BCT) for early stage breast cancer (c/iT1–2 c/iN0) can be avoided without reducing oncological safety. After inclusion of 1001 patients there was general acceptance of the complex study design by patients and study doctors so that recruitment for the first randomisation (axillary sentinel lymph node biopsy [SLNB]: yes or no) achieved predicted case numbers. The second randomisation however (SLNB alone versus complete axillary dissection when one or two macrometastases are present at SLNB) recruited fewer cases than expected for the following three reasons: a) the 13 % rate of one or two macrometastases after SLNB in the INSEMA trial collective was lower than expected; b) around 20 % of patients refused the second randomisation; c) there was delayed inclusion of the Austrian study centres, which only recruited for the second randomisation. Lack of knowledge of nodal status when SLNB is avoided represents a new challenge for the postoperative tumour board. In particular decisions on chemotherapy for luminal-like tumours and irradiation of the lymphatics (excluding axilla) must be guided by tumour biological parameters. The INSEMA trial does not provide answers to some important questions, e.g. it remains unclear whether patients without SLNB can be offered partial breast irradiation alone in low-risk situations and whether SLNB can also be avoided in patients with stage T1–2 tumours who have a mastectomy indication.

Key words

breast cancer - INSEMA trial - nodal status - sentinel lymph node biopsy - radiotherapy
 

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