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

Tsutsumi, Daisuke; Hayama, Tatsuya; Miura, Katsuhiro; Uchiike, Akihiro; Tsuboi, Shinya; Otsuka, Susumu; Hatta, Yoshihiro; Kishikawa, Yukinaga

doi:10.1007/s11096-021-01348-6

Cited by 1 publication

(2 citation statements)

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“…Importantly, the incidence of IRRs to rituximab in the treatment group decreased significantly compared with that in the control group in the 1st and the 2nd cycle; however, no marked differences were observed in the 3rd and 4th cycles for both groups. These results were in line with previous study results ( 6 , 21 ), highlighting the necessity and importance of monitoring IRRs to rituximab in the first two courses of immunochemotherapy for patients with DLBCL. Clinically, the incidence of IRRs to rituximab gradually reduced over the therapeutic courses and with the decrease of tumor burden in patients with DLBCL.…”

Section: Discussionsupporting

confidence: 92%

“…Generally, the majority of IRRs to rituximab were of mild to moderate degree, whereas ~10% of patients with B-cell NHL experienced severe or life-threatening IRRs, which greatly affected the patients' compliance and treatment continuity ( 8 ). Tsutsumi et al ( 21 ) established a risk-stratified rituximab protocol for patients with B-cell NHL to minimize IRRs to rituximab. During the 1st cycle of rituximab infusion, the patients in the low- and moderate-risk groups received standard infusions of 25–200 mg/h (total of 4.3 h).…”

Section: Discussionmentioning

confidence: 99%

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A novel prednisone premedication protocol significantly decreases infusion‑related reactions of rituximab in newly diagnosed diffuse large B‑cell lymphoma

Ding

Leng

Gu³

et al. 2023

Oncol Lett

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Rituximab is a widely used anti-CD20 monoclonal antibody with a high incidence of infusion-related reactions (IRRs) during administration. Reducing the incidence of IRRs remains problematic in hematological practices. In the present study, a novel strategy of a prednisone pretreatment regimen was designed similar to the combination of rituximab, cyclophosphamide, epirubicin, vincristine and prednisone (R-CHOP) with the aim of exploring the effect on the incidence of IRRs to rituximab in patients with diffuse large B-cell lymphoma (DLBCL). A prospective, randomized (1:1) and controlled study was conducted in three regional hospitals in two groups (n=44 for each group): i) A control group treated with standard R-CHOP-like regimen; and ii) a group receiving a prednisone-pretreatment, modified R-CHOP-like protocol for newly diagnosed patients with DLBCL. The primary endpoint was to assess the incidence of IRRs to rituximab, as well as the association of IRRs with the efficacy of treatment. The second endpoint involved clinical outcomes. The total incidence of IRRs to rituximab in the treatment group was significantly lower compared with that in the control group (15.9 vs. 43.2%; P=0.0051). The different grade incidence of IRRs was lower in the treatment group compared with that in the control group (P=0.0053). In total, 29.5% of patients (26/88) experienced >1 IRR episode. The incidence of IRRs in the pre-treatment group was decreased compared with that in the control group in the 1st cycle (15.9 vs. 43.2%; P=0.0051) and 2nd cycle (6.8 vs. 27.3%; P=0.0107). The overall response rate was similar between the two groups (P>0.05). Median progression-free survival and median overall survival time were not statistically distinct between the two groups (P=0.5244 and P=0.5778, respectively). Grade ≥III toxicities mainly included vomiting and nausea (<20%), leukopenia and granulocytopenia (<20%), and alopecia (<25%). No death events were reported. Apart from IRRs to rituximab, the incidence of other adverse events was similar in both groups. The novel prednisone-pretreatment R-CHOP-like protocol in the present study significantly decreased the total and different grade incidences of IRRs to rituximab among newly diagnosed patients with DLBCL. This clinical trial was retrospectively registered with the Chinese Clinical Trial Registry (registration number, ChiCTR2300070327; date of registration, 10 April 2023).

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%