Cited 3 times in
Phase II study of a trastuzumab biosimilar in combination with paclitaxel for HER2-positive recurrent or metastatic urothelial carcinoma: KCSG GU18-18
DC Field | Value | Language |
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dc.contributor.author | 신상준 | - |
dc.date.accessioned | 2024-01-03T00:35:32Z | - |
dc.date.available | 2024-01-03T00:35:32Z | - |
dc.date.issued | 2023-08 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/197311 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | BMJ | - |
dc.relation.isPartOf | ESMO OPEN | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Biosimilar Pharmaceuticals* / adverse effects | - |
dc.subject.MESH | Carcinoma, Transitional Cell* | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Paclitaxel / pharmacology | - |
dc.subject.MESH | Trastuzumab / adverse effects | - |
dc.subject.MESH | Urinary Bladder Neoplasms* | - |
dc.title | Phase II study of a trastuzumab biosimilar in combination with paclitaxel for HER2-positive recurrent or metastatic urothelial carcinoma: KCSG GU18-18 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | M Kim | - |
dc.contributor.googleauthor | J L Lee | - |
dc.contributor.googleauthor | S J Shin | - |
dc.contributor.googleauthor | W K Bae | - |
dc.contributor.googleauthor | H J Lee | - |
dc.contributor.googleauthor | J H Byun | - |
dc.contributor.googleauthor | Y J Choi | - |
dc.contributor.googleauthor | J Youk | - |
dc.contributor.googleauthor | C Y Ock | - |
dc.contributor.googleauthor | S Kim | - |
dc.contributor.googleauthor | H Song | - |
dc.contributor.googleauthor | K H Park | - |
dc.contributor.googleauthor | B Keam | - |
dc.identifier.doi | 10.1016/j.esmoop.2023.101588 | - |
dc.contributor.localId | A02105 | - |
dc.relation.journalcode | J03799 | - |
dc.identifier.eissn | 2059-7029 | - |
dc.identifier.pmid | 37385153 | - |
dc.subject.keyword | HER2 | - |
dc.subject.keyword | paclitaxel | - |
dc.subject.keyword | targeted therapy | - |
dc.subject.keyword | trastuzumab-pkrb | - |
dc.subject.keyword | urothelial carcinoma | - |
dc.contributor.alternativeName | Shin, Sang Joon | - |
dc.contributor.affiliatedAuthor | 신상준 | - |
dc.citation.volume | 8 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 101588 | - |
dc.identifier.bibliographicCitation | ESMO OPEN, Vol.8(4) : 101588, 2023-08 | - |
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