R-CHOP与CHOP方案治疗初治弥漫大B细胞型淋巴瘤在中国的多中心随机对照研究

Comparison between R-CHOP Regimen and CHOP Regimen in Treating Naive Diffuse Large B-cell Lymphoma in China -- a Multi-center Randomized Trail

背景与目的:CHOP化疗方案是目前治疗弥漫性大B细胞型非霍奇金淋巴瘤(non-HodgkinTslymphoma,NHL)的标准方案。利妥昔单抗(美罗华)作为一种针对CD20抗原表达阳性的B细胞的嵌合型单克隆抗体,对弥漫性大B细胞型淋巴瘤具有良好的疗效。在欧洲和美国,利妥昔单抗联合标准化疗方案治疗进展型NHL已经获得批准。本研究旨在比较利妥昔单抗加标准CHOP方案与标准CHOP方案治疗中国人CD20阳性的弥漫大B细胞型NHL患者的疗效和安全性。方法:2003年9月至2004年11月在全国9个研究中心进行,共有63例患者入组,其中CHOP组32例,R-CHOP组31例。所有入组患者均签署并提供知情同意书。CHOP组患者接受每3周为1个疗程共6个疗程的CHOP方案治疗;R-CHOP组患者在每个疗程开始的第1天联用利妥昔单抗的CHOP治疗方案。比较两组的完全缓解率、总体缓解率以及不良反应情况。结果:R-CHOP组和CHOP组的完全缓解率相似(41.9%vs.37.5%,P=0.719),而总体缓解率前者要高于后者(83.8%vs.65.6%,P=0.096),但无显著性差异。治疗期间CHOP组有21.9%的患者疾病进展,而R-CHOP组仅为3.2%,两组有显著性差异(P=0.026)。R-CHOP组和CHOP组的不良反应发生率相似(65.6%vs.67.7%),差异无显著性(P=0.859)。最常见的不良反应均为白细胞下降;R-CHOP组其次常见不良反应是发热和寒战,可能与输注利妥昔单抗有关。两组的临床相关毒副作用相似,差异无显著性。结论:利妥昔单抗联合CHOP方案治疗CD20阳性的弥漫大B细胞型NHL与单纯CHOP方案相比,能显著降低治疗失败率,同时并不增加化疗的毒副反应。

BACKGROUND ＆ OBJECTIVE： CHOP regimen is a standard treament for patients with diffuse large B-cell non-Hodgkin＇s lymphoma （NHL）, and its 5-year overall survival （OS） rate is 30%-40%. Rituximab is a chimeric monoclonal antibody （MoAb） directly against CD20-positive B cells, and has good effect on diffuse large B-cell NHL. Rituximab combined with standard chemotherapy has been approved for treating aggressive B-cell NHL in Europe and the US. This study was to determine efficacy and safety of the combination of Rituximab and CHOP regimen in treating Chinese patients with CD20-positive diffuse large B-cell NHL. METHODS： From Sep. 2003 to Nov. 2004, a total of 63 patients in 9 centers were enrolled. All the patients were randomized into 2 groups： 32 received CHOP regimen alone （CHOP group）, and 31 received Rituximab and CHOP regimen （R-CHOP group）. All patients signed informed consent. The complete response rates, overall response rates, and side events of the 2 groups were compared. RESULTS： The complete response rates were similar in R-CHOP and CHOP groups （41.9% vs. 37.5%, P=0.719）; the overall response rates were slightly higher in R-CHOP group than in CHOP group （83.8% vs. 65.6%, P=0.096）. Disease progression during treatment was reported for 7 （21.9%） patients in CHOP group and 1 （3.2%） patient in R-CHOP group （P=0.026）. The occurrence rates of adverse events were similar in R-CHOP and CHOP groups （65.6% vs. 67.7%, P=0.859）. The most common adverse event was leukopenia; fever and chills were rather common in R-CHOP group. Clinically relevant toxicity was similar in both groups. CONCLUSION： When compared with standard CHOP alone, the addition of Rituximab to standard CHOP regimen reduces the risk of treatment failure in patients with diffuse large B-cell NHL, and doesn＇t increase the occurrence of chemotherapy-related adverse events.