Abstract：
The GALLIUM study showed a progression-free survival advantage of 7% in favor of obinutuzumab vs. rituximab-based immunochemotherapies as first-line therapy in follicular lymphoma (FL) patients. Yet, the toxicity appears to be increased with obinutuzumab-based therapy. This is a multicenter retrospective-cohort study including adult FL patients comparing the toxicity of first-line rituximab vs. obinutuzumab-based chemo-immunotherapies (R and O groups, respectively). We compared the best standard-of-care therapy used per time period, before and after obinutuzumab approval. The primary outcome was any infection during induction and 6 months post-induction. Secondary outcomes included rates of febrile neutropenia, severe and fatal infections, other adverse events, and all-cause mortality. Outcomes were compared between groups. A total of 156 patients were included in the analysis, 78 patients per group. Most patients received bendamustine (59%) or CHOP (31.4%) as adjacent chemotherapy. Half of the patients received growth-factor prophylaxis. Overall, 69 patients (44.2%) experienced infections, and a total of 106 infectious episodes were recorded. Patients in the R and O groups had similar rates of any infection (44.8% and 43.5%, p = 1), severe infections (43.3% vs. 47.8%, p = 0.844), febrile neutropenia (15% vs. 19.6%, p = 0.606), and treatment discontinuation, as well as similar types of infections. No covariate was associated with infection in multivariable analysis. No statistically significant difference was evident in adverse events of grades 3-5 (76.9% vs. 82%, p = 0.427). To conclude, in this largest real-life study of first-line treated FL patients comparing R- to O-based therapy, we did not observe any difference in toxicity during the induction and 6 months post-induction period.
摘要：
GALLIUM研究显示，与obinutuzumab相比，无进展生存优势为7％基于利妥昔单抗的免疫化疗作为滤泡性淋巴瘤（FL）患者的一线治疗。然而，使用基于奥比妥珠单抗的治疗,毒性似乎增加.这是一项多中心回顾性队列研究，包括成人FL患者，比较一线利妥昔单抗的毒性与基于奥比努珠单抗的化学免疫疗法(R和O组，分别)。我们比较了每个时间段使用的最佳标准治疗，在奥比努珠单抗批准之前和之后。主要结果是诱导期间和诱导后6个月的任何感染。次要结果包括发热性中性粒细胞减少症的发生率，严重和致命的感染，其他不良事件,和全因死亡率。比较各组的结果。共有156名患者被纳入分析，每组78名患者。大多数患者接受苯达莫司汀（59％）或CHOP（31.4％）作为邻近化疗。一半的患者接受了生长因子预防。总的来说,69例患者（44.2%）出现感染，共记录了106起传染病。R组和O组患者的任何感染率相似（44.8％和43.5％，p=1),严重感染（43.3%vs.47.8%,p=0.844),发热性中性粒细胞减少症（15%vs.19.6%,p=0.606)，停止治疗，以及类似类型的感染。在多变量分析中，没有协变量与感染相关。3-5级不良事件无统计学差异（76.9%vs.82%,p=0.427)。最后，在这项对一线治疗的FL患者进行的最大的现实生活研究中，比较了基于R到O的治疗，在诱导期间和诱导后6个月,我们没有观察到任何毒性差异.
