Okselklierdissectie versus okselbestraling bij borstkankerpatiënten met een positieve schildwachtklier: De EORTC 10981 AMAROS-studie

Mila Donker, Leen Slaets, Geertjan van Tienhoven, Emiel J. Th. Rutgers

Research output: Contribution to journalArticleProfessional

Abstract

Objective: To investigate whether axillary radiotherapy (ART) in patients with primary breast cancer and a tumour-positive sentinel node results in a similar axillary tumour recurrence rate compared with axillary lymph node dissection (ALND), and whether ART results in lower morbidity. Design: Randomised, multicentre non-inferiority trial. Method: Patients with breast cancer ≤ 5 cm without clinical signs of lymph node metastases but with a tumour-positive sentinel node were randomised between ALND or ART. The primary endpoint was the 5-year axillary recurrence rate. Secondary endpoints were disease-free survival, overall survival, morbidity (lymphoedema and shoulder function) and quality of life. (www.clinicaltrials.gov, study number NCT00014612.) Results: Between 2001 and 2010, 1425 patients with a tumour-positive sentinel node were included, 744 of whom had been randomised to ALND and 681 to ART. After a median follow-up period of 6.1 years, the 5-year axillary recurrence rate was 0.43% after ALND and 1.19% after ART; the difference was not statistically significant. The primary analysis was underpowered due to the low number of axillary recurrences. At 5 years the diseasefree survival rate was 86.9% after ALND and 82.7% after ART. Overall survival was 93.3% and 92.5% respectively. Lymphoedema was noted significantly more often after ALND than after ART at 1 year, 3 years and 5 years. There were no significant differences in shoulder function or quality of life. Conclusion: Both ART and ALND produce very low axillary recurrence rates in patients with breast cancer ≤ 5 cm and a tumour-positive sentinel node. ART results in significantly less lymphoedema than ALND.
Original languageDutch
Article numberA9302
JournalNederlands Tijdschrift voor Geneeskunde
Volume159
Issue number44
Publication statusPublished - 2015
Externally publishedYes

Cite this

@article{017ea92083584a478e8bbf10d709e037,
title = "Okselklierdissectie versus okselbestraling bij borstkankerpati{\"e}nten met een positieve schildwachtklier: De EORTC 10981 AMAROS-studie",
abstract = "Objective: To investigate whether axillary radiotherapy (ART) in patients with primary breast cancer and a tumour-positive sentinel node results in a similar axillary tumour recurrence rate compared with axillary lymph node dissection (ALND), and whether ART results in lower morbidity. Design: Randomised, multicentre non-inferiority trial. Method: Patients with breast cancer ≤ 5 cm without clinical signs of lymph node metastases but with a tumour-positive sentinel node were randomised between ALND or ART. The primary endpoint was the 5-year axillary recurrence rate. Secondary endpoints were disease-free survival, overall survival, morbidity (lymphoedema and shoulder function) and quality of life. (www.clinicaltrials.gov, study number NCT00014612.) Results: Between 2001 and 2010, 1425 patients with a tumour-positive sentinel node were included, 744 of whom had been randomised to ALND and 681 to ART. After a median follow-up period of 6.1 years, the 5-year axillary recurrence rate was 0.43{\%} after ALND and 1.19{\%} after ART; the difference was not statistically significant. The primary analysis was underpowered due to the low number of axillary recurrences. At 5 years the diseasefree survival rate was 86.9{\%} after ALND and 82.7{\%} after ART. Overall survival was 93.3{\%} and 92.5{\%} respectively. Lymphoedema was noted significantly more often after ALND than after ART at 1 year, 3 years and 5 years. There were no significant differences in shoulder function or quality of life. Conclusion: Both ART and ALND produce very low axillary recurrence rates in patients with breast cancer ≤ 5 cm and a tumour-positive sentinel node. ART results in significantly less lymphoedema than ALND.",
author = "Mila Donker and Leen Slaets and {van Tienhoven}, Geertjan and Rutgers, {Emiel J. Th.}",
year = "2015",
language = "Dutch",
volume = "159",
journal = "Nederlands Tijdschrift voor Geneeskunde",
issn = "0028-2162",
publisher = "Bohn Stafleu van Loghum",
number = "44",

}

Okselklierdissectie versus okselbestraling bij borstkankerpatiënten met een positieve schildwachtklier: De EORTC 10981 AMAROS-studie. / Donker, Mila; Slaets, Leen; van Tienhoven, Geertjan; Rutgers, Emiel J. Th.

In: Nederlands Tijdschrift voor Geneeskunde, Vol. 159, No. 44, A9302, 2015.

Research output: Contribution to journalArticleProfessional

TY - JOUR

T1 - Okselklierdissectie versus okselbestraling bij borstkankerpatiënten met een positieve schildwachtklier: De EORTC 10981 AMAROS-studie

AU - Donker, Mila

AU - Slaets, Leen

AU - van Tienhoven, Geertjan

AU - Rutgers, Emiel J. Th.

PY - 2015

Y1 - 2015

N2 - Objective: To investigate whether axillary radiotherapy (ART) in patients with primary breast cancer and a tumour-positive sentinel node results in a similar axillary tumour recurrence rate compared with axillary lymph node dissection (ALND), and whether ART results in lower morbidity. Design: Randomised, multicentre non-inferiority trial. Method: Patients with breast cancer ≤ 5 cm without clinical signs of lymph node metastases but with a tumour-positive sentinel node were randomised between ALND or ART. The primary endpoint was the 5-year axillary recurrence rate. Secondary endpoints were disease-free survival, overall survival, morbidity (lymphoedema and shoulder function) and quality of life. (www.clinicaltrials.gov, study number NCT00014612.) Results: Between 2001 and 2010, 1425 patients with a tumour-positive sentinel node were included, 744 of whom had been randomised to ALND and 681 to ART. After a median follow-up period of 6.1 years, the 5-year axillary recurrence rate was 0.43% after ALND and 1.19% after ART; the difference was not statistically significant. The primary analysis was underpowered due to the low number of axillary recurrences. At 5 years the diseasefree survival rate was 86.9% after ALND and 82.7% after ART. Overall survival was 93.3% and 92.5% respectively. Lymphoedema was noted significantly more often after ALND than after ART at 1 year, 3 years and 5 years. There were no significant differences in shoulder function or quality of life. Conclusion: Both ART and ALND produce very low axillary recurrence rates in patients with breast cancer ≤ 5 cm and a tumour-positive sentinel node. ART results in significantly less lymphoedema than ALND.

AB - Objective: To investigate whether axillary radiotherapy (ART) in patients with primary breast cancer and a tumour-positive sentinel node results in a similar axillary tumour recurrence rate compared with axillary lymph node dissection (ALND), and whether ART results in lower morbidity. Design: Randomised, multicentre non-inferiority trial. Method: Patients with breast cancer ≤ 5 cm without clinical signs of lymph node metastases but with a tumour-positive sentinel node were randomised between ALND or ART. The primary endpoint was the 5-year axillary recurrence rate. Secondary endpoints were disease-free survival, overall survival, morbidity (lymphoedema and shoulder function) and quality of life. (www.clinicaltrials.gov, study number NCT00014612.) Results: Between 2001 and 2010, 1425 patients with a tumour-positive sentinel node were included, 744 of whom had been randomised to ALND and 681 to ART. After a median follow-up period of 6.1 years, the 5-year axillary recurrence rate was 0.43% after ALND and 1.19% after ART; the difference was not statistically significant. The primary analysis was underpowered due to the low number of axillary recurrences. At 5 years the diseasefree survival rate was 86.9% after ALND and 82.7% after ART. Overall survival was 93.3% and 92.5% respectively. Lymphoedema was noted significantly more often after ALND than after ART at 1 year, 3 years and 5 years. There were no significant differences in shoulder function or quality of life. Conclusion: Both ART and ALND produce very low axillary recurrence rates in patients with breast cancer ≤ 5 cm and a tumour-positive sentinel node. ART results in significantly less lymphoedema than ALND.

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M3 - Article

VL - 159

JO - Nederlands Tijdschrift voor Geneeskunde

JF - Nederlands Tijdschrift voor Geneeskunde

SN - 0028-2162

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M1 - A9302

ER -