Retrospective comparison of a weight-based dose every 2 weeks with a fixed dose every month: a real-life analysis of nivolumab in the treatment of advanced melanoma.

IF 1.5 4区 医学 Q3 DERMATOLOGY Melanoma Research Pub Date : 2024-06-01 Epub Date: 2024-03-15 DOI:10.1097/CMR.0000000000000965
Marie Leroy, Eve Desmedt, Laure Deramoudt, Michèle Vasseur, Pascal Odou, Hélène Béhal, Bertrand Décaudin, Laurent Mortier, Nicolas Simon
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Abstract

Nivolumab was first authorized at a weight-based dose (WBD) of 3 mg/kg every two weeks (Q2W). Since 2017, a fixed dose (FD) regimen [first 240 mg Q2W and then 480 mg per month (Q4W)] was allowed. The objective of the study was to compare a WBD regimen and an FD regimen with regard to effectiveness and safety. We conducted a single-center, retrospective, real-life study of consecutive adult patients who had received a WBD of nivolumab or an FD of 480 mg Q4W. The primary endpoint was the occurrence of grade ≥3 immune-related adverse events (irAEs). The secondary endpoints were overall survival and cost of the treatment. In all, 342 patients were included: 71 in the WBD cohort and 271 in the FD cohort. Of these patients, 201 patients (59.6%) experienced an irAE, and 24 of these events were graded as ≥3. At 12 months, there was no significant difference in irAE occurrence between the two cohorts [hazard ratio (95% confidence interval): 0.54 (0.21-1.36), P  = 0.19]. The 12-month overall survival rate was significantly lower in the WBD cohort ( P  < 0.001). Switching from a fortnightly weight dose to a fixed monthly dose halves the cost of hospitalization. Our results did not show a significant difference between WBD and FD cohort in the occurrence of severe irAEs. However overall survival appeared to be significantly higher in FD group. Some clinical trials are investigating a hybrid dosing regimen in which a WBD is capped by an FD. The present results need to be confirmed in prospective studies.

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基于体重的每两周一次的剂量与每月一次的固定剂量的回顾性比较:治疗晚期黑色素瘤的 nivolumab 的实际生活分析。
Nivolumab 最初获准采用基于体重的剂量(WBD),即每两周 3 毫克/千克(Q2W)。自2017年起,允许采用固定剂量(FD)方案[先是240毫克Q2W,然后是每月480毫克(Q4W)]。本研究旨在比较 WBD 方案和 FD 方案的有效性和安全性。我们对连续接受尼妥珠单抗 WBD 或 480 毫克 Q4W FD 的成年患者进行了一项单中心、回顾性、真实生活研究。主要终点是发生≥3级免疫相关不良事件(irAEs)。次要终点是总生存期和治疗费用。共纳入了 342 名患者:其中71例为WBD队列,271例为FD队列。201名患者(59.6%)发生了虹膜AE,其中24例≥3级。12 个月时,两组患者的虹膜急性灶事件发生率无明显差异[危险比(95% 置信区间):0.54 (0.21-1.36),P = 0.19]。WBD 组群的 12 个月总生存率明显低于 WBD 组群(P<0.05)。
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来源期刊
Melanoma Research
Melanoma Research 医学-皮肤病学
CiteScore
3.40
自引率
4.50%
发文量
139
审稿时长
6-12 weeks
期刊介绍: ​​​​​​Melanoma Research is a well established international forum for the dissemination of new findings relating to melanoma. The aim of the Journal is to promote the level of informational exchange between those engaged in the field. Melanoma Research aims to encourage an informed and balanced view of experimental and clinical research and extend and stimulate communication and exchange of knowledge between investigators with differing areas of expertise. This will foster the development of translational research. The reporting of new clinical results and the effect and toxicity of new therapeutic agents and immunotherapy will be given emphasis by rapid publication of Short Communications. ​Thus, Melanoma Research seeks to present a coherent and up-to-date account of all aspects of investigations pertinent to melanoma. Consequently the scope of the Journal is broad, embracing the entire range of studies from fundamental and applied research in such subject areas as genetics, molecular biology, biochemistry, cell biology, photobiology, pathology, immunology, and advances in clinical oncology influencing the prevention, diagnosis and treatment of melanoma.
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