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A novel rituximab administration protocol to minimize infusion-related adverse reactions in patients with B-cell lymphoma

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Abstract

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/m2, 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.

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Acknowledgements

The authors thank Mr. I. Odagiri, Mr. T. Yamauchi, Dr. H. Takahashi, Dr. M. Nakagawa, Dr. Y. Uchino, Dr. K. Iizuka, Dr. T. Hamada, and Dr. N. Iriyama for their enormous contributions to this work.

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This study was not funded by any third parties.

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Correspondence to Katsuhiro Miura.

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Conflicts of interest

K. M. and Y. H. received speaker fees from Chugai and Kyowa-Kirin, which manufactures rituximab and its biosimilar products in Japan. The other authors have no conflicts of interest to disclose.

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This study was registered in UMIN-CTR (https://www.umin.ac.jp/english/) on 19th April 2018 (Registration ID: UMIN000032309).

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Tsutsumi, D., Hayama, T., Miura, K. et al. A novel rituximab administration protocol to minimize infusion-related adverse reactions in patients with B-cell lymphoma. Int J Clin Pharm 44, 366–373 (2022). https://doi.org/10.1007/s11096-021-01348-6

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