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).

Autor:	van Roozendaal LM; Division of Surgical Oncology, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands.; GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands., Vane MLG; Division of Surgical Oncology, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands. marissa.vane@mumc.nl.; GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands. marissa.vane@mumc.nl., van Dalen T; Division of Surgical Oncology, Diakonessenhuis Hospital, Utrecht, the Netherlands., van der Hage JA; Division of Surgical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands., Strobbe LJA; Division of Surgical Oncology, Canisius-Wilhelmina Hospital, Nijmegen, the Netherlands., Boersma LJ; GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.; Department of Radiation Oncology, Maastricht University Medical Centre (MAASTRO clinic), Maastricht, the Netherlands., Linn SC; Division of Medical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands., Lobbes MBI; Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, the Netherlands., Poortmans PMP; Department of Radiation Oncology, Radboud University Medical Centre, Nijmegen, the Netherlands., Tjan-Heijnen VCG; GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.; Division of Medical Oncology, Maastricht University Medical Centre, Maastricht, the Netherlands., Van de Vijver KKBT; Department of Pathology, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands., de Vries J; Department of Medical and Clinical Psychology, Tilburg University, Tilburg, the Netherlands., Westenberg AH; Radiation Oncology, Radiotherapy group, Arnhem, the Netherlands., Kessels AGH; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, the Netherlands., de Wilt JHW; Division of Surgical Oncology, Radboud University Medical Centre, Nijmegen, the Netherlands., Smidt ML; Division of Surgical Oncology, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ, Maastricht, The Netherlands.; GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands.
Jazyk:	angličtina
Zdroj:	BMC cancer [BMC Cancer] 2017 Jul 01; Vol. 17 (1), pp. 459. Date of Electronic Publication: 2017 Jul 01.
DOI:	10.1186/s12885-017-3443-x
Abstrakt:	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. Trial Registration: The BOOG 2013-08 study is registered in ClinicalTrials.gov since October 20, 2014, Identifier: NCT02271828. https://clinicaltrials.gov/ct2/show/NCT02271828.
Databáze:	MEDLINE
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