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替莫唑胺胶囊单药治疗 IIIB-IVM1c 期黑色素瘤患者:系统评价和荟萃分析。

Single agent Talimogene Laherparepvec for stage IIIB-IVM1c melanoma patients: A systematic review and meta-analysis.

机构信息

Department of Surgical Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek (NKI-AVL), Amsterdam, The Netherlands.

Department of Surgical Oncology, Erasmus Medical Center, Rotterdam, The Netherlands; Department of Medical Oncology, Erasmus Medical Center, Rotterdam, The Netherlands.

出版信息

Crit Rev Oncol Hematol. 2022 Jul;175:103705. doi: 10.1016/j.critrevonc.2022.103705. Epub 2022 May 13.

DOI:10.1016/j.critrevonc.2022.103705
PMID:35569723
Abstract

Single-agent Talimogene Laherparepvec (T-VEC) was developed for treatment of unresectable and injectable stage III-IV melanoma. Since its approval and reimbursement, studies have reported varying response rates. The purpose of this systematic review and meta-analysis was to investigate the efficacy and safety of T-VEC. Of 341 publications that were identified, eight studies with a total of 642 patients were included. In patients with stage IIIB-IVM1a, the pooled complete- and overall response rate (CRR and ORR) were 41% and 64%, respectively. In patients with stage IIIB-IVM1c, the pooled CRR and ORR were 30% and 44%, respectively. In patients with stage IVM1b and IVM1c, the pooled CRR and ORR were 4% and 9%, respectively. Adverse events (AEs) were seen in 41-100% of all patients and 0-11% of AEs were severe. In conclusion, single agent T-VEC achieves the highest response rates in patients with early metastatic melanoma and is well-tolerated with generally only mild toxicities.

摘要

单药替莫唑胺(T-VEC)是为治疗不可切除和可注射的 III-IV 期黑色素瘤而开发的。自获得批准和报销以来,已有研究报告了不同的反应率。本系统评价和荟萃分析的目的是研究 T-VEC 的疗效和安全性。在确定的 341 篇出版物中,有 8 项研究共纳入 642 名患者。在 IIIB-IVM1a 期患者中,完全缓解率和总缓解率(CRR 和 ORR)的合并值分别为 41%和 64%。在 IIIB-IVM1c 期患者中,CRR 和 ORR 的合并值分别为 30%和 44%。在 IVM1b 和 IVM1c 期患者中,CRR 和 ORR 的合并值分别为 4%和 9%。所有患者的不良反应(AE)发生率为 41%-100%,AE 发生率为 0-11%,且为严重程度较低的不良反应。总之,单药 T-VEC 在早期转移性黑色素瘤患者中可达到最高的缓解率,且耐受性良好,一般仅出现轻微毒性。

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