日本放射性碘难治性分化型甲状腺癌患者低剂量起始lenvatinib的实际临床经验。

IF 2.1 4区 医学 Q4 ENDOCRINOLOGY & METABOLISM
Yomi Nakashima, Ichiro Horie, Haruka Arimori, Mayu Ueda, Shinpei Nishikido, Yuta Nakamura, Keita Nakaji, Tetsuro Niri, Ayaka Sako, Ai Haraguchi, Toshiyuki Ikeoka, Satoru Akazawa, Akie Moriuchi, Misa Imaizumi, Toshiro Usa, Atsushi Kawakami
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引用次数: 0

摘要

Lenvatinib被批准用于放射性碘难治性分化型甲状腺癌(RR-DTC)的一线治疗,起始剂量为24mg /天,但其高毒性经常需要减少剂量和中断治疗。为了明确低剂量起始lenvatinib的有效性和安全性,特别是对于体型较小和/或虚弱的亚洲人,我们回顾性检查了43名接受lenvatinib治疗的日本RR-DTC患者的结局,重点关注初始剂量。23名患者开始全剂量(24mg /天)lenvatinib, 20名患者开始减少剂量(≤14mg /天)。在全剂量起始组中,23例患者中有14例(60.8%)因不良反应需要在~30天内停药,明显高于减剂量起始组(25.0%)(p = 0.018),全剂量起始组中有5例患者未恢复治疗。与全剂量起始组相比,减剂量起始组年龄更大(无统计学意义),体重更低,总日剂量暴露更低,不良事件发生频率(≥2级)更低,但在整个观察期内,剂量中断率和每公斤日剂量暴露相当。在无进展生存期和总生存期的多变量分析中,恶性胸腔积液和症状性转移与较差的预后显著相关,而lenvatinib的起始剂量与此无关。根据患者的身体状况,降低lenvatinib的起始剂量可能是一种选择,不仅不良事件更低,而且疗效与全剂量相当。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-world clinical experience of reduced-dose initiation of lenvatinib in Japanese patients with radioiodine-refractory differentiated thyroid cancer.

Lenvatinib is approved for the first-line treatment for radioiodine-refractory differentiated thyroid cancer (RR-DTC) at a starting dose of 24 mg/day, but its high toxicity often necessitates dose reductions and interruptions. To clarify the efficacy and safety of the reduced dose-initiation of lenvatinib, especially for smaller-build and/or frail Asians, we retrospectively examined outcomes of 43 Japanese individuals with RR-DTC who were treated with lenvatinib, focusing on the initial dose. Twenty-three patients initiated lenvatinib at a full-dose (24 mg/day) and 20 patients initiated at a reduced-dose (≤14 mg/day). In the full dose-initiation group, 14 of 23 (60.8%) patients required discontinuation of lenvatinib within ~30 days due to adverse effects, which was significantly higher rate compared to that (25.0%) of the reduced dose-initiation group (p = 0.018), and 5 patients of the full dose-initiation group did not resume treatment. Compared to the full dose-initiation group, the reduced dose-initiation group were older (nonsignificant) and had significantly lower body weights, lower overall daily dose exposure, and a lower frequency of adverse events (≥grade 2) but a comparable dose interruption rate and daily dose exposure per kg during overall observation period. In multivariate analyses for progression-free survival and overall survival, malignant pleural effusion and symptomatic metastases but not the starting dose of lenvatinib were significantly associated with worse outcomes. Initiating lenvatinib at a reduced dose based on patients' physical status may be an option, with not only lower adverse events but also efficacy comparable to that of the full dose.

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来源期刊
Endocrine journal
Endocrine journal 医学-内分泌学与代谢
CiteScore
4.30
自引率
5.00%
发文量
224
审稿时长
1.5 months
期刊介绍: Endocrine Journal is an open access, peer-reviewed online journal with a long history. This journal publishes peer-reviewed research articles in multifaceted fields of basic, translational and clinical endocrinology. Endocrine Journal provides a chance to exchange your ideas, concepts and scientific observations in any area of recent endocrinology. Manuscripts may be submitted as Original Articles, Notes, Rapid Communications or Review Articles. We have a rapid reviewing and editorial decision system and pay a special attention to our quick, truly scientific and frequently-citable publication. Please go through the link for author guideline.
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