Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, Tex.
Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, Tex.
J Thorac Cardiovasc Surg. 2022 Nov;164(5):1327-1337. doi: 10.1016/j.jtcvs.2022.01.019. Epub 2022 Jan 23.
Surgical outcomes for non-small cell lung cancer after neoadjuvant immune checkpoint inhibitors continue to be debated. We assessed perioperative outcomes of patients treated with Nivolumab or Nivolumab plus Ipilimumab (NEOSTAR) and compared them with patients treated with chemotherapy or previously untreated patients with stage I-IIIA non-small cell lung cancer.
Forty-four patients with stage I to IIIA non-small cell lung cancer (American Joint Committee on Cancer Staging Manual, seventh edition) were randomized to nivolumab (N; 3 mg/kg intravenously on days 1, 15, and 29; n = 23) or nivolumab with ipilimumab (NI; I, 1 mg/kg intravenously on day 1; n = 21). Curative-intent operations were planned between 3 and 6 weeks after the last dose of neoadjuvant N. Patients who completed resection upfront or after chemotherapy from the same time period were used as comparison.
In the N arm, 21 (91%) were resected on-trial, 1 underwent surgery off-trial, and one was not resected (toxicity-related). In the NI arm, 16 (76%) resections were performed on-trial, one off-trial, and 4 were not resected (none toxicity-related). Median time to operation was 31 days, and consisted of 2 (5%) pneumonectomies, 33 (89%) lobectomies, and 1 (3%) each of segmentectomy and wedge resection. The approach was 27 (73%) thoracotomy, 7 (19%) thoracoscopy, and 3 (8%) robotic-assisted. Conversion occurred in 17% (n = 2/12) of minimally invasive cases. All 37 achieved R0 resection. Pulmonary, cardiac, enteric, neurologic, and wound complications occurred in 9 (24%), 4 (11%), 2 (5%), 1 (3%), and 1 (3%) patient, respectively. The 30- and 90-day mortality rate was 0% and 2.7% (n = 1), respectively. Postoperative complication rates were comparable with lung resection upfront or after chemotherapy.
Operating after neoadjuvant N or NI is overall safe and effective and yields perioperative outcomes similar to those achieved after chemotherapy or upfront resection.
新辅助免疫检查点抑制剂治疗非小细胞肺癌的手术结果仍存在争议。我们评估了接受纳武利尤单抗或纳武利尤单抗联合伊匹单抗（NEOSTAR）治疗的患者的围手术期结局，并将其与接受化疗或未经治疗的 I 期至 IIIA 期非小细胞肺癌患者进行比较。
44 例 I 期至 IIIA 期非小细胞肺癌（美国癌症联合委员会肿瘤分期手册，第 7 版）患者被随机分为纳武利尤单抗（N；3mg/kg 静脉注射，第 1、15 和 29 天；n=23）或纳武利尤单抗联合伊匹单抗（NI；I，1mg/kg 静脉注射，第 1 天；n=21）组。新辅助 N 治疗后 3 至 6 周计划进行根治性手术。从同一时期接受化疗后直接手术或先行化疗的患者作为比较。
在 N 组中，21 例（91%）在试验中接受了手术，1 例在试验外接受了手术，1 例未接受手术（与毒性相关）。在 NI 组中，16 例（76%）进行了试验内手术，1 例试验外手术，4 例未手术（均与毒性无关）。中位手术时间为 31 天，包括 2 例（5%）全肺切除术、33 例（89%）肺叶切除术、1 例（3%）肺段切除术和楔形切除术。手术方式为 27 例（73%）开胸术、7 例（19%）胸腔镜手术和 3 例（8%）机器人辅助手术。微创病例中有 17%（n=2/12）发生了转换。所有 37 例均达到 R0 切除。9 例（24%）发生肺部、心脏、肠、神经和伤口并发症，分别为 4 例（11%）、4 例（11%）、2 例（5%）、1 例（3%）和 1 例（3%）。30 天和 90 天死亡率分别为 0%和 2.7%（n=1）。术后并发症发生率与直接或化疗后肺切除术相似。
新辅助 N 或 NI 后手术总体上是安全有效的，并且获得的围手术期结果与化疗或直接切除相似。
