Infusion of trastuzumab maintenance doses over 30 minutes

Ring, Alistair; Simcock, Richard; Mitra, Sonali; Bloomfield, David; King, Jenny; Simpson, Sylwia; Sadler, Georgia Robins; Webb, Andrew R.

doi:10.1093/annonc/mdn390

Cited by 9 publications

(9 citation statements)

References 2 publications

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“…It should be noted that the number of patients who received the 8 mg/kg loading dose in our analysis was small. Of note, the administration of higher maintenance doses (e.g., 6 mg/kg) for 30 minutes did not appear to be associated with increased rates of IRRs, consistent with the Chan and Ring data [9,10] discussed previously.…”

Section: Discussionsupporting

confidence: 87%

“…The incidence of IRRs before and after the implementation of 30-minute infusions of 2, 4, or 6 mg/kg maintenance doses was similar (0.11% before 30-minute infusion implementation; 0.04% after 30-minute infusion implementation), and the authors concluded that doses up to 6 mg/kg can be safely administered for 30 minutes. Lastly, in a letter to the editor, Ring et al [10] reported that an every 3-week dosing regimen with 30-minute maintenance infusions was well tolerated (IRR incidence: 3.5% of patients, 1.5% of doses).…”

Section: Introductionmentioning

confidence: 99%

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Incidence, Risk Factors, and Management of Infusion-Related Reactions in Breast Cancer Patients Receiving Trastuzumab

et al. 2014

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Identify risk factors associated with trastuzumab-associated infusion-related reactions.Describe the impact of premedications on the incidence and/or severity of trastuzumab-associated infusion-related reactions. ABSTRACTBackground. Trastuzumab has become a mainstay of therapy for human epidermal growth factor receptor-2 overexpressed breast cancer in nearly all stages of the disease. Like many monoclonal antibodies, trastuzumab is associated with infusionrelated reactions (IRRs) that are not well described, and incidence varies widely between reports (0.7%-40% of patients). Materials and Methods. A retrospective chart review of breast cancer patients who received trastuzumab was conducted. The primary objective was to describe the incidence, risk factors, and management of IRRs during the first 12 weeks of trastuzumab therapy in a general population of breast cancer patients. Results. A total of 197 patients who received trastuzumab (1,788 doses) were evaluated. Thirty-three IRRs were identified

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Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

Incidence, Risk Factors, and Management of Infusion-Related Reactions in Breast Cancer Patients Receiving Trastuzumab

et al. 2014

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“…Moreover, the patient did not present any symptoms without premedication or extension of administration time following second and subsequent CT-P6 administrations. Ring et al reported that trastuzumab-induced IRR incidence was 3.5% and that of grade 3 IRR was 1.2% during maintenance infusion 21) ; Thompson et al reported this incidence to be 1.5% with no severe symptoms, 14) consistent with our study findings. Therefore, it is acceptable to use this administration method during the switch from the reference trastuzumab in maintenance infusion.…”

Section: Discussionsupporting

confidence: 91%

“…19) Moreover, Vogel et al reported that the infusion duration and/or peak serum concentrations of the monoclonal antibody affect the incidence of IRRs. 20) However, such reactions have been reported at a lower frequency following subsequent maintenance infusion. 13,14) It is unclear how to administer biosimilars when switching from the reference medicines, especially the duration of infusion in case of trastuzumab.…”

Section: Discussionmentioning

confidence: 99%

Safety Evaluation of Initial CT-P6 Administration for 30 min during the Switch from Reference Trastuzumab in Maintenance Infusion: A Multicenter Observational Study

Saito

Tamaki

Hasegawa

et al. 2021

Biological & Pharmaceutical Bulletin

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CT-P6 is a biosimilar of trastuzumab and is recommended to be administered for 30-90 min in subsequent maintenance infusions to prevent infusion-related reactions (IRRs). We administered CT-P6 for 30 min as the first injection and as an alternative to reference trastuzumab in the maintenance infusion and evaluated the safety of the administration. A total of 140 patients with breast or gastric cancer, who received a switch from tri-weekly reference trastuzumab to CT-P6 for 30 min in maintenance infusions, were retrospectively evaluated. Premedication was administered prior to an infusion of CT-P6 and a cytotoxic agent. However, premedication was not provided when CT-P6 was co-administered with pertuzumab or administered alone. The primary endpoint was the incidence of IRRs. The secondary endpoint was the incidence of diarrhea and skin toxicity. Ninety-five percent of the patients had breast cancer, and 44.3% had advance-stage cancer. The treatment included CT-P6 alone (17.9%) or with cytotoxic agents (23.6%), antihormonal drugs (25.7%), and pertuzumab (62.9%). Median administration time of trastuzumab at the switch was 13 administrations (range 2-140). Premedication was administered to 20.7% patients. One patient (0.7%) experienced grade 3 IRR. The frequency of diarrhea in the reference trastuzumab group and the CT-P6 group was 7.1 and 6.4%, respectively, and that of skin toxicity was 6.4 and 5.0%, respectively, without differences. In conclusion, we first demonstrated that an initial CT-P6 administration for 30 min during the switch from reference trastuzumab in maintenance infusion is an acceptable administration method.

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“…Baselga et al explained the higher incidence compared to other trials by the broad definition of infusionrelated reactions that was used (57). Ring et al reported an infusion reaction incidence of 3.5% for all patients with 30min infusion for all maintenance doses (58). Abe et al investigated whether 30-min infusion of trastuzumab with 100 ml saline from the second dose differed from trastuzumab with 250 ml saline, as is recommended by the product specification.…”

Section: Resultsmentioning

confidence: 99%

Systematic Review on Infusion Reactions to and Infusion Rate of Monoclonal Antibodies Used in Cancer Treatment

et al. 2020

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Background: Patients with cancer who are treated with monoclonal antibodies are at risk for developing infusion reactions. However, for some monoclonal antibodies, the incidence of infusion reactions is low or can be lowered by the use of adequate premedication schedules. It is often feasible to increase the infusion rate/lower the post-administration observation time. This review gives an overview of infusion reactions and the possibility of accelerating infusion rates. Materials and Methods: Data on infusion reactions and infusion rates for all monoclonal antibodies that are licensed in the European Union for treatment of solid tumors or hematological malignancies, found by a literature search, were included in this review. Results: For 11 out of the 21 monoclonal antibodies data exceeding the registration text were found and described. Faster infusion schedules are possible for bevacizumab, ipilimumab, nivolumab, panitimumab, and rituximab. Conclusion: We propose optimal infusion schedules for each drug.

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Infusion of trastuzumab maintenance doses over 30 minutes

Cited by 9 publications

References 2 publications

Incidence, Risk Factors, and Management of Infusion-Related Reactions in Breast Cancer Patients Receiving Trastuzumab

Incidence, Risk Factors, and Management of Infusion-Related Reactions in Breast Cancer Patients Receiving Trastuzumab

Safety Evaluation of Initial CT-P6 Administration for 30 min during the Switch from Reference Trastuzumab in Maintenance Infusion: A Multicenter Observational Study

Systematic Review on Infusion Reactions to and Infusion Rate of Monoclonal Antibodies Used in Cancer Treatment

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