Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

Rituximab Infusion-related Adverse Events and Risk Factors

Rituximab 주입관련 부작용발생 및 위험인자 분석

  • Lee, Eun Jung (Graduate School of Clinical Health Sciences, Ewha Womans University) ;
  • Kim, Young Joo (College of Pharmacy & Division of Life and Pharmaceutical Sciences, Ewha Womans University) ;
  • Rhie, Sandy J (Graduate School of Clinical Health Sciences, Ewha Womans University)
  • 이은정 (이화여자대학교 임상보건과학대학원) ;
  • 김영주 (국립암센터 약제부) ;
  • 이정연 (이화여자대학교 임상보건과학대학원)
  • Received : 2013.08.27
  • Accepted : 2013.09.10
  • Published : 2013.09.30
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Abstract

Objective: This study aimed to identify the status and risk factors of rituximab infusion-related adverse events (ADE) in rituximab-na$\ddot{i}$ve patients with cancer diseases. Method: A retrospective analysis using electronic medical records review was conducted. Inclusions were patients with a diagnosis of cancer disease with the initiation of rituximab-included treatment who were na$\ddot{i}$ve to rituximab during January 2011 to March 2013 at National Cancer Center (NCC) in Korea. Result: Total 110 patients, 582 cases of rituximab administrations, were reported in the study. About 57.2% of patients were 51-70 years old and evenly distributed between two genders and 72.7% were BMI less than $25kg/m^2$. All of study patients were diagnosed with non-Hodgkin lymphoma. Fifty patients (45.4%) and 54 cases (9.3%) were experienced rituximab infusion-related AEs even with conservative administration protocol at NCC. The most frequently occurring AEs were shivering followed by rash and itching. In single variant analysis, we found that the early stage of NHL, low exposure to rituximab administrations, high white blood cell counts, high lymphocyte counts, high absolute neutrophil count and low lactate dehydrogenase were associated with infusion-related AEs (p<0.05). The early stage of disease, high lymphocyte counts, low exposure to rituximab administrations were also related significantly with AEs in multiple variants analysis (p<0.05). Conclusion: Rituximab infusion-related AEs for patients who were na$\ddot{i}$ve to rituximab were still a concern with conservative administration protocol. The adverse drug reactions were significantly associated with early stage of NHL, higher lymphocyte counts and low exposure to rituximab administrations. The factors need to be considered with close monitoring to prevent rituximab infusion-related AE.

Keywords

References

  1. Cheson BD, Leonard JP. Monoclonal antibody therapy for B-cell non-Hodgkin's lymphoma. The NEJM 2008; 359(6): 613-26. https://doi.org/10.1056/NEJMra0708875
  2. Roche (2012) Mabthera, Roche Products Pty Limited [updated 21 April 2012]; Available from : http://www.roche. co.kr/fmfiles/re7198001/product/insertpaper/Mabthera_inj.pdf. Last accessed on 22 April 2013.
  3. Dillman RO. Infusion reactions associated with the therapeutic use of monoclonal antibodies in the treatment of malignancy. Cancer metastasis reviews 1999; 18(4): 465-71. https://doi.org/10.1023/A:1006341717398
  4. Lenz HJ. Management and preparedness for infusion and hypersensitivity reactions. The oncologist 2007; 12(5): 601-9. https://doi.org/10.1634/theoncologist.12-5-601
  5. Institute NC. Common Terminology Criteria for Adverse Events(CTACE) v4.03. 2010.
  6. Kimby E. Tolerability and safety of rituximab (MabThera). Cancer treatment reviews 2005; 31(6): 456-73. https://doi.org/10.1016/j.ctrv.2005.05.007
  7. Kang SP, Saif MW. Infusion-related and hypersensitivity reactions of monoclonal antibodies used to treat colorectal cancer--identification, prevention, and management. The journal of supportive oncology 2007; 5(9): 451-7.
  8. Czuczman MS, Grillo-Lopez AJ, White CA, et al., Treatment of patients with low-grade B-cell lymphoma with the combination of chimaeric anti CD-20 monoclonal antibody and CHOP chemotherapy. J Clin Oncol 1999; 17: 268-76.
  9. Tuthill M, Crook T, Corbet T, et al., Rapid infusion of rituximab over 60 min. Eur J Haematol 2009; 82(4): 322-5. https://doi.org/10.1111/j.1600-0609.2009.01215.x
  10. Al Zahrani A, Ibrahim N, Al Eid A. Rapid infusion rituximab changing practice for patient care. J Oncol Pharm Pract 2009; 15(3): 183-6. https://doi.org/10.1177/1078155208100527
  11. Atmar J. Review of the safety and feasibility of rapid infusion of rituximab. Journal of oncology practice. American Society of Clinical Oncology 2010; 6(2): 91-3.
  12. Davis TA, Grillo-Lopez AJ, White CA, et al., Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lymphoma: safety and efficacy of re-treatment. Journal of clinical oncology 2000; 18(17): 3135-43.
  13. Maloney DG, Grillo-Lopez AJ, White CA, et al., IDECC2B8 (Rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood 1997; 90(6): 2188-95.
  14. Maloney DG, Liles TM, Czerwinski DK, et al., Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood 1994; 84(8): 2457-66.
  15. Maloney DG, Grillo-Lopez AJ, Bodkin DJ, et al., IDECC2B8: results of a phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma. Journal of clinical oncology 1997; 15(10): 3266-74.
  16. McLaughlin P, Grillo-Lopez AJ, Link BK, et al., Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. Journal of clinical oncology 1998; 16(8): 2825-33.
  17. Piro LD, White CA, Grillo-Lopez AJ, et al., Extended Rituximab (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non- Hodgkin's lymphoma. Annals of oncology 1999; 10(6): 655-61. https://doi.org/10.1023/A:1008389119525
  18. Dillman RO, Hendrix CS. Unique aspects of supportive care using monoclonal antibodies in cancer treatment. Supportive cancer therapy 2003; 1(1): 38-48. https://doi.org/10.3816/SCT.2003.n.003
  19. Breslin S. Cytokine-release syndrome: overview and nursing implications. Clinical journal of oncology nursing 2007; 11(1 Suppl): 37-42. https://doi.org/10.1188/07.CJON.S1.37-42
  20. Lang DS, Keefe DM, Schultz T, et al., Predictors of acute adverse events from rapid rituximab infusion. Supportive care in cancer 2013; Epub ahead of print.
  21. Hong J, Kim JY, Ahn HK, et al., Bone marrow involvement is predictive of infusion-related reaction during rituximab administration in patients with B cell lymphoma. Supportive care in cancer 2013; 21(4): 1145-52. https://doi.org/10.1007/s00520-012-1639-9
  22. Byrd JC, Waselenko JK, Maneatis TJ, 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. Journal of clinical oncology 1999; 17(3): 791-5.
  23. Winkler U, Jensen M, Manzke O, et al., Cytokine-release syndrome in patients with B-cell chronic lymphocytic leukemia and high lymphocyte counts after treatment with an anti-CD20 monoclonal antibody (rituximab, IDECC2B8). Blood 1999; 94(7): 2217-24.
  24. Plosker GL, Figgitt DP. Rituximab: a review of its use in non-Hodgkin's lymphoma and chronic lymphocytic leukaemia. Drugs 2003; 63(8): 803-43. https://doi.org/10.2165/00003495-200363080-00005
  25. Coiffier B, Lepage E, Briere J, et al., CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. NEJM 2002; 346(4): 235-42. https://doi.org/10.1056/NEJMoa011795