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)

被引:60
作者
van Roozendaal, L. M. [1 ,15 ,16 ]
de Wilt, J. H. W. [2 ]
van Dalen, T. [3 ]
van der Hage, J. A. [4 ]
Strobbe, L. J. A. [5 ]
Boersma, L. J. [6 ,15 ]
Linn, S. C. [7 ]
Lobbes, M. B. I. [8 ,15 ]
Poortmans, P. M. P. [9 ]
Tjan-Heijnen, V. C. G. [10 ,15 ]
Van de Vijver, K. K. B. T. [11 ]
de Vries, J. [12 ]
Westenberg, A. H. [13 ]
Kessels, A. G. H. [14 ]
Smidt, M. L. [1 ,15 ]
机构
[1] Maastricht Univ, Med Ctr, Div Surg Oncol, Maastricht, Netherlands
[2] Radboud Univ Nijmegen, Med Ctr, Div Surg Oncol, NL-6525 ED Nijmegen, Netherlands
[3] Diakonessenhuis Hosp, Div Surg Oncol, Utrecht, Netherlands
[4] Antoni van Leeuwenhoek Hosp, Netherlands Canc Inst, Div Surg Oncol, Amsterdam, Netherlands
[5] Canisius Wilhelmina Hosp, Div Surg Oncol, Nijmegen, Netherlands
[6] Maastricht Univ, Med Ctr, MAASTRO Clin, Dept Radiat Oncol, Maastricht, Netherlands
[7] Antoni van Leeuwenhoek Hosp, Netherlands Canc Inst, Div Med Oncol, Amsterdam, Netherlands
[8] Maastricht Univ, Med Ctr, Dept Radiol & Nucl Med, Maastricht, Netherlands
[9] Radboud Univ Nijmegen, Med Ctr, Dept Radiat Oncol, NL-6525 ED Nijmegen, Netherlands
[10] Maastricht Univ, Med Ctr, Div Med Oncol, Maastricht, Netherlands
[11] Antoni van Leeuwenhoek Hosp, Netherlands Canc Inst, Dept Pathol, Amsterdam, Netherlands
[12] Tilburg Univ, Dept Med & Clin Psychol, NL-5000 LE Tilburg, Netherlands
[13] Arnhem Inst Radiat Oncol, Radiat Oncol, Arnhem, Netherlands
[14] Maastricht Univ, Med Ctr, Dept Clin Epidemiol & Med Technol Assessment, Maastricht, Netherlands
[15] Maastricht Univ, Med Ctr, GROW Sch Oncol & Dev Biol, Maastricht, Netherlands
[16] Maastricht Univ, Med Ctr, Dept Surg Oncol, Maastricht, Netherlands
来源
BMC CANCER | 2015年 / 15卷
关键词
QUALITY-OF-LIFE; LYMPH-NODES; EUROPEAN-ORGANIZATION; NEEDLE-BIOPSY; DISSECTION; ULTRASOUND; CHEMOTHERAPY; MAMMOGRAPHY; METASTASIS; ACCURACY;
D O I
10.1186/s12885-015-1613-2
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
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共 33 条
[1]   THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY [J].
AARONSON, NK ;
AHMEDZAI, S ;
BERGMAN, B ;
BULLINGER, M ;
CULL, A ;
DUEZ, NJ ;
FILIBERTI, A ;
FLECHTNER, H ;
FLEISHMAN, SB ;
DEHAES, JCJM ;
KAASA, S ;
KLEE, M ;
OSOBA, D ;
RAZAVI, D ;
ROFE, PB ;
SCHRAUB, S ;
SNEEUW, K ;
SULLIVAN, M ;
TAKEDA, F .
JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1993, 85 (05) :365-376
[2]   Axillary Lymph Nodes Suspicious for Breast Cancer Metastasis: Sampling with US-guided 14-Gauge Core-Needle Biopsy-Clinical Experience in 100 Patients [J].
Abe, Hiroyuki ;
Schmidt, Robert A. ;
Kulkarni, Kirti ;
Sennett, Charlene A. ;
Mueller, Jeffrey S. ;
Newstead, Gillian M. .
RADIOLOGY, 2009, 250 (01) :41-49
[3]   The standard tangential fields used for breast irradiation do not allow optimal coverage and dose distribution in axillary levels I-II and the sentinel node area [J].
Belkacemi, Y. ;
Allab-Pan, Q. ;
Bigorie, V. ;
Khodari, W. ;
Beaussart, P. ;
Totobenazara, J. -L. ;
Mege, J. -P. ;
Caillet, P. ;
Pigneur, F. ;
Dao, T. -H. ;
Salmon, R. ;
Calitchi, E. ;
Bosc, R. .
ANNALS OF ONCOLOGY, 2013, 24 (08) :2023-2028
[4]   Lymphoedema Functioning, Disability and Health Questionnaire (Lymph-ICF): Reliability and Validity [J].
Devoogdt, Nele ;
Van Kampen, Marijke ;
Geraerts, Inge ;
Coremans, Tina ;
Christiaens, Marie-Rose .
PHYSICAL THERAPY, 2011, 91 (06) :944-957
[5]   Value of Preoperative Ultrasound-Guided Axillary Lymph Node Biopsy for Preventing Completion Axillary Lymph Node Dissection in Breast Cancer: A Systematic Review and Meta-Analysis [J].
Diepstraten, Suzanne C. E. ;
Sever, Ali R. ;
Buckens, Constantinus F. M. ;
Veldhuis, Wouter B. ;
van Dalen, Thijs ;
van den Bosch, Maurice A. A. J. ;
Mali, Willem P. Th. M. ;
Verkooijen, Helena M. .
ANNALS OF SURGICAL ONCOLOGY, 2014, 21 (01) :51-59
[6]   Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis [J].
DiSipio, Tracey ;
Rye, Sheree ;
Newman, Beth ;
Hayes, Sandi .
LANCET ONCOLOGY, 2013, 14 (06) :500-515
[7]   Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial [J].
Donker, Mila ;
van Tienhoven, Geertjan ;
Straver, Marieke E. ;
Meijnen, Philip ;
van de Velde, Cornelis J. H. ;
Mansel, Robert E. ;
Cataliotti, Luigi ;
Westenberg, A. Helen ;
Klinkenbijl, Jean H. G. ;
Orzalesi, Lorenzo ;
Bouma, Willem H. ;
van der Mijle, Huub C. J. ;
Nieuwenhuijzen, Grard A. P. ;
Veltkamp, Sanne C. ;
Slaets, Leen ;
Duez, Nicole J. ;
de Graaf, Peter W. ;
van Dalen, Thijs ;
Marinelli, Andreas ;
Rijna, Herman ;
Snoj, Marko ;
Bundred, Nigel J. ;
Merkus, Jos W. S. ;
Belkacemi, Yazid ;
Petignat, Patrick ;
Schinagl, Dominic A. X. ;
Coens, Corneel ;
Messina, Carlo G. M. ;
Bogaerts, Jan ;
Rutgers, Emiel J. T. .
LANCET ONCOLOGY, 2014, 15 (12) :1303-1310
[8]   Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer [J].
Fisher, B ;
Anderson, S ;
Bryant, J ;
Margolese, RG ;
Deutsch, M ;
Fisher, ER ;
Jeong, J ;
Wolmark, N .
NEW ENGLAND JOURNAL OF MEDICINE, 2002, 347 (16) :1233-1241
[9]   Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial [J].
Galimberti, Viviana ;
Cole, Bernard F. ;
Zurrida, Stefano ;
Viale, Giuseppe ;
Luini, Alberto ;
Veronesi, Paolo ;
Baratella, Paola ;
Chifu, Camelia ;
Sargenti, Manuela ;
Intra, Mattia ;
Gentilini, Oreste ;
Mastropasqua, Mauro G. ;
Mazzarol, Giovanni ;
Massarut, Samuele ;
Garbay, Jean-Remi ;
Zgajnar, Janez ;
Galatius, Hanne ;
Recalcati, Angelo ;
Littlejohn, David ;
Bamert, Monika ;
Colleoni, Marco ;
Price, Karen N. ;
Regan, Meredith M. ;
Goldhirsch, Aron ;
Coates, Alan S. ;
Gelber, Richard D. ;
Veronesi, Umberto .
LANCET ONCOLOGY, 2013, 14 (04) :297-305
[10]   Locoregional Recurrence After Sentinel Lymph Node Dissection With or Without Axillary Dissection in Patients With Sentinel Lymph Node Metastases [J].
Giuliano, Armando E. ;
McCall, Linda ;
Beitsch, Peter ;
Whitworth, Pat W. ;
Blumencranz, Peter ;
Leitch, A. Marilyn ;
Saha, Sukamal ;
Hunt, Kelly K. ;
Morrow, Monica ;
Ballman, Karla .
ANNALS OF SURGERY, 2010, 252 (03) :426-433