Grading of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel.
Grading of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel.
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DOI：
10.1186/s13045-018-0571-y
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发表时间：
2018-03-02
影响因子：
28.5
通讯作者：
Grupp SA
中科院分区：
文献类型：
--
作者：
Porter D;Frey N;Wood PA;Weng Y;Grupp SA
抗CD 19 CAR T细胞疗法在复发性或难治性（r/r）B细胞恶性肿瘤患者中表现出高应答率，但与显著毒性相关。细胞因子释放综合征（CRS）是与CAR T细胞治疗相关的最重要的并发症，并且在CAR T细胞输注后具有可重复且简单的方法来对CRS进行分级至关重要。不良事件通用术语标准量表不足以对与细胞治疗相关的CRS进行分级。宾夕法尼亚大学（Penn）抗CD 19 CAR T细胞疗法tisagenlecleucel的临床经验用于开发CRS的Penn分级量表。Penn分级量表取决于容易获得的临床特征;不依赖于护理的位置或支持性护理的定量;分配等级以指导CRS管理;区分轻度、中度、重度和危及生命的CRS;并适用于与T细胞治疗相关的早发性和迟发性CRS。采用来自55例r/r B细胞急性淋巴细胞白血病和42例r/r慢性淋巴细胞淋巴瘤患儿的临床数据，以证实Penn分级量表的当前应用。我们表明，Penn分级量表提供了可重复的CRS分级，可用于指导治疗，并可应用于临床试验和治疗平台。
Anti-CD19 CAR T cell therapy has demonstrated high response rates in patients with relapsed or refractory (r/r) B cell malignancies but is associated with significant toxicity. Cytokine release syndrome (CRS) is the most significant complication associated with CAR T cell therapy, and it is critical to have a reproducible and easy method to grade CRS after CAR T cell infusions. The Common Terminology Criteria for Adverse Events scale is inadequate for grading CRS associated with cellular therapy. Clinical experience with the anti-CD19 CAR T cell therapy tisagenlecleucel at the University of Pennsylvania (Penn) was used to develop the Penn grading scale for CRS. The Penn grading scale depends on easily accessible clinical features; does not rely on location of care or quantitation of supportive care; assigns grades to guide CRS management; distinguishes between mild, moderate, severe, and life-threatening CRS; and applies to both early-onset and delayed-onset CRS associated with T cell therapies. Clinical data from 55 pediatric patients with r/r B cell acute lymphoblastic leukemia and 42 patients with r/r chronic lymphocytic lymphoma treated with tisagenlecleucel were used to demonstrate the current application of the Penn grading scale. We show that the Penn grading scale provides reproducible CRS grading that can be useful to guide therapy and that can be applied across clinical trials and treatment platforms.
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DOI：
10.1038/nrclinonc.2017.148
发表时间：
2018-01
期刊：
Nature reviews. Clinical oncology
影响因子：
--
作者：
Neelapu SS;Tummala S;Kebriaei P;Wierda W;Gutierrez C;Locke FL;Komanduri KV;Lin Y;Jain N;Daver N;Westin J;Gulbis AM;Loghin ME;de Groot JF;Adkins S;Davis SE;Rezvani K;Hwu P;Shpall EJ
通讯作者：
Shpall EJ
影响因子：
8.8
作者：
Fitzgerald JC;Weiss SL;Maude SL;Barrett DM;Lacey SF;Melenhorst JJ;Shaw P;Berg RA;June CH;Porter DL;Frey NV;Grupp SA;Teachey DT
通讯作者：
Teachey DT
影响因子：
45.3
作者：
Kochenderfer, James N.;Somerville, Robert P. T.;Rosenberg, Steven A.
通讯作者：
Rosenberg, Steven A.
影响因子：
46.9
作者：
Maher, J;Brentjens, RJ;Sadelain, M
通讯作者：
Sadelain, M
DOI：
10.1056/nejmoa1407222
发表时间：
2014-10-16
期刊：
The New England journal of medicine
影响因子：
--
作者：
Maude SL;Frey N;Shaw PA;Aplenc R;Barrett DM;Bunin NJ;Chew A;Gonzalez VE;Zheng Z;Lacey SF;Mahnke YD;Melenhorst JJ;Rheingold SR;Shen A;Teachey DT;Levine BL;June CH;Porter DL;Grupp SA
通讯作者：
Grupp SA