接受保乳治疗的临床淋巴结阴性乳腺癌患者，前哨淋巴结手术与随访：一项荷兰随机对照多中心试验（BOOG 2013 - 08）
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).
作者信息
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
机构信息
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.
出版信息
BMC Cancer. 2017 Jul 1;17(1):459. doi: 10.1186/s12885-017-3443-x.
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.
背景
研究表明，对于接受保乳治疗的乳腺癌患者，若前哨淋巴结阳性，则可安全地省略腋窝淋巴结清扫术。由于前哨淋巴结活检的结果并无临床意义，该操作本身的价值受到质疑。BOOG 2013 - 08试验的目的是研究在接受保乳治疗的临床腋窝淋巴结阴性乳腺癌患者中，是否可安全地省略前哨淋巴结活检。
方法
BOOG 2013 - 08是一项荷兰前瞻性非劣效性随机多中心试验。病理确诊为临床腋窝淋巴结阴性的T1 - 2期浸润性乳腺癌且接受保乳治疗的女性将被随机分为前哨淋巴结活检组与无前哨淋巴结活检组。终点指标包括随访5年（主要终点）和10年后的区域复发、无远处疾病生存率和总生存率、生活质量、发病率及成本效益。既往数据显示，对照组5年区域无复发生存率为99%，研究组为96%。结合5%的非劣效性界限和0.8的概率，得出样本量为1644例患者，包括10%的失访率。主要和次要终点指标将在随访5年和10年后报告。
讨论
如果在接受保乳治疗的临床腋窝淋巴结阴性乳腺癌患者中可安全地省略前哨淋巴结活检，本研究将在不降低区域控制、无远处疾病生存率和总生存率的情况下，以成本效益的方式降低腋窝发病率，从而提高生活质量。
试验注册
BOOG 2013 - 08研究自2014年10月20日起在ClinicalTrials.gov注册，标识符：NCT02271828。https://clinicaltrials.gov/ct2/show/NCT02271828
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