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首页> 外文期刊>BMC Cancer >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)
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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)

机译：接受保乳治疗，前哨淋巴结手术与随访的临床淋巴结阴性乳腺癌患者：一项荷兰随机对照多中心试验（BOOG 2013-08）

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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
机译：背景研究表明，在采用乳腺癌保乳治疗的乳腺癌患者中，如果前哨淋巴结阳性，可以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没有临床意义，因此该过程本身的价值受到质疑。 BOOG 2013–08试验的目的是研究在采用保乳疗法治疗的临床淋巴结阴性的乳腺癌患者中，是否可以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自卑性随机多中心试验。经病理证实为临床淋巴结阴性的T1–2浸润性乳腺癌且接受保乳治疗的妇女将被随机分为前哨淋巴结活检和无前哨淋巴结活检。终点包括随访5年（主要终点）和10年后的区域复发，无远处疾病和总体存活率，生活质量，发病率和成本效益。先前的数据表明，对照组的5年区域无复发存活率为99％，研究组为96％。结合5％的非劣效性限制和0.8的可能性，这导致1.644名患者的样本量，包括10％的失访率。主要和次要终点将在随访5年和10年后报告。讨论如果在接受乳腺癌保乳治疗的临床淋巴结阴性的乳腺癌患者中，如果可以安全地省略前哨淋巴结活检，则本研究将经济有效地降低腋窝发病率，从而改善生活质量，且区域控制不差，远-无疾病生存期和总体生存期。试验注册BOOG 2013-08研究自2014年10月20日起在ClinicalTrials.gov进行注册，标识号：NCT02271828。 https://clinicaltrials.gov/ct2/show/NCT02271828

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