R-GemOx与RICE方案二线治疗复发或难治性弥漫大B细胞淋巴瘤的临床对比研究

摘要

目的:对比美罗华联合奥沙利铂和吉西他滨 (R-GemOx) 与RICE方案二线治疗复发或难治性的弥漫大B细胞淋巴瘤(DLBCL) 的疗效及毒副作用.方法:选取复发或难治性弥漫大B细胞淋巴瘤患者65例,随机分为两组,分别接受R-GemOx方案和RICE方案化疗.R-GemOx组方案为:美罗华,375 mg/m2静脉滴注,d0,吉西他滨 (GEM) 1 000 mg/m2,静脉滴注,d1、8; 奥沙利铂(L-OHP) 130 mg/m2,静脉滴注,d1; 21天为1周期.RICE组方案为:美罗华,375 mg/m2,静脉滴注,d0; 异环磷酰胺 (IFO) 1 g/m2,静脉滴注,d1～d3; Mesna解救400mg,静脉滴注q8h,d1～d3; 卡铂 (CBP),AUC=5,静脉滴注,d2; 依托泊苷 (VP-16) 100mg/m2,静脉滴注,d1～d3.21天为1个周期.每2周期进行疗效及毒性评价.结果:65例患者中,R-GemOx方案组,完全缓解 (CR) 4例(12.5%),部分缓解 (PR) 17例 (53.1%),稳定 (SD) 6例,进展 (PD) 5例,总有效率 (CR+PR) 为65.6%,临床获益率 (CR+PR+SD) 达到84.4%.RICE组CR 4例 (12.1%),PR 16例 (48.5%),SD 7例,PD 6例,总有效率60.6%,临床获益率81.8%.两组的不良反应主要为骨髓抑制,其中R-GemOx组白细胞下降Ⅲ度5例,Ⅳ度2例; 贫血Ⅲ度2例; 血小板下降Ⅲ度4例,Ⅳ度2例.RICE组白细胞下降Ⅲ度16例,Ⅳ度5例; 贫血Ⅲ度2例; 血小板下降Ⅲ度5例,Ⅳ度3例.胃肠道反应RICE组较R-GemOx组为重,其中Ⅲ度2例,Ⅳ度1例.比较两组毒副反应,R-GemOx组在中性粒细胞减少,消化道反应方面明显好于RICE组 (P<0.05).而RICE组未出现一例末梢神经毒性.结论:R-GemOx方案是二线治疗复发或难治性弥漫大B细胞淋巴瘤较为安全且有效的化疗方案,其远期疗效尚需进一步观察.%Objective: To compare the efficacy and safety of R-GemOx and RICE regimens for treating relapsed or refractory non-Hodgkin's lymphoma (NHL). Methods: Up to 65 cases with relapsed and refractory diffuse large B cell lymphoma (DLBCL) were randomly divided into two groups. These patients received R-GemOx and RICE regime, respectively. The R-GemOx regimen included rituximab at 375 mg/m2. ivd, d0; GEM at 1000 mg/m2, ivd, d1, 8; and L-OHP at 130 mg/m2, ivd, d1 at 21 days per cycle. The RICE regime included rituximad at 375 mg/m2, ivd d0; IFO at 1 g/m2, ivd, d1-d3; Mesna at 400 mg, ivd q8h, dl~d3; CBPAUC = 5, ivd d2; and Yp-16 at 100 mg/m2, ivd, d1~d3 at 21 days per cycle. Their efficacy and safety were evaluated every two weeks. Results: For the R-Ge-mOx group, complete remission ( CR ) was achieved in 4 cases (12.5% ), partial remission ( PR) in 17 cases ( 53.1%), stable disease ( SD ) in 6 cases, and progressive disease ( PD )in 5 cases. The overall response rate ( CR-PR ) was 65.6%, and the clinical benefit rate ( CR+PR+ SD ) was 84.4%. For the RICE group, CR was achieved in 4 cases ( 12.1%), PR in 16 cases ( 48.5%), SD in 7 cases, and PD in 6 cases. The overall response rate ( CR+PR) was 60.6%, and the clinical benefit rate ( CR+PR+ SD ) was 81.8%. The main side effect" was bone marrow suppression. In the R-GemOx group, leukopenia was observed with 5 cases at grade Ⅲ and 2 eases at grade Ⅳ; anemia was observed with 2 cases at grade Ⅲ; thrombocytoperria was observed with 5 cases at grade Ⅲ and 3 cases at grade Ⅳ. In the RICH group, leukopenia was observed with 16 cases at grade Ⅲ and 5 cases at grade Ⅳ; anemia was observed with 2 cases at grade Ⅲ; thrombocytoperria was observed with 5 cases at grade Ⅲ and 3 cases at grade Ⅳ. The gastrointestinal tract reaction in the RICH group was more serious than in the R-GemOx group: 2 cases at grade Ⅲ and 1 case at grade Ⅳ. Comparison of the side effects in the two groups revealed that R-GemOx was better for neuirocytopenia and gastrointestinal tract reaction than RICE ( P < 0.05 ). Conclusion: R-GemOx is a safer and more effective regimen for Treating relapsed or refractory DLBCL, and its efficacy requires observation and research.