Infliximab associated with faster symptom resolution compared with corticosteroids alone for the management of immune-related enterocolitis.
Infliximab associated with faster symptom resolution compared with corticosteroids alone for the management of immune-related enterocolitis.
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DOI：
10.1186/s40425-018-0412-0
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发表时间：
2018-10-11
影响因子：
10.9
通讯作者：
Diab A
中科院分区：
文献类型：
--
作者：
Johnson DH;Zobniw CM;Trinh VA;Ma J;Bassett RL Jr;Abdel-Wahab N;Anderson J;Davis JE;Joseph J;Uemura M;Noman A;Abu-Sbeih H;Yee C;Amaria R;Patel S;Tawbi H;Glitza IC;Davies MA;Wong MK;Woodman S;Hwu WJ;Hwu P;Wang Y;Diab A
免疫相关性小肠结肠炎(IREC)是检查点抑制剂(CPIs)最常见的严重并发症。目前IREC的一线治疗，即大剂量皮质类固醇(CS)，有显著的副作用，延长治疗时间可能会降低CPI-抗肿瘤活性。早期应用肿瘤坏死因子-α抑制剂如英夫利昔单抗可加速症状缓解，缩短CS病程。因此，据我们所知，我们进行了第一项回顾性研究，评估接受和不接受IFX治疗的IREC患者的症状缓解情况。数据收集自被诊断为IREC的患者的医疗记录。主要终点是接受IFX加CS(IFX组)和单纯CS(CS组)治疗的患者IREC的症状缓解时间。次要终点为CS持续时间、总生存期(OS)和治疗失败时间(TTF)。在75名IREC患者中，52%的患者仅接受CS治疗，48%的患者接受IFX治疗。尽管IFX组的结肠炎级别较高(3/4级：86%比34%；p <； 0.001)，但IFx组的腹泻缓解(3d比9d；p <； 0.001)和类固醇滴定(4vs.13天；p <； 0.001)的中位时间比CS组短，对总转移因子或OS没有负面影响。IFX组的总类固醇持续时间(中位数35天对51天；p = 0.150)在数字上较低。尽管3/4级结肠炎的发生率较高，但在CS中加入IFX用于治疗IREC患者的症状缓解时间显著缩短。这些数据表明，在进行明确的前瞻性临床试验之前，应考虑对IREC患者及早引入IFX。本文的在线版本(10.1186/s40425-0180412-0)包含补充材料，可供授权用户使用。
Immune-related enterocolitis (irEC) is the most common serious complication from checkpoint inhibitors (CPIs). The current front-line treatment for irEC, high-dose corticosteroids (CS), have significant side effects and prolonged therapy may reduce CPI-anti-tumor activity. Early addition of TNF-α inhibitors such as infliximab (IFX) may expedite symptom resolution and shorten CS duration. Thus, we conducted the first retrospective study, to our knowledge, evaluating symptom resolution in patients with irEC treated with and without IFX. Data were collected from the medical records of patients diagnosed with irEC. The primary endpoint was time to symptom resolution for irEC for cases managed with IFX plus CS (IFX group) versus CS alone (CS group). Duration of CS, overall survival (OS), and time to treatment failure (TTF) were secondary endpoints. Among 75 patients with irEC, 52% received CS alone, and 48% received IFX. Despite higher grade colitis in the IFX group (grade 3/4: 86% vs. 34%; p < 0.001), median times to diarrhea resolution (3 vs. 9 days; p < 0.001) and to steroid titration (4 vs. 13 days; p < 0.001) were shorter in the IFX group than in the CS group without a negative impact on TTF or OS. Total steroid duration (median 35 vs. 51 days; p = 0.150) was numerically lower in the IFX group. Despite higher incidence of grade 3/4 colitis, IFX added to CS for the treatment of patients with irEC was associated with a significantly shorter time to symptom resolution. The data suggest that early introduction of IFX should be considered for patients with irEC until definitive prospective clinical trials are conducted. The online version of this article (10.1186/s40425-018-0412-0) contains supplementary material, which is available to authorized users.
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DOI：
10.1056/nejmoa1709684
发表时间：
2017-10-05
期刊：
The New England journal of medicine
影响因子：
--
作者：
Wolchok JD;Chiarion-Sileni V;Gonzalez R;Rutkowski P;Grob JJ;Cowey CL;Lao CD;Wagstaff J;Schadendorf D;Ferrucci PF;Smylie M;Dummer R;Hill A;Hogg D;Haanen J;Carlino MS;Bechter O;Maio M;Marquez-Rodas I;Guidoboni M;McArthur G;Lebbé C;Ascierto PA;Long GV;Cebon J;Sosman J;Postow MA;Callahan MK;Walker D;Rollin L;Bhore R;Hodi FS;Larkin J
通讯作者：
Larkin J
影响因子：
27.4
作者：
Clark, J;Vagenas, P;Cope, AP
通讯作者：
Cope, AP
影响因子：
45.3
作者：
Sznol, Mario;Ferrucci, Pier Francesco;Wolchok, Jedd D.
通讯作者：
Wolchok, Jedd D.
影响因子：
45.3
作者：
Weber, Jeffrey S.;Hodi, F. Stephen;Robert, Caroline
通讯作者：
Robert, Caroline
影响因子：
168.9
作者：
BRAEGGER, CP;NICHOLLS, S;MACDONALD, TT
通讯作者：
MACDONALD, TT