目的:为了加强癌症免疫细胞治疗的科学证据,并进一步检查其安全性,2015年10月,我院与全国39家医疗机构共同成立了肿瘤免疫细胞治疗评估小组(CITEG)。
方法:医疗信息,如患者的背景特征,从每个设施获得的临床疗效和治疗细胞类型,已经积累,通过CITEG进行分析和评估。在这项前瞻性研究中,我们分析了截至2022年9月底与免疫细胞治疗相关的不良事件,并进行了中期安全性评估.
结果:共3839例恶性肿瘤患者接受免疫细胞治疗,年龄中位数为64岁(范围,13-97岁),男女比例为1:1.08(1846:1993)。大多数患者首次就诊时的表现状态为0或1(86.8%),3234例(84.2%)为晚期或复发病例,占大多数。CITEG报告的给药总数为31890次,其中960次(3.0%)出现不良事件。在19661次αβT细胞治疗中,由治疗引起的不良事件的数量为363次(1.8%),845次施用γδT细胞疗法中的9次(1.1%)和626次施用自然杀伤细胞疗法中的10次(1.6%)。由树突状细胞(DC)疫苗治疗引起的不良事件数量为10748次给药中的578次(5.4%),明显大于其他治疗方法。多变量分析显示,αβT细胞治疗在表现状态1或更高的情况下发生不良事件的风险显著增加。和64岁以下的患者,女性或辅助免疫细胞治疗在DC疫苗治疗中发生不良事件的风险更大.注射部位反应是最常见的不良事件。449个事件,其中大部分与DC疫苗治疗相关.在所有其他不良事件中,发烧(228个事件),我们经常报告疲劳(141例)和瘙痒(131例).相比之下,三名患者出现不良事件(发烧,腹痛和间质性肺炎)需要住院治疗,尽管它们与这种疗法的联系较弱;相反,它被认为是治疗原发性疾病的效果。
结论:癌症的免疫细胞疗法被认为是一种安全的治疗方法,没有严重的不良事件。
With the aim of strengthening the scientific evidence of immune-cell therapy for cancer and further examining its safety, in October 2015, our hospital jointly established the Cancer Immune-Cell Therapy Evaluation Group (CITEG) with 39 medical facilities nationwide.
Medical information, such as patients\' background characteristics, clinical efficacy and therapeutic cell types obtained from each facility, has been accumulated, analyzed and evaluated by CITEG. In this prospective study, we analyzed the adverse events associated with immune-cell therapy until the end of September 2022, and we presented our interim safety evaluation.
A total of 3839 patients with malignant tumor were treated with immune-cell therapy, with a median age of 64 years (range, 13-97 years) and a male-to-female ratio of 1:1.08 (1846:1993). Most patients\' performance status was 0 or 1 (86.8%) at the first visit, and 3234 cases (84.2%) were advanced or recurrent cases, which accounted for the majority. The total number of administrations reported in CITEG was 31890, of which 960 (3.0%) showed adverse events. The numbers of adverse events caused by treatment were 363 (1.8%) of 19661 administrations of αβT cell therapy, 9 of 845 administrations of γδT-cell therapy (1.1%) and 10 of 626 administrations of natural killer cell therapy (1.6%). The number of adverse events caused by dendritic cell (DC) vaccine therapy was 578 of 10748 administrations (5.4%), which was significantly larger than those for other treatments. Multivariate analysis revealed that αβT cell therapy had a significantly greater risk of adverse events at performance status 1 or higher, and patients younger than 64 years, women or adjuvant immune-cell therapy had a greater risk of adverse events in DC vaccine therapy. Injection-site reactions were the most frequently reported adverse events, with 449 events, the majority of which were associated with DC vaccine therapy. Among all other adverse events, fever (228 events), fatigue (141 events) and itching (131 events) were frequently reported. In contrast, three patients had adverse events (fever, abdominal pain and interstitial pneumonia) that required hospitalization, although they were weakly related to this therapy; rather, it was considered to be the effect of treatment for the primary disease.
Immune-cell therapy for cancer was considered to be a safe treatment without serious adverse events.