TY  - JOUR
TI  - 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
AB  - Objective: 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.
AU  - MAHFOUF, Hassen
AU  - errihani, hassan
AU  - ÖZGÜROGLU, MUSTAFA
AU  - Çiçin, Irfan
AU  - Yumuk, Perran Fulden
AU  - Alsaleh, Khalid
AU  - BELBARAKA, RHIZLANE
AU  - Goktas, Burce
AU  - Amel, Mezlini
AU  - LARBAOUI, Blaha
AU  - ben ahmed, slim
AU  - OUKKAL, Mohammed
DO  - 10.4274/ejbh.galenos.2021.2021-9-9
PY  - 2022
JO  - European Journal of Breast Health
VL  - 18
IS  - 1
SN  - 2587-0831
SP  - 63
EP  - 73
DB  - TRDizin
UR  - http://search/yayin/detay/525840
ER  -