Medeot Marta, Zaja Francesco, Vianelli Nicola, Battista Marta, Baccarani Michele, Patriarca Francesca, Soldano Franca, Isola Miriam, De Luca Stefano, Fanin Renato
Clinica Ematologica, DIRM, University of Udine, Udine, Italy.
Eur J Haematol. 2008 Sep;81(3):165-9. doi: 10.1111/j.1600-0609.2008.01100.x. Epub 2008 May 27.
To evaluate the long-term activity and toxicity profile of rituximab in adult patients with idiopathic immune thrombocytopenic purpura (ITP).
Twenty-six patients with active and symptomatic ITP relapsed or refractory received weekly infusions of rituximab 375 mg/m(2) for 4 wk. Median time from diagnosis to rituximab was 34.5 months. The following parameters of efficacy and toxicity were considered: complete response (CR) and partial response (PR), relapse rate, relapse-free survival (RFS), therapy-free survival (TFS), short- and long-term toxicity.
CR and PR were 14/26 (54%) and 4/26 (15%), respectively. Median time of observation was 56.5 months (range 39-77). Nine of the 18 responding patients relapsed after a median of 21 months (range 8-66); 9/26 patients (35%) maintained the response, with a median follow-up of 57 months (range 39-69), and 11/26 (42%) did not necessitate further therapy; estimated 5 yr RFS and TFS were 61% and 72%, respectively. Younger age and shorter interval from diagnosis to rituximab appeared indicators of better outcome. Rituximab administration was associated with two episodes of short-term toxicity, with one case of serum sickness syndrome; no infectious or other significant long-term complications were documented.
Rituximab therapy may achieve long-lasting remission in nearly one-third of patients with relapsed or refractory ITP, with a good safety profile.
评估利妥昔单抗在成年特发性免疫性血小板减少性紫癜（ITP）患者中的长期活性和毒性特征。
26例活动性且有症状的ITP复发或难治患者接受每周一次静脉输注利妥昔单抗375mg/m²，共4周。从诊断到使用利妥昔单抗的中位时间为34.5个月。评估以下疗效和毒性参数：完全缓解（CR）和部分缓解（PR）、复发率、无复发生存期（RFS）、无需治疗生存期（TFS）、短期和长期毒性。
CR和PR分别为14/26（54%）和4/26（15%）。中位观察时间为56.5个月（范围39 - 77个月）。18例缓解患者中有9例在中位时间21个月（范围8 - 66个月）后复发；9/26例患者（35%）维持缓解，中位随访57个月（范围39 - 69个月），11/26例（42%）无需进一步治疗；估计5年RFS和TFS分别为61%和72%。较年轻的年龄以及从诊断到使用利妥昔单抗的间隔时间较短似乎提示预后较好。使用利妥昔单抗与2次短期毒性发作相关，其中1例血清病综合征；未记录到感染或其他显著的长期并发症。
利妥昔单抗治疗可使近三分之一的复发或难治性ITP患者实现持久缓解，且安全性良好。
