氟达拉滨联合表柔比星治疗复发难治性惰性非霍奇金淋巴瘤

Fludarabine Combined with Epirubicin Second-line Chemotherapy for Patients with Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

目的:探讨FE(氟达拉滨联合表柔比星)方案作为二线解救方案治疗复发难治性的惰性淋巴瘤(Non-Hodgkin's Lymphoma,NHL)的有效性和安全性。方法:经组织病理学证实的复发难治性惰性NHL79例,按信封法随机分为FE方案组与FMD方案组。39例采用FE方案化疗(氟达拉滨25mg/m^2/d,d1～d3;表柔比星(EPI)60mg/m^2/d,d1,28天为1周期),40例采用FMD方案化疗(氟达拉滨25mg/m^2/d,d1～d3;米托蒽醌10mg/m^2/d,d1;地塞米松20mg/d,d1～d5,28d为1周期)。所有患者均至少完成2个周期化疗。结果:FE组有效率(CR+PR)64.1%,临床受益率(CR+PR+SD)79.5%,中位无进展生存期21个月,2年总生存率71.8%;FMD组有效率(CR+PR)57.5%,临床受益率(CR+PR+SD)75%,中位无进展生存期20个月,2年总生存率60%。FE组的疗效略优于FMD组,但两组间差异无统计学意义(P>0.05)。中位无进展生存期和2年总生存率两组间亦无统计学意义(P>0.05)。两组不良反应均以中性粒细胞减少和感染最为常见,其中Ⅲ～Ⅳ度骨髓抑制FE组15.4%(6/39),FMD组29%(15/40),经升血治疗处理恢复;肺感染FE组5.1%(2/39),FMD组22.5%(9/40)。FE组Ⅲ～Ⅳ度中性粒细胞缺乏和肺感染发生率均较FMD组轻,两组不良反应发生率间有统计学差异(P<0.05)。结论:FE方案治疗复发难治性惰性NHL的疗效肯定,骨髓毒性和肺感染发生率明显低于FMD组,是复发难治性惰性NHL患者安全有效的解救方案,值得进一步推广应用。

Objective： To evaluate the efficacy and safety of a Fludarabine and Epirubicin （FE） regimen in the treatment of refractory or relapsed indolent non-Hodgkin＇ s lymphoma （NHL）. Methods： A total of 79 patients with histopathologically verified relapsed or refractory indolent NHL were randomly assigned to be treated with FE regimen （Fludarabine 25 mg/m2× 3, d1 -d3; Epirubicin 60 mg/m2, dl, one cycle for 28 days） or FMD regimen （Fludarabine 25 mg/m2x3, d1-d3; Noventrone 10 mg/m2, dl; Dexamethasone 20 mg/d, d1 -d5）. All patients received treatment for about 2 cycles. Results： The response rate, clinical benefit response, median progression-free survival and 2-year survival rates in the two groups were 64.1% vs. 57.5%, 79.5% vs. 75%, 21 months vs. 20 months, and 71.8% vs. 60%, respectively. There was no statistically significant difference in the overall response rate or the 2-year overall survival rate between the 2 groups （P〉0.05）. The main side effects were leucopenia and infection. The incidence of Ⅲ-Ⅳ myelosuppression was 15.4% vs. 29% in the FE and FMD groups; symptoms of infection occurred in 5.1% vs. 22.5% of the FE and FMD groups, respectively. The incidence of Ⅲ-Ⅳleucopenia and pneumonia in the FE group was slightly lower than in the FMD group, and the difference had statistical significance （P〈0.05）. Conclusion： The efficacy of the FE regimen was as good as that of the FMD regimen, but the FE group had a lower incidence of Ⅲ-Ⅳ leucopenia and pneumonia than the FMD group. Thus the FE regimen is a promising and effective second-line salvage regimen for the treatment of relapsed or refractory indolent non-Hodgkin＇ s lymphoma, worthy of wider use.