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口服化疗联合 7 肽鸡尾酒疫苗治疗转移性结直肠癌的临床试验。

Clinical trial of a 7-peptide cocktail vaccine with oral chemotherapy for patients with metastatic colorectal cancer.

机构信息

Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka, Japan

Department of Surgery, Kinki University Faculty of Medicine, Osaka-sayama, Osaka, Japan.

出版信息

Anticancer Res. 2014 Jun;34(6):3045-52.

PMID:24922671
Abstract

AIM

The combination of a peptide vaccine and tegafur-uracil plus leucovorin (UFT/LV) were evaluated in patients with metastatic colorectal cancer refractory to standard chemotherapy.

PATIENTS AND METHODS

Thirty human leukocyte antigen (HLA)-A2402-positive patients were enrolled in the study. In a cycle of treatment, a vaccine comprising of seven synthetic peptides (five tumor antigen-derived and two vascular endothelial growth factor receptor-derived) was injected weekly, and oral chemotherapy, UFT/LV was given daily for four weeks followed by one week of rest. The immunological and clinical responses were evaluated at the end of every five weeks.

RESULTS

Notable adverse events included grade 1 injection site redness/induration in 25 patients. Tumor imaging showed partial response in three patients, stable disease in 15, and progressive disease in 12. Survival analysis indicated that patients who exhibited positive cytotoxic T lymphocyte responses to all seven peptides had longer overall survival compared to other patients.

CONCLUSION

A 7-peptide vaccine used with UFT/LV is safe and is recommended for further trials in patients with metastatic colorectal cancer.

摘要

目的

评估肽疫苗联合替加氟-尿嘧啶/亚叶酸(UFT/LV)治疗对标准化疗耐药的转移性结直肠癌患者的疗效。

患者和方法

本研究纳入了 30 名人类白细胞抗原(HLA)-A2402 阳性患者。在一个治疗周期中,每周注射一次包含七种合成肽(五种肿瘤抗原衍生肽和两种血管内皮生长因子受体衍生肽)的疫苗,同时给予口服化疗药物 UFT/LV,每日一次,连用四周,然后休息一周。每五周结束时评估免疫和临床反应。

结果

显著的不良反应包括 25 名患者出现 1 级注射部位红肿/硬结。肿瘤影像学显示 3 名患者部分缓解,15 名患者疾病稳定,12 名患者疾病进展。生存分析表明,对所有七种肽均产生细胞毒性 T 淋巴细胞阳性反应的患者总生存期较长。

结论

UFT/LV 联合使用 7 肽疫苗是安全的,建议在转移性结直肠癌患者中进一步进行临床试验。

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