Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone:: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group
Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone:: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group
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DOI：
10.1182/blood-2005-01-0016
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发表时间：
2005-12-01
期刊：
影响因子：
20.3
通讯作者：
Unterhalt, M
中科院分区：
文献类型：
--
作者：
Hiddemann, W;Kneba, M;Unterhalt, M
2期研究表明，单克隆抗体利妥昔单抗可能会改善滤泡性淋巴瘤（FL）患者的预后，当它被添加到化疗。在本研究中，428例未经治疗的晚期FL患者被随机分配接受环磷酰胺、多柔比星、长春新碱和泼尼松（CHOP）单药治疗（n = 205）或CHOP联合利妥昔单抗（R-CHOP）治疗（n = 223）。R-CHOP使治疗失败的相对风险降低了60%，并显著延长了治疗失败的时间（P <0.001）。此外，总体缓解率显著更高（96% vs 90%; P = 0.011），缓解持续时间延长（P = 0.001）。尽管观察时间相对较短，但这些有益效果甚至转化为上级的总生存率（P = 0.016），在前3年内，R-CHOP组有6例死亡，而CHOP组有17例死亡。主要的治疗相关不良反应是骨髓抑制。R-CHOP后更常观察到重度粒细胞减少症（63% vs 53%; P = .01）。然而，R-CHOP和CHOP后严重感染罕见且频率相似（5%和7%）。因此，将利妥昔单抗添加到CHOP中显著改善了先前未经治疗的晚期FL患者的结局，并且不会引起重大不良反应。
Phase 2 studies suggest that the monoclonal antibody rituximab may improve the prognosis of patients with follicular lymphoma (FL) when it is added to chemotherapy. In the current study, 428 patients with untreated, advanced-stage FL were randomly assigned for therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) alone (n = 205) or CHOP combined with rituximab (R-CHOP) (n = 223). R-CHOP reduced the relative risk for treatment failure by 60% and significantly prolonged the time to treatment failure (P < .001). In addition, a significantly higher overall response rate (96% vs 90%; P = .011) and a prolonged duration of remission (P = .001) were achieved. In spite of a relatively short observation time, these beneficial effects even translated to superior overall survival (P = .016), with 6 deaths in the R-CHOP group compared with 17 deaths in the CHOP group within the first 3 years. The predominant treatment-related adverse effect was myelosuppression. Severe granulocytopenia was more frequently observed after R-CHOP (63% vs 53%; P = .01). However, severe infections were rare and of similar frequency after R-CHOP and CHOP (5% and 7%). Hence, adding rituximab to CHOP significantly improves the outcome for patients with previously untreated advanced-stage FL and does not induce major adverse effects.