THURSDAY, April 24, 2025 -- For patients with unresectable metastatic uveal melanoma (mUM), the drug/device combination melphalan/hepatic delivery system (HDS) is efficacious and has a favorable risk-benefit profile compared with best alternative care (BAC), according to a study published online April 7 in the .

2025年4月24日，星期四——一项研究显示，对于无法手术切除的转移性葡萄膜黑色素瘤（mUM）患者，与最佳替代治疗（BAC）相比，药物/设备组合美法仑/肝递送系统（HDS）有效且具有良好的风险收益比。该研究于4月7日在线发表在《》上。

Annals of Surgical Oncology

外科肿瘤学年鉴

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Jonathan S. Zager, M.D., from the Moffit Cancer Center in Tampa, Florida, and colleagues randomly assigned 85 eligible patients with unresectable mUM to receive melphalan/HDS 3 mg/kg ideal body weight once every six to eight weeks for a maximum of six cycles or BAC (43 and 42 patients, respectively); 72 patients actually received study treatment (40 and 32 patients, respectively).

Jonathan S. Zager，医学博士，来自佛罗里达州坦帕市的莫菲特癌症中心，他和同事随机分配了85名符合条件的无法切除的转移性葡萄膜黑色素瘤患者，分别接受每六到八周一次、最大剂量为6个周期的美法仑/高剂量疗法（3 mg/kg理想体重）或BAC治疗（分别为43名和42名患者）；实际上有72名患者接受了研究治疗（分别为40名和32名患者）。

The study design was amended to a single-arm melphalan/HDS study, and all efficacy analyses of the randomized study were treated as exploratory..

研究设计被修改为单臂美法仑/HDS研究，随机研究的所有疗效分析均被视为探索性分析。

The researchers observed numerical differences consistently favoring the melphalan/HDS arm versus BAC in exploratory analyses of efficacy end points (median overall survival, 18.5 versus 14.5 months; median progression-free survival, 9.1 versus 3.3 months; objective response rate, 27.5 versus 9.4 percent; disease control rate, 80.0 versus 46.9 percent).

研究人员在对疗效终点的探索性分析中观察到，数值差异始终倾向于美法仑/HDS组而非BAC组（中位总生存期为18.5个月对14.5个月；中位无进展生存期为9.1个月对3.3个月；客观缓解率为27.5％对9.4％；疾病控制率为80.0％对46.9％）。

Serious adverse events occurred in 51.2 and 21.9 percent of patients receiving melphalan/HDS and BAC, respectively. Thrombocytopenia, neutropenia, leukopenia, and febrile neutropenia were the most common serious adverse events in patients receiving melphalan/HDS (19.5, 9.8, 9.8, and 7.3 percent, respectively), while in patients receiving BAC, cholecystitis, nausea, and vomiting were the most common serious adverse events (6.3 percent each).

接受美法仑/HDS和BAC治疗的患者中，分别有51.2%和21.9%发生了严重不良事件。血小板减少、中性粒细胞减少、白细胞减少和发热性中性粒细胞减少是接受美法仑/HDS治疗患者最常见的严重不良事件（分别为19.5%、9.8%、9.8%和7.3%），而在接受BAC治疗的患者中，胆囊炎、恶心和呕吐是最常见的严重不良事件（各占6.3%）。

There were no treatment-related deaths reported..

没有报告与治疗相关的死亡。

'This therapy offers a treatment option for patients with this rare condition which is associated with a poor prognosis and limited treatment options,' the authors write.

“这种疗法为患有这种罕见疾病、预后较差且治疗选择有限的患者提供了一种治疗选择，”作者写道。

Several authors disclosed ties to the pharmaceutical industry; the study was funded by Delcath Systems.

几位作者透露了与制药行业的关系；这项研究由Delcath Systems公司资助。

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