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钇-90 微球放射性栓塞联合静脉顺铂治疗葡萄膜黑素瘤肝转移的初步研究。

A pilot study of intrahepatic yttrium-90 microsphere radioembolization in combination with intravenous cisplatin for uveal melanoma liver-only metastases.

机构信息

Medical Oncology Unit, Austin Health, Heidelberg, Victoria, Australia.

Cancer Immuno-Biology Laboratory, Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia.

出版信息

Cancer Rep (Hoboken). 2019 Aug;2(4):e1183. doi: 10.1002/cnr2.1183. Epub 2019 May 14.

DOI:10.1002/cnr2.1183
PMID:32721131
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7941455/
Abstract

BACKGROUND

Metastatic uveal melanoma is a highly aggressive disease with no standard of care treatment option. A large proportion of patients have liver-only metastatic disease which raises the question if liver-directed therapy can be efficacious in this subpopulation.

AIMS

The study aims to evaluate the safety and efficacy of radiosensitizing chemotherapy in combination with yttrium-90 microspheres in patients with uveal melanoma with liver-only metastases.

METHODS AND RESULTS

This single arm, open labeled, non-randomized study enrolled 10 patients with liver-only metastatic uveal melanoma between November 2012 and January 2018. Eligible patients received intrahepatic yttrium-90 microspheres followed by intravenous cisplatin (20 mg/m) for 5 days. Ten patients were enrolled, but nine patients received treatment who were included in the final analysis with a median follow-up of 30 months (range 7 to 44). Five (50%) were female, five (50%) had an elevated lactate dehydrogenase (LDH), and one (10%) had prior anti-PD-1 therapy. The combination was well tolerated with no greater than or equal to grade 3 toxicity observed. The liver objective response rate (ORR) was 33% (3/9), the median progression-free survival (PFS) in the liver was 3 months (95% CI, 3-NA), and the extrahepatic PFS was 3 months (95% CI, 3-NA). Seventy-eight percent (7/9) received an immune checkpoint inhibitor on disease progression, with no responses seen. The median overall survival (OS) was 10 months (95% CI, 7-NA).

CONCLUSION

The combination of cisplatin with yttrium-90 microspheres was well tolerated; however, it was associated with intrahepatic disease control of relatively short duration. No responses were seen in patients treated with immune checkpoint inhibitors post radioembolization.

摘要

背景

转移性葡萄膜黑色素瘤是一种高度侵袭性疾病,目前尚无标准的治疗方法。很大一部分患者仅有肝脏转移病灶,这就提出了一个问题,即肝靶向治疗是否对这部分患者有效。

目的

本研究旨在评估钇-90 微球联合放射增敏化疗治疗仅有肝脏转移的葡萄膜黑色素瘤患者的安全性和疗效。

方法和结果

这项单臂、开放标签、非随机研究纳入了 2012 年 11 月至 2018 年 1 月期间的 10 例仅有肝脏转移的葡萄膜黑色素瘤患者。符合条件的患者接受肝内钇-90 微球治疗,随后静脉注射顺铂(20mg/m2)5 天。共纳入 10 例患者,但 9 例患者接受了治疗并纳入最终分析,中位随访时间为 30 个月(范围为 7 至 44 个月)。其中 5 例(50%)为女性,5 例(50%)乳酸脱氢酶(LDH)升高,1 例(10%)曾接受过抗 PD-1 治疗。联合治疗耐受性良好,未观察到≥3 级毒性。肝脏客观缓解率(ORR)为 33%(3/9),肝脏无进展生存期(PFS)的中位数为 3 个月(95%CI,3-NR),肝外 PFS 为 3 个月(95%CI,3-NR)。78%(7/9)例患者在疾病进展时接受了免疫检查点抑制剂治疗,但均未见应答。中位总生存期(OS)为 10 个月(95%CI,7-NR)。

结论

顺铂联合钇-90 微球治疗耐受性良好,但与相对较短的肝内疾病控制期相关。接受放射性栓塞后免疫检查点抑制剂治疗的患者未见应答。

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