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Eribulin plus Pyrotinib in Trastuzumab-Resistant, HER2-Positive Advanced Breast Cancer: A Single-Arm, Multicenter Phase II Trial (EPIC Trial)

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Titel: Eribulin plus Pyrotinib in Trastuzumab-Resistant, HER2-Positive Advanced Breast Cancer: A Single-Arm, Multicenter Phase II Trial (EPIC Trial)
Autoren: Li R, Wang M, Kong X, Ma J, Qi X, Song Z
Quelle: Drug Design, Development and Therapy, Vol 19, Iss Issue 1, Pp 8463-8474 (2025)
Verlagsinformationen: Dove Medical Press, 2025.
Publikationsjahr: 2025
Bestand: LCC:Therapeutics. Pharmacology
Schlagwörter: Breast cancer, Human epidermal growth factor receptor 2, Trastuzumab-resistant, Pyrotinib, Eribulin, Therapeutics. Pharmacology, RM1-950
Beschreibung: Ruoyang Li,1 Meiqi Wang,1 Xiangshun Kong,2 Jie Ma,3 Xiuheng Qi,4 Zhenchuan Song1 1Breast Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, People’s Republic of China; 2Department of Breast Surgery, Xingtai People’s Hospital, Xingtai, People’s Republic of China; 3Department of Breast Surgery, TangShan People’s Hospital, Tangshan, People’s Republic of China; 4Department of Oncology, Hebei Petrochina Central Hospital, Langfang, People’s Republic of ChinaCorrespondence: Zhenchuan Song, Breast Center, Fourth Hospital of Hebei Medical University, No. 169 Tianshan Street, Shijiazhuang, 050035, People’s Republic of China, Fax +86 311 66696310, Email songzhch@hebmu.edu.cnPurpose: This study aimed to assess the efficacy and safety of combining Eribulin with Pyrotinib in patients diagnosed with advanced HER2-positive breast cancer and exhibiting resistance to trastuzumab. This subgroup of patients typically faces a bleak clinical prognosis with limited guidance available for treatment decisions.Patients and Methods: Patients (N=30) with HER2-positive metastatic breast cancer, ECOG 0– 1, and prior trastuzumab/taxane therapy received oral Pyrotinib 400 mg daily and intravenous Eribulin 1.4 mg/m² (days 1/8 of 21-day cycles for 6 cycles), followed by Pyrotinib until progression/intolerable toxicity. The primary endpoint was progression-free survival (PFS).Results: Between February 2021 and September 2023, 30 patients were enrolled in the study, with a median age of 57 years. All patients had previously received treatment with trastuzumab and taxanes. As of April 14, 2025, the median follow-up duration was 26 months. 18 patients experienced disease progression or death. The median progression-free survival (PFS) was 13.47 months (95% confidence interval [CI], 8.17– 16.27), with a 12-month PFS rate of 61.7% (95% CI, 44.2%– 86.0%). 12-month overall survival (OS) rate of 75.3% (95% CI 66.2– 84.4). The objective response rate was 56.7% (17/30). The disease control rate (DCR) reached 80.0% (24/30), while the clinical benefit rate (CBR) was 73.3% (22/30). The median overall survival was not reached. Any adverse event (AE) of any grade with an incidence of more than 30% was Neutropenia (73.3%), diarrhea (70%), nausea/vomiting (66.7%), Peripheral neuropathy (63.3%), AST/ALT increased (43.3%), Anorexia (33.3%). There were no treatment-related deaths.Conclusion: The combination of Eribulin and Pyrotinib emerges as a viable treatment option for HER2-positive advanced breast cancer patients who have exhibited resistance to trastuzumab. Despite advancements in anti-HER2 therapies, further research is required to address remaining challenges in this specific clinical scenario.Keywords: breast cancer, human epidermal growth factor receptor 2, trastuzumab-resistant, pyrotinib, eribulin
Publikationsart: article
Dateibeschreibung: electronic resource
Sprache: English
ISSN: 1177-8881
Relation: https://www.dovepress.com/eribulin-plus-pyrotinib-in-trastuzumab-resistant-her2-positive-advance-peer-reviewed-fulltext-article-DDDT; https://doaj.org/toc/1177-8881
Zugangs-URL: https://doaj.org/article/5438a3776c034b4fb255bc1a46b62384
Dokumentencode: edsdoj.5438a3776c034b4fb255bc1a46b62384
Datenbank: Directory of Open Access Journals
Beschreibung
Abstract:Ruoyang Li,1 Meiqi Wang,1 Xiangshun Kong,2 Jie Ma,3 Xiuheng Qi,4 Zhenchuan Song1 1Breast Center, Fourth Hospital of Hebei Medical University, Shijiazhuang, People’s Republic of China; 2Department of Breast Surgery, Xingtai People’s Hospital, Xingtai, People’s Republic of China; 3Department of Breast Surgery, TangShan People’s Hospital, Tangshan, People’s Republic of China; 4Department of Oncology, Hebei Petrochina Central Hospital, Langfang, People’s Republic of ChinaCorrespondence: Zhenchuan Song, Breast Center, Fourth Hospital of Hebei Medical University, No. 169 Tianshan Street, Shijiazhuang, 050035, People’s Republic of China, Fax +86 311 66696310, Email songzhch@hebmu.edu.cnPurpose: This study aimed to assess the efficacy and safety of combining Eribulin with Pyrotinib in patients diagnosed with advanced HER2-positive breast cancer and exhibiting resistance to trastuzumab. This subgroup of patients typically faces a bleak clinical prognosis with limited guidance available for treatment decisions.Patients and Methods: Patients (N=30) with HER2-positive metastatic breast cancer, ECOG 0– 1, and prior trastuzumab/taxane therapy received oral Pyrotinib 400 mg daily and intravenous Eribulin 1.4 mg/m² (days 1/8 of 21-day cycles for 6 cycles), followed by Pyrotinib until progression/intolerable toxicity. The primary endpoint was progression-free survival (PFS).Results: Between February 2021 and September 2023, 30 patients were enrolled in the study, with a median age of 57 years. All patients had previously received treatment with trastuzumab and taxanes. As of April 14, 2025, the median follow-up duration was 26 months. 18 patients experienced disease progression or death. The median progression-free survival (PFS) was 13.47 months (95% confidence interval [CI], 8.17– 16.27), with a 12-month PFS rate of 61.7% (95% CI, 44.2%– 86.0%). 12-month overall survival (OS) rate of 75.3% (95% CI 66.2– 84.4). The objective response rate was 56.7% (17/30). The disease control rate (DCR) reached 80.0% (24/30), while the clinical benefit rate (CBR) was 73.3% (22/30). The median overall survival was not reached. Any adverse event (AE) of any grade with an incidence of more than 30% was Neutropenia (73.3%), diarrhea (70%), nausea/vomiting (66.7%), Peripheral neuropathy (63.3%), AST/ALT increased (43.3%), Anorexia (33.3%). There were no treatment-related deaths.Conclusion: The combination of Eribulin and Pyrotinib emerges as a viable treatment option for HER2-positive advanced breast cancer patients who have exhibited resistance to trastuzumab. Despite advancements in anti-HER2 therapies, further research is required to address remaining challenges in this specific clinical scenario.Keywords: breast cancer, human epidermal growth factor receptor 2, trastuzumab-resistant, pyrotinib, eribulin
ISSN:11778881