An Open-Label, Multinational, Multicenter, Phase IIIb Study with Subcutaneous Administration of Trastuzumab in Patients with HER2-Positive Early Breast Cancer to Evaluate Patient Satisfaction

Basit Öğe Kaydı
dc.authoridOUKKAL, Mohammed/0000-0002-4306-8377
dc.authoridYumuk, Perran Fulden/0000-0001-8650-299X
dc.authoridAlsaleh, Khalid/0000-0002-5801-5745
dc.authoridBELBARAKA, RHIZLANE/0000-0002-3947-775X
dc.authoridJellis-Johnson, Kevin Scott/0000-0002-8033-3555
dc.authoridCicin, Irfan/0000-0002-7584-3868
dc.authorwosidalsaleh, khalid/KIB-0310-2024
dc.authorwosidYumuk, Perran Fulden/A-6189-2018
dc.contributor.authorCicin, Irfan
dc.contributor.authorOukkal, Mohammed
dc.contributor.authorMahfouf, Hassen
dc.contributor.authorMezlini, Amel
dc.contributor.authorLarbaoui, Blaha
dc.contributor.authorBen Ahmed, Slim
dc.contributor.authorErrihani, Hassan
dc.date.accessioned2024-06-12T11:15:45Z
dc.date.available2024-06-12T11:15:45Z
dc.date.issued2022
dc.departmentTrakya Üniversitesien_US
dc.description.abstractObjective: This study was designed to investigate treatment satisfaction in patients and Health Care Professionals (HCP) and to evaluate the safety and tolerability of subcutaneous (SC) trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC). Materials and Methods: Two-hundred and twenty-three patients with eBC were screened, of whom 173 patients met the eligibility criteria and received at least one dose of SC trastuzumab. The primary efficacy endpoint was to assess patient satisfaction via a questionnaire. Results: The majority of patients (n = 166, 97.6%) reported satisfaction with the SC route. Patients and HCPs stated that SC trastuzumab was easy to use (93.5% and 62.5%, respectively) compared to the intravenous (IV) route and all HCPs (n = 16) expressed satisfaction with the SC route. Progression, disease recurrence or death was reported in 24 patients (13.8%) by two years of follow up. Four-year disease-free survival (DFS) and overall survival (OS) rates were 84.2% (+/- 3.1) and 90.5% (+/- 4.7), respectively. A total of 1299 adverse events (AEs) were recorded over 4-years follow-up, nearly 97% of which were judged non-serious. The most common AEs were arthralgia (n = 54, 4.2%), flu-like symptoms (n = 41, 3.2%) and nausea (n = 39, 3.0%). Fifty-four cardiac events, including left ventricular dysfunction, left ventricular failure and cardiotoxicity, were reported. Ejection fraction (EF) decrease [median decrease 3.5% (0.12-19.0)] was reported in 5.4% of cases. SC trastuzumab treatment was interrupted due to decreased EF in two cases. Conclusion: SC trastuzumab was widely acceptable to both patients and HCPs. The safety and tolerability of SC trastuzumab was consistent with the known safety profile of SC and IV administration.en_US
dc.identifier.doi10.4274/ejbh.galenos.2021.2021-9-9
dc.identifier.endpage73en_US
dc.identifier.issn2587-0831
dc.identifier.issue1en_US
dc.identifier.pmid35059593en_US
dc.identifier.scopus2-s2.0-85146068936en_US
dc.identifier.scopusqualityN/Aen_US
dc.identifier.startpage63en_US
dc.identifier.trdizinid525840en_US
dc.identifier.urihttps://doi.org/10.4274/ejbh.galenos.2021.2021-9-9
dc.identifier.urihttps://search.trdizin.gov.tr/yayin/detay/525840
dc.identifier.urihttps://hdl.handle.net/20.500.14551/24065
dc.identifier.volume18en_US
dc.identifier.wosWOS:000753912600010en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakTR-Dizinen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherGalenos Yayinciliken_US
dc.relation.ispartofEuropean Journal Of Breast Healthen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectSubcutaneousen_US
dc.subjectTrastuzumaben_US
dc.subjectBreast Canceren_US
dc.subjectHER2en_US
dc.subjectPatient Satisfactionen_US
dc.subjectAdjuvant Chemotherapyen_US
dc.subjectFinal Analysisen_US
dc.subjectSafetyen_US
dc.subjectTolerabilityen_US
dc.subjectExperienceen_US
dc.titleAn Open-Label, Multinational, Multicenter, Phase IIIb Study with Subcutaneous Administration of Trastuzumab in Patients with HER2-Positive Early Breast Cancer to Evaluate Patient Satisfactionen_US
dc.typeArticleen_US

Dosyalar

Koleksiyon

WoS İndeksli Yayınlar Koleksiyonu
PubMed İndeksli Yayınlar Koleksiyonu
Scopus İndeksli Yayınlar Koleksiyonu
TR-Dizin İndeksli Yayınlar Koleksiyonu