Sentinel node biopsy for early-stage melanoma - Accuracy and morbidity in MSLT-I, an international multicenter trial
Sentinel node biopsy for early-stage melanoma - Accuracy and morbidity in MSLT-I, an international multicenter trial
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DOI：
10.1097/01.sla.0000181092.50141.fa
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发表时间：
2005-09-01
影响因子：
9
通讯作者：
Wang, HJ
中科院分区：
文献类型：
--
作者：
Morton, DL;Cochran, AJ;Wang, HJ
目的：本研究的目的是在一项国际多中心III期试验中评估术中淋巴测图和前哨淋巴结活检（LM/SNB）对早期黑色素瘤患者局部淋巴结区分期的准确性、使用和发病率。背景资料：自我们于1990年引入LM/SNB以来，该技术已被广泛采用，并已成为美国癌症联合委员会（AJCC）分期系统的一部分。11年前，作者开始了国际多中心选择性淋巴结切除术试验（MSLT-I），比较两种治疗方法：前哨淋巴结（SN）转移的广泛切除（WE）加LM/SNB与立即完全淋巴结切除术（CLND），以及延迟至临床明显淋巴结转移的WE加术后观察。方法：当每个中心在30例学习阶段的SN识别准确率达到85%后，原发性皮肤黑色素瘤（>= 1 mm， Clark水平>= III，或任何厚度，Clark水平>= IV）患者以4:6的比例随机分配到WE +观察（WEO），淋巴结复发延迟CLND，或WE + LM/SNB， SN转移立即CLND。LM/SNB的准确性是通过比较LM/SNB组SN的识别率和SN转移的发生率，以及随后在肿瘤阴性SN患者的区域淋巴结池中淋巴结转移的发展来确定的。通过比较两组患者的并发症发生率来评估LM/SNB的早期发病率。2001例患者入组后，试验于2002年3月31日完成。结果：SN的初始识别率总体为95.3%，腹股沟为99.3%，腋窝为95.3%，颈盆为84.5%。在试验阶段，假阴性LM/SNB的比率，通过肿瘤阴性解剖SN盆地的淋巴结复发率来测量，随着每个中心病例量的增加而下降：前25例为10.3%，25例后为5.2%。无手术死亡。LM/SNB术后的低并发症发生率（10.1%）随着CLND的加入而增加到37.2%；CLND也增加了并发症的严重程度。结论：LM/SNB是一种安全、低发病率的早期黑色素瘤局部淋巴结分期手术。即使在30个案例学习阶段和25个LM/SNB案例之后，LM/SNB的准确性仍在随着中心经验的增加而不断提高。LM/SNB应成为原发性皮肤黑色素瘤患者局部淋巴结分期的标准护理。
Objective:The objective of this study was to evaluate, in an international multicenter phase III trial, the accuracy, use, and morbidity of intraoperative lymphatic mapping and sentinel node biopsy (LM/SNB) for staging the regional nodal basin of patients with early-stage melanoma.Summary Background Data: Since our introduction of LM/SNB in 1990, this technique has been widely adopted and has become part of the American Joint Committee on Cancer (AJCC) staging system. Eleven years ago, the authors began the international Multicenter Selective Lymphadenectomy Trial (MSLT-I) to compare 2 treatment approaches: wide excision (WE) plus LM/SNB with immediate complete lymphadenectomy (CLND) for sentinel node (SN) metastases, and WE plus postoperative observation with CLND delayed until the subsequent development of clinically evident nodal metastases.Methods: After each center achieved 85% accuracy of SN identification during a 30-case learning phase, patients with primary cutaneous melanoma (>= 1 mm with Clark level >= III, or any thickness with Clark level >= IV) were randomly assigned in a 4:6 ratio to WE plus observation (WEO) with delayed CLND for nodal recurrence, or to WE plus LM/SNB with immediate CLND for SN metastasis. The accuracy of LM/SNB was determined by comparing the rates of SN identification and the incidence of SN metastases in the LM/SNB group versus the subsequent development of nodal metastases in the regional nodal basin of those patients with tumor-negative SNs. Early morbidity of LM/SNB was evaluated by comparing complication rates between the 2 treatment groups. Trial accrual was completed on March 31, 2002, after enrollment of 2001 patients.Results: Initial SN identification rate was 95.3% overall: 99.3% for the groin, 95.3% for the axilla, and 84.5% for the neck basins. The rate of false-negative LM/SNB during the trial phase, as measured by nodal recurrence in a tumor-negative dissected SN basin, decreased with increasing case volume at each center: 10.3% for the first 25 cases versus 5.2% after 25 cases. There were no operative mortalities. The low (10.1%) complication rate after LM/SNB increased to 37.2% with the addition of CLND; CLND also increased the severity of complications.Conclusions: LM/SNB is a safe, low-morbidity procedure for staging the regional nodal basin in early melanoma. Even after a 30-case learning phase and 25 additional LM/SNB cases, the accuracy of LM/SNB continues to increase with a center's experience. LM/SNB should become standard care for staging the regional lymph nodes of patients with primary cutaneous melanoma.