Phase I Study of Brentuximab Vedotin (SGN-35) in Japanese Children With Relapsed or Refractory CD30-positive Hodgkin's Lymphoma or Systemic Anaplastic Large Cell Lymphoma
Phase I Study of Brentuximab Vedotin (SGN-35) in Japanese Children With Relapsed or Refractory CD30-positive Hodgkin's Lymphoma or Systemic Anaplastic Large Cell Lymphoma
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Brentuximab Vedotin (SGN-35) 在患有复发或难治性 CD30 阳性霍奇金淋巴瘤或系统性间变性大细胞淋巴瘤的日本儿童中的 I 期研究
DOI：
10.1007/s12185-020-02820-1
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发表时间：
2020
期刊：
影响因子：
--
通讯作者：
Yuhki Koga
中科院分区：
文献类型：
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作者：
Soji Morishita;Tomonori Ochiai;Kyohei Misawa;Tadaaki Inano;Yasutaka Fukuda;Yasumitsu Kurokawa;Yoko Edahiro;Marito Araki;Akimichi Ohsaka;Norio Komatsu;清原千貴，菅原教史，前田峻大，宮島真理，高野幹，西谷匡央，西谷真来，佐々木了政，岡野良昭，上原さつき，古和田周吾，小宅達郎，伊藤薫樹;Yuhki Koga
brentuximab vedotin治疗儿科患者的数据有限。本研究的目的是评估brentuximab vedotin治疗复发或难治性霍奇金淋巴瘤（HL）或系统性间变性大细胞淋巴瘤（sALCL）的日本儿童的安全性和耐受性。儿童患者，年龄2-17岁，复发或难治性HL或sALCL被招募。布伦妥昔单抗韦多汀静脉滴注1.8 mg/kg，每3周1次。主要终点是剂量限制性毒性和安全性。在2016年9月至2018年3月期间，纳入了6例患者（中位年龄11.5岁，范围5-14岁），4例复发或难治性HL患者和2例复发或难治性sALCL患者。6例患者均未见剂量限制性毒性。虽然6例患者中有3例（50%）经历了至少一次≥3级不良事件，但没有患者经历严重不良事件。brentuximab vedotin在儿科患者中的药代动力学特征与在成人中的报道相当。达到总体缓解的患者比例为60%（95%可信区间14.7-94.7）。对于复发或难治性HL或sALCL患儿，Brentuximab vedotin剂量为1.8 mg/kg，每3周1次被认为是可耐受的。
Data on the treatment of pediatric patients with brentuximab vedotin are limited. The aims of the present study were to assess the safety and tolerability of brentuximab vedotin in Japanese children with relapsed or refractory Hodgkin’s lymphoma (HL) or systemic anaplastic large-cell lymphoma (sALCL). Pediatric patients, aged 2–17 years, with relapsed or refractory HL or sALCL were recruited. Brentuximab vedotin were administered at 1.8 mg/kg via intravenous infusion once every 3 weeks. Primary endpoints were dose-limiting toxicity and safety. Between September 2016, and March 2018, six patients (median age 11.5, range 5–14 years), four with relapsed or refractory HL and two with relapsed or refractory sALCL were enrolled. Dose limiting toxicity was not observed in any of the six patients. Although three of six patients (50%) experienced at least one grade ≥ 3 adverse event, no patient experienced a serious adverse event. The pharmacokinetic profile of brentuximab vedotin in pediatric patients was comparable to that reported in adults. The proportion of patients who achieved overall response was 60% (95% confidence interval 14.7–94.7). Brentuximab vedotin at 1.8 mg/kg once every 3 weeks was considered tolerable in children with relapsed or refractory HL or sALCL.