Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in Cuba
PURPOSE: Dual HER2 blockade chemotherapy is the standard of care for localized HER2+ breast cancer (BC). However, despite the efficacy of neoadjuvant therapy, relapses occurring in around 10% of patients highlight the need to improve its clinical approach. Therefore, this study aimed to evaluate the...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-01-01
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| Series: | Cancer Treatment and Research Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2468294222001617 |
| _version_ | 1811176480763281408 |
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| author | Elías A. Gracia Medina Brenda Benítez Caballero Karen López Miguel Zaili Aleaga Gutiérrez Braulio Mestre Fernández Luis E. Alsina Tul Luis E. Martín Rodríguez Orlando Valdés Guerrero Idania G. Sánchez Varela María de la Caridad Campos Bernardo Yoandri Calderón Montero Mónica Ramos Ortiz Julien Martínez Carrasco Keytia Peña Torres Yenia I. Díaz Prado María Caridad Rubio Inés M. Pérez Braojo |
| author_facet | Elías A. Gracia Medina Brenda Benítez Caballero Karen López Miguel Zaili Aleaga Gutiérrez Braulio Mestre Fernández Luis E. Alsina Tul Luis E. Martín Rodríguez Orlando Valdés Guerrero Idania G. Sánchez Varela María de la Caridad Campos Bernardo Yoandri Calderón Montero Mónica Ramos Ortiz Julien Martínez Carrasco Keytia Peña Torres Yenia I. Díaz Prado María Caridad Rubio Inés M. Pérez Braojo |
| author_sort | Elías A. Gracia Medina |
| collection | DOAJ |
| description | PURPOSE: Dual HER2 blockade chemotherapy is the standard of care for localized HER2+ breast cancer (BC). However, despite the efficacy of neoadjuvant therapy, relapses occurring in around 10% of patients highlight the need to improve its clinical approach. Therefore, this study aimed to evaluate the effectiveness/safety of neoadjuvant therapy with subcutaneous (SC) trastuzumab- pertuzumab chemotherapy (real world) to extend the evidence, which comes mainly from clinical trials (selected population; intravenous [IV] trastuzumab).MATERIALS AND METHODS: A prospective, longitudinal, observational study in a Cuban hospital. Population: women aged ≥18 years with histologically confirmed HER2+ early-stage BC (2017–2021) eligible for neoadjuvant treatment (IV pertuzumab, SC trastuzumab, taxane-based chemotherapy). The aim was to determine the pathological complete response (pCR) rate to this scheme, its safety, and the impact of patient's characteristics on the outcomes.RESULTS: Eighty-seven women were included: n=29 (DPT [docetaxel-IV pertuzumab- SC trastuzumab 600 mg; 4 cycles]); n=58 (ddAC-DPT [dose-dense anthracycline-based scheme+DPT]; 8 cycles). The median age was 57 years (range 30–83), ECOG 0: 97%. Time from diagnosis to treatment (median) was 28 days. The overall pCR rate was 62.1% (55.2%, DPT; 66.5%, ddAC-DPT; p =0.351); HR+, 47.7% vs. HR-, 76.7% (p=0.006). There were no statistically significant differences based on nodal status, stage, or Ki-67 levels. Overall, 94.2% of patients experienced ≥1 adverse event related to treatment, all of them grade 1-3 and more common with ddAC-DPT. The main cause of treatment delays (n=19; ddAC-DPT, 16; DPT, 3) was treatment-related toxicities.CONCLUSION: Neoadjuvant trastuzumab (SC) and pertuzumab plus chemotherapy for HER2+ early-stage BC showed benefits in a real-life setting, with an acceptable safety profile. |
| first_indexed | 2024-04-10T19:52:16Z |
| format | Article |
| id | doaj.art-eae1f9a3cbab4ede850c096eb5bfbbb8 |
| institution | Directory Open Access Journal |
| issn | 2468-2942 |
| language | English |
| last_indexed | 2024-04-10T19:52:16Z |
| publishDate | 2023-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Cancer Treatment and Research Communications |
| spelling | doaj.art-eae1f9a3cbab4ede850c096eb5bfbbb82023-01-28T04:08:07ZengElsevierCancer Treatment and Research Communications2468-29422023-01-0134100670Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in CubaElías A. Gracia Medina0Brenda Benítez Caballero1Karen López Miguel2Zaili Aleaga Gutiérrez3Braulio Mestre Fernández4Luis E. Alsina Tul5Luis E. Martín Rodríguez6Orlando Valdés Guerrero7Idania G. Sánchez Varela8María de la Caridad Campos Bernardo9Yoandri Calderón Montero10Mónica Ramos Ortiz11Julien Martínez Carrasco12Keytia Peña Torres13Yenia I. Díaz Prado14María Caridad Rubio15Inés M. Pérez Braojo16Instituto Nacional de Oncología y Radiobiología (Cuba). Medical Oncology Department; Corresponding author: Instituto Nacional de Oncología y Radiobiología Address: F #710 e/ 29 y Final, La Habana, CubaInstituto Nacional de Oncología y Radiobiología (Cuba). Medical Oncology DepartmentInstituto Nacional de Oncología y Radiobiología (Cuba). Medical Oncology DepartmentInstituto Nacional de Oncología y Radiobiología (Cuba). Pathology DepartmentInstituto Nacional de Oncología y Radiobiología (Cuba). Medical Oncology DepartmentInstituto Nacional de Oncología y Radiobiología (Cuba). Medical Oncology DepartmentInstituto Nacional de Oncología y Radiobiología (Cuba). Mastology ServiceInstituto Nacional de Oncología y Radiobiología (Cuba). Mastology ServiceInstituto Nacional de Oncología y Radiobiología (Cuba). Mastology ServiceInstituto Nacional de Oncología y Radiobiología (Cuba). Radiology DepartmentInstituto Nacional de Oncología y Radiobiología (Cuba). Radiology DepartmentInstituto Nacional de Oncología y Radiobiología (Cuba). Mastology ServiceInstituto Nacional de Oncología y Radiobiología (Cuba). Mastology ServiceInstituto Nacional de Oncología y Radiobiología (Cuba). Mastology ServiceInstituto Nacional de Oncología y Radiobiología (Cuba). Mastology ServiceInstituto Nacional de Oncología y Radiobiología (Cuba). Mastology ServiceInstituto Nacional de Oncología y Radiobiología (Cuba). Mastology ServicePURPOSE: Dual HER2 blockade chemotherapy is the standard of care for localized HER2+ breast cancer (BC). However, despite the efficacy of neoadjuvant therapy, relapses occurring in around 10% of patients highlight the need to improve its clinical approach. Therefore, this study aimed to evaluate the effectiveness/safety of neoadjuvant therapy with subcutaneous (SC) trastuzumab- pertuzumab chemotherapy (real world) to extend the evidence, which comes mainly from clinical trials (selected population; intravenous [IV] trastuzumab).MATERIALS AND METHODS: A prospective, longitudinal, observational study in a Cuban hospital. Population: women aged ≥18 years with histologically confirmed HER2+ early-stage BC (2017–2021) eligible for neoadjuvant treatment (IV pertuzumab, SC trastuzumab, taxane-based chemotherapy). The aim was to determine the pathological complete response (pCR) rate to this scheme, its safety, and the impact of patient's characteristics on the outcomes.RESULTS: Eighty-seven women were included: n=29 (DPT [docetaxel-IV pertuzumab- SC trastuzumab 600 mg; 4 cycles]); n=58 (ddAC-DPT [dose-dense anthracycline-based scheme+DPT]; 8 cycles). The median age was 57 years (range 30–83), ECOG 0: 97%. Time from diagnosis to treatment (median) was 28 days. The overall pCR rate was 62.1% (55.2%, DPT; 66.5%, ddAC-DPT; p =0.351); HR+, 47.7% vs. HR-, 76.7% (p=0.006). There were no statistically significant differences based on nodal status, stage, or Ki-67 levels. Overall, 94.2% of patients experienced ≥1 adverse event related to treatment, all of them grade 1-3 and more common with ddAC-DPT. The main cause of treatment delays (n=19; ddAC-DPT, 16; DPT, 3) was treatment-related toxicities.CONCLUSION: Neoadjuvant trastuzumab (SC) and pertuzumab plus chemotherapy for HER2+ early-stage BC showed benefits in a real-life setting, with an acceptable safety profile.http://www.sciencedirect.com/science/article/pii/S2468294222001617Early breast cancerNeoadjuvantPertuzumabReal-world dataSubcutaneous trastuzumab |
| spellingShingle | Elías A. Gracia Medina Brenda Benítez Caballero Karen López Miguel Zaili Aleaga Gutiérrez Braulio Mestre Fernández Luis E. Alsina Tul Luis E. Martín Rodríguez Orlando Valdés Guerrero Idania G. Sánchez Varela María de la Caridad Campos Bernardo Yoandri Calderón Montero Mónica Ramos Ortiz Julien Martínez Carrasco Keytia Peña Torres Yenia I. Díaz Prado María Caridad Rubio Inés M. Pérez Braojo Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in Cuba Cancer Treatment and Research Communications Early breast cancer Neoadjuvant Pertuzumab Real-world data Subcutaneous trastuzumab |
| title | Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in Cuba |
| title_full | Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in Cuba |
| title_fullStr | Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in Cuba |
| title_full_unstemmed | Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in Cuba |
| title_short | Neoadjuvant Trastuzumab and Pertuzumab in Combination with Standard Chemotherapy for HER2-Positive Early Breast Cancer: Real-World Practice in Cuba |
| title_sort | neoadjuvant trastuzumab and pertuzumab in combination with standard chemotherapy for her2 positive early breast cancer real world practice in cuba |
| topic | Early breast cancer Neoadjuvant Pertuzumab Real-world data Subcutaneous trastuzumab |
| url | http://www.sciencedirect.com/science/article/pii/S2468294222001617 |
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