Safeher: A Study of Assisted- and Self-Administered Subcutaneous Trastuzumab (H-SC) as Adjuvant Therapy in Patients With Early HER2-Positive Breast Cancer (EBC)

Gligorov, Joseph; Azim, Hatem A.; Ataseven, Beyhan; DeLaurentiis, Michelino; Jung, Ki‐Hong; Herbst, Friederike; Llombart, Antonio; Manikhas, A.; Osborne, Stuart; Pivot, Xavier

doi:10.1016/s0923-7534(20)32881-7

Cited by 5 publications

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“…Therefore, the ongoing APHINITY trial is evaluating concurrent chemotherapy and trastuzumab with or without pertuzumab as adjuvant therapy in patients with nonmetastatic primary invasive HER2+ breast cancer [ 86 ]. An ongoing, non-randomized, open-label study (SafeHer) is evaluating safety, efficacy, and patient satisfaction with SC trastuzumab as adjuvant therapy in nonmetastatic HER2+ breast cancer [ 87 ]. Other ongoing adjuvant trials are evaluating T-DM1 alone or in combination with pertuzumab versus trastuzumab-containing regimens ( Table 5 ).…”

Section: The Evolving Treatment Landscape Of Her2+ Breast Cancermentioning

confidence: 99%

Evolving landscape of human epidermal growth factor receptor 2-positive breast cancer treatment and the future of biosimilars

2017

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Human epidermal growth factor receptor 2-positive (HER2+) breast cancer comprises approximately 15%-20% of all breast cancers and is associated with a poor prognosis. The introduction of anti-HER2 therapy has significantly improved clinical outcomes for patients with HER2+ breast cancer, and multiple HER2-directed agents (ie, trastuzumab, pertuzumab, lapatinib, and ado-trastuzumab emtansine [T-DM1]) are approved for clinical use in various settings. The treatment landscape for patients with HER2+ breast cancer is continuing to evolve. While novel agents and therapeutic strategies are emerging, biologic therapies, particularly trastuzumab, are likely to remain a mainstay of treatment. However, access issues create barriers to the use of biologics, and there is evidence for underuse of trastuzumab worldwide. A biosimilar is a biologic product that is highly similar to a licensed biologic in terms of product safety and effectiveness. Biosimilars of trastuzumab are in development and may soon become available. The introduction of biosimilars may improve access to anti-HER2 therapies by providing additional treatment options and lower-cost alternatives. Because HER2-targeted drugs may be administered for extended periods of time and in combination with other systemic therapies, biosimilars have the potential to result in significant savings for healthcare systems. Herein we review current and emerging treatment options for, and discuss the possible role of biosimilars in, treating patients with HER2+ breast cancer.

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Section: The Evolving Treatment Landscape Of Her2+ Breast Cancermentioning

confidence: 99%

Evolving landscape of human epidermal growth factor receptor 2-positive breast cancer treatment and the future of biosimilars

2017

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“…SafeHer es un ensayo internacional 18 , abierto, aleatorizado y en curso, que analizará seguridad y tolerabilidad de dos sistemas de administración subcutánea, uno de ellos autoadministrable. Un póster presentado en ESMO 2015 analizó los resultados de tolerabilidad y seguridad en una cohorte de pacientes de bajo peso y pacientes asiáticos del SafeHer 19 .…”

Section: Desarrollounclassified

Trastuzumab subcutáneo en el tratamiento del cáncer de mama HER2 positivo

Díaz-Cantón

Vega

2016

RevOnco

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La sobreexpresión o amplificación del receptor HER2 se observa en el 20% de pacientes con cáncer de mama y se asocia con un pronóstico adverso. El agente anti HER2 más ampliamente utilizado en la clínica es el trastuzumab, anticuerpo monoclonal. El tratamiento adyuvante tiene una duración de 12 meses y en cáncer de mama metastásico se continúa más allá de la progresión. La mayoría de los pacientes recibirá trastuzumab durante 1 año, muchos recibirán 2 a 3 años, y algunos han recibido/recibirán más de 8 años. Surge así un interés creciente por la vía subcutánea (SC) de administración: menos invasiva, menos costosa y más cómoda. El estudio HannaH, ensayo de fase III, abierto y aleatorizado, utilizó una dosis fija subcutánea de 600 mg de trastuzumab en combinación con quimioterapia neoadyuvante y la comparó con la vía de administración endovenosa (EV) aprobada. Se incluyeron pacientes con cáncer de mama HER2 (+) operable, localmente avanzado e inflamatorio. Los objetivos primarios fueron: concentración sérica mínima predosis del ciclo 8 y respuesta patológica completa. Se aleatorizaron 299 pacientes a trastuzumab EV y 297 a trastuzumab SC. La concentración sérica mínima media fue 57.8 μ/ml en el grupo EV y 78.7 en el grupo SC. El 40.7% de los pacientes en el grupo EV y el 45.4% en el grupo SC logró respuesta patológica completa. Trastuzumab SC resultó no inferior para ambos objetivos primarios. La incidencia de eventos adversos grados 3 a 5 fue similar en ambos grupos. La demostración de no-inferioridad sugiere que el trastuzumab SC ofrece una válida y más conveniente alternativa al trastuzumab EV.

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Subcutaneous trastuzumab: a review of its use in HER2-positive breast cancer

Sanford¹

2014

Targ Oncol

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Trastuzumab (Herceptin®) is a humanized IgG1 monoclonal antibody that is an efficacious treatment for HER2-positive breast and gastric cancers. Subcutaneous trastuzumab is a new formulation approved in the European Union for use in patients with early or metastatic breast cancer. In the randomized, open-label, multinational HannaH (enHANced treatment with NeoAdjuvant Herceptin) study of neoadjuvant/adjuvant trastuzumab in patients with early HER2-positive breast cancer, the pharmacokinetics of neoadjuvant subcutaneous trastuzumab were similar to those after intravenous administration, meeting the noninferiority criterion for mean predose trough concentrations, as assessed prior to surgery (primary pharmacokinetic endpoint). Trastuzumab blood concentrations throughout the dosing interval remained above those considered necessary for anticancer activity. In this study, the pathologic complete response rates (primary efficacy endpoint) were 45.4 and 40.7 % in the subcutaneous and intravenous administration groups, respectively, meeting a study noninferiority criterion. In the randomized, open-label, crossover, multinational PrefHer study of neoadjuvant/adjuvant or adjuvant trastuzumab in early HER2-positive breast cancer, subcutaneous administration of trastuzumab was preferred over intravenous administration by >85 % of patients, most commonly because it was time saving and induced less pain and discomfort. In the HannaH study, the tolerability profile of subcutaneous trastuzumab was similar to that of intravenous trastuzumab, except that the rate of serious adverse events was 21 % (vs. 12 % with intravenous administration), partly because of more infections with subcutaneous administration. Whether this finding is of any clinical significance should emerge from ongoing studies. On the evidence, subcutaneous trastuzumab is an effective and generally well-tolerated treatment option that is preferred by patients over intravenous administration.

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Safeher: A Study of Assisted- and Self-Administered Subcutaneous Trastuzumab (H-SC) as Adjuvant Therapy in Patients With Early HER2-Positive Breast Cancer (EBC)

Cited by 5 publications

References 0 publications

Evolving landscape of human epidermal growth factor receptor 2-positive breast cancer treatment and the future of biosimilars

Evolving landscape of human epidermal growth factor receptor 2-positive breast cancer treatment and the future of biosimilars

Trastuzumab subcutáneo en el tratamiento del cáncer de mama HER2 positivo

Subcutaneous trastuzumab: a review of its use in HER2-positive breast cancer

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