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
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).Mat...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Galenos Publishing House
2022-01-01
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| Series: | European Journal of Breast Health |
| Subjects: | |
| Online Access: |
http://www.eurjbreasthealth.com/archives/archive-detail/article-preview/an-open-label-multinational-multicenter-phase-b-st/50673
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| _version_ | 1797924031724257280 |
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| author | İrfan Cicin Mohammed Oukkal Hassen Mahfouf Amel Mezlini Blaha Larbaoui Slim Ben Ahmed Hassan Errihani Khalid Alsaleh Rhizlane Belbaraka Perran Fulden Yumuk Burce Goktas Mustafa Özgüroğlu |
| author_facet | İrfan Cicin Mohammed Oukkal Hassen Mahfouf Amel Mezlini Blaha Larbaoui Slim Ben Ahmed Hassan Errihani Khalid Alsaleh Rhizlane Belbaraka Perran Fulden Yumuk Burce Goktas Mustafa Özgüroğlu |
| author_sort | İrfan Cicin |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-10T14:55:20Z |
| format | Article |
| id | doaj.art-44aa8ae6d88d49109eadb32a73987363 |
| institution | Directory Open Access Journal |
| issn | 2587-0831 |
| language | English |
| last_indexed | 2024-04-10T14:55:20Z |
| publishDate | 2022-01-01 |
| publisher | Galenos Publishing House |
| record_format | Article |
| series | European Journal of Breast Health |
| spelling | doaj.art-44aa8ae6d88d49109eadb32a739873632023-02-15T16:07:23ZengGalenos Publishing HouseEuropean Journal of Breast Health2587-08312022-01-01181637310.4274/ejbh.galenos.2021.2021-9-913049054An Open-Label, Multinational, Multicenter, Phase IIIb Study with Subcutaneous Administration of Trastuzumab in Patients with HER2-Positive Early Breast Cancer to Evaluate Patient Satisfactionİrfan Cicin0Mohammed Oukkal1Hassen Mahfouf2Amel Mezlini3Blaha Larbaoui4Slim Ben Ahmed5Hassan Errihani6Khalid Alsaleh7Rhizlane Belbaraka8Perran Fulden Yumuk9Burce Goktas10Mustafa Özgüroğlu11 Department of Medical Oncology, Trakya University Faculty of Medicine, Edirne, Turkey Department of Medical Oncology, Beni Messous University Hospital, Beni Messous, Algeria Centre Hospitalo-Univerisitaire de Rouiba, Service D’oncologie Médicale, Rouiba, Algeria Service de Médecine Carcinologique, Institut Salah Azaïz, Tunis, Tunisia Service D’oncologie Médicale, EHS Oncologie Emir Abdelkader Oran, Oran, Algeria Deparment of Oncology, Farhat Hached Hospital, Sousse, Tunisia Department of Oncology, National Institute of Oncology, Mohammed V University, Rabat, Morocco College of Medicine, Department of Medicine, King Saud University, Riyadh, Saudi Arabia Cadi Ayyad University, Faculty of Medicine, Medical Oncology Department, Marrakech, Morocco Deparment of Medical Oncology, Marmara University School of Medicine, Marmara University Pendik Training and Research Hospital, İstanbul, Turkey Roche Müstahzarları Industry Inc., İstanbul, Turkey İstanbul University-Cerrahpasa Cerrahpasa Medical Faculty, İstanbul, Turkey 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. http://www.eurjbreasthealth.com/archives/archive-detail/article-preview/an-open-label-multinational-multicenter-phase-b-st/50673 subcutaneoustrastuzumabbreast cancerher2patient satisfaction |
| spellingShingle | İrfan Cicin Mohammed Oukkal Hassen Mahfouf Amel Mezlini Blaha Larbaoui Slim Ben Ahmed Hassan Errihani Khalid Alsaleh Rhizlane Belbaraka Perran Fulden Yumuk Burce Goktas Mustafa Özgüroğlu 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 European Journal of Breast Health subcutaneous trastuzumab breast cancer her2 patient satisfaction |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | open label multinational multicenter phase iiib study with subcutaneous administration of trastuzumab in patients with her2 positive early breast cancer to evaluate patient satisfaction |
| topic | subcutaneous trastuzumab breast cancer her2 patient satisfaction |
| url |
http://www.eurjbreasthealth.com/archives/archive-detail/article-preview/an-open-label-multinational-multicenter-phase-b-st/50673
|
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