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目的观察白细胞介素2(IL-2)基因修饰人胃癌细胞瘤苗(HG-1/IL-2)治疗胃癌术后复发和/或转移患者的临床安全性,并初步评价其对患者免疫指标的影响和疗效。方法应用基因工程技术,以逆转录病毒载体将人IL-2cDNA转导入HLA-A2阳性的人胃癌细胞株MKN-45,经60Co照射灭活后,制备成HG-1/IL-2。15例胃癌术后复发/转移患者入组。以5次接种为1疗程,接种时间分别在第1、8、15、29和58天,每次于一侧腹股沟和对侧腋部皮下注射。每次接种后严格观察不良反应,并在治疗开始前1周和治疗结束后进行免疫学指标和临床受益评价。结果除1例因疾病快速进展,在接种3次后死于多脏器功能衰竭外,余14例均完成5次接种。接种后发热和注射局部红肿、酸胀感是最常见的反应。治疗后未观察到患者血液、肝肾功能等指标的明显异常。部分患者治疗后血清转铁蛋白、免疫球蛋白(Ig)G、IgA、IgM、IL-2等体液免疫和CD3、CD4、CD8等细胞免疫指标有一定程度提高。4例获部分缓解,6例稳定,4例病情进展。结论IL-2基因修饰胃癌细胞瘤苗治疗耐受性好,部分患者体液和细胞免疫指标改善明显。该药物可作为辅助治疗手段,应用于胃癌术后复发转移的综合治疗。
Objective To observe the clinical safety of interleukin 2 (IL-2) gene modified human gastric cancer cell vaccine (HG-1/IL-2) in the treatment of postoperative recurrence and/or metastasis of gastric cancer, and to evaluate its immune index in patients. The effects and efficacy. Methods Human gene IL-2 cDNA was transfected into HLA-A2 positive human gastric cancer cell line MKN-45 using retroviral vectors and inactivated by 60Co irradiation to prepare HG-1/IL-2. Patients with postoperative recurrence/metastasis of gastric cancer were enrolled. The five inoculations were used as a course of treatment. The inoculation time was on days 1, 8, 15, 29, and 58 and was injected subcutaneously on one side of the inguinal and contralateral side. Adverse reactions were strictly observed after each vaccination, and immunological indicators and clinical benefit evaluations were performed 1 week before the start of treatment and after the end of treatment. Results In addition to 1 case of rapid progression due to disease, after vaccinating 3 times died of multiple organ failure, the remaining 14 patients completed 5 inoculations. After the inoculation, fever and injection of local swelling and soreness were the most common reactions. No significant abnormalities in blood, liver and kidney function were observed after treatment. After treatment, humoral immunity such as serum transferrin, IgG, IgA, IgM, IL-2, and CD3, CD4, CD8, and other cellular immune indicators were increased in some patients. In 4 cases, partial remission was achieved, 6 cases were stable, and 4 cases progressed. Conclusion IL-2 gene-modified gastric cancer cell vaccines are well tolerated, and some patients have obvious improvement in humoral and cellular immune parameters. The drug can be used as an adjunct treatment for the comprehensive treatment of postoperative recurrence and metastasis of gastric cancer.