晚期弥漫性大b细胞淋巴瘤患者每2周使用硼替佐米加CHOP (CHOP-14)的I/II期研究。

The Korean Journal of Hematology Pub Date : 2012-03-01 Epub Date: 2012-03-28 DOI:10.5045/kjh.2012.47.1.53
Jeong Eun Kim, Dok Hyun Yoon, Geundoo Jang, Dae Ho Lee, Shin Kim, Chan-Sik Park, Jooryung Huh, Won Seog Kim, Jinny Park, Jae Hoon Lee, Soon Il Lee, Cheolwon Suh
{"title":"晚期弥漫性大b细胞淋巴瘤患者每2周使用硼替佐米加CHOP (CHOP-14)的I/II期研究。","authors":"Jeong Eun Kim,&nbsp;Dok Hyun Yoon,&nbsp;Geundoo Jang,&nbsp;Dae Ho Lee,&nbsp;Shin Kim,&nbsp;Chan-Sik Park,&nbsp;Jooryung Huh,&nbsp;Won Seog Kim,&nbsp;Jinny Park,&nbsp;Jae Hoon Lee,&nbsp;Soon Il Lee,&nbsp;Cheolwon Suh","doi":"10.5045/kjh.2012.47.1.53","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Bortezomib targets molecular dysregulation of nuclear factor-κB activation and cell cycle control, which are characteristic features of diffuse large B-cell lymphoma (DLBCL). We evaluated the safety and efficacy of bortezomib treatment with dose-dense cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks (CHOP-14).</p><p><strong>Methods: </strong>Untreated DLBCL patients were enrolled. A phase I dose-escalation study with 1.0, 1.3, and 1.6 mg/m(2) bortezomib administration on day 1 and 4 in addition to the CHOP-14 regimen was performed to determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT). Lenograstim 5 µg/kg/d was administered on day 4-13. The bortezomib dose from the phase I study was used in the phase II study.</p><p><strong>Results: </strong>Nine and 37 patients were enrolled in the phase I and phase II studies, respectively. The analysis of the phase II results (40 patients) included data of the 3 patients in the last MTD dose cohort of the phase I trial. During the phase I trial, no DLT was observed at any bortezomib dose; therefore, the recommended dose was 1.6 mg/m(2). In phase II, the overall response rate was 95% (complete response: 80%; partial response: 15%). Nine out of the 40 patients showed grade 3 sensory neuropathy, and 22 required at least 1 dose reduction. Three patients could not complete the intended 6 cycles of treatment because of severe neuropathy.</p><p><strong>Conclusion: </strong>Bortezomib plus CHOP-14 was highly effective for the treatment of untreated DLBCL patients, but in many cases, dose or schedule modification was required to reduce neurotoxicity.</p>","PeriodicalId":23001,"journal":{"name":"The Korean Journal of Hematology","volume":"47 1","pages":"53-9"},"PeriodicalIF":0.0000,"publicationDate":"2012-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.5045/kjh.2012.47.1.53","citationCount":"12","resultStr":"{\"title\":\"A phase I/II study of bortezomib plus CHOP every 2 weeks (CHOP-14) in patients with advanced-stage diffuse large B-cell lymphomas.\",\"authors\":\"Jeong Eun Kim,&nbsp;Dok Hyun Yoon,&nbsp;Geundoo Jang,&nbsp;Dae Ho Lee,&nbsp;Shin Kim,&nbsp;Chan-Sik Park,&nbsp;Jooryung Huh,&nbsp;Won Seog Kim,&nbsp;Jinny Park,&nbsp;Jae Hoon Lee,&nbsp;Soon Il Lee,&nbsp;Cheolwon Suh\",\"doi\":\"10.5045/kjh.2012.47.1.53\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Bortezomib targets molecular dysregulation of nuclear factor-κB activation and cell cycle control, which are characteristic features of diffuse large B-cell lymphoma (DLBCL). We evaluated the safety and efficacy of bortezomib treatment with dose-dense cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks (CHOP-14).</p><p><strong>Methods: </strong>Untreated DLBCL patients were enrolled. A phase I dose-escalation study with 1.0, 1.3, and 1.6 mg/m(2) bortezomib administration on day 1 and 4 in addition to the CHOP-14 regimen was performed to determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT). Lenograstim 5 µg/kg/d was administered on day 4-13. The bortezomib dose from the phase I study was used in the phase II study.</p><p><strong>Results: </strong>Nine and 37 patients were enrolled in the phase I and phase II studies, respectively. The analysis of the phase II results (40 patients) included data of the 3 patients in the last MTD dose cohort of the phase I trial. During the phase I trial, no DLT was observed at any bortezomib dose; therefore, the recommended dose was 1.6 mg/m(2). In phase II, the overall response rate was 95% (complete response: 80%; partial response: 15%). Nine out of the 40 patients showed grade 3 sensory neuropathy, and 22 required at least 1 dose reduction. Three patients could not complete the intended 6 cycles of treatment because of severe neuropathy.</p><p><strong>Conclusion: </strong>Bortezomib plus CHOP-14 was highly effective for the treatment of untreated DLBCL patients, but in many cases, dose or schedule modification was required to reduce neurotoxicity.</p>\",\"PeriodicalId\":23001,\"journal\":{\"name\":\"The Korean Journal of Hematology\",\"volume\":\"47 1\",\"pages\":\"53-9\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2012-03-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.5045/kjh.2012.47.1.53\",\"citationCount\":\"12\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"The Korean Journal of Hematology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5045/kjh.2012.47.1.53\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2012/3/28 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"The Korean Journal of Hematology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5045/kjh.2012.47.1.53","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2012/3/28 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 12

摘要

背景:硼替佐米靶向核因子-κB活化和细胞周期控制的分子失调,这是弥漫性大b细胞淋巴瘤(DLBCL)的特征。我们每2周(CHOP-14)评估硼替佐米与剂量密集环磷酰胺、阿霉素、长春新碱和强的松(CHOP)联合治疗的安全性和有效性。方法:纳入未经治疗的DLBCL患者。在CHOP-14方案的基础上,在第1天和第4天分别给药1.0、1.3和1.6 mg/m(2)硼替佐米进行I期剂量递增研究,以确定最大耐受剂量(MTD)和剂量限制性毒性(DLT)。第4-13天给予Lenograstim 5µg/kg/d。来自I期研究的硼替佐米剂量用于II期研究。结果:分别有9名和37名患者入组I期和II期研究。II期结果分析(40例患者)包括I期试验最后一次MTD剂量队列中的3例患者的数据。在I期试验中,任何剂量的硼替佐米均未观察到DLT;因此,推荐剂量为1.6 mg/m(2)。在II期,总缓解率为95%(完全缓解:80%;部分缓解:15%)。40例患者中有9例出现3级感觉神经病变,22例需要至少减少一次剂量。3例患者因严重的神经病变未能完成预期的6个疗程的治疗。结论:硼替佐米联合CHOP-14治疗未经治疗的DLBCL患者非常有效,但在许多情况下,需要改变剂量或方案以减少神经毒性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

摘要图片

摘要图片

摘要图片

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
A phase I/II study of bortezomib plus CHOP every 2 weeks (CHOP-14) in patients with advanced-stage diffuse large B-cell lymphomas.

Background: Bortezomib targets molecular dysregulation of nuclear factor-κB activation and cell cycle control, which are characteristic features of diffuse large B-cell lymphoma (DLBCL). We evaluated the safety and efficacy of bortezomib treatment with dose-dense cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) every 2 weeks (CHOP-14).

Methods: Untreated DLBCL patients were enrolled. A phase I dose-escalation study with 1.0, 1.3, and 1.6 mg/m(2) bortezomib administration on day 1 and 4 in addition to the CHOP-14 regimen was performed to determine the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT). Lenograstim 5 µg/kg/d was administered on day 4-13. The bortezomib dose from the phase I study was used in the phase II study.

Results: Nine and 37 patients were enrolled in the phase I and phase II studies, respectively. The analysis of the phase II results (40 patients) included data of the 3 patients in the last MTD dose cohort of the phase I trial. During the phase I trial, no DLT was observed at any bortezomib dose; therefore, the recommended dose was 1.6 mg/m(2). In phase II, the overall response rate was 95% (complete response: 80%; partial response: 15%). Nine out of the 40 patients showed grade 3 sensory neuropathy, and 22 required at least 1 dose reduction. Three patients could not complete the intended 6 cycles of treatment because of severe neuropathy.

Conclusion: Bortezomib plus CHOP-14 was highly effective for the treatment of untreated DLBCL patients, but in many cases, dose or schedule modification was required to reduce neurotoxicity.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
期刊最新文献
Long-term survival of a patient with bone marrow gelatinous degeneration of idiopathic origin. Simplified flow cytometric immunophenotyping panel for multiple myeloma, CD56/CD19/CD138(CD38)/CD45, to differentiate neoplastic myeloma cells from reactive plasma cells. Prognostic significance of gelsolin and MMP12 in Langerhans cell histiocytosis. Central nervous system (CNS) involvement is a critical prognostic factor for hemophagocytic lymphohistiocytosis. Surgery in patients with congenital factor VII deficiency: A single center experience.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1