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.
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.
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DOI：
10.1016/s1470-2045(14)70460-7
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发表时间：
2014-11
期刊：
影响因子：
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通讯作者：
Rutgers EJ
中科院分区：
文献类型：
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作者：
Donker M;van Tienhoven G;Straver ME;Meijnen P;van de Velde CJ;Mansel RE;Cataliotti L;Westenberg AH;Klinkenbijl JH;Orzalesi L;Bouma WH;van der Mijle HC;Nieuwenhuijzen GA;Veltkamp SC;Slaets L;Duez NJ;de Graaf PW;van Dalen T;Marinelli A;Rijna H;Snoj M;Bundred NJ;Merkus JW;Belkacemi Y;Petignat P;Schinagl DA;Coens C;Messina CG;Bogaerts J;Rutgers EJ
如果在乳腺癌的乳腺癌患者中表明，腋窝淋巴结清扫是当前的标准评估腋窝放射疗法是否提供较少副作用的可比较区域控制。
T1-2原发性乳腺癌和无触觉淋巴结病的患者被纳入随机的，多中心的开放标签，第3阶段的非耐用性EORTC EORTC 10981-22023 AMAROS试验（1：1）。在阳性前哨节点的情况下，分配时间表或腋窝放射疗法是由机构分层的。与腋窝淋巴结清扫术中的预期2％相比，腋窝放射疗法组不超过4％的腋窝复发。 .gov，编号NCT00014612。
在2001年2月19日和2010年4月29日之间，有4823名来自9个欧洲国家的中心招募了4806个中心，其中4806名符合随机分配的2402名患者。在1425例阳性延髓淋巴结阳性的患者中，有744例被随机分配给腋窝淋巴结清扫术，681分配给腋窝放射疗法;这些患者构成了对治疗的人类疗法的中位数。 （33％）在接受腋窝淋巴结清扫术的672例患者中，腋窝淋巴结中的四名患者中有腋窝复发。放射疗法组为5年的腋复发为0·43％（95％CI 0·00–0·92），腋窝淋巴结清扫术后1·19％（0·31–2·08）由于事件的数量较低，因此非劣势测试的功率不足。同侧手臂中的淋巴水肿腋窝淋巴结清扫术后的频率要高于1年，3年和5年后的腋窝放射治疗后的频率要高。
前哨淋巴结阳性后的腋窝淋巴结清扫术和腋窝放射疗法为T1-2原发性乳腺癌患者提供了出色的和可比的腋窝对照，没有可触及的淋巴结障碍疗法。
EORTC慈善信托基金。
If treatment of the axilla is indicated in patients with breast cancer who have a positive sentinel node, axillary lymph node dissection is the present standard. Although axillary lymph node dissection provides excellent regional control, it is associated with harmful side-effects. We aimed to assess whether axillary radiotherapy provides comparable regional control with fewer side-effects. Patients with T1–2 primary breast cancer and no palpable lymphadenopathy were enrolled in the randomised, multicentre, open-label, phase 3 non-inferiority EORTC 10981-22023 AMAROS trial. Patients were randomly assigned (1:1) by a computer-generated allocation schedule to receive either axillary lymph node dissection or axillary radiotherapy in case of a positive sentinel node, stratified by institution. The primary endpoint was non-inferiority of 5-year axillary recurrence, considered to be not more than 4% for the axillary radiotherapy group compared with an expected 2% in the axillary lymph node dissection group. Analyses were by intention to treat and per protocol. The AMAROS trial is registered with ClinicalTrials.gov, number NCT00014612. Between Feb 19, 2001, and April 29, 2010, 4823 patients were enrolled at 34 centres from nine European countries, of whom 4806 were eligible for randomisation. 2402 patients were randomly assigned to receive axillary lymph node dissection and 2404 to receive axillary radiotherapy. Of the 1425 patients with a positive sentinel node, 744 had been randomly assigned to axillary lymph node dissection and 681 to axillary radiotherapy; these patients constituted the intention-to-treat population. Median follow-up was 6·1 years (IQR 4·1–8·0) for the patients with positive sentinel lymph nodes. In the axillary lymph node dissection group, 220 (33%) of 672 patients who underwent axillary lymph node dissection had additional positive nodes. Axillary recurrence occurred in four of 744 patients in the axillary lymph node dissection group and seven of 681 in the axillary radiotherapy group. 5-year axillary recurrence was 0·43% (95% CI 0·00–0·92) after axillary lymph node dissection versus 1·19% (0·31–2·08) after axillary radiotherapy. The planned non-inferiority test was underpowered because of the low number of events. The one-sided 95% CI for the underpowered non-inferiority test on the hazard ratio was 0·00–5·27, with a non-inferiority margin of 2. Lymphoedema in the ipsilateral arm was noted significantly more often after axillary lymph node dissection than after axillary radiotherapy at 1 year, 3 years, and 5 years. Axillary lymph node dissection and axillary radiotherapy after a positive sentinel node provide excellent and comparable axillary control for patients with T1–2 primary breast cancer and no palpable lymphadenopathy. Axillary radiotherapy results in significantly less morbidity. EORTC Charitable Trust.