Long-term follow-up analysis after rituximab salvage therapy in adult patients with immune thrombocytopenia

Long-term follow-up analysis after rituximab salvage therapy in adult patients with immune thrombocytopenia
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DOI:
10.1002/ajh.23272
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发表时间:
2012-09-01
影响因子:
12.8
通讯作者:
Fanin, Renato
Fanin, Renato
中科院分区:
医学1区
文献类型:
--
作者:
Zaja, Francesco;Volpetti, Stefano;Fanin, Renato

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我们报告了 57 名连续患有免疫性血小板减少症的成年患者接受利妥昔单抗治疗后的长期结果结果。根据治疗的不同时期,患者接受标准剂量(SD)利妥昔单抗(即每周375 mg/m2,持续4周)或低剂量(LD)利妥昔单抗(即每周100 mg固定剂量,持续4周)。总体 (OR) 和完全缓解 (CR) 率分别为 60% 和 40%。患者的中位随访时间为 52 个月,SD 组为 82 个月,LD 组为 44 个月; 34 名有反应的患者中有 15 名 (44%) 复发,中位反应持续时间为 24 个月(范围 3120)。估计的 4 年无事件生存率(EFS,考虑第 2 个月的无反应状态或有反应者复发的事件)为 30%。接受 SD 利妥昔单抗治疗的患者与 LD 利妥昔单抗治疗的患者在短期缓解(OR 66 vs. 52%,CR 50 vs. 28%)、复发率(38 vs. 54%)、实现和维持长期缓解的概率(41 vs. 24%)和估计 4 年 EFS(35 vs. 23%)方面具有更好的结果。诊断与利妥昔单抗治疗之间间隔较长的患者 EFS 较差 [HR = 1.005; 95%IC:(1.0021.009),P = 0.019]。 3 名患者出现短期不良事件,2 名患者出现血清病,1 名患者出现间质性肺炎。在长期随访期间,记录了四例恶性肿瘤和两例带状疱疹再激活病例;一名患者因脑出血死亡。 Rituximab SD 似乎是一种安全且有效的药物,可使近 40% 的病例实现长期缓解和保留脾切除的效果。是。 J.赫马托尔。 2012。(c) 2012 Wiley 期刊公司。
We report the long-term outcome results of 57 consecutive adult patients with immune thrombocytopenia after being treated with rituximab. According to the different period of therapy, patients received either standard dose (SD) rituximab (i.e., 375 mg/m2 weekly for 4 weeks) or low dose (LD) rituximab (i.e., 100 mg flat dose weekly for 4 weeks). Overall (OR) and complete response (CR) rates were 60 and 40%, respectively. Patients' median follow-up was 52 months, 82 months in the SD, and 44 months in the LD group; 15 out of 34 responsive patients (44%) relapsed, with median response duration of 24 months (range 3120). The estimated 4-years event-free survival (EFS, considering events the non response status at month 2 or relapses in responders) was 30%. Patients who received SD vs. LD rituximab had better outcome with regard to short term response (OR 66 vs. 52%, CR 50 vs. 28%), relapse rate (38 vs. 54%), probability to achieve and maintain long-term response (41 vs. 24%) and estimated 4-years EFS (35 vs. 23%). Patients with a longer interval between diagnosis and rituximab therapy had worse EFS [HR = 1.005; 95%IC: (1.0021.009), P = 0.019]. Three patients developed short-term adverse events, two-serum sickness, and one interstitial pneumonia. Four cases of malignancies and two herpes zoster reactivations were registered during long-term follow-up; one patient died for cerebral bleeding. Rituximab SD appears a safe and active agent allowing in nearly 40% of cases to achieve long-term response and splenectomy sparing effect. Am. J. Hematol. 2012. (c) 2012 Wiley Periodicals, Inc.