文章：

不同纳武利尤单抗治疗方案在日本晚期黑色素瘤患者中的真实世界疗效与副作用：一项单中心回顾性研究

The Real-World Efficacy and Side Effects of Different Nivolumab Regimens in Japanese Patients with Advanced Melanoma: A Single-Center Retrospective Study

原文发布日期：10 July 2025

DOI: 10.3390/cancers17142299

类型: Article

开放获取: 是

英文摘要：

Background/Objectives: Nivolumab is a key therapy for advanced-stage melanoma; however, limited data are available from Asian populations comparing the efficacy and side effects of four dosing regimens: 3 mg/kg every 2 weeks (3mg/kgQ2W), 2 mg/kg every 3 weeks (2mg/kgQ3W), 240 mg every 2 weeks (240mgQ2W), and 480 mg every 4 weeks (480mgQ4W). This retrospective study evaluated Japanese patients with advanced melanoma treated with various nivolumab regimens to assess the impact of dosing interval and dosage on treatment efficacy and immune-related adverse events (irAEs).Methods: We reviewed the records of 153 participants with stage IV melanoma who received nivolumab monotherapy between February 2012 and December 2024 at Shizuoka Cancer Center. Patients were categorized by nivolumab regimen, dosing interval, and dose per body weight. We then compared treatment efficacy and incidence of irAEs across groups.Results: No significant differences were observed in objective response rate (ORR), progression-free survival (PFS), overall survival (OS), or irAE incidence between the 240mgQ2W and 480mgQ4W groups. Similar results were observed in the 3mg/kgQ2W and 2mg/kgQ3W groups. However, participants who received nivolumab within 3 weeks exhibited a significantly higher ORR than those who received nivolumab more than 3 weeks. No significant differences were found in PFS or OS.Conclusions: The administration of nivolumab at shorter intervals may provide short-term benefits in Japanese patients with advanced melanoma. However, long-term efficacy and side effects did not differ significantly across the studied nivolumab regimens.

摘要翻译： 

背景/目的：纳武利尤单抗是晚期黑色素瘤的关键疗法；然而，关于亚洲人群比较四种给药方案疗效与副作用的数据有限，这四种方案包括：每2周3 mg/kg（3mg/kgQ2W）、每3周2 mg/kg（2mg/kgQ3W）、每2周240 mg（240mgQ2W）以及每4周480 mg（480mgQ4W）。本回顾性研究评估了接受不同纳武利尤单抗方案治疗的日本晚期黑色素瘤患者，旨在探讨给药间隔与剂量对疗效及免疫相关不良事件（irAEs）的影响。 方法：我们回顾了2012年2月至2024年12月期间在静冈癌症中心接受纳武利尤单抗单药治疗的153例IV期黑色素瘤患者的病历。根据纳武利尤单抗方案、给药间隔及单位体重剂量对患者进行分组，随后比较各组间的治疗效果及irAEs发生率。 结果：240mgQ2W组与480mgQ4W组在客观缓解率（ORR）、无进展生存期（PFS）、总生存期（OS）及irAEs发生率方面均未观察到显著差异。3mg/kgQ2W组与2mg/kgQ3W组的结果相似。然而，接受纳武利尤单抗给药间隔在3周内的患者，其ORR显著高于给药间隔超过3周的患者。在PFS或OS方面未发现显著差异。 结论：缩短纳武利尤单抗给药间隔可能为日本晚期黑色素瘤患者带来短期获益。但在所研究的纳武利尤单抗方案中，长期疗效与副作用未见显著差异。

原文链接：

The Real-World Efficacy and Side Effects of Different Nivolumab Regimens in Japanese Patients with Advanced Melanoma: A Single-Center Retrospective Study