Hayama Tatsuya, Miura Katsuhiro, Uchiike Akihiro, Nakagawa Masaru, Tsutsumi Daisuke, Sakagami Masashi, Yoshida Yoshikazu, Takei Masami
Department of Pharmacy, Nihon University Itabashi Hospital, 30-1 Oyaguchikamicho, Itabashi Ward, Tokyo, 173-8610, Japan.
Tumor Center, Nihon University Itabashi Hospital, 30-1 Oyaguchikamicho, Itabashi Ward, Tokyo, 173-8610, Japan.
Int J Clin Pharm. 2017 Apr;39(2):380-385. doi: 10.1007/s11096-017-0429-3. Epub 2017 Jan 31.
Background Infusion-related reactions (IRRs) are a major adverse event of rituximab. Objective To develop a prediction model for IRRs to rituximab among patients with B cell non- Hodgkin's lymphomas (B-NHL). Setting A 1000-bed university hospital in Tokyo. Methods Patients with B-NHL treated with rituximab at our institution from 2004 to 2014 were retrospectively analysed. Chills, fever, rash, nausea, asthenia, headache, cardiovascular symptoms, and respiratory symptoms of any grade, in association with rituximab infusion, were identified as IRRs. Risk factors for IRRs to rituximab found in the intergroup analysis were subsequently evaluated by using multivariate analysis. Main outcome measure Occurrence of IRRs to rituximab. Results A total of 140 patients with various types of B-NHL, including 74% with diffuse large Bcell lymphoma, were analysed. Among them, 55 and 85 patients were assigned to the IRR group and the non-IRR group, respectively. Indolent histological subtypes, bulky disease (>10 cm), B symptoms, higher serum soluble interleukin-2 receptor concentration, and bone marrow involvement were more common in the IRR group. The multivariate logistic regression analysis identified low-grade lymphomas [odds ratio (OR) 2.81, p = 0.017] and bulky disease (OR 2.52, p = 0.037) as independent risk factors for IRRs to rituximab. The incidence rates of IRRs to rituximab among patients with neither, one, or both of these risk factors were 26, 54, and 78%, respectively (χ = 16.4, p < 0.001). Conclusions A simple combination of histopathological subtype and bulkiness of disease could predict the risk of IRRs to rituximab among patients with B-NHL.
背景 输液相关反应（IRRs）是利妥昔单抗的主要不良事件。目的 建立B细胞非霍奇金淋巴瘤（B-NHL）患者中利妥昔单抗相关IRRs的预测模型。地点 东京一家拥有1000张床位的大学医院。方法 对2004年至2014年在我院接受利妥昔单抗治疗的B-NHL患者进行回顾性分析。与利妥昔单抗输注相关的任何级别的寒战、发热、皮疹、恶心、乏力、头痛、心血管症状和呼吸道症状被确定为IRRs。随后通过多变量分析评估在组间分析中发现的利妥昔单抗相关IRRs的危险因素。主要观察指标 利妥昔单抗相关IRRs的发生情况。结果 共分析了140例各种类型的B-NHL患者，其中74%为弥漫性大B细胞淋巴瘤。其中，55例和85例患者分别被分配到IRR组和非IRR组。惰性组织学亚型、肿块较大（>10 cm）、B症状、血清可溶性白细胞介素-2受体浓度较高和骨髓受累在IRR组中更为常见。多变量逻辑回归分析确定低级别淋巴瘤[比值比（OR）2.81，p = 0.017]和肿块较大（OR 2.52，p = 0.037）是利妥昔单抗相关IRRs的独立危险因素。无这些危险因素、有一个危险因素或有两个危险因素的患者中利妥昔单抗相关IRRs的发生率分别为26%、54%和78%（χ² = 16.4，p < 0.001）。结论 组织病理学亚型和疾病肿块大小的简单组合可以预测B-NHL患者中利妥昔单抗相关IRRs的风险。
