Tsutsumi Daisuke, Hayama Tatsuya, Miura Katsuhiro, Uchiike Akihiro, Tsuboi Shinya, Otsuka Susumu, Hatta Yoshihiro, Kishikawa Yukinaga
Laboratory of Clinical Pharmacy, Nihon University School of Pharmacy, 7-7-1 Narashinodai, Funabashi City, Chiba, 274-8555, Japan.
Department of Pharmacy, Nihon University Itabashi Hospital, 30-1 Oyaguchikamicho, Itabashi City, Tokyo, 173-8610, Japan.
Int J Clin Pharm. 2022 Apr;44(2):366-373. doi: 10.1007/s11096-021-01348-6. Epub 2021 Dec 11.
Background Infusion-related reactions (IRRs) during rituximab administration are occasionally severe and remain problematic in oncology practice. Aim To establish a safer, risk-stratified rituximab protocol for patients with B-cell lymphoma. Method We stratified patients into low-, moderate-, and high-risk groups according to the number of risk factors for IRRs, specifically, low-grade histology and bulky tumors (> 10 cm): Then, the administrating schedule of rituximab (375 mg/m, diluted in 1 mg/mL concentration) was individualized. For the first rituximab cycle, the low- and moderate-risk groups underwent conventional infusion #1 (25-200 mg/h, ~4.3 h), and the high-risk group underwent long infusion (25-100 mg/h, 6.8 h). Patients in the low-, moderate-, and high-risk groups without IRRs in the first cycle underwent short infusion (100-400 mg/h, 2.3 h), conventional infusion #2 (100-200 mg/h, 3.5 h), and conventional infusion #1, respectively. Patients with IRRs in the first cycle received a second rituximab cycle with the same schedule as the first cycle. The procedure for the third cycle was at the attending physician's discretion. Results Among 81 patients, the overall incidence of IRRs was 28%. IRR incidences in the low- (n = 39), moderate- (n = 35), and high-risk groups (n = 7) were 31%, 20%, and 57%, respectively. All IRRs were grade ≤ 2. The overall conversion rate to short infusion in the third cycle was 54%, without any IRRs. Conclusions Our step-by-step rituximab protocol demonstrated a fewer incidence of severe IRRs among B-cell lymphoma patients receiving rituximab.
利妥昔单抗给药期间的输液相关反应（IRR）偶尔较为严重，在肿瘤学实践中仍然是个问题。目的：为B细胞淋巴瘤患者建立更安全、风险分层的利妥昔单抗方案。方法：根据IRR的风险因素数量将患者分为低、中、高风险组，具体为低级别组织学和大肿块肿瘤（>10 cm）：然后，利妥昔单抗（375 mg/m，以1 mg/mL浓度稀释）的给药方案个体化。在第一个利妥昔单抗周期，低风险和中风险组进行常规输注#1（25 - 200 mg/h，约4.3小时），高风险组进行长时间输注（25 - 100 mg/h，6.8小时）。第一个周期未发生IRR的低、中、高风险组患者分别进行短时间输注（100 - 400 mg/h，2.3小时）、常规输注#2（100 - 200 mg/h，3.5小时）和常规输注#1。第一个周期发生IRR的患者接受与第一个周期相同方案的第二个利妥昔单抗周期。第三个周期的程序由主治医生决定。结果：在81例患者中，IRR的总体发生率为28%。低风险组（n = 39）、中风险组（n = 35）和高风险组（n = 7）的IRR发生率分别为31%、20%和57%。所有IRR均为≤2级。第三个周期短时间输注的总体转化率为54%，无任何IRR。结论：我们的逐步利妥昔单抗方案显示，接受利妥昔单抗治疗的B细胞淋巴瘤患者中严重IRR的发生率较低。
