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摘自：NCCN Guidelines Version 4.2021 B-Cell Lymphomas
First-line Therapy: Preferred Regimens
一线治疗：首选方案
Chemoimmunotherapy with anti-CD20 Monoclonal Antibody (obinutuzumab or rituximab) Bendamustine, CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CVP (cyclophosphamide, vincristine, and prednisone) with obinutuzumab or rituximab and lenalidomide + rituximab are included as preferred regimens, based on the results from phase III randomized trials (discussed below).
首选方案包括免疫化疗，即用一个抗CD20单克隆抗体（奥妥珠单抗或利妥昔单抗）联合苯达莫司汀或CHOP（环磷酰胺、阿霉素、长春新碱和泼尼松）或CVP（环磷酰胺、长春新碱和泼尼松），或来那度胺+利妥昔单抗，这些方案是基于三期随机临床试验的结果（下文讨论）。
The multicenter randomized phase III study (StiL NHL1) that compared bendamustine and rituximab (BR) and RCHOP as first-line treatment for patients with indolent and MCLs showed that BR was superior to RCHOP in terms of PFS in all histologic subtypes. At a median follow-up of 45 months, the median PFS was 69 months and 31 months (P < .0001), respectively, for BR and RCHOP. The ORR was similar between treatment arms (93% with BR; 91% with RCHOP), although the CR rate was significantly higher in the BR arm (40% vs. 30%; P = .021). BR was associated with less frequent grade 3 or 4 neutropenia (29% vs. 69%) or infections (any grade; 37% vs. 50%), whereas erythema (16% vs. 9%) and allergic skin reactions (15% vs. 6%) were more common with BR compared with RCHOP. The incidence of secondary malignancies was similar (8% with BR and 9% with RCHOP). However, the OS outcomes were not significantly different between treatment arms, even after long-term follow-up; the estimated 10-year survival rates were 71% and 66%, respectively, for BR and RCHOP.
多中心随机III期研究（StiL NHL1）比较了苯达莫司汀和利妥昔单抗（BR）与RCHOP作为惰性非霍奇金淋巴瘤以及套细胞淋巴瘤患者的一线治疗，结果表明，BR在所有组织学亚型的PFS方面均优于RCHOP。在45个月的中位随访中，BR和RCHOP的中位PFS分别为69个月和31个月（P<0.0001）。治疗组之间的ORR相似（BR组为93%；RCHOP组为91%），但BR组的CR率显著较高（40%比30%；P=0.021）。BR与较不常见的3级或4级中性粒细胞减少症（29%对69%）或感染（任何级别；37%对50%）相关，而与RCHOP相比，BR更常见的是红斑（16%对9%）和过敏性皮肤反应（15%对6%）。继发性恶性肿瘤的发生率相似（BR为8%，RCHOP为9%）。然而，即使经过长期随访，治疗组之间的OS结果也没有显著差异；BR和RCHOP的估计10年生存率分别为71%和66%。
Another randomized phase III study (BRIGHT) demonstrated that BR was noninferior to RCHOP or RCVP (in terms of PFS) as first-line treatment of patients with indolent or MCL (224 patients were randomized to receive BR and 223 patients were randomized to receive RCHOP or RCVP). At a median follow up of 5 years, the 5-year PFS rate for the overall study population was 66% and 56% (P = .0025), for BR and RCHOP/RCVP, respectively. The 5-year OS rate was not statistically different between the treatment groups and the incidence of opportunistic infections and secondary malignancies were slightly higher in patients treated with BR.
另一项随机III期研究（BRIGHT）表明，作为惰性非霍奇金淋巴瘤或套细胞淋巴瘤患者的一线治疗，BR不劣效于RCHOP或RCVP（就PFS而言）（224名患者随机接受BR，223名患者随机接受RCHOP或RCVP）。在5年的中位随访中，对于BR和RCHOP/RCVP，整个研究人群的5年PFS率分别为66%和56%（P=0.0025）。治疗组之间的5年OS率没有统计学差异，使用BR治疗的患者机会性感染和继发恶性肿瘤的发生率略高。
The phase III randomized trial (GALLIUM trial) compared the efficacy and safety of obinutuzumab compared to rituximab when used in combination with chemotherapy (bendamustine, CHOP, or CVP) in patients with previously untreated advanced stage FL (1202 patients were randomized [1:1] to receive obinutuzumab or rituximab in combination with chemotherapy). Patients with disease responding to induction chemoimmunotherapy received maintenance treatment with the same antibody for up to 2 years. However, this trial was not designed to compare the chemotherapy regimens. After a median follow-up of 34 months, a planned interim analysis showed that obinutuzumab-based chemoimmunotherapy was associated with significantly longer PFS and lower risk of progression and relapse than rituximab-based chemoimmunotherapy. The estimated 3-year PFS rates were 80% and 73%, respectively. However, response rates at the end of induction treatment were not significantly different between the two groups (88% for the obinutuzumab-based chemoimmunotherapy and 87% for rituximab-based chemoimmunotherapy) and OS was similar in both groups. In addition, grade 3 to 5 adverse events were higher with Obinutuzumab than with rituximab (infections, 20% vs. 16%; neutropenia, 46% vs. 39%; and infusion-related reactions, 12% vs. 7%) and bendamustine was associated with higher rates of grade 3 to 5 infections and secondary cancers. Non-relapse-related fatal adverse events were also more common with bendamustine (6% in the obinutuzumab group and 4% in the rituximab group) than with CHOP or CVP (2% for both regimens when used in combination with obinutuzumab or rituximab).
III期随机试验（GALLIUM研究）比较了奥妥珠单抗与利妥昔单抗联合化疗（苯达莫司汀、CHOP或CVP）对先前未经治疗的晚期滤泡性患者的疗效和安全性（1202名患者随机[1:1]接受奥妥珠单抗或利妥昔单抗联合化疗）。对诱导免疫化疗有反应的患者接受相同抗体的维持治疗长达2年。然而，这项试验并不是为了比较化疗方案。在中位随访34个月后，一项计划中的中期分析显示，与利妥昔单抗为基础的免疫化疗相比，基于奥妥珠单抗的免疫化疗的PFS显著延长，进展和复发风险降低。估计的3年PFS发生率分别为80%和73%。然而，两组诱导治疗结束时的应答率无显著差异（基于奥妥珠单抗的免疫化疗为88%，基于利妥昔单抗的免疫化疗为87%），两组的OS相似。此外，奥妥珠单抗组的3-5级不良事件发生率高于利妥昔单抗组（感染率，分别为20%和16%；中性粒细胞减少症，分别为46%和39%；输注相关反应，分别为12%和7%），苯达莫司汀组的3-5级感染和继发癌症发生率较高。与CHOP或CVP相比，苯达莫司汀（奥妥珠单抗组6%，利妥昔单抗组4%）的非复发相关致命不良事件也更为常见（与奥妥珠单抗或利妥昔单抗联合使用时，两种方案均为2%）。
The panel acknowledged that chemoimmunotherapy with anti-CD20 monoclonal antibody (obinutuzumab or rituximab) is an appropriate first-line therapy for patients with advanced stage FL requiring treatment. However, in the absence of data from randomized trials showing significant OS benefit for one chemoimmunotherapy regimen over another, the panel concluded that the available data are not strong enough to designate obinutuzumab-based chemoimmunotherapy as superior to rituximab-based chemoimmunotherapy. The panel consensus was to list all of the chemoimmunotherapy regimens as preferred regimens with category 2A recommendation.
专家组承认，对于需要治疗的晚期滤泡性淋巴瘤患者，使用抗CD20单克隆抗体（奥妥珠单抗或利妥昔单抗）进行免疫化疗是一种合适的一线治疗方法。然而，在缺乏随机试验数据显示一种免疫化疗方案比另一种方案具有显著的OS益处的情况下，专家组的结论是，现有数据不足以证明基于奥妥珠单抗的免疫化疗优于基于利妥昔单抗的免疫化疗。因此，专家组的共识是将所有免疫化疗方案均列为推荐的2A类首选方案。
The selection of a chemoimmunotherapy regimen should be highly individualized according to the patient’s age, extent of disease, presence of comorbid conditions, and the goals of therapy. When choosing an initial therapy, care should be given to avoid excessively myelotoxic regimens in patients who may subsequently be candidates for HDT/ASCR. Chemoimmunotherapy regimens may be associated with risks for HBV reactivation, which can lead to hepatitis and hepatic failure. Therefore, prior to initiation of therapy, HBV testing (including HBsAg and HBcAb testing) should be performed for all patients; viral load should be monitored routinely for patients with positive test results. In addition, the use of empiric antiviral therapy or upfront prophylaxis should be incorporated into the treatment plan. In the GALLIUM study, there was an increased risk of mortality from opportunistic infections and secondary malignancies in patients receiving bendamustine, and the rates of severe infections were also higher with bendamustine than CHOP or CVP duringthe maintenance and follow-up phases.71 The panel recommends that prophylaxis for pneumocystis jirovecii pneumonia (PJP) and varicella zoster virus (VZV) should be administered for patients receiving
bendamustine.
免疫化疗方案的选择应根据患者的年龄、疾病程度、共病情况和治疗目标高度个性化。在选择初始治疗方案时，应注意避免对随后可能成为大剂量化疗、自体造血干细胞移植（HDT/ASCR）候选患者的过度骨髓毒性的方案。免疫化疗方案可能与HBV再激活风险相关，这可能导致肝炎和肝衰竭。因此，在开始治疗之前，应对所有患者进行HBV检测（包括HBsAg和HBcAb检测）；对于检测结果呈阳性的患者，应定期监测病毒载量。此外，应将经验性抗病毒治疗或前期预防纳入治疗计划。在GALLIUM研究中，接受苯达莫司汀治疗的患者机会性感染和继发恶性肿瘤的死亡率增加，在维持期和随访期，苯达莫司汀的严重感染率也高于CHOP或CVP。因此，专家小组建议，接受苯达莫司汀治疗的患者应进行卡氏肺孢子虫肺炎（PJP）和水痘带状疱疹病毒（VZV）的预防。
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