{"title":"Efficacy and safety of cancer vaccine therapy in malignant melanoma: a systematic review.","authors":"Takeshi Seta, Shohei Nakamura, Mitsuaki Oura, Kazuki Yokoyama, Yoshitaka Nishikawa, Nobuaki Hoshino, Kiichiro Ninomiya, Tatsunori Shimoi, Katsuyuki Hotta, Takeo Nakayama","doi":"10.1007/s10147-025-02753-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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<sup>2</sup> = 59.0%), and the pooled RD was 0.02 (-0.01 to 0.06, I<sup>2</sup> = 74.0%) at 12 months. PFS, DFS, and RFS did not show statistically significant differences, and AEs did not increase significantly.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1080-1097"},"PeriodicalIF":2.4000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10147-025-02753-x","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/6 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
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, I2 = 59.0%), and the pooled RD was 0.02 (-0.01 to 0.06, I2 = 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.
期刊介绍:
The International Journal of Clinical Oncology (IJCO) welcomes original research papers on all aspects of clinical oncology that report the results of novel and timely investigations. Reports on clinical trials are encouraged. Experimental studies will also be accepted if they have obvious relevance to clinical oncology. Membership in the Japan Society of Clinical Oncology is not a prerequisite for submission to the journal. Papers are received on the understanding that: their contents have not been published in whole or in part elsewhere; that they are subject to peer review by at least two referees and the Editors, and to editorial revision of the language and contents; and that the Editors are responsible for their acceptance, rejection, and order of publication.