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The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy : a Dutch randomized controlled multicentre trial (BOOG 2013-07)

(2015) BMC CANCER. 15.
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Abstract
Background: Trials failed to demonstrate additional value of completion axillary lymph node dissection in case of limited sentinel lymph node metastases in breast cancer patients undergoing breast conserving therapy. It has been suggested that the low regional recurrence rates in these trials might partially be ascribed to accidental irradiation of part of the axilla by whole breast radiation therapy, which precludes extrapolation of results to mastectomy patients. The aim of the randomized controlled BOOG 2013-07 trial is therefore to investigate whether completion axillary treatment can be safely omitted in sentinel lymph node positive breast cancer patients treated with mastectomy. Design: This study is designed as a non-inferiority randomized controlled multicentre trial. Women aged 18 years or older diagnosed with unilateral invasive clinically T1-2 N0 breast cancer who are treated with mastectomy, and who have a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases, will be randomized for completion axillary treatment versus no completion axillary treatment. Completion axillary treatment can consist of completion axillary lymph node dissection or axillary radiation therapy. Primary endpoint is regional recurrence rate at 5 years. Based on a 5-year regional recurrence free survival rate of 98 % among controls and 96 % for study subjects, the sample size amounts 439 per arm (including 10 % lost to follow-up), to be able to reject the null hypothesis that the rate for study and control subjects is inferior by at least 5 % with a probability of 0.8. Results will be reported after 5 and 10 years of follow-up. Discussion: We hypothesize that completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing mastectomy. If confirmed, this study will significantly decrease the number of breast cancer patients receiving extensive treatment of the axilla, thereby diminishing the risk of morbidity and improving quality of life, while maintaining excellent regional control and without affecting survival.
Keywords
QUALITY-OF-LIFE, LYMPH-NODES, EUROPEAN-ORGANIZATION, NEEDLE-BIOPSY, DISSECTION, ULTRASOUND, CHEMOTHERAPY, METAANALYSIS, MAMMOGRAPHY, IRRADIATION

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Chicago
van Roozendaal, LM, JHW de Wilt, T van Dalen, JA van der Hage, LJA Strobbe, LJ Boersma, SC Linn, et al. 2015. “The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy : a Dutch Randomized Controlled Multicentre Trial (BOOG 2013-07).” Bmc Cancer 15.
APA
van Roozendaal, L., de Wilt, J., van Dalen, T., van der Hage, J., Strobbe, L., Boersma, L., Linn, S., et al. (2015). The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy : a Dutch randomized controlled multicentre trial (BOOG 2013-07). BMC CANCER, 15.
Vancouver
1.
van Roozendaal L, de Wilt J, van Dalen T, van der Hage J, Strobbe L, Boersma L, et al. The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy : a Dutch randomized controlled multicentre trial (BOOG 2013-07). BMC CANCER. 2015;15.
MLA
van Roozendaal, LM, JHW de Wilt, T van Dalen, et al. “The Value of Completion Axillary Treatment in Sentinel Node Positive Breast Cancer Patients Undergoing a Mastectomy : a Dutch Randomized Controlled Multicentre Trial (BOOG 2013-07).” BMC CANCER 15 (2015): n. pag. Print.
@article{8578584,
  abstract     = {Background: Trials failed to demonstrate additional value of completion axillary lymph node dissection in case of limited sentinel lymph node metastases in breast cancer patients undergoing breast conserving therapy. It has been suggested that the low regional recurrence rates in these trials might partially be ascribed to accidental irradiation of part of the axilla by whole breast radiation therapy, which precludes extrapolation of results to mastectomy patients. The aim of the randomized controlled BOOG 2013-07 trial is therefore to investigate whether completion axillary treatment can be safely omitted in sentinel lymph node positive breast cancer patients treated with mastectomy. 
Design: This study is designed as a non-inferiority randomized controlled multicentre trial. Women aged 18 years or older diagnosed with unilateral invasive clinically T1-2 N0 breast cancer who are treated with mastectomy, and who have a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases, will be randomized for completion axillary treatment versus no completion axillary treatment. Completion axillary treatment can consist of completion axillary lymph node dissection or axillary radiation therapy. Primary endpoint is regional recurrence rate at 5 years. Based on a 5-year regional recurrence free survival rate of 98 % among controls and 96 % for study subjects, the sample size amounts 439 per arm (including 10 % lost to follow-up), to be able to reject the null hypothesis that the rate for study and control subjects is inferior by at least 5 % with a probability of 0.8. Results will be reported after 5 and 10 years of follow-up. 
Discussion: We hypothesize that completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing mastectomy. If confirmed, this study will significantly decrease the number of breast cancer patients receiving extensive treatment of the axilla, thereby diminishing the risk of morbidity and improving quality of life, while maintaining excellent regional control and without affecting survival.},
  articleno    = {610},
  author       = {van Roozendaal, LM and de Wilt, JHW and van Dalen, T and van der Hage, JA and Strobbe, LJA and Boersma, LJ and Linn, SC and Lobbes, MBI and Poortmans, PMP and Tjan-Heijnen, VCG and Van de Vijver, Koen and de Vries, J and Westenberg, AH and Kessels, AGH and Smidt, ML},
  issn         = {1471-2407},
  journal      = {BMC CANCER},
  keywords     = {QUALITY-OF-LIFE,LYMPH-NODES,EUROPEAN-ORGANIZATION,NEEDLE-BIOPSY,DISSECTION,ULTRASOUND,CHEMOTHERAPY,METAANALYSIS,MAMMOGRAPHY,IRRADIATION},
  language     = {eng},
  pages        = {8},
  title        = {The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy : a Dutch randomized controlled multicentre trial (BOOG 2013-07)},
  url          = {http://dx.doi.org/10.1186/s12885-015-1613-2},
  volume       = {15},
  year         = {2015},
}

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