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德国和瑞士黑色素瘤患者在辅助治疗期间对毒性与黑色素瘤复发的偏好(GERMELATOX-A 试验)。

Preferences of German and Swiss melanoma patients for toxicities versus melanoma recurrence during adjuvant treatment (GERMELATOX-A-trial).

机构信息

Department of Dermatology, University Hospital Schleswig-Holstein (UKSH), Campus Kiel, Kiel, Germany.

Department of Dermatology, Dortmund, Germany.

出版信息

J Cancer Res Clin Oncol. 2023 Oct;149(13):11705-11718. doi: 10.1007/s00432-023-05027-z. Epub 2023 Jul 5.

Abstract

PURPOSE

Adjuvant treatment with immune checkpoint inhibitors like PD1-antibodies (ICI) ± CTLA4-antibodies (cICI) or targeted therapy with BRAF/MEK inhibitors (TT) in high-risk melanoma patients demonstrate a significant improvement in disease-free survival (DFS). Due to specific side effects, the choice of treatment is very often driven by the risk for toxicity. This study addressed for the first time in a multicenter setting the attitudes and preferences of melanoma patients for adjuvant treatment with (c)ICI and TT.

METHODS

In this study ("GERMELATOX-A"), 136 low-risk melanoma patients from 11 skin cancer centers were asked to rate side effect scenarios typical for each (c)ICI and TT with mild-to-moderate or severe toxicity and melanoma recurrence leading to cancer death. We asked patients about the reduction in melanoma relapse and the survival increase at 5 years they would require to tolerate defined side-effects.

RESULTS

By VAS, patients on average valued melanoma relapse worse than all scenarios of side-effects during treatment with (c)ICI or TT. In case of severe side effects, patients required a 15% higher rate of DFS at 5 years for (c)ICI (80%) compared to TT (65%). For survival, patients required an increase of 5-10% for melanoma survival during (c)ICI (85%/80%) compared to TT (75%).

CONCLUSION

Our study demonstrated a pronounced variation of patient preferences for toxicity and outcomes and a clear preference for TT. As adjuvant melanoma treatment with (c)ICI and TT will be increasingly implemented in earlier stages, precise knowledge of the patient perspective can be helpful for decision making.

摘要

目的

在高危黑色素瘤患者中,辅助治疗采用免疫检查点抑制剂(如 PD1 抗体(ICI)±CTLA4 抗体(cICI))或靶向治疗采用 BRAF/MEK 抑制剂(TT),可显著改善无病生存期(DFS)。由于特定的副作用,治疗的选择通常取决于毒性风险。本研究首次在多中心环境中探讨了黑色素瘤患者对辅助治疗(c)ICI 和 TT 的态度和偏好。

方法

在这项名为“GERMELATOX-A”的研究中,来自 11 个皮肤癌中心的 136 名低危黑色素瘤患者被要求对每种(c)ICI 和 TT 治疗中具有轻度至中度或重度毒性和导致癌症死亡的黑色素瘤复发的典型副作用情景进行评分。我们询问了患者在容忍特定副作用的情况下,他们需要降低多少黑色素瘤复发率和增加多少 5 年生存率。

结果

通过视觉模拟评分(VAS),患者平均将黑色素瘤复发的严重程度评估得比(c)ICI 或 TT 治疗过程中的所有副作用情景都要严重。在出现严重副作用的情况下,患者需要在 5 年内 DFS 提高 15%,才能接受(c)ICI(80%),而不是 TT(65%)。对于生存,患者需要在(c)ICI(85%/80%)期间提高 5-10%的黑色素瘤生存率,而不是 TT(75%)。

结论

我们的研究表明,患者对毒性和结果的偏好存在明显差异,并且明显倾向于 TT。由于(c)ICI 和 TT 在早期阶段越来越多地用于辅助黑色素瘤治疗,因此准确了解患者的观点可能有助于决策。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/94ec/11796970/2288207da07e/432_2023_5027_Fig1_HTML.jpg

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