A clinical prediction model for infusion-related reactions to rituximab in patients with B cell lymphomas
- 567 Downloads
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 (χ2 = 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.
KeywordsB-cell non-Hodgkin’s lymphoma CD20 Infusion-related reactions Rapid infusion Rituximab
The authors would like to thank to Dr. H. Takahashi, Dr. D. Kurita, Dr. S. Ohtake, Dr. Y. Uchino, Dr. H. Kodaira, Dr. N. Iriyama, Dr. A. Hojo, Dr. Y. Kobayashi, and Professor Y. Hatta for their valuable contribution to this work.
Conflicts of interest
K. Miura and M. Takei received speaker’s fees from Chugai Pharmaceuticals Co. LTD., which manufactures rituximab in Japan. M. Takei also received research grants from Chugai Pharmaceuticals Co. LTD. All remaining authors have declared no conflicts of interest.
This study was not financially supported by any third parties.
- 6.DeSantis CE, Lin CC, Mariotto AB, Siegel RL, Stein KD, Kramer JL, et al. Cancer treatment and survivorship statistics, 2014. CA: A Cancer J Clin. 2014;64:252–71.Google Scholar
- 8.HIGHLIGHTS OF PRESCRIBING INFORMATION, RITUXAN® (rituximab) injection, for intravenous use. Last updated 2013. http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103705s5414lbl.pdf. Accessed 30 Nov 2016.
- 9.National Cancer Institute. Common terminology criteria for adverse events (CTCAE) v4.0. 2010. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_40. Accessed 30 Nov 2016.
- 10.Miura K, Takei K, Kobayashi S, Kiso S, Hirabayashi Y, Hojo A et al. An effective salvage treatment using ifosfamide, etoposide, cytarabine, dexamethasone, and rituximab (R-IVAD) for patients with relapsed or refractory aggressive B-cell lymphoma. Int J Hematol. 2011;94:90–6.CrossRefPubMedGoogle Scholar
- 12.Byrd JC, Waselenko JK, Maneatis TJ, Murphy T, Ward FT, Monahan BP, et al. Rituximab therapy in hematologic malignancy patients with circulating blood tumor cells: association with increased infusion-related side effects and rapid blood tumor clearance. J Clin Oncol. 1999;17:791–5.CrossRefPubMedGoogle Scholar
- 14.Sehn LH, Donaldson J, Filewich A, Fitzgerald C, Gill KK, Runzer N, et al. Rapid infusion rituximab in combination with corticosteroid-containing chemotherapy or as maintenance therapy is well tolerated and can safely be delivered in the community setting. Blood. 2007;109:4171–3.CrossRefPubMedGoogle Scholar