CAR-T(CAR-T)细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Low-dose administration of prednisone has a good effect on the treatment of prolonged hematologic toxicity post-CD19 CAR-T cell therapy.
Low-dose administration of prednisone has a good effect on the treatment of prolonged hematologic toxicity post-CD19 CAR-T cell therapy.
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我们认为低剂量泼尼松是 CAR-T 细胞后 PHT 的一种有益且可耐受的治疗。
收集接受CD19 CAR-T 治疗的复发/难治性B-ALL患者资料,纳入对促红细胞生成素、血小板受体激动剂、输血或G-CSF无效并最终接受低剂量泼尼松的PHT患者,回顾分析疗效和安全性。
109例患者中86例(78.9%)评估为PHT。其中15例输注后持续血液学毒性,包括12例3/4级血细胞减少、12例三系减少和3例两系减少;另2例在第28天后出现原因不明的血细胞减少。泼尼松起始剂量为0.5 mg/kg/日,中位起效时间21天(7至40天)。血象恢复率100%,完全恢复率60%至66.67%。停药后6例复发,再次用泼尼松后缓解。中位随访14.97个月,12个月PFS和OS率分别为58.8%和64.7%。除可用药物控制的高血糖和高血压外,未观察到其他泼尼松副作用。讨论:低剂量泼尼松可能是CAR-T 后PHT有益且耐受良好的治疗。试验注册号ChiCTR-ONN-16009862和ChiCTR1800015164。
We collected clinical data from patients with relapsed refractory B-ALL treated with CD19 CAR-T cells. Patients with PHT who did not respond to erythropoietin, platelet receptor agonists, transfusion, or G-CSF and eventually received low-dose prednisone therapy were included in the analysis. We retrospectively analyzed the efficacy and safety of low-dose prednisone on PHT.
Among 109 patients treated with CD19 CAR-T cells, 78.9% (86/109) of patients were evaluated as PHT. Of these, 15 patients had persistent hematological toxicity after infusion (12 were grade 3/4 cytopenia, 12 were trilineage cytopenia and 3 were bilineage cytopenia), 2 developed cytopenia without apparent cause after D28. The initial prednisone dose was 0.5 mg/kg/day, and the median response time was 21 days (7-40 days). The recovery rate of blood count was 100%, and the complete recovery rate ranged from 60% to 66.67%. Especially exciting was that HT recurred in 6 patients after stopping prednisone. They were relieved again after the administration of prednisone. The median follow-up time was 14.97 months (4.1-31.2 months). Twelve-month duration of PFS and OS rates were 58.8% ( 11.9%) and 64.7% ( 11.6%). We did not observe any other side effects of prednisone apart from drug-controllable hyperglycemia and hypertension. DISCUSSION: We suggest that low-dose prednisone is a beneficial and tolerable therapy for PHT after CAR-T cells. The trials have been registered at www.chictr.org.cn as ChiCTR-ONN-16009862 (November 14, 2016) and ChiCTR1800015164 (March 11, 2018).
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