Tetsuya Mitsudomi, John V Heymach, Martin Reck, Janis M Taube, Shugeng Gao, Yoshitsugu Horio, Jian You, Gaofeng Li, Dinh Van Luong, Somcharoen Saeteng, Fumihiro Tanaka, Stefan B Watzka, Laszlo Urban, Zsuzsanna Szalai, Hiroaki Akamatsu, Jin Hyoung Kang, Francisco J Orlandi, Guzel Z Mukhametshina, Andreas Pircher, Carlos Henrique Andrade Teixeira, Mike Aperghis, Gary J Doherty, Ruth Doake, Tamer M Fouad, David Harpole
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Of the patients who underwent surgery, similar proportions had open (49.2% versus 50.7%) and minimally invasive (49.2% versus 47.0%) procedures; lobectomy was the most common procedure (88.1% versus 85.4%). R0 resection rates were numerically higher in the durvalumab versus placebo arm (94.7% versus 91.3%). The median time from surgery to first adjuvant dose was 50.0 versus 52.0 days. In exploratory analyses, a numerically higher proportion of patients in the durvalumab versus placebo arm with baseline N2 nodal status had downstaging from N2 to N0 (47.3% versus 40.2%) or, with baseline N1 nodal status, from N1 to N0 (53.6% versus 46.2%) after surgery. 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引用次数: 0
摘要
在爱琴海，围手术期durvalumab联合新辅助化疗，与单独新辅助化疗相比，显著提高无事件生存期和病理完全缓解(主要终点；改良ITT [mITT]人群，排除已知EGFR/ALK异常的患者)在可切除(R)-NSCLC患者中具有可控的安全性。在这里，我们报告了爱琴海的手术结果。方法：treatment-naïve R-NSCLC （ii期- iiib期[N2]）和ECOG PS 0/1患者在手术前随机（1:1）接受以铂为基础的化疗+杜伐单抗或安慰剂IV （Q3W， 4个周期），随后接受杜伐单抗或安慰剂（Q4W， 12个周期）。采用描述性统计方法总结mITT人群的手术结果。结果：737/740例mITT患者接受了治疗，durvalumab组和安慰剂组分别为366和371例；80.6%和80.7%接受手术，77.6%和76.7%完成手术，在接受手术的295名和302名患者中，17.3%和22.2%延迟手术。两组从最后一次新辅助剂量到手术的中位时间为34.0天。在接受手术的患者中，相似比例的患者接受开放（49.2%对50.7%）和微创（49.2%对47.0%）手术；肺叶切除术是最常见的手术（88.1%对85.4%）。durvalumab组的R0切除率高于安慰剂组（94.7% vs 91.3%）。从手术到第一次辅助用药的中位时间分别为50.0天和52.0天。在探索性分析中，与安慰剂组相比，durvalumab组中基线N2淋巴结状态的患者在手术后从N2降至N0（47.3%对40.2%）或基线N1淋巴结状态从N1降至N0（53.6%对46.2%）的比例更高。相似比例的手术并发症（59.1% vs 60.1%），主要是1/2级（53.0% vs 51.8%，修改的安全性分析集）。结论：与单独新辅助化疗相比，在新辅助化疗中加入durvalumab对手术的可行性、方法、类型或时间没有不利影响，并且与可耐受的手术安全性相关。临床试验：政府标识符：NCT03800134。
Surgical Outcomes With Neoadjuvant Durvalumab Plus Chemotherapy Followed by Adjuvant Durvalumab in Resectable NSCLC.
Introduction: In AEGEAN, perioperative durvalumab plus neoadjuvant chemotherapy, versus neoadjuvant chemotherapy alone, significantly improved event-free survival (p = 0.004) and pathologic complete response (p < 0.001; primary end points; modified intention-to-treat [mITT] population, which excluded patients with known EGFR or ALK aberrations) with a manageable safety profile in patients with resectable (R)-NSCLC. Here, we report surgical outcomes from AEGEAN.
Methods: Patients with treatment-naive R-NSCLC (stage II-IIIB [N2]) and Eastern Cooperative Oncology Group performance status 0 or 1 were randomized (1:1) to platinum-based chemotherapy plus durvalumab or placebo intravenously (every 3 wk, 4 cycles) before surgery, followed by durvalumab or placebo (every 4 wk, 12 cycles). Surgical outcomes were summarized for the mITT population using descriptive statistics.
Results: A total of 737 out of 740 mITT patients received treatment, 366 and 371 in the durvalumab and placebo arms, respectively; 80.6% and 80.7% underwent surgery, 77.6% and 76.7% completed surgery, and of the 295 and 302 patients who underwent surgery, 17.3% and 22.2% had delayed surgery. The median time from last neoadjuvant dose to surgery was 34.0 days in both arms. Of the patients who underwent surgery, similar proportions had open (49.2% versus 50.7%) and minimally invasive (49.2% versus 47.0%) procedures; lobectomy was the most common procedure (88.1% versus 85.4%). R0 resection rates were numerically higher in the durvalumab versus placebo arm (94.7% versus 91.3%). The median time from surgery to first adjuvant dose was 50.0 versus 52.0 days. In exploratory analyses, a numerically higher proportion of patients in the durvalumab versus placebo arm with baseline N2 nodal status had downstaging from N2 to N0 (47.3% versus 40.2%) or, with baseline N1 nodal status, from N1 to N0 (53.6% versus 46.2%) after surgery. Similar proportions had surgical complication(s) (59.1% versus 60.1%), primarily grade 1 or 2 (53.0% versus 51.8%, modified safety analysis set).
Conclusion: The addition of durvalumab to neoadjuvant chemotherapy had no detrimental effect on the feasibility, approach, type, or timing of surgery and was associated with a tolerable surgical safety profile, versus neoadjuvant chemotherapy alone.
期刊介绍：
Journal of Thoracic Oncology (JTO), the official journal of the International Association for the Study of Lung Cancer,is the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis, and treatment of all thoracic malignancies.The readship includes epidemiologists, medical oncologists, radiation oncologists, thoracic surgeons, pulmonologists, radiologists, pathologists, nuclear medicine physicians, and research scientists with a special interest in thoracic oncology.
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