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伊布替尼治疗慢性淋巴细胞白血病和套细胞淋巴瘤患者的临床试验汇总分析:低级别关节痛、肌痛和肌肉骨骼痛的特征。

Characterization of low-grade arthralgia, myalgia, and musculoskeletal pain with ibrutinib therapy: pooled analysis of clinical trials in patients with chronic lymphocytic leukemia and mantle cell lymphoma.

机构信息

City of Hope National Medical Center, Duarte, CA, USA.

Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA, USA.

出版信息

Leuk Lymphoma. 2022 Jul;63(7):1580-1588. doi: 10.1080/10428194.2022.2038372. Epub 2022 Feb 28.

DOI:10.1080/10428194.2022.2038372
PMID:35227147
Abstract

Joint and muscle pain, including arthralgia, myalgia, and musculoskeletal pain, are among the common adverse events (AEs) reported for ibrutinib, a once-daily Bruton's tyrosine kinase inhibitor approved for the treatment of various B-cell malignancies, including chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). This pooled analysis from nine clinical trials of ibrutinib in CLL and MCL ( = 1178) evaluated patterns of these AEs. Any grade arthralgia, myalgia, and musculoskeletal pain occurred in 18%, 10%, and 6% of patients, respectively. AEs were primarily low-grade (grade 1/2: 97‒99%) and occurred during the first year of treatment; most resolved (67%-80%) at first occurrence. Few (<5%) patients required ibrutinib dose modification; no patients discontinued ibrutinib due to these AEs. Among patients evaluated for concomitant medication use, all those receiving concomitant medications after the first AE occurrence experienced AE resolution. These data suggest that these AEs were not treatment-limiting during ibrutinib therapy.

摘要

关节和肌肉疼痛,包括关节痛、肌痛和肌肉骨骼疼痛,是伊布替尼(一种每日一次的布鲁顿酪氨酸激酶抑制剂,用于治疗包括慢性淋巴细胞白血病(CLL)和套细胞淋巴瘤(MCL)在内的多种 B 细胞恶性肿瘤)报告的常见不良事件(AE)之一。本项来自伊布替尼治疗 CLL 和 MCL 的 9 项临床试验的汇总分析(n=1178)评估了这些 AE 的模式。分别有 18%、10%和 6%的患者出现任何等级的关节痛、肌痛和肌肉骨骼疼痛。AE 主要为低级别(1/2 级:97%99%),发生在治疗的第一年;大多数在首次发生时得到缓解(67%80%)。少数(<5%)患者需要调整伊布替尼剂量;没有因这些 AE 而停用伊布替尼的患者。在评估伴随用药的患者中,所有首次出现 AE 后接受伴随用药的患者都经历了 AE 的缓解。这些数据表明,这些 AE 在伊布替尼治疗期间并不是治疗受限的。

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