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癌症疫苗疗法在恶性黑色素瘤中的疗效与安全性:一项系统评价

Efficacy and safety of cancer vaccine therapy in malignant melanoma: a systematic review.

作者信息

Seta Takeshi, Nakamura Shohei, Oura Mitsuaki, Yokoyama Kazuki, Nishikawa Yoshitaka, Hoshino Nobuaki, Ninomiya Kiichiro, Shimoi Tatsunori, Hotta Katsuyuki, Nakayama Takeo

机构信息

Department of Gastroenterology and Hepatology and Gastrointestinal Cancer Center, JRC Wakayama Medical Center, 4-20, Komatsubara-Dori, Wakayama City, Wakayama, 640-8558, Japan.

Department of Medical Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-Ku, Tokyo, 113-8677, Japan.

出版信息

Int J Clin Oncol. 2025 May 6. doi: 10.1007/s10147-025-02753-x.

Abstract

INTRODUCTION

Malignant melanoma is a cancer that develops from melanocytes in the skin and mucous membranes. Surgery, and chemotherapy, radiation therapy, or immunotherapy are also used in cases of distant metastasis. Immunotherapy includes immune checkpoint inhibitors and cancer vaccine therapy; however, their efficacy remains limited.

METHODS

A systematic review and meta-analysis of cancer vaccine therapies were conducted. PubMed was used to search the literature up to December 2023, and clinical trials were also identified for the same period. RCTs involving patients with resectable or unresectable malignant melanoma were included. The primary outcome was OS, and secondary outcomes were PFS, DFS, and RFS. Safety was assessed based on AEs. Integrated results were presented as risk ratio and risk difference.

RESULTS

The initial search identified 418 studies on cancer vaccine therapy and 44 studies on effector T-cell therapy. We supplemented this with our PubMed search, extracting 149 studies. After database searches and screening, 611 studies were initially considered. Following exclusions based on eligibility criteria, 20 RCTs using cancer vaccines remained. For the primary outcome, OS, the pooled RR was 1.11 (95% CI, 0.97-1.32, I = 59.0%), and the pooled RD was 0.02 (-0.01 to 0.06, I = 74.0%) at 12 months. PFS, DFS, and RFS did not show statistically significant differences, and AEs did not increase significantly.

CONCLUSION

Cancer vaccine therapy, neither alone, or in combination with other agents for malignant melanoma did not show a significant improvement in OS, PFS, DFS, or RFS nor did it significantly increase AEs.

摘要

引言

恶性黑色素瘤是一种起源于皮肤和黏膜黑色素细胞的癌症。对于远处转移的病例,也会采用手术、化疗、放疗或免疫疗法。免疫疗法包括免疫检查点抑制剂和癌症疫苗疗法;然而,它们的疗效仍然有限。

方法

对癌症疫苗疗法进行了系统评价和荟萃分析。使用PubMed检索截至2023年12月的文献,并确定同期的临床试验。纳入涉及可切除或不可切除恶性黑色素瘤患者的随机对照试验。主要结局是总生存期(OS),次要结局是无进展生存期(PFS)、疾病无进展生存期(DFS)和复发无进展生存期(RFS)。基于不良事件评估安全性。综合结果以风险比和风险差异表示。

结果

最初的检索确定了418项关于癌症疫苗疗法的研究和44项关于效应T细胞疗法的研究。我们通过PubMed检索进行补充,提取了149项研究。经过数据库检索和筛选,最初考虑了611项研究。根据纳入标准排除后,仍有20项使用癌症疫苗的随机对照试验。对于主要结局OS,12个月时合并风险比(RR)为1.11(95%置信区间,0.97 - 1.32,I² = 59.0%),合并风险差异(RD)为0.02(-0.01至0.06,I² = 74.0%)。PFS、DFS和RFS未显示出统计学显著差异,不良事件也未显著增加。

结论

癌症疫苗疗法单独或与其他药物联合用于恶性黑色素瘤,在OS、PFS、DFS或RFS方面均未显示出显著改善,也未显著增加不良事件。

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