Incidence of immune-related adverse events and its association with treatment outcomes: the MD Anderson Cancer Center experience.
Incidence of immune-related adverse events and its association with treatment outcomes: the MD Anderson Cancer Center experience.
复制标题
DOI：
10.1007/s10637-017-0534-0
复制
发表时间：
2018-08
影响因子：
3.4
通讯作者：
Naing A
中科院分区：
文献类型：
--
作者：
Fujii T;Colen RR;Bilen MA;Hess KR;Hajjar J;Suarez-Almazor ME;Alshawa A;Hong DS;Tsimberidou A;Janku F;Gong J;Stephen B;Subbiah V;Piha-Paul SA;Fu S;Sharma P;Mendoza T;Patel A;Thirumurthi S;Sheshadri A;Meric-Bernstam F;Naing A
免疫疗法正在成为治疗晚期癌症患者的基石，但与T细胞活性不受控制相关的显著毒性（免疫相关不良事件[irAE]）仍然是一个问题。对2010年2月至2015年9月期间在德克萨斯大学MD安德森癌症中心研究性癌症治疗系接受基于免疫疗法的临床试验治疗的290例晚期癌症患者的电子病历进行了回顾性审查。收集临床和实验室参数，以确定irAE的发生率、风险因素及其与治疗结局的相关性。290例患者中有98例（34%）发生了任何级别的irAE。在15例（5.2%）发生≥3级irAE的患者中，最常见的irAE为皮炎和小肠结肠炎。尽管80%发生≥3级irAE的患者需要全身性皮质类固醇，但所有15例患者均从irAE中恢复。在再激发时，接受全身性皮质类固醇治疗irAE的5例患者中有4例继续应答。无irAE相关死亡。重要的是，与未发生≥ 3级irAE的患者相比，发生≥3级irAE的患者的总缓解率提高（25 vs. 6%; p=0.039），中位至进展时间延长（30周vs. 10周; p=0.0040）。使用免疫抑制剂时irAE的发生率表明免疫状态活跃，提示对患者具有潜在临床获益。需要在一项大型前瞻性研究中进一步验证这种关联。
Immunotherapy is emerging as the cornerstone for treatment of patients with advanced cancer, but significant toxicity (immune-related adverse events [irAEs]) associated with unbridled T cell activity remains a concern. A retrospective review of the electronic medical records of 290 patients with advanced cancer treated on an immunotherapy-based clinical trial in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center between February 2010 and September 2015 was performed. Clinical and laboratory parameters were collected to determine the incidence of irAEs, risk factors, and their association with treatment outcomes. Ninety eight of 290 patients (34%) experienced any grade irAEs. Among the 15 (5.2%) patients with grade ≥3 irAEs, the most common irAEs were dermatitis and enterocolitis. Although 80% of the patients with grade ≥3 irAEs required systemic corticosteroids, all the 15 patients recovered from the irAEs. On re-challenge, 4 of the 5 patients who had received systemic corticosteroids for irAE continued to respond. There were no irAE-related deaths. Importantly, patients with grade ≥3 irAEs had improved overall response rate (25 vs. 6%; p=0.039) and longer median time to progression (30 weeks vs. 10 weeks; p=0.0040) when compared to those without grade ≥3 irAEs. Incidence of irAEs with immunotherapeutic agents indicates an active immune status, suggestive of potential clinical benefit to the patient. Further validation of this association in a large prospective study is warranted.
登录
查看更多内容
DOI：
10.1056/nejmoa1003466
发表时间：
2010-08-19
期刊：
The New England journal of medicine
影响因子：
--
作者：
Hodi FS;O'Day SJ;McDermott DF;Weber RW;Sosman JA;Haanen JB;Gonzalez R;Robert C;Schadendorf D;Hassel JC;Akerley W;van den Eertwegh AJ;Lutzky J;Lorigan P;Vaubel JM;Linette GP;Hogg D;Ottensmeier CH;Lebbé C;Peschel C;Quirt I;Clark JI;Wolchok JD;Weber JS;Tian J;Yellin MJ;Nichol GM;Hoos A;Urba WJ
通讯作者：
Urba WJ
影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
影响因子：
6.2
作者：
Higano, Celestia S.;Schellhammer, Paul F.;Frohlich, Mark W.
通讯作者：
Frohlich, Mark W.
影响因子：
45.3
作者：
Nanda, Rita;Chow, Laura Q. M.;Buisseret, Laurence
通讯作者：
Buisseret, Laurence
影响因子：
158.5
作者：
Robert, Caroline;Schachter, Jacob;Ribas, Antoni
通讯作者：
Ribas, Antoni