R-CHOP方案与CHOP方案治疗初治弥漫性大B细胞淋巴瘤的临床研究

Comparison Between Efficacy and Safety of Rituximab plus CHOP Regimen and CHOP Regimen for Treatment of Newly Diagnosed Patients with Diffuse Large B-cell Lymphoma

为比较利妥昔单克隆抗体联合标准CHOP方案与标准CHOP方案治疗初治CD20阳性的弥漫慢大B细胞淋巴瘤(DLBCL)患者的疗效和安全性,采用同期(2003年7月至2006年12月)非随机对照的前瞻性研究方法,将69例在我院住院的初治DLBCL患者分为R-CHOP组和CHOP组,其中CHOP组36例,R-CHOP组33例,比较两组的完全缓解率、生存期及不良反应情况。结果显示:R-CHOP组23例(69.7%)获完全缓解(CR),部分缓解(PR)6例(18.2%),总有效率为88.5%,高于CHOP组;CHOP组17例(47.2%)获CR,11例(30.6%)获PR,总有效率77.8%(p=0.049)。尤其在男性、Ann ArborⅢ-Ⅳ和IPI3-5分的患者中,R-CHOP方案的CR率明显高于CHOP方案,且差异具有统计学意义(p=0.017、p=0.005和p=0.000)。R-CHOP组预计的平均生存时间(OS)为45.7个月,长于CHOP组的35.2个月,但经Log-Rank检验,差异无统计学意义(p=0.145);R-CHOP组预计的平均无疾病进展生存时间(PFS)为38.5个月,长于CHOP组的24.6个月,经Log-Rank检验,差异有统计学意义(p=0.017)。R-CHOP组的不良反应主要为发热等输注相关的不良反应,而骨髓抑制情况与CHOP组类似。结论:利妥昔单克隆抗体联合CHOP方案治疗CD20阳性的DLBCL与单纯CHOP方案相比,能显著提高疗效,同时并不增加化疗的毒副反应。

The aim of this study was to compare the efficacy of rituximab plus CHOP regimen and CHOP regimen on newly diagnosed patients with diffuse large B-cell lymphoma （ DLBCL）, and analyze their toxicities. A total of 69 patients were enrolled from July 2003 to Dec 2006. The patients were non-randomly were divided into 2 groups： 36 received CHOP alone （CHOP group） and 33 received rituximab plus CHOP （R-CHOP group）. The complete response （CR） rates, overall survival （OS） and side events of the 2 groups were compared. The results showed that the CR rate in R-CHOP group was higher than that in CHOP group （69.7% vs 47.2%, p =0. 049） ; especially in patients of male, Ann Arbor Ⅲ - Ⅳ and IPI 3 -5 （p = 0. 017, p = 0. 005 and p = 0.000）. The estimated mean OS in R-CHOP group was longer than that in CHOP group （45.7 months vs 35.2 months, p = 0. 145 ）, and also in the estimated mean progression free survival （ PFS ） （ 38.5 months vs. 24.6 months, p = 0. 017 ）. The major adverse events in combination group were infusion-related responses which could be well tolerated in patients, and hematological toxicities which were similar to those in CHOP group. In conclusions, Rituximab increases the therapeutic efficacy of CHOP regimen on newly diagnosed patients with DLBCL, without a clinically significant increase in toxicity.