国产苯达莫司汀联合利妥昔单抗一线治疗惰性B细胞淋巴瘤及老年套细胞淋巴瘤的疗效及安全性——多中心、前瞻性、Ⅱ期临床研究北大核心CSCD

目的评价国产苯达莫司汀联合利妥昔单抗一线治疗惰性B细胞淋巴瘤(B-iNHL)和老年套细胞淋巴瘤(MCL)的有效性和安全性。方法于2020年12月1日至2022年9月10日在山东省内10家三甲医院多中心前瞻性研究国产苯达莫司汀联合利妥昔单抗治疗初诊B-iNHL和老年MCL患者的疗效和安全性,所有患者均已完成至少4个周期诱导治疗。结果共入组B-iNHL与年MCL患者72例,中位年龄为55(24~74)岁,美国东部肿瘤协作组体能状态评分(ECOG评分)0~1分者占76.4%,ECOG 2分者占23.6%。滤泡淋巴瘤(FL)占51.4%,边缘区淋巴瘤(MZL)占33.3%,老年MCL占11.1%,不能分类占4.2%。Ann Arbor分期:Ⅲ期占16.7%、Ⅳ期占65.3%。4个周期诱导治疗后,总有效率为98.6%,其中完全缓解(CR)率为83.3%,部分缓解(PR)率为15.3%。仅1例MCL患者治疗中进展,1例FL患者复发。考虑到PET/CT评估与CT评估的差异,即使按照CT评估,其CR率为63.9%。中位随访11(4~22)个月,无进展生存(PFS)率为96.8%,总生存(OS)率为100.0%。主要血液学不良反应包括:3~4级白细胞减少(27.8%,其中8.3%的患者出现粒细胞缺乏伴发热),3~4级淋巴细胞减少(23.6%),3~4级贫血(5.6%)及3~4级血小板减少(4.2%)。非血液学不良反应主要为乏力、恶心/呕吐、皮疹、感染,发生率均低于20.0%。结论国产苯达莫司汀联合利妥昔单抗一线治疗B-iNHL和老年MCL患者安全有效。     

奥妥珠单抗治疗滤泡性淋巴瘤的研究进展

滤泡性淋巴瘤(FL)是常见惰性非霍奇金淋巴瘤(NHL)亚型之一。随着对FL靶向治疗研究的深入, Ⅰ型CD20单克隆抗体利妥昔单抗联合化疗作为FL患者的一线治疗方案在临床中广泛应用, 使患者的生存率显著提升, 但是仍有部分患者由于耐药或者治疗相关不良发应, 出现复发或者疾病进展。奥妥珠单抗是首个人源化Ⅱ型糖基化工程CD20单克隆抗体, 可单独或者联合其他药物应用于初治或者复发/难治性FL患者。与利妥昔单抗相比, 奥妥珠单抗的抗FL活性良好, 可延长患者的生存期, 并且患者耐受性良好。采取奥妥珠单抗治疗FL常见的不良反应包括输注相关反应(IRR)、血细胞减少等。笔者拟就奥妥珠单抗治疗FL的作用机制、用药方案、临床疗效及不良反应等新研究进展进行综述, 旨在为奥妥珠单抗临床治疗FL患者提供参考。     

伴弥漫大B细胞成分的初诊滤泡淋巴瘤患者的临床特征及生存北大核心CSCD

目的探索初诊伴弥漫大B细胞成分的滤泡淋巴瘤(FL)患者的临床特征及生存.方法纳入国内11个医学中心2000-2020年间分级1-3a级、年龄≥18岁初诊FL患者1845例,筛选伴弥漫大B细胞成分的患者.回顾性分析患者的临床资料及生存数据,应用单因素及多因素分析筛选影响预后的因素.结果146例(7.9%)初诊FL患者病理伴弥漫大B细胞成分,中位年龄56(25~83)岁,男79例(54.1%).127例患者病理提示弥漫大B细胞成分比例,依据弥漫大B细胞比例是否≥50%将患者分为2组.研究发现,弥漫大B细胞成分≥50%患者较弥漫大B细胞成分<50%患者有更高的3级比例(94.3%对91.9%,P=0.010)、Ki-67指数≥70%比例(58.5%对32.9%,P=0.013)及PET-CT的SUVmax≥13比例(72.4%对46.3%,P=0.030).所有患者均接受CHOP或CHOP样±利妥昔单抗方案化疗,总反应率(ORR)为88.2%,完全缓解(CR)率为76.4%.在不同比例弥漫大B细胞成分组中,诱导治疗后缓解率及治疗后2年内疾病进展(POD24)发生率的差异均无统计学意义(P值均>0.05).总体预计5年无进展生存(PFS)率为58.9%,5年总生存(OS)率为90.4%,POD24患者的5年OS率较非POD24患者下降(70.3%对98.5%,P<0.001).与利妥昔单抗不维持治疗相比,利妥昔单抗维持治疗不能使患者的5年PFS率获益(57.7%对58.8%,P=0.543),5年OS率具有获益趋势,但差异无统计学意义(100%对87.8%,P=0.082).多因素分析显示,诱导治疗后未达到CR是影响患者PFS的独立危险因素(P=0.006),而LDH高于正常值是影响患者OS的独立危险因素(P=0.031).结论伴弥漫大B细胞成分≥50%的FL患者,临床及病理特征更具侵袭性,CHOP/CHOP样±利妥昔单抗方案可以改善患者的临床疗效,利妥昔单抗维持治疗不能使患者的PFS和OS获益,诱导治疗后未达到CR是影响患者PFS的独立危险因素.     

苯达莫司汀联合利妥昔单抗治疗复发滤泡性淋巴瘤的临床分析北大核心CSCD

滤泡性淋巴瘤(FL)是较为常见的小B细胞来源的非霍奇金淋巴瘤(NHL)。免疫化疗方案R-CHOP(利妥昔单抗+环磷酰胺+多柔比星+长春新碱+泼尼松)/R-CVP(利妥昔单抗+环磷酰胺+长春新碱+泼尼松)的应用使初治FL患者获得了较好的疗效。国内外研究报道应用R-CHOP样免疫化疗方案能够使40%~76%的FL患者达到完全缓解(CR), 总有效率超过90%[1,2]。但目前Ⅲ/Ⅳ期患者仍不能治愈, 随着复发次数的增加, R-CHOP方案的疗效显著下降[3]。     

含利妥昔单抗方案治疗晚期套细胞淋巴瘤临床分析

目的 探讨含利妥昔单抗化疗方案治疗晚期套细胞淋巴瘤(MCL)患者临床疗效及预后。方法 回顾性分析2011年7月至2021年7月丹东市第一医院收治的42例晚期MCL患者的临床资料,化疗方案中均包括利妥昔单抗。采用MCL国际预后指数(MIPI)评估患者预后,ECOG评分评估患者功能状态,评估治疗疗效、疾病控制率(DCR)、客观缓解率(ORR)及不良反应发生率,采用Kaplan-Meier法评估无进展生存期(PFS)及总生存期(OS),应用Cox回归对筛选的临床特征、分子病理、治疗反应以及预后因素进行分析。结果 42例患者中位发病年龄为70岁,其中男性31例、女性11例。27例接受利妥昔单抗联合CHOP方案化疗,6例接受利妥昔单抗联合苯达莫斯汀方案化疗,9例接受利妥昔单抗联合伊布替尼方案化疗。42例晚期MCL的客观缓解率为42.8%,疾病控制率为61.9%,中位OS为63个月(95%CI:50.030～75.930),中位PFS为18个月(95%CI:6.645～29.355)。皮疹和间质性肺炎为最常见的不良反应。结论 晚期MCL患者应用含利妥昔单抗方案治疗具有较好的近期疗效,不良反应可耐受...     

R-CHOP方案治疗弥漫大B细胞性淋巴瘤患者疗效分析

目的 研究评价在中国的初治弥漫大B细胞性淋巴瘤患者中应用利妥昔单抗联合环磷酰胺、阿霉素、长春新碱和强的松(CHOP)方案的长期疗效和安全性.方法 本研究为单中心回顾性分析.患者接受4～6个疗程的利妥昔单抗和CHOP方案化疗,其中利妥昔单抗(375 mg/m2)于每个CHOP方案第一天静脉滴注,CHOP则在每一疗程第三天开始,每一疗程间隔21天重复.共计82例患者入选本次研究,年龄分布18～76岁,中位年龄45岁.结果 总反应率(0R)和完全缓解率(CR)分别为90.2%和70.7%,预计5年无进展生存率(PFS)和5年总体生存率(OS)分别可达(56.4±8.3)%和(74.1±7.4)%.血液学毒性较轻,5例有既往慢性乙型肝炎病史的患者出现肝炎病毒再激活.结论 本研究表明对于中国的初治弥漫大B细胞性淋巴瘤患者利妥昔单抗联合CHOP方案是有效且可以耐受的.     

吉西他滨、奥沙利铂、地塞米松±利妥昔单抗挽救治疗复发或难治性非霍奇金淋巴瘤的临床观察

目的：临床观察吉西他滨、奥沙利铂、地塞米松加减利妥昔单抗（Gemox＋Dxm±R）挽救性治疗复发或难治性非霍奇金淋巴瘤（NHL）的近期临床疗效和毒副反应。方法回顾性分析25例经正规标准方案治疗复发或难治的NHL患者,采用Gemox＋Dxm±R（吉西他滨1000 mg/m2,静脉滴注,第1、8天;奥沙利泊130 mg/m2,静脉滴注,第1天;地塞米松20 mg/d,第1～5天;±利妥昔单抗375 mg/m2,第0天）,21～28 d为一个周期,每化疗2个周期后评价疗效,每1个周期化疗后评价毒副反应。结果25例患者均接受2～4个疗程化疗,每例都可接受评价疗效。16例获得缓解（64%）,其中完全缓解（CR）3例,部分缓解（PR）13例。9例患者在初诊时使用过利妥昔单抗,6例患者在复发难治后首次使用利妥昔单抗联合该挽救化疗方案,3例患者在二线挽救性方案化疗获得缓解后接受自体造血干细胞支持下的大剂量的化疗。化疗后主要毒副反应为胃肠道反应、骨髓抑制、脱发、乏力、末梢神经病变。中位随访13个月（1～36个月）,1年,2年,3年的生存率分别为92%,60%,36%。结论 Gemox＋Dxm±R组成的二线挽救性方案对复发难治性NHL近期疗效较好,毒副反应小,患者都能耐受。该研究方案对复发难治性NHL治疗在临床疗效方面具有重要意义,也是安全、有效的,值得进一步多中心大宗病例的临床研究。     

以皮肤结节为首诊表现的滤泡性淋巴瘤转化为弥漫性大B细胞淋巴瘤一例

滤泡性淋巴瘤（FL）转化的病例已有报道,但以皮肤损害为首诊表现的转化较为罕见。该文报道1例FL转化为弥漫性大B细胞淋巴瘤（DLBCL）的53岁女性患者,其以乳房多发性皮肤结节为首诊表现,追问患者既往病史并行皮肤组织病理和免疫组织化学检查后确诊。予以R2+ICE方案（R2：利妥昔单抗+来那度胺,I：异环磷酰胺,C：卡铂,E：依托泊苷）化学治疗及对症支持治疗,并建议其接受造血干细胞移植,但因经济问题患者及其家属放弃治疗,患者出院后2个月死亡。     

曲妥珠单抗联合不同化疗方案治疗人表皮生长因子受体-2阳性晚期胃癌患者的回顾性研究

目的对比分析曲妥珠单抗联合卡培他滨加奥沙利铂(XELOX)方案与曲妥珠单抗联合替吉奥加奥沙利铂(SOX)方案治疗人表皮生长因子受体-2 (Her-2)阳性晚期胃癌的疗效和不良反应。方法将曾经以曲妥珠单抗联合XELOX或曲妥珠单抗联合SOX作为一线化疗方案进行治疗的患者(n=40)分别纳入曲妥珠单抗-XELOX组(n=21)或曲妥珠单抗-SOX组(n=19)。曲妥珠单抗-XELOX组、曲妥珠单抗-SOX组的治疗方案分别为卡培他滨(850 mg/m2,第1～14天每天2次,每3周为1个周期)、替吉奥(40 mg/m2,第1～14天每天2次,每3周为1个周期)口服,2组中奥沙利铂(130 mg/m2)在每周期第1天静脉滴注,曲妥珠单抗在第1周期第1天以8 mg/kg首剂,随后6 mg/kg静脉滴注。比较2组患者的疗效和不良反应发生情况。结果曲妥珠单抗-XELOX组患者的客观缓解率(RR)、疾病控制率(DCR)和中位无进展生存期(PFS)分别为38. 1%、85. 7%和7. 6个月,曲妥珠单抗-SOX组患者的RR、DCR和中位PFS分别为47. 4%、84. 2%和8. 2个月,2组近期、远期疗效比较,差异无统计学意义(P 0. 05)。曲妥珠单抗-XELOX组3～4度手足综合征的发生率显著高于曲妥珠单抗-SOX组(P 0. 05),其他不良反应发生率比较,差异无统计学意义(P0. 05)。结论曲妥珠单抗联合SOX方案与曲妥珠单抗联合XELOX方案的疗效相当,但安全性更好,可与曲妥珠单抗联合XELOX方案互换用于Her-2阳性晚期胃癌的一线治疗。     

口服蛋白酶体抑制剂伊沙佐米治疗多发性骨髓瘤的疗效和安全性研究

目的:评价口服蛋白酶体抑制剂伊沙佐米治疗多发性骨髓瘤的有效性及安全性。方法:选择2018年7月1日至2019年4月4日于复旦大学附属中山医院接受2周期或以上伊沙佐米治疗的多发性骨髓瘤患者(排除轻链淀粉样变性及浆细胞白血病患者)。治疗方案包括伊沙佐米单药以及联合其他药物(来那度胺、沙利度胺或地塞米松等)的两药或三药方案。伊沙佐米的起始剂量为4 mg,第1、8、15天口服,28 d为1个周期。治疗第2周期及第4周期后进行疗效和安全性评估。结果:共27例多发性骨髓瘤患者符合入选标准,包括复发/难治15例、初发12例。复发/难治患者总体反应率(ORR)为53.3%,其中2例完全缓解(CR)、1例非常好的部分缓解(VGPR)、5例部分缓解(PR);中位获得反应时间为53 d。其中,既往硼替佐米治疗难治者ORR为54.5%(6/11)。可评估初发患者9例,ORR 100.0%,2例CR、3例VGPR、4例PR;中位获得反应时间为38 d。伊沙佐米治疗3～4级不良事件发生率为29.6%。主要血液学毒性为淋巴细胞、血小板及中性粒细胞计数降低和贫血;其他常见不良反应包括乏力和胃肠道反应。所有患者未出现3～4级外周神经毒性。结论:在中国真实世界中,伊沙佐米对初诊及复发/难治的多发性骨髓瘤患者具有良好的疗效及安全性。     

Matching-adjusted Indirect Comparisons of the Efficacy and Safety of Acalabrutinib Versus Other Targeted Therapies in Relapsed/Refractory Mantle Cell Lymphoma

PurposeMantle cell lymphoma (MCL) is a rare subtype of B-cell non-Hodgkin lymphoma that can be either aggressive or indolent. Although MCL usually responds well to initial treatment with chemotherapy-based regimens, the disease often relapses or becomes refractory within a few years. Acalabrutinib is a highly selective, potent, covalent Bruton tyrosine kinase inhibitor with minimal off-target activity. WIthout head-to-head clinical trial data, estimation of the comparative efficacy and safety of new therapeutic entities provides valuable information for patients, clinicians, and health care payers. The objective of this analysis was to compare the efficacy and safety of acalabrutinib versus other targeted therapies employed for the treatment of relapsed/refractory MCL by using matching-adjusted indirect comparisons.MethodsIndividual data from 124 patients treated with acalabrutinib in the Phase II ACE-LY-004 trial were adjusted to match average baseline characteristics of populations from studies using alternative targeted treatment regimens for relapsed/refractory MCL (for monotherapy: ibrutinib, bortezomib, lenalidomide, and temsirolimus; for combination therapies: ibrutinib + rituximab, bendamustine + rituximab, and lenalidomide + rituximab). Patient populations were matched on age, sex, race, Eastern Cooperative Oncology Group performance status, Simplified MCL International Prognostic Index score, tumor bulk, lactate dehydrogenase concentration, extranodal disease, bone marrow involvement, and number of previous treatment regimens. Outcomes assessed included overall response rate (ORR), complete response (CR) rate, overall survival (OS), progression-free survival (PFS), and adverse events.FindingsAfter matching, acalabrutinib was associated with significant increases in ORR and CR rate (estimated treatment difference [95% CI]) versus ibrutinib (ORR, 9.3% [0.3–18.3]; CR, 14.9% [5.4–24.3]), bortezomib (ORR, 50.6% [40.2–61.0]; CR, 18.8% [9.1–28.5]), lenalidomide (ORR, 38.1% [27.1–49.1]; CR, 43.5% [34.8–52.3]), and temsirolimus (ORR, 40.7% [31.0–50.4]; CR, 27.1% [19.2–35.0]). PFS (hazard ratio [95% CI]) with acalabrutinib was significantly increased versus bortezomib (0.36 [0.26–0.51]), lenalidomide (0.65 [0.48–0.89]), lenalidomide + rituximab (0.57 [0.35–0.93]), and temsirolimus (0.33 [0.24–0.45]). Acalabrutinib was associated with significantly increased OS (hazard ratio) versus bortezomib (0.36 [0.22–0.61]) and temsirolimus (0.32 [0.23–0.44]). The overall safety profile of acalabrutinib was similar or better compared with the monotherapies; however, infection risk increased versus bendamustine + rituximab, and anemia increased risk versus lenalidomide + rituximab and ibrutinib + rituximab.ImplicationsThis comparison of targeted therapies used in the treatment of relapsed/refractory MCL showed that acalabrutinib has the potential to provide increased response rates, with trends for increased PFS and OS, and an improved safety profile.     

达雷妥尤单抗治疗复发/难治多发性骨髓瘤的疗效与安全性

目的:探讨达雷妥尤单抗治疗复发/难治多发性骨髓瘤（RRMM）的疗效与安全性。方法:回顾性分析2017年9月至2020年3月上海长征医院接受达雷妥尤单抗治疗的46例RRMM患者的临床资料。结果:所有RRMM患者均采用以达雷妥尤单抗为基础的方案进行治疗,其中Dd（达雷妥尤单抗+地塞米松）方案组8例,DRd（达雷妥尤单抗+来...     

Comparative Efficacy of Treatments for Previously Treated Multiple Myeloma: A Systematic Literature Review and Network Meta-analysis

Purpose

New therapies, including daratumumab plus lenalidomide plus dexamethasone (DRd) and daratumumab plus bortezomib plus dexamethasone (DVd), have recently been approved in the United States for patients with multiple myeloma (MM) who have received at least 1 prior line of therapy. However, few treatments have been compared in head-to-head clinical trials to determine the most efficacious therapy. In an update of the POLLUX (Phase 3 Study Comparing DRd Versus Rd in Subjects with Relapsed or Refractory Multiple Myeloma [RRMM]) trial, median progression-free survival (PFS) for DRd was not reached; the hazard ratio compared with Rd was 0.41. In an update of the CASTOR (Phase 3 Study Comparing DVd Versus Vd in Subjects with RRMM) trial, median PFS for DVd was 16.7 months, compared with 7.1 months for Vd with a PFS hazard ratio of 0.31. A systematic literature review and network meta-analysis (NMA) was performed to estimate the relative efficacy of treatments for previously treated patients with MM.

来那度胺在慢性淋巴细胞白血病中应用的研究进展

近年来,慢性淋巴细胞白血病发病率越来越高,微环境和免疫系统异常在其发病机制中起重要作用。常规化疗方案如FCR会加重免疫系统功能缺陷,导致患者感染率增加,造成不良预后。来那度胺的出现改变了这种状况。近年来的研究表明,来那度胺单药应用治疗难治复发CLL患者总有效率（ORR）大概32％-47％,完全缓解（CR）大概7％-13％;来那度胺与美罗华联用治疗复发难治CLL患者ORR大概53％-66％,CR大概12％-3％;且与其他药物如ofatumumab联合时,均显著提高了复发难治CLL患者的疗效且大大减少了不良反应,其不良反应主要为中性粒细胞减少症、血小板减少症、贫血、溶瘤综合征（tumorlysissyndrome,TLS）、燃瘤反应（TFR）和静脉血栓栓塞（VTE）。本文就近几年来那度胺在CLL中的应用进展做-综述。     

Use of Mabtera (rituximab) in treating patients with refractory courses of B-cell lymphoma,along with high-dose chemotherapy and autologous transplantation of hematopoietic stem cells

AIM: To study efficacy of rituximab in patients with resistant B-cell lymphoma on high-dose chemotherapy. MATERIAL AND METHODS: From September 2000 to April 2002 we studied efficacy and tolerance of rituximab at different stages of high-dose chemotherapy. The treatment was given to 10 patients with histologically verified CD20+ non-Hodgkin's lymphoma: diffuse large-cell (n = 4), Berkitt's (n = 2), follicular (n = 3), mantle-cell (n = 1). Five patients with diffuse large-cell lymphoma and Berkitt's lymphoma had a primary resistant course of the disease, one patient with diffuse large-cell lymphoma had a refractory recurrence. Follicular and mantle-cell lymphomas were characterized by a resistant course and large tumor masses. The patients received 1-2 courses of induction chemotherapy with dexa-BEAM with collection of peripheral stem cells followed by high-dose chemotherapy (BEAM-9, CBV + mitoxantron-1) with transplantation of autologous stem blood cells. Rituximab infusion (375 mg/m2) was conducted before the collection of the stem cells, prior to high-dose chemotherapy and in posttransplantation period after recovery of hemopoiesis. RESULTS: 4 patients achieved complete remission, 3-partial remission, 2 had progression and 1-stabilization. In mean follow-up 11 (2-20) months 7 of 10 patients were alive, overall survival being 15 +/- 2.4 months (95% confidence interval 10-19.7), median was not reached. 5 patients are in complete remission: 2 of them without further treatment, 3-after progression and repeat therapy including rituximab and interferon-alpha or rotuximab and CHOP chemotherapy. CONCLUSION: The addition of rituximab can improve the results of high-dose chemotherapy of patients with non-Hodgkin's lymphoma resistant to standard doses of cytostatics. Repeat use of this drug can be effective in some patients with progression after high-dose chemotherapy with rituximab.     

Indirect Treatment Comparisons of Ibrutinib Versus Physician’s Choice and Idelalisib Plus Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia

Purpose

Treatment options for patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL) are limited. Until recently, few effective treatment options existed, and even with the advent of new agents, studies evaluating comparative efficacy are scarce. In the Ibrutinib Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RESONATE) Phase III study, ibrutinib, an oral, once-a-day, first-in-class covalent Bruton tyrosine kinase inhibitor, improved progression-free survival (PFS) and overall survival (OS) compared with ofatumumab (PFS hazard ratio [HR] = 0.106 and OS HR = 0.369 [adjusted for crossover] at a median of 16 months’ follow-up). We sought to establish the relative efficacy of ibrutinib versus other treatment options for patients with R/R CLL using indirect comparison methods.

First-line treatment of follicular lymphoma in the era of monoclonal antibodies

This review describes the recent evolution in the first-line treatment of patients with follicular lymphoma. In cases without adverse prognostic parameters, delayed treatment still is the best option. The combination of rituximab plus chemotherapy in patients with adverse prognostic parameters is the treatment associated with the highest complete response rates and the longer time to progression compared to chemotherapy or rituximab alone. The best chemotherapy regimen is not yet described. Also yet to be described is the place of radioimmunotherapy versus rituximab plus chemotherapy. High-dose therapies with autologous stem-cell transplant have a place in the treatment of these patients but not in first line.     

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

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、AnnArbor Ⅲ—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。