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)

L. M. van Roozendaal; M. L. G. Vane; T. van Dalen; J. A. van der Hage; L. J. A. Strobbe; L. J. Boersma; S. C. Linn; M. B. I. Lobbes; P. M. P. Poortmans; V. C. G. Tjan-Heijnen; K. K. B. T. Van de Vijver; J. de Vries; A. H. Westenberg; A. G. H. Kessels; J. H. W. de Wilt; M. L. Smidt

doi:10.1186/s12885-017-3443-x

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)

L. M. van Roozendaal, M. L. G. Vane^*, T. van Dalen, J. A. van der Hage, L. J. A. Strobbe, L. J. Boersma, S. C. Linn, M. B. I. Lobbes, P. M. P. Poortmans, V. C. G. Tjan-Heijnen, K. K. B. T. Van de Vijver, J. de Vries, A. H. Westenberg, A. G. H. Kessels, J. H. W. de Wilt, M. L. Smidt

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

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.

Original language	English
Article number	459
Number of pages	8
Journal	BMC Cancer
Volume	17
DOIs	https://doi.org/10.1186/s12885-017-3443-x
Publication status	Published - 1 Jul 2017

Keywords

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

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van Roozendaal, L. M., Vane, M. L. G., van Dalen, T., van der Hage, J. A., Strobbe, L. J. A., Boersma, L. J., Linn, S. C., Lobbes, M. B. I., Poortmans, P. M. P., Tjan-Heijnen, V. C. G., Van de Vijver, K. K. B. T., de Vries, J., Westenberg, A. H., Kessels, A. G. H., de Wilt, J. H. W., & Smidt, M. L. (2017). 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). BMC Cancer, 17, Article 459. https://doi.org/10.1186/s12885-017-3443-x

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title = "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)",

abstract = "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.",

keywords = "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",

author = "{van Roozendaal}, {L. M.} and Vane, {M. L. G.} and {van Dalen}, T. and {van der Hage}, {J. A.} and Strobbe, {L. J. A.} and Boersma, {L. J.} and Linn, {S. C.} and Lobbes, {M. B. I.} and Poortmans, {P. M. P.} and Tjan-Heijnen, {V. C. G.} and {Van de Vijver}, {K. K. B. T.} and {de Vries}, J. and Westenberg, {A. H.} and Kessels, {A. G. H.} and {de Wilt}, {J. H. W.} and Smidt, {M. L.}",

year = "2017",

month = jul,

day = "1",

doi = "10.1186/s12885-017-3443-x",

language = "English",

volume = "17",

journal = "BMC Cancer",

issn = "1471-2407",

publisher = "BioMed Central Ltd",

}

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, KKBT, de Vries, J, Westenberg, AH, Kessels, AGH, de Wilt, JHW & Smidt, ML 2017, '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)', BMC Cancer, vol. 17, 459. https://doi.org/10.1186/s12885-017-3443-x

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). / van Roozendaal, L. M.; Vane, M. L. G.; van Dalen, T. et al.
In: BMC Cancer, Vol. 17, 459, 01.07.2017.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up

T2 - a Dutch randomized controlled multicentre trial (BOOG 2013-08)

AU - van Roozendaal, L. M.

AU - Vane, M. L. G.

AU - van Dalen, T.

AU - van der Hage, J. A.

AU - Strobbe, L. J. A.

AU - Boersma, L. J.

AU - Linn, S. C.

AU - Lobbes, M. B. I.

AU - Poortmans, P. M. P.

AU - Tjan-Heijnen, V. C. G.

AU - Van de Vijver, K. K. B. T.

AU - de Vries, J.

AU - Westenberg, A. H.

AU - Kessels, A. G. H.

AU - de Wilt, J. H. W.

AU - Smidt, M. L.

PY - 2017/7/1

Y1 - 2017/7/1

N2 - 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.

AB - 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.

KW - Breast neoplasms

KW - Breast cancer

KW - Sentinel lymph node biopsy

KW - Breast conserving therapy

KW - QUALITY-OF-LIFE

KW - AXILLARY DISSECTION

KW - EUROPEAN-ORGANIZATION

KW - RADIATION-THERAPY

KW - NEEDLE-BIOPSY

KW - ULTRASOUND

KW - CHEMOTHERAPY

KW - METASTASES

KW - SELECTION

KW - RADIOTHERAPY

U2 - 10.1186/s12885-017-3443-x

DO - 10.1186/s12885-017-3443-x

M3 - Article

C2 - 28668073

SN - 1471-2407

VL - 17

JO - BMC Cancer

JF - BMC Cancer

M1 - 459

ER -