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Safety and efficacy study of oral metronomic capecitabine combined with pyrotinib in HER2-positive metastatic breast cancer: A phase II trial.
- Source :
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Breast (Edinburgh, Scotland) [Breast] 2023 Dec; Vol. 72, pp. 103581. Date of Electronic Publication: 2023 Sep 20. - Publication Year :
- 2023
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Abstract
- Purpose: To analyze the safety and efficacy of orally administered metronomic capecitabine plus pyrotinib in HER2 positive metastatic breast cancer (MBC) patients, we conducted a prospective phase II study with a single-arm design.<br />Methods: HER2 positive patients received oral metronomic capecitabine 500 mg three times a day and pyrotinib 400 mg per day. The primary endpoint was progression-free survival (PFS). Other endpoints included objective response rate (ORR), overall survival (OS), clinical benefit rate (CBR) and safety.<br />Results: The study included 50 patients with MBC that was HER2-positive, while 1 patient was excluded due to nonstandard medication. The median PFS and OS was 11.9 months (95%CI 8.8-14.6) and 29.3 months (95%CI 24.4-34.8) respectively. ORR was 34.7%, and CBR was 81.6% with 2 CR (4.1%), 15 PR (30.6%) and 23 SD (46.9%). The mPFS in first- or second-line treatment was 12.2 months. The most frequent treatment-related adverse events included hand-foot syndrome, diarrhea, vomiting and nausea. Grade 3 adverse events occurred in 15(30.6%) patients, including hand-foot syndrome (12.2%), diarrhea (12.2%), vomiting (4.1%), and nausea (2.0%). 1 grade 4 adverse event of diarrhea (2.0%) was observed.<br />Conclusion: The combination of metronomic capecitabine and pyrotinib is a promising regimen with competitive efficacy and improved tolerability in HER2 positive metastatic breast cancer patients.<br />Competing Interests: Declaration of Competing interest The authors declare that there are no conflict of interests, we do not have any possible conflicts of interest.<br /> (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Subjects :
- Female
Humans
Diarrhea chemically induced
Hand-Foot Syndrome etiology
Nausea chemically induced
Prospective Studies
Receptor, ErbB-2
Vomiting chemically induced
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Breast Neoplasms pathology
Capecitabine adverse effects
Capecitabine therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1532-3080
- Volume :
- 72
- Database :
- MEDLINE
- Journal :
- Breast (Edinburgh, Scotland)
- Publication Type :
- Academic Journal
- Accession number :
- 37742492
- Full Text :
- https://doi.org/10.1016/j.breast.2023.103581