Duke University Medical Center, Durham, North Carolina.
Department of Cardiothoracic Surgery, Stanford University, Stanford, California.
Ann Thorac Surg. 2018 Mar;105(3):924-929. doi: 10.1016/j.athoracsur.2017.09.030. Epub 2017 Dec 16.
The objective of this study was to evaluate the safety and feasibility of using neoadjuvant chemotherapy plus ipilimumab followed by surgery as a treatment strategy for stage II-IIIA non-small cell lung cancer.
From 2013 to 2017, postoperative data from patients who underwent surgery after neoadjuvant chemotherapy plus ipilimumab in the TOP1201 trial, an open label phase II trial (NCT01820754), were prospectively collected. The surgical outcomes from TOP1201 were compared with outcomes in a historical cohort of patients receiving standard preoperative chemotherapy followed by surgery identified from our institution's prospectively collected thoracic surgery database.
In the TOP1201 trial, 13 patients were treated with preoperative chemotherapy and ipilimumab followed by surgery. In the historical cohort, 42 patients received preoperative chemotherapy by a platinum doublet regimen preoperative chemotherapy by a platinum doublet regimen without ipilimumab followed by lobectomy or pneumonectomy. The 30-day mortality in both groups was 0%. The most frequently occurring perioperative complications in the TOP1201 group were prolonged air leak (n = 2, 15%) and urinary tract infection (n = 2, 15%). The most common perioperative complication in the preoperative chemotherapy alone group was atrial fibrillation (n = 6, 14%). One patient (8%) had atrial fibrillation in the TOP1201 group. There was no apparent increased occurrence of adverse surgical outcomes for patients in the TOP1201 group compared with patients receiving standard of care neoadjuvant chemotherapy alone before surgery for stage II-IIIA non-small cell lung cancer.
This report is the first to demonstrate the safety and feasibility of surgical resection after treatment with ipilimumab and chemotherapy in stage II-IIIA non-small-cell lung cancer.
本研究旨在评估新辅助化疗联合伊匹单抗后手术治疗 II 期-IIIA 期非小细胞肺癌的安全性和可行性。
2013 年至 2017 年,在 TOP1201 试验(NCT01820754)的开放标签 II 期试验中,接受新辅助化疗联合伊匹单抗治疗后手术的患者术后数据被前瞻性收集。TOP1201 的手术结果与从我们机构前瞻性收集的胸外科数据库中确定的接受标准术前化疗后手术的历史队列患者的结果进行比较。
TOP1201 试验中,13 例患者接受术前化疗和伊匹单抗治疗,然后手术。在历史队列中,42 例患者接受术前化疗,方案为铂类双药化疗,无伊匹单抗治疗,然后行肺叶切除术或全肺切除术。两组的 30 天死亡率均为 0%。TOP1201 组最常见的围手术期并发症为持续性漏气(n=2,15%)和尿路感染(n=2,15%)。术前化疗组最常见的围手术期并发症为心房颤动(n=6,14%)。TOP1201 组有 1 例(8%)患者发生心房颤动。与术前接受标准护理新辅助化疗的患者相比,接受伊匹单抗和化疗治疗的 II 期-IIIA 期非小细胞肺癌患者的手术不良结局发生率似乎没有明显增加。
本报告首次证明了在 II 期-IIIA 期非小细胞肺癌中,伊匹单抗和化疗治疗后手术切除的安全性和可行性。