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学科主题: 临床医学
题名:
Siltuximab for multicentric Castleman′s disease: a randomised, double-blind, placebo-controlled trial
作者: van Rhee, Frits1; Wong, Raymond S.2; Munshi, Nikhil3; Rossi, Jean-Francois4; Ke, Xiao-Yan5; Fossa, Alexander6; Simpson, David7; Capra, Marcelo8; Liu, Ting9; Hsieh, Ruey Kuen10; Goh, Yeow Tee11; Zhu, Jun12; Cho, Seok-Goo13; Ren, Hanyun14; Cavet, James15,16; Bandekar, Rajesh17; Rothman, Margaret18; Puchalski, Thomas A.17; Reddy, Manjula17; van de Velde, Helgi19; Vermeulen, Jessica20; Casper, Corey21
刊名: LANCET ONCOLOGY
发表日期: 2014-08-01
DOI: 10.1016/S1470-2045(14)70319-5
卷: 15, 期:9, 页:966-974
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Oncology
研究领域[WOS]: Oncology
关键词[WOS]: ANTI-INTERLEUKIN-6 MONOCLONAL-ANTIBODY ; LYMPH-NODE HYPERPLASIA ; RITUXIMAB ; SPECTRUM
英文摘要:

Background Multicentric Castleman′s disease is a rare lymphoproliferative disorder driven by dysregulated production of interleukin 6. No randomised trials have been done to establish the best treatment for the disease. We assessed the safety and efficacy of siltuximab-a chimeric monoclonal antibody against interleukin 6-in HIV-negative patients with multicentric Castleman′s disease.

Methods We did this randomised, double-blind, placebo-controlled study at 38 hospitals in 19 countries worldwide. We enrolled HIV-negative and human herpesvirus-8-seronegative patients with symptomatic multicentric Castleman′s disease. Treatment allocation was randomised with a computer-generated list, with block size six, and stratification by baseline corticosteroid use. Patients and investigators were masked to treatment allocation. Patients were randomly assigned (2: 1) to siltuximab (11 mg/kg intravenous infusion every 3 weeks) or placebo; all patients also received best supportive care. Patients continued treatment until treatment failure. The primary endpoint was durable tumour and symptomatic response for at least 18 weeks for the intention-to-treat population. Enrolment has been completed. The study is registered with ClinicalTrials.gov, number NCT01024036.

Findings We screened 140 patients, 79 of whom were randomly assigned to siltuximab (n=53) or placebo (n=26). Durable tumour and symptomatic responses occurred in 18 (34%) of 53 patients in the siltuximab group and none of 26 in the placebo group (difference 34 0%, 95% CI 11.1-54.8, p=0.0012). The incidence of grade 3 or more adverse events (25 [47%]vs 14 [54%]) and serious adverse events (12 [23%] vs five [19%]) was similar in each group despite longer median treatment duration with siltuximab than with placebo (375 days [range 1-1031] vs 152 days [23-666]). The most common grade 3 or higher were fatigue (five vs one), night sweats (four vs one), and anaemia (one vs three). Three (6%) of 53 patients had serious adverse events judged reasonably related to siltuximab (lower respiratory tract infection, anaphylactic reaction, sepsis).

Interpretation Siltuximab plus best supportive care was superior to best supportive care alone for patients with symptomatic multicentric Castleman′s disease and well tolerated with prolonged exposure. Siltuximab is an important new treatment option for this disease.

语种: 英语
项目资助者: Janssen Research Development
WOS记录号: WOS:000341311600041
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/65401
Appears in Collections:北京大学第三临床医学院_期刊论文

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作者单位: 1.Peking Univ, Hosp 3, Beijing 100871, Peoples R China
2.Oslo Univ Hosp, Oslo, Norway
3.North Shore Hosp, Takapuna Auckland, New Zealand
4.Hosp Mae de Deus, Porto Alegre, RS, Brazil
5.Sichuan Univ, West China Hosp, Chengdu 610064, Peoples R China
6.Univ Arkansas Med Sci, Myeloma Inst Res & Therapy, Little Rock, AR 72205 USA
7.Chinese Univ Hong Kong, Prince Wales Hosp, Hong Kong, Hong Kong, Peoples R China
8.Dana Farber Canc Inst, Boston, MA 02115 USA
9.CHU Montpellier, Hop St Eloi, Montpellier, France
10.Mackay Mem Hosp, Taipei, Taiwan
11.Singapore Gen Hosp, Singapore, Singapore
12.Beijing Canc Hosp, Beijing, Peoples R China
13.Seoul St Marys Hosp, Seoul, South Korea
14.Peking Univ, Hosp 1, Beijing 100871, Peoples R China
15.Christie NHS Fdn Trust, Manchester, Lancs, England
16.Univ Manchester, Manchester, Lancs, England
17.Janssen Res & Dev, Spring House, PA USA
18.Janssen Res & Dev, Washington, GA USA
19.Janssen Res & Dev, Beerse, Belgium
20.Janssen Res & Dev, Leiden, Netherlands
21.Fred Hutchinson Canc Res Ctr, Seattle, WA 98104 USA

Recommended Citation:
van Rhee, Frits,Wong, Raymond S.,Munshi, Nikhil,et al. Siltuximab for multicentric Castleman′s disease: a randomised, double-blind, placebo-controlled trial[J]. LANCET ONCOLOGY,2014,15(9):966-974.
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