新辅助治疗后 IIIA（N2）期非小细胞肺癌术前胸腔镜纵隔重新分期的前瞻性 II 期试验：CALGB 方案 39803 的结果。
Prospective phase II trial of preresection thoracoscopic mediastinal restaging after neoadjuvant therapy for IIIA (N2) non-small cell lung cancer: results of CALGB Protocol 39803.
机构信息
Division of Thoracic Surgery, Brigham and Women's Hospital, Boston, Mass 02115, USA.
出版信息
J Thorac Cardiovasc Surg. 2013 Jul;146(1):9-16. doi: 10.1016/j.jtcvs.2012.12.069.
OBJECTIVE
Accurate pathologic restaging of N2 stations after neoadjuvant therapy in stage IIIA (N2) non-small cell lung cancer is needed.
METHODS
A prospective multi-institutional trial was designed to judge the feasibility of videothoracoscopy to restage the ipsilateral nodes in mediastinoscopy-proven stage IIIA (N2) non-small cell lung cancer after 2 cycles of platinum-based chemotherapy and/or 40 Gy or more of radiotherapy. The goals included biopsy of 3 negative N2 node stations or to identify 1 positive N2 node or pleural carcinomatosis.
RESULTS
Ten institutions accrued 68 subjects. Of the 68 subjects, 46 (68%) underwent radiotherapy and 66 (97%) underwent chemotherapy. Videothoracoscopy successfully met the prestudy feasibility in 27 patients (40%): 3 negative stations confirmed at thoracotomy in 7, persistent stage N2 disease in 16, and pleural carcinomatosis in 4. In 20 procedures (29%), no N2 disease was found, 3 stations were not biopsied because of unanticipated nodal obliteration. Thus, 47 videothoracoscopy procedures (69%, 95% confidence interval, 57%-80%) restaged the mediastinum. Videothoracoscopy was unsuccessful in 21 patients (31%) because the procedure had to be aborted (n = 11) or because of false-negative stations (n = 10). Of the 21 failures, 15 were right-sided, and 10 had a positive 4R node. The sensitivity of videothoracoscopy was 67% (95% confidence interval, 47%-83%), and the negative predictive value was 73% (95% confidence interval, 56%-86%) if patients with obliterated nodal tissue were included. The sensitivity was 83% (95% confidence interval, 63%-95%) and the negative predictive value was 64% (95% confidence interval, 31%-89%) if those patients were excluded. The specificity was 100%. One death occurred after thoracotomy.
CONCLUSIONS
Videothoracoscopy restaging was "feasible" in this prospective multi-institutional trial and provided pathologic specimens of the ipsilateral nodes. Videothoracoscopy restaging was limited by radiation and the 4R nodal station.
目的
新辅助治疗后 IIIA（N2）期非小细胞肺癌患者需要准确的病理 N2 分期。
方法
设计了一项前瞻性多中心试验，以判断在接受 2 周期铂类化疗和/或 40Gy 以上放疗后，电视胸腔镜对经纵隔镜证实的 IIIA（N2）期非小细胞肺癌同侧淋巴结进行再分期的可行性。目标包括对 3 个阴性 N2 淋巴结站进行活检，或确定 1 个阳性 N2 淋巴结或胸膜癌转移。
结果
10 家机构共入组 68 例患者。68 例患者中，46 例（68%）接受放疗，66 例（97%）接受化疗。27 例患者（40%）成功达到研究前的可行性标准：7 例在开胸手术时证实 3 个阴性站，16 例持续存在 N2 期疾病，4 例存在胸膜癌转移。20 例（29%）未发现 N2 疾病，由于未预料到的淋巴结闭塞，3 个淋巴结站未进行活检。因此，47 例电视胸腔镜检查（69%，95%置信区间，57%-80%）重新分期了纵隔。21 例患者（31%）的手术不成功，其中 11 例因手术中断，10 例因假阴性站而失败。21 例失败中有 15 例为右侧，10 例为 4R 阳性淋巴结。如果包括有闭塞性淋巴结组织的患者，电视胸腔镜检查的敏感性为 67%（95%置信区间，47%-83%），阴性预测值为 73%（95%置信区间，56%-86%）。如果排除这些患者，敏感性为 83%（95%置信区间，63%-95%），阴性预测值为 64%（95%置信区间，31%-89%）。特异性为 100%。1 例患者在开胸手术后死亡。
结论
这项前瞻性多中心试验中，电视胸腔镜再分期是“可行的”，并提供了同侧淋巴结的病理标本。电视胸腔镜再分期受到放射治疗和 4R 淋巴结站的限制。
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