Implications of IV monoclonal antibody infusion reaction for the patient, caregiver, and practice: results of a multicenter study

Schwartzberg, Lee S.; Stepanski, Edward J.; Walker, Mark S.; Mathias, Susan D.; Houts, Arthur C.; Fortner, Barry

doi:10.1007/s00520-008-0474-5

Cited by 34 publications

(27 citation statements)

References 12 publications

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“…Nevertheless, the incidence rate found in this study is consistent with the 7% reported by Schwartzberg et al [4] in their prospective multicenter study.…”

Section: Discussionsupporting

confidence: 93%

“…The severity of IRs varies from mild itching, flushing, and fever to life-threatening cardiopulmonary events. In a few extreme cases, deaths have resulted from severe IRs [2–4]. …”

Section: Introductionmentioning

confidence: 99%

“…Nevertheless, recent studies have reported higher incidence rates of severe IRs among patients receiving cetuximab. In a prospective, multicenter time-and-motion study of patients with cancer using cetuximab, Schwartzberg et al [4] found that 7% of patients experienced severe IRs. O'Neil et al [5] examined IR rates in patients treated with cetuximab in medical centers from Tennessee and North Carolina and found that 22% of patients experienced severe IRs.…”

Section: Introductionmentioning

confidence: 99%

“…In a time-and-motion study of patients with cancer, those patients who had an IR required between 31% and 80% additional staff time [4]. A retrospective study of patients who suffered severe IRs found that 22% were hospitalized and had an average length of stay of 4 days [3].…”

Section: Introductionmentioning

confidence: 99%

“…O'Neil et al [5] also noted that the experience of an IR can be traumatic for patients, family members, and the clinical staff managing these events. Although some studies begin to provide assessments of the clinical and economic burden of IRs, only one study estimated the cost impact of IRs on staff time [4]. …”

Section: Introductionmentioning

confidence: 99%

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Clinical and economic impact of infusion reactions in patients with colorectal cancer treated with cetuximab

et al. 2010

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Background: Systemic agents in cancer treatment were often associated with possible infusion reactions (IRs). This study estimated the incidence of IRs requiring medical intervention and assessed the clinical and economic impacts of IRs in patients with colorectal cancer (CRC) treated with cetuximab.Patients and methods: Details on patients with CRC receiving cetuximab in 2004–2006 were extracted from a large USA administrative claims database. IRs were identified based on the occurrence of outpatient treatment, emergency room (ER) visit, and/or hospitalization for hypersensitivity and allergic reactions. Multivariate regressions were used to examine potential risk factors and quantify the economic impact of IRs.Results: A total of 1122 CRC patients receiving cetuximab were identified. The incidence of IRs requiring medical intervention was 8.4%. Sixty-eight percent of the patients had treatment disruptions and 34% discontinued cetuximab treatment. Mean adjusted costs were $13 863 for cetuximab administrations with an IR requiring ER visit or hospitalization and $6280 for those with an IR requiring outpatient treatment, compared with $4555 for those without an IR.Conclusions: The incidence rate of cetuximab-related IRs requiring medical intervention in clinical practice was found to be higher than rates reported in the product label and clinical trials. The clinical and economic impacts of these IRs are substantial.

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“…Nevertheless, the incidence rate found in this study is consistent with the 7% reported by Schwartzberg et al [4] in their prospective multicenter study.…”

Section: Discussionsupporting

confidence: 93%

“…The severity of IRs varies from mild itching, flushing, and fever to life-threatening cardiopulmonary events. In a few extreme cases, deaths have resulted from severe IRs [2–4]. …”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Clinical and economic impact of infusion reactions in patients with colorectal cancer treated with cetuximab

et al. 2010

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Premedication with montelukast and rupatadine decreased rituximab infusion time, rate, severity of reactions and use of rescue medications

Kotchetkov

McLean

Nay

et al. 2020

Intl Journal of Cancer

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Rituximab‐associated infusion reactions (IRs) are significant burdens on oncology patients, caregivers and healthcare providers. We evaluated whether montelukast and rupatadine improve rituximab delivery, decrease frequency/severity of IRs and the number of medications used to control IRs. Using a nonrandomized clinical study design, we assessed adult rituximab naïve patients with B‐cell lymphoid malignancies from January 2017 to July 2019. Prior to the first rituximab infusion patients received one of the premedication regimens: (i) standard premedications, diphenhydramine hydrochloride and acetaminophen (“SP” group); (ii) SP + montelukast (“M” group); (iii) SP + rupatadine (“R” group); (iv) SP + rupatadine + montelukast Schedule 1 (“M + R Schedule 1” group); (v) SP + rupatadine + montelukast Schedule 2 (“M + R Schedule 2” group). A total of 223 patients with a median age of 69 years were assessed. Demographics and treatment groups were comparable among all five groups. Mean rituximab infusion time was 290 min in the SP group versus 273, 261, 243 and 236 min in the M, R, M + R Schedule 1 and M + R Schedule 2 groups, respectively. The incidence of rituximab IRs was 75% in the SP group versus 44, 41, 22 and 22% in the M, R, M + R Schedule 1 and M + R Schedule 2 groups, respectively. The median reaction grade was 2 in the SP group and 0 in all other groups. The median number of rescue medications was 3 in the SP group and 0 in all other groups. In conclusion, montelukast and rupatadine significantly improved rituximab delivery, decreased the rate and severity of IRs and reduced the need for rescue medications.

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Incidence and risk factors of infusion reactions in patients with breast cancer administered trastuzumab plus pertuzumab-based regimen

Tabuchi

Tsujimoto

Yamamoto

et al. 2022

Cancer Chemother Pharmacol

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Implications of IV monoclonal antibody infusion reaction for the patient, caregiver, and practice: results of a multicenter study

Abstract: IRs following cetuximab and rituximab administration are common and are associated with measurably increased costs of care. The frequency of IRs suggests the importance of identifying clinical guidelines for intervention and management.

Cited by 34 publications

References 12 publications

Clinical and economic impact of infusion reactions in patients with colorectal cancer treated with cetuximab

Clinical and economic impact of infusion reactions in patients with colorectal cancer treated with cetuximab

Premedication with montelukast and rupatadine decreased rituximab infusion time, rate, severity of reactions and use of rescue medications

Incidence and risk factors of infusion reactions in patients with breast cancer administered trastuzumab plus pertuzumab-based regimen

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