Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up : a Dutch randomized controlled multicentre trial (BOOG 2013-08)

Background: Studies showed that axillary lymph node dissection can be safely omitted in presence of positive sentinel lymph node(s) in breast cancer patients treated with breast conserving therapy. Since the outcome of the sentinel lymph node biopsy has no clinical consequence, the value of the procedure itself is being questioned. The aim of the BOOG 2013-08 trial is to investigate whether the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients treated with breast conserving therapy. Methods: The BOOG 2013-08 is a Dutch prospective non-inferiori... Mehr ...

Verfasser: van Roozendaal, LM
Vane, MLG
van Dalen, T
van der Hage, JA
Strobbe, LJA
Boersma, LJ
Linn, SC
Lobbes, MBI
Poortmans, PMP
Tjan-Heijnen, VCG
Van de Vijver, Koen
de Vries, J
Westenberg, AH
Kessels, AGH
de Wilt, JHW
Smidt, ML
Dokumenttyp: journalarticle
Erscheinungsdatum: 2017
Schlagwörter: Medicine and Health Sciences / Breast neoplasms / Breast cancer / Sentinel lymph node biopsy / Breast conserving therapy / QUALITY-OF-LIFE / AXILLARY DISSECTION / EUROPEAN-ORGANIZATION / RADIATION-THERAPY / NEEDLE-BIOPSY / ULTRASOUND / CHEMOTHERAPY / METASTASES / SELECTION / RADIOTHERAPY
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-29033429
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://biblio.ugent.be/publication/8577776

Background: Studies showed that axillary lymph node dissection can be safely omitted in presence of positive sentinel lymph node(s) in breast cancer patients treated with breast conserving therapy. Since the outcome of the sentinel lymph node biopsy has no clinical consequence, the value of the procedure itself is being questioned. The aim of the BOOG 2013-08 trial is to investigate whether the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients treated with breast conserving therapy. Methods: The BOOG 2013-08 is a Dutch prospective non-inferiority randomized multicentre trial. Women with pathologically confirmed clinically node negative T1-2 invasive breast cancer undergoing breast conserving therapy will be randomized for sentinel lymph node biopsy versus no sentinel lymph node biopsy. Endpoints include regional recurrence after 5 (primary endpoint) and 10 years of follow-up, distant-disease free and overall survival, quality of life, morbidity and cost-effectiveness. Previous data indicate a 5-year regional recurrence free survival rate of 99% for the control arm and 96% for the study arm. In combination with a non-inferiority limit of 5% and probability of 0.8, this result in a sample size of 1.644 patients including a lost to follow-up rate of 10%. Primary and secondary endpoints will be reported after 5 and 10 years of follow-up. Discussion: If the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy, this study will cost-effectively lead to a decreased axillary morbidity rate and thereby improved quality of life with non-inferior regional control, distant-disease free survival and overall survival.