Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial.
Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial.
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DOI：
10.1016/s1470-2045(13)70035-4
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发表时间：
2013-04
期刊：
影响因子：
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通讯作者：
International Breast Cancer Study Group Trial 23-01 investigators
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文献类型：
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作者：
Galimberti V;Cole BF;Zurrida S;Viale G;Luini A;Veronesi P;Baratella P;Chifu C;Sargenti M;Intra M;Gentilini O;Mastropasqua MG;Mazzarol G;Massarut S;Garbay JR;Zgajnar J;Galatius H;Recalcati A;Littlejohn D;Bamert M;Colleoni M;Price KN;Regan MM;Goldhirsch A;Coates AS;Gelber RD;Veronesi U;International Breast Cancer Study Group Trial 23-01 investigators
对于具有转移性哨兵淋巴结（SN）的乳腺癌患者，腋窝（AD）是标准治疗方法。
在多个中心的试验中，随机的AD或没有AD的患者限于临床上可降低的腋窝淋巴结和原发性肿瘤≤5cm，在哨兵淋巴结活检后，有一个或多个微观的（≤2mm）的哨兵淋巴结。无广告vs的危险比<1·25。 AD分析的意图是通过1：1的比例分配给AD，或者通过中心分层和更年期。
从2001年到2010年，评估了934名患者（在AD组中为464例，NO AD组中的467例）。 26；事件3）。 ·0042）。据报道，AD组中的3个运动神经病（3级）和1级运动神经病是一个严重的不良事件。
在这项研究中代表的早期乳腺癌患者中（大多数肿瘤<3 cm（92％; 856/931），接受了乳房保存手术（91％； 845/931），并且调整全身治疗（96％; 892/931）应在SN涉及最小的轴向效果时，因此应避免使用轴向疾病，从而消除轴向疾病的复杂性。
部分支持：当地参与中心，IBCSG中央基金，美国国家癌症研究所的CA075362和瑞士癌症联盟/癌症研究 - 瑞士/Oncosuisse（ICPOCS 01688-03-2005）。
For breast cancer patients with a metastatic sentinel node (SN), axillary dissection (AD) has been standard treatment. However, for patients with minimal SN involvement, AD may be overtreatment. IBCSG Trial 23-01 was designed to determine whether no AD is non-inferior to AD in patients with one or more micrometastatic (≤2 mm) SNs and tumour ≤5 cm. In this multicentre trial patients were randomised to AD or no AD. Eligibility was limited to patients with clinically-palpable axillary lymph node(s) and a primary tumour ≤ 5 cm who, after sentinel node biopsy, had one or more micrometastatic (≤ 2 mm) sentinel lymphs nodes with no extracapsular extension. The primary endpoint was disease-free survival (DFS). Non-inferiority was defined as a hazard ratio of <1·25 for no AD vs. AD. The analysis was intention to treat. Patients were randomly allocated in a 1:1 ratio to AD or no AD with stratification by centre and menopausal status. There was no attempt to blind the treatment assignment. The trial is registered with ClinicalTrials.gov, NCT00072293. Per protocol, disease and survival information continues to be collected yearly. From 2001 to 2010, 934 patients were randomised; 931 were evaluable (464 in the AD group and 467 in the no AD group). After a median follow-up of 5·0 (IQR 3.6–7.3) years, there were 124 DFS events, including breast-cancer-related events in 95 patients (local, 18; contralateral breast, 12; regional, 6; and distant, 59), and other events in 29 (second malignancy, 26; death without prior cancer event, 3). Five-year DFS was 87·8% (95% CI 84·4%–91·2%) in the no AD group and 84·4% (95% CI 80·7%–88·1%) in the AD group (log-rank p=0·16) (HR no AD vs. AD=0·78, 95% CI 0·55–1·11, non-inferiority p=0·0042). Patients with reported long-term surgical events (grade 3–4) included 1 sensory neuropathy (grade 3), 3 lymphedema (2 grade 3 and 1 grade 4), and 3 motor neuropathy (grade 3), all in the AD group, and 1 grade 3 motor neuropathy in the no AD group. One serious adverse event was reported, a post-operative infection in the axilla in the AD group. AD in patients with early breast cancer represented in this study (most had tumours < 3 cm (92%; 856/931), received breast conserving surgery (91%; 845/931) and adjuvant systemic therapy (96%; 892/931)) should be avoided when the SN is minimally involved, thus eliminating complications of axillary surgery with no adverse effect on survival. Supported in part: local participating centres, IBCSG central funds, CA075362 from the U.S. National Cancer Institute, and Swiss Cancer League/Cancer Research- Switzerland/Oncosuisse (ICPOCS 01688-03-2005). No pharmaceutical company funds were used.