利妥昔单克隆抗体联合GDP方案化疗治疗复发弥漫大B细胞淋巴瘤的疗效、预后和安全性分析

Efficacy,Prognosis and Safety of Rituximab Combined with GDP Regime for Patients with Relapsed Diffuse Large B-cell Lymphoma

目的探究利妥昔单克隆抗体(RTX)联合吉西他滨+地塞米松+顺铂(GDP)化疗方案治疗复发弥漫大B细胞淋巴瘤(DLBCL)的疗效、预后和安全性。方法选择2012年1月-2015年1月于我院就诊的DLBCL复发患者82例,随机数法分为GDP组(41例)和RGDP组(41例),GDP组采用GDP方案治疗,RGDP组在GDP组的基础上联合应用RTX。比较两组患者的疗效、总生存期(OS)、无进展生存期(PFS)、早期死亡率和不良反应发生率,并应用多因素Cox回归模型探究影响患者预后的独立危险因素。结果两组患者的临床疗效比较,差异有统计学意义(Z=2.196,P=0.028),RGDP组的ORR显著高于GDP组(68.29%vs. 46.34%,χ2=4.038,P=0.044)。化疗后,RGDP组和GDP组分别有13例(31.71%)和12例(29.27%)接受干细胞移植,差异无统计学意义(χ2=0.058,P=0.810)。RGDP组的死亡风险明显低于GDP组[HR=0.534,95%CI(0.294~0.970),P=0.035]。GDP组和RGDP组的中位EFS分别为15(4~32)个月和26(9~35)个月,RGDP组的疾病进展风险明显低于GDP组[HR=0.556,95%CI(0.333~0.928),P=0.020]。GDP组和RGDP组的早期死亡率(2.44%vs. 2.44%,χ2=0,P=1)和Ⅲ级以上不良反应发生率(17.07%vs. 24.09%,χ2=0.688,P=0.414)比较,差异均无统计学意义。Cox回归分析显示,IPI危险分级(HR=3.373,P=0.000)是复发DLBCL患者死亡的独立危险因素,而HSCT(HR=0.384,P=0.036)、RTX(HR=0.597,P=0.029)是其保护因素。结论 RTX联合GDP方案治疗复发DLBCL的疗效较好,可改善患者的OS和PFS,而安全性与GDP方案相似;IPI危险分级是复发DLBCL患者死亡的独立危险因素,HSCT、RTX是其保护因素。

Objective To observe the efficacy, prognosis and safety of Rituximab (RTX) combined with Gemcitabine, dexamethasone and cisplatin (GDP) for patients with relapsed diffuse large B-cell lymphoma (DLBCL). Methods Eighty-two patients with relapsed DLBCL who were admitted to our hospital between January 2012 and January 2015 were divided into the GDP group (41 cases) and the RGDP group (41 cases) by random number table. The GDP group was treated by GDP plan, and the RGDP group was treated by GDP plan combined with RTX. The efficacy, overall survival (OS), event free survival (EFS), and the incidence of early death and adverse reactions were compared between the two groups. The multivariate Cox regression model was used to explore the independent prognostic risk factors. Results There was a statistically significant difference in the clinical efficacy between the two groups (Z=2.196, P=0.028). The ORR of the RGDP group was significantly higher than that of the GDP group (68.29% vs. 46.34 %,χ^2=4.038, P=0.044). After chemotherapy, there were respectively 13 cases (31.71%) and 12 cases (29.27%) in the RGDP and GDP group receiving stem cell transplantation (χ^2=0.058, P=0.810). The death risk in the RGDP group was significantly lower than in the GDP group[ HR=0.534, 95% CI (0.294, 0.970), P=0.035]. The medium EFS was 15 (4~32) months in GDP group and 26 (9~35) months in RGDP group;the disease progression risk of the RGDP group was significantly lower than that of the GDP group[ HR=0.556, 95% CI (0.333~0.928), P=0.020]. There were no significant differences in the incidence of early death (2.44% vs. 2.44%,χ^2=0, P=1) and the incidence of adverse reactions above grade Ⅲ(17.07% vs. 24.09%,χ^2=0.688, P=0.414) between GDP and RGDP group. Cox regression analysis showed that IPI risk grade (HR=3.373, P=0.000) was an independent risk factor for death, and that HSCT (HR=0.384, P=0.036), RTX (HR=0.507, P=0.029) were protective factors of patients with recurrent DLBCL. Conclusions Rituximab combined with GDP regimen is effective for recurrent diffuse large B-cell lymphoma. It could improve overall survival and progression-free survival of patients, and the safety is similar to the GDP plan. IPI risk classification is independent risk factor for the death of patients with recurrent DLBCL, while HSCT and RTX are its protective factors.