肿瘤细胞治疗研究
英文原题：Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent.
评估在I至III期接受根治性放疗或手术的局部NSCLC患者中免疫治疗（不包括检查点抑制剂）的有效性和安全性。
非小细胞肺癌（NSCLC）是最常见的肺癌，约占所有病例的80%至85%。对于局限性NSCLC（I至III期）患者，推测免疫治疗可能有助于降低术后复发率，或改善当前不可切除肿瘤治疗的临床结局。这是2017年首次发表的Cochrane综述的更新，新增了两项随机对照试验（RCT）。
评估免疫治疗（不包括检查点抑制剂）在I至III期接受根治性放疗或手术的局部NSCLC患者中的有效性和安全性。检索方法：我们检索了以下数据库（从建库至2021年5月19日）：CENTRAL、MEDLINE、Embase、CINAHL和五个试验注册库。我们还检索了会议论文集和纳入试验的参考文献列表。选择标准：我们纳入了在手术切除后诊断为I至III期NSCLC的成人（18岁）中开展的RCT，以及接受根治性放疗的不可切除局部晚期III期NSCLC患者。我们纳入了接受原发性手术治疗、术后放疗或放化疗的参与者，前提是干预组和对照组均提供相同策略。数据收集与分析：两名综述作者独立选择符合条件的试验、评估偏倚风险并提取数据。我们使用生存分析合并时间至事件数据，采用风险比（HR）。我们使用风险比（RR）处理二分类数据，使用均数差（MD）处理连续数据，并计算95%置信区间（CI）。由于临床异质性（免疫治疗药物具有不同的潜在机制），我们应用随机效应模型合并数据。主要结果：我们纳入了11项RCT，涉及5128名参与者（自2017年1月20日最后一次检索以来，这包括2项新试验，共188名参与者）。接受手术切除或接受根治性放疗的参与者被随机分配到免疫治疗组或对照组。免疫干预为主动免疫治疗卡介苗（BCG）过继性细胞转移（即转移因子（TF）、TIL（肿瘤浸润淋巴细胞）、树突状细胞/细胞因子诱导的杀伤细胞（DC/CIK）、抗原特异性癌症疫苗（黑色素瘤相关抗原3（MAGE-A3）和L-BLP25）以及靶向自然杀伤（NK）细胞。七项试验在至少一个偏倚风险领域存在高偏倚风险。三项试验在所有领域均为低偏倚风险，一项小型试验因提供的信息不足而偏倚风险不明确。我们纳入了11项试验中9项的数据进行meta分析，涉及4863名受试者。在以下任何结局方面，均无证据表明免疫治疗药物与对照之间存在差异：总生存期（HR 0.94，95% CI 0.84至1.05；P = 0.27；4项试验，3848名受试者；高质量证据）、无进展生存期（HR 0.94，95% CI 0.86至1.03；P = 0.19；中等质量证据）、不良事件（RR 1.12，95% CI 0.97至1.28；P = 0.11；4项试验，4126名接受评估的受试者；低质量证据）以及严重不良事件（RR 1.14，95% CI 0.92至1.40；6项试验，4546名接受评估的受试者；低质量证据）。不同时间点的生存率显示，免疫治疗药物与对照之间无差异证据。1年随访时的生存率（RR 1.02，95% CI 0.96至1.08；I 2 = 57%；7项试验，4420名受试者；低质量证据）、2年随访时（RR 1.02，95% CI 0.93至1.12；7项试验，4420名受试者；中等质量证据）、3年随访时（RR 0.99，95% CI 0.90至1.09；7项试验，4420名受试者；I 2 = 22%；中等质量证据）以及5年随访时（RR 0.98，95% CI 0.86至1.12；I 2 = 0%；7项试验，4389名受试者；中等质量证据）。仅
BACKGROUND: Non-small cell lung cancer (NSCLC) is the most common lung cancer, accounting for approximately 80% to 85% of all cases. For people with localised NSCLC (stages I to III), it has been speculated that immunotherapy may be helpful for reducing postoperative recurrence rates, or improving the clinical outcomes of current treatment for unresectable tumours. This is an update of a Cochrane Review first published in 2017 and it includes two new randomised controlled trials (RCTs). OBJECTIVES: To assess the effectiveness and safety of immunotherapy (excluding checkpoint inhibitors) among people with localised NSCLC of stages I to III who received curative intent of radiotherapy or surgery. SEARCH METHODS: We searched the following databases (from inception to 19 May 2021): CENTRAL, MEDLINE, Embase, CINAHL, and five trial registers. We also searched conference proceedings and reference lists of included trials. SELECTION CRITERIA: We included RCTs conducted in adults ( 18 years) diagnosed with NSCLC stage I to III after surgical resection, and those with unresectable locally advanced stage III NSCLC receiving radiotherapy with curative intent. We included participants who underwent primary surgical treatment, postoperative radiotherapy or chemoradiotherapy if the same strategy was provided for both intervention and control groups. DATA COLLECTION AND ANALYSIS: Two review authors independently selected eligible trials, assessed risk of bias, and extracted data. We used survival analysis to pool time-to-event data, using hazard ratios (HRs). We used risk ratios (RRs) for dichotomous data, and mean differences (MDs) for continuous data, with 95% confidence intervals (CIs). Due to clinical heterogeneity (immunotherapeutic agents with different underlying mechanisms), we combined data by applying random-effects models. MAIN RESULTS: We included 11 RCTs involving 5128 participants (this included 2 new trials with 188 participants since the last search dated 20 January 2017). Participants who underwent surgical resection or received curative radiotherapy were randomised to either an immunotherapy group or a control group. The immunological interventions were active immunotherapy Bacillus Calmette-Gu rin (BCG) adoptive cell transfer (i.e. transfer factor (TF), tumour-infiltrating lymphocytes (TIL), dendritic cell/cytokine-induced killer (DC/CIK), antigen-specific cancer vaccines (melanoma-associated antigen 3 (MAGE-A3) and L-BLP25), and targeted natural killer (NK) cells. Seven trials were at high risk of bias for at least one of the risk of bias domains. Three trials were at low risk of bias across all domains and one small trial was at unclear risk of bias as it provided insufficient information. We included data from nine of the 11 trials in the meta-analyses involving 4863 participants. There was no evidence of a difference between the immunotherapy agents and the controls on any of the following outcomes: overall survival (HR 0.94, 95% CI 0.84 to 1.05; P = 0.27; 4 trials, 3848 participants; high-quality evidence), progression-free survival (HR 0.94, 95% CI 0.86 to 1.03; P = 0.19; moderate-quality evidence), adverse events (RR 1.12, 95% CI 0.97 to 1.28; P = 0.11; 4 trials, 4126 evaluated participants; low-quality evidence), and severe adverse events (RR 1.14, 95% CI 0.92 to 1.40; 6 trials, 4546 evaluated participants; low-quality evidence). Survival rates at different time points showed no evidence of a difference between immunotherapy agents and the controls. Survival rate at 1-year follow-up (RR 1.02, 95% CI 0.96 to 1.08; I 2 = 57%; 7 trials, 4420 participants; low-quality evidence), 2-year follow-up (RR 1.02, 95% CI 0.93 to 1.12; 7 trials, 4420 participants; moderate-quality evidence), 3-year follow-up (RR 0.99, 95% CI 0.90 to 1.09; 7 trials, 4420 participants; I 2 = 22%; moderate-quality evidence) and at 5-year follow-up (RR 0.98, 95% CI 0.86 to 1.12; I 2 = 0%; 7 trials, 4389 participants; moderate-quality evidence). Only
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