Phase II study of a trastuzumab biosimilar in combination with paclitaxel for HER2-positive recurrent or metastatic urothelial carcinoma: KCSG GU18-18
- Abstract
- Background: Human epidermal growth factor receptor 2 (HER2) is a widely explored therapeutic target in solid tumors. We evaluated the efficacy and safety of trastuzumab-pkrb, a biosimilar of trastuzumab, in combination with paclitaxel, in HER2-positive recurrent or metastatic urothelial carcinoma (UC).
Patients and methods: We enrolled 27 patients; they were administered a loading dose of 8 mg/kg trastuzumab-pkrb on day 1, followed by 6 mg/kg and 175 mg/m2 paclitaxel on day 1 every 3 weeks, intravenously. All patients received six cycles of the combination treatment and continued to receive trastuzumab-pkrb maintenance until disease progression, unacceptable toxicity, or for up to 2 years. HER2 positivity (based on immunohistochemistry analysis) was determined according to the 2013 American Society of Clinical Oncology /College of American Pathologists HER2 testing guidelines. The primary endpoint was objective response rate (ORR); the secondary endpoints were overall survival (OS), progression-free survival (PFS), and safety.
Results: Twenty-six patients were evaluated via primary endpoint analysis. The ORR was 48.1% (1 complete and 12 partial responses) and the duration of response was 6.9 months [95% confidence interval (CI) 4.4-9.3 months]. With a median follow-up of 10.5 months, the median PFS and OS were 8.4 months (95% CI 6.2-8.8 months) and 13.5 months (95% CI 9.8 months-not reached), respectively. The most common treatment-related adverse event (TRAE) of any grade was peripheral neuropathy (88.9%). The most common grade 3/4 TRAEs were neutropenia (25.9%), thrombocytopenia (7.4%), and anemia (7.4%).
Conclusions: Trastuzumab-pkrb plus paclitaxel demonstrates promising efficacy with manageable toxicity profiles in patients with HER2-positive recurrent or metastatic UC.
- Author(s)
- M. Kim; J. L. Lee; S. J. Shin; W. K. Bae; H. J. Lee; J. H. Byun; Y. J. Choi; J. Youk; C. Y. Ock; S. Kim; H. Song; K. H. Park; B. Keam
- Issued Date
- 2023
- Type
- Article
- Keyword
- HER2; paclitaxel; trastuzumab-pkrb; targeted therapy; urothelial carcinoma
- DOI
- 10.1016/j.esmoop.2023.101588
- URI
- https://oak.ulsan.ac.kr/handle/2021.oak/16619
- Publisher
- Esmo Open
- Language
- 영어
- ISSN
- 2059-7029
- Citation Volume
- 8
- Citation Number
- 4
- Citation Start Page
- 1
- Citation End Page
- 8
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- Medicine > Nursing
- 공개 및 라이선스
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