免疫联合放疗一线治疗局部晚期肺鳞癌15例临床观察

Clinical Observation of 15 Cases of Locally Advanced Lung Squamous Cell Carcinoma Treated with Immunotherapy Combined with Radiotherapy

摘要: 目的：通过免疫检查点抑制剂联合调强放疗一线治疗局部晚期肺鳞癌15例回顾性观察，进一步验证免疫联合放疗的可行性及安全性，高效性，前景值得期待。方法：2019年7月至2020年7月共15例肺鳞癌患者，均有明确病理及临床分期(IIIA-IIIB)。无免疫治疗及放疗禁忌。15例患者均一线接受国产免疫检查点抑制剂信迪利单抗联合局部调强放疗。放疗首日同步信迪利单抗(PD-1) 200 mg静滴，放疗期间至放疗结束继续维持免疫治疗至12个月。放疗模式选择IMRT，验证方法每周CBCT验证。总剂量：95% PTV 6000 CGy/30 f。疗效评估采用回访至2022年8月。结果：15例患者目前均在随访中。评价目标肿瘤主要参考RECIST1.1标准。其中1年：9例PR，CR 6例。ORR 100%。一年生存率100%，2年：CR 5例，PR 7例，SD 2例，PD 1例。2年局部控制率 > 85%，2年生存率100%。中位PFS (Progression-Free Survival)未达到。继续观察中。毒副作用主要依据CTC2.0版药物治疗毒作用分级标准，CSCO指南的免疫治疗毒作用分级标准。15例患者均未出现II度以上毒副作用。结论：免疫联合放疗一线治疗局部晚期非小细胞肺癌方法可行，近期疗效显著，远期生存继续观察评估。值得进一步扩大样本观察推广。

Abstract: Objective: To retrospectively observe 15 cases of locally advanced lung squamous cell carcinoma treated with immune checkpoint inhibitors combined with intensity-modulated radiotherapy (IMRT), and to further verify the feasibility, safety, efficiency of immunotherapy combined with radiotherapy, and the prospect of it is worth looking forward to. Methods: From July 2019 to July 2020, a total of 15 patients with squamous cell carcinoma of the lung were enrolled. All patients had clear pathological and clinical stages (IIIA-IIIB). There were no contraindications of immunotherapy and radiotherapy in all cases. All 15 patients received first-line immune checkpoint inhibitor Sindilizumab combined with local intensity modulated radiotherapy. On the first day of radiotherapy, Sindilizumab (pd-1) 200 mg was simultaneously intravenous dripped, and the immunotherapy was maintained until 12 months after the end of radiotherapy. Radiotherapy Way: IMRT, Verification method: weekly CBCT validation. Totol dose: 95% PTV 6000 cGY/30 f. The efficacy was evaluated by follow-up visits until August 2022. Results: All 15 patients are currently under follow-up. Target tumor was evaluated mainly according to RECIST1.1 criteria. Among them, 9 cases had partial response in one year, and 6 cases had complete response. ORR was 100%. The one-year survival rate was 100%. There were 7 cases with partial remission, 5 cases with complete remission, 2 cases with stable disease, and 1 case with progressive disease. The 2-year local control rate was more than 85%, and the 2-year survival rate was 100%. The median PFS was not reached. The toxicity and side effects were mainly based on the toxicity grading standards of drug therapy (CTC2.0) and immunotherapy toxicity grading standards of CSCO guidelines. None of the 15 patients had toxic side effects more severe than grade II. Results: Immunotherapy combined with radiotherapy was feasible for the first-line treatment of locally advanced non-small cell lung cancer, and the short-term efficacy was significant. Long-term survival is continuing to be assessed under observation. It is worth further expanding the sample observation and promotion.