Phase II Investigator-Initiated Study of Brentuximab Vedotin in Mycosis Fungoides and Sezary Syndrome With Variable CD30 Expression Level: A Multi-Institution Collaborative Project
Phase II Investigator-Initiated Study of Brentuximab Vedotin in Mycosis Fungoides and Sezary Syndrome With Variable CD30 Expression Level: A Multi-Institution Collaborative Project
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DOI：
10.1200/jco.2014.60.3969
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发表时间：
2015-11-10
影响因子：
45.3
通讯作者：
Horwitz, Steven M.
中科院分区：
文献类型：
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作者：
Kim, Youn H.;Tavallaee, Mahkam;Horwitz, Steven M.
目的与霍奇金淋巴瘤和系统性间变性大细胞淋巴瘤相比，蕈样肉芽肿（MF）和Szary综合征（SS）恶性淋巴细胞CD30的表达变化很大。 brentuximab vedotin（一种 CD30 靶向抗体药物缀合物）的临床活性和安全性在 MF 和 SS 中进行了评估。探索了临床反应的组织和血液生物标志物。患者和方法在这项 II 期研究中，CD30 表达水平可忽略不计至 100% 的 MF 或 SS 患者每 3 周接受一次 brentuximab vedotin (1.8 mg/kg) 治疗，最多 16 剂。主要终点是全球总体缓解率。次要终点包括组织 CD30 表达水平与临床反应、反应时间、反应持续时间、无进展和无事件生存率以及安全性的相关性。 结果 在 32 名入组和治疗的患者中，30 名患者进行了疗效评估。 30 名患者中有 21 名（70%）观察到客观总体缓解（90% CI，53% 至 83%）。通过免疫组织化学评估的 CD30 表达变化很大，CD30max 中位数为 13%（范围为 0% 至 100%）。那些有
PurposeIn contrast to Hodgkin lymphoma and systemic anaplastic large-cell lymphoma, CD30 expression of malignant lymphocytes in mycosis fungoides (MF) and Szary syndrome (SS) is quite variable. Clinical activity and safety of brentuximab vedotin, a CD30 targeting antibody-drug conjugate, was evaluated in MF and SS. Tissue and blood biomarkers of clinical response were explored.Patients and MethodsIn this phase II study, patients with MF or SS with negligible to 100% CD30 expression levels were treated with brentuximab vedotin (1.8 mg/kg) every 3 weeks for a maximum of sixteen doses. The primary end point was overall global response rate. Secondary end points included correlation of tissue CD30 expression level with clinical response, time to response, duration of response, progression-free and event-free survivals, and safety.ResultsOf the 32 patients enrolled and treated, 30 patients had available efficacy evaluations. Objective global response was observed in 21 (70%) of 30 patients (90% CI, 53% to 83%). CD30 expression assessed by immunohistochemistry was highly variable, with a median CD30max of 13% (range, 0% to 100%). Those with