Subcutaneous herceptin therapy

O’Donoghue, Niamh; Quintyne, Keith Ian; Woulfe, Bernie; Gupta, Rajnish K.; O’Reilly, Seamus

doi:10.1002/jcph.171

Cited by 3 publications

(3 citation statements)

References 6 publications

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“…If the tumor is found to have the HER-2/neu receptor, special recommendations for targeted biological therapy might be recommended as part of the treatment. HER-2 negative is a favorable prognostic factor; being positive is not favorable [11].…”

Section: Introductionmentioning

confidence: 98%

Correlation between Her2/Neu and Histopatholoical Finding among Sudanese Female Breast Cancer Patients

Hamed

Abdelbadie

Osman

et al. 2015

International Journal of Medical and Health Sciences Research

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Background: This study is one of very few studies which have investigated HER-2/neu expression and its correlation with histopathological finding. A total of 328 breast cancer tissue samples had been ILC are (1%), whereas positive are (1%). Lastly, HER-2/neu negative with others histological subtype are (3%), whereas positive are (0%). HER-2/neu negative histological grade I are (6%), whereas positive are (2%). HER-2/neu negative histological grade II are (21%), while positive are (7%). Lastly, HER-2/neu negative histological grade II are (40%), whereas positive are (24%). HER-2/neu negative lympho- International Journal of Medical and Health Sciences Research 2015 Vol.2, No.4, pp.62-69 ISSN(e): 2313-2752 ISSN(p): 2313-7746 DOI: 10.18488/journal.9/2015.2.4/9.4.62.69 © 2015

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Section: Introductionmentioning

confidence: 98%

Correlation between Her2/Neu and Histopatholoical Finding among Sudanese Female Breast Cancer Patients

Hamed

Abdelbadie

Osman

et al. 2015

International Journal of Medical and Health Sciences Research

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“…In reply to the correspondence from Dr O'Donoghue and colleagues regarding fixed dosing of subcutaneous (SC) trastuzumab in overweight and obese breast cancer patients, we agree that the increasing incidence of obesity in many developed countries makes this a highly relevant clinical question. Monoclonal antibodies generally have a relatively large therapeutic window, and analysis found that the effects of bodyweight on these agents when administered in fixed doses are small or moderate .…”

mentioning

confidence: 99%

“…The phase III study found that, overall, the SC formulation had noninferior efficacy and similar safety and pharmacokinetic profiles to standard IV administration, and patient weight had no significant effect on efficacy or safety . The group of patients receiving trastuzumab SC included 28.6% with a bodyweight of ≥79 kg, comparable to the >20% weighing >80 kg reported by O'Donoghue et al in their real‐life patient sample. Based on the results of this pivotal study, the European Union's Committee for Medicinal Products for Human Use (CHMP) recently recommended approval of fixed‐dose trastuzumab SC for the treatment of HER2‐positive breast cancer…”

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confidence: 99%

Reply to: Letter to the editor “Subcutaneous herceptin therapy”

Wynne

Harvey

Schwabe

et al. 2013

The Journal of Clinical Pharmacology

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Is weight-based IV dosing of trastuzumab preferable to SC fixed-dose in some patients? A systematic scoping review

et al. 2021

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Trastuzumab, a key treatment for HER2-positive breast cancer, is available in weight-based IV and fixed-dose (600 mg) SC formulations. While the Phase 3 HannaH trial indicated non-inferiority of the SC formulation, there is some concern that the target plasma concentration may not be reached in overweight/obese patients whereas low-body-weight patients may be at risk of toxicity. This scoping review evaluated whether overweight/obese patients are at risk of below-target exposure with fixed-dose SC trastuzumab, whether low-body-weight patients are at risk of increased toxicity, especially cardiotoxicity, and whether IV and SC trastuzumab are equivalent in terms of treatment-emergent adverse events (TEAEs) (e.g. infections). Thirty-seven publications that met the eligibility criteria were included. Body weight is not an important determinant of exposure to trastuzumab at steady state (i.e. pre-dose cycle 8); however, real-world evidence suggests that the target concentration (20 μg/mL) may not be reached with the first SC dose in overweight/obese patients. There is no evidence that low-body-weight patients are at increased risk of cardiotoxicity with SC trastuzumab, although this may be confounded by the higher rate of cardiovascular comorbidities in overweight patients. In Phase 3 trials, SC trastuzumab was associated with higher rates of ISRs, ADAs and SAEs, the latter often requiring hospitalization and occurring during adjuvant treatment when patients are not burdened by chemotherapy. The route of administration of trastuzumab (IV vs SC) in different treatment settings should be discussed with the patient, taking into account the risks and benefits associated with each route.

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Subcutaneous herceptin therapy

Cited by 3 publications

References 6 publications

Correlation between Her2/Neu and Histopatholoical Finding among Sudanese Female Breast Cancer Patients

Correlation between Her2/Neu and Histopatholoical Finding among Sudanese Female Breast Cancer Patients

Reply to: Letter to the editor “Subcutaneous herceptin therapy”

Is weight-based IV dosing of trastuzumab preferable to SC fixed-dose in some patients? A systematic scoping review

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