METHODS: Two reviewers (JFB and GNM) independently searched electronic databases for studies including SNB as the main intervention. Filters were applied to retrieve only clinical trials (randomized or experimental non-randomized); non-oncological outcomes were excluded. The selected studies were considered to construct a narrative review focused on inclusion criteria and survival outcomes, followed by recommendations.
RESULTS: Fourteen (n = 14) trials were selected, including eleven (n = 11) randomized trials for upfront surgery, and three (n = 3) single-group clinical trials for surgery following neoadjuvant therapy. All trials for upfront surgery provided long-term survival data for SNB, that was equivalent or non-inferior to axillary dissection, in tumors without palpable adenopathy (caution for larger T3 and T4 tumors) - Grade of recommendation: A. In tumors up to 5 cm, complete axillary dissection is not necessary if up to two sentinel nodes are positive for macrometastasis, and radiation therapy is planned - Grade of recommendation: A. If there are more than two sentinel nodes positive for macrometastasis, or a positive node other than the sentinel one, complete axillary dissection is recommended - Grade of recommendation: A. Following neoadjuvant chemotherapy, considering 10% as an acceptable false negative rate, SNB might be offered for cN0 patients who have remained negative, and for cN1 (caution for cN2) patients become clinically negative; complete axillary dissection might not be necessary if at least two sentinel lymph nodes are retrieved, and there is no residual disease - Grade of recommendation: B.
CONCLUSIONS: SNB can be performed in most cases of clinically negative nodes. After neoadjuvant chemotherapy, SNB is feasible and may have acceptable performance for cN0 and cN1 tumors, although prospective survival data is still awaited.
方法:两名审稿人(JFB和GNM)独立地在电子数据库中搜索包括SNB作为主要干预措施的研究。过滤器仅用于检索临床试验(随机或实验性非随机);排除非肿瘤学结果。选定的研究被认为构建了一个叙述性综述,重点是纳入标准和生存结果。其次是建议。
结果:选择了十四个(n=14)试验,包括11项(n=11)前期手术的随机试验,和三项(n=3)新辅助治疗后手术的单组临床试验。所有前期手术试验都提供了SNB的长期生存数据,相当于或不低于腋窝解剖,在没有明显腺病的肿瘤中(对于较大的T3和T4肿瘤要谨慎)-推荐等级:A.在最大5厘米的肿瘤中,如果两个前哨淋巴结对大转移呈阳性,则不需要完整的腋窝淋巴结清扫,并且计划进行放射治疗-推荐等级:A.如果有两个以上的前哨淋巴结对大转移呈阳性,或者前哨节点以外的正节点,建议进行完整的腋窝清扫-推荐等级:A.新辅助化疗后,考虑到10%是可接受的假阴性率,SNB可能会提供给cN0阴性的患者,并且对于cN1(对cN2的警告)患者变为临床阴性;如果取回至少两个前哨淋巴结,则可能不需要进行完整的腋窝清扫,并且没有残留疾病-推荐等级:B。
结论:SNB可以在大多数临床阴性淋巴结中进行。新辅助化疗后,SNB是可行的,对于cN0和cN1肿瘤可能具有可接受的性能,尽管仍在等待前瞻性生存数据。