Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
Department of Thoracic Surgery, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China; Medical Graduate School, Nanchang University, Nanchang, China.
Ann Thorac Surg. 2022 Sep;114(3):949-958. doi: 10.1016/j.athoracsur.2022.01.039. Epub 2022 Feb 15.
Evidence of neoadjuvant chemoimmunotherapy for locally advanced non-small cell lung cancer remains investigational and requires prospective validation. This phase II trial (https://www.chictr.org.cn/historyversionpub.aspx?regno=ChiCTR1900023758) aimed to investigate the safety and effectiveness of neoadjuvant PD-1 inhibitor sintilimab in addition to chemotherapy in the management of resectable stage IIIA non-small cell lung cancer.
Eligible patients received two to four 21-day cycles of neoadjuvant therapy: sintilimab (200 mg) and carboplatin (area under the curve 5) on day 1, gemcitabine (1000 mg/m) on day 1 and day 8 for squamous cell carcinoma, or pemetrexed (500 mg/m) on day 1 for adenocarcinoma and non-small cell lung cancer not otherwise specified. The primary endpoints were adverse events and major pathological response. The secondary endpoint was disease-free survival at 1 year.
Fifty patients were enrolled, and 23 (46%) achieved partial response after neoadjuvant chemoimmunotherapy. Four (8%) patients experienced grade 3 to 5 adverse events. Thirty patients received surgery, none of whom experienced treatment-related surgery delays, and 13 (43.3%) of 30 patients achieved major pathological response (viable tumor ≤10%). With a median follow-up of 13.6 months, 85.3% of patients were disease-free at 1 year (N = 50).
Neoadjuvant sintilimab with platinum-containing dual-agent chemotherapy was feasible and safe for patients with resectable stage IIIA non-small cell lung cancer.
新辅助化疗免疫治疗局部晚期非小细胞肺癌的证据仍在研究中，需要前瞻性验证。这项 II 期试验（https://www.chictr.org.cn/historyversionpub.aspx?regno=ChiCTR1900023758）旨在研究 PD-1 抑制剂信迪利单抗联合化疗在可切除 IIIA 期非小细胞肺癌治疗中的安全性和有效性。
符合条件的患者接受两到四个 21 天周期的新辅助治疗：信迪利单抗（200mg）和卡铂（曲线下面积 5）第 1 天，吉西他滨（1000mg/m）第 1 天和第 8 天用于鳞状细胞癌，或培美曲塞（500mg/m）第 1 天用于腺癌和非小细胞肺癌未另作规定。主要终点是不良事件和主要病理反应。次要终点是 1 年无病生存率。
共纳入 50 例患者，23 例（46%）新辅助化疗免疫治疗后获得部分缓解。4 例（8%）患者发生 3 至 5 级不良事件。30 例患者接受手术，均无治疗相关手术延迟，30 例患者中有 13 例（43.3%）达到主要病理缓解（存活肿瘤≤10%）。中位随访 13.6 个月时，50 例患者中有 85.3%（N=50）在 1 年内无疾病。
信迪利单抗联合铂类双药化疗新辅助治疗可切除 IIIA 期非小细胞肺癌是可行和安全的。
