A multicenter, prospective phase II trial of gemcitabine plus axitinib in patients with renal cell carcinoma with a predominant sarcomatoid component
DC Field | Value | Language |
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dc.contributor.author | Park, Inkeun | - |
dc.contributor.author | Lee, Hyo Jin | - |
dc.contributor.author | Bae, Woo Kyoon | - |
dc.contributor.author | Yoon, Shinkyo | - |
dc.contributor.author | Lee, Jae Lyun | - |
dc.date.available | 2020-03-03T06:48:59Z | - |
dc.date.created | 2020-02-24 | - |
dc.date.issued | 2019-12 | - |
dc.identifier.issn | 0167-6997 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/17887 | - |
dc.description.abstract | Introduction We conducted a multicenter, phase 2 trial using gemcitabine plus axitinib (GX) in patients with recurrent or metastatic sarcomatoid renal cell carcinoma (SRCC) to evaluate its efficacy and safety. Methods Patients with advanced RCC and a sarcomatoid component of >= 25% on resected kidney or exclusive sarcomatoid carcinoma on needle biopsy were included. Patients received gemcitabine 1000 mg/m(2) intravenously on days 1 and 8 of a 3-week cycle and axitinib 5 mg twice daily. Primary endpoint was objective response rate (ORR) according to the response evaluation criteria in solid tumors version 1.1, and secondary end points were progression-free (PFS) and overall (OS) survivals and adverse events. Results Twenty-five patients were enrolled. Median age was 61 (range: 33-80), and 84% were men. The Eastern Cooperative Oncology Group performance status was one in 23 patients (92%). Clear cell carcinoma was the most common histology of the carcinoma component (60%). ORR was 56%, and 28% patients achieved stable disease with a control rate of 84%. With a median follow-up duration of 24.8 months, the median PFS was 4.2 months (95% CI, 2.3-6.1) and median OS was 8.4 months (95% CI 3.3-13.4 months). The most common grade 3 or higher adverse events were neutropenia (36%), hypertension (12%), and anorexia (12%). Most adverse events were manageable, and no unexpected toxicities were found. Conclusion GX showed promising efficacy in patients with SRCC. GX could be considered as a treatment option for patients with SRCC and should be confirmed in larger clinical trials. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | SPRINGER | - |
dc.relation.isPartOf | INVESTIGATIONAL NEW DRUGS | - |
dc.subject | BEVACIZUMAB | - |
dc.subject | SORAFENIB | - |
dc.subject | TRANSFORMATION | - |
dc.subject | CHEMOTHERAPY | - |
dc.subject | ANTIBODY | - |
dc.subject | THERAPY | - |
dc.subject | PD-1 | - |
dc.title | A multicenter, prospective phase II trial of gemcitabine plus axitinib in patients with renal cell carcinoma with a predominant sarcomatoid component | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000496709000013 | - |
dc.identifier.doi | 10.1007/s10637-019-00817-0 | - |
dc.identifier.bibliographicCitation | INVESTIGATIONAL NEW DRUGS, v.37, no.6, pp.1239 - 1246 | - |
dc.identifier.scopusid | 2-s2.0-85067893200 | - |
dc.citation.endPage | 1246 | - |
dc.citation.startPage | 1239 | - |
dc.citation.title | INVESTIGATIONAL NEW DRUGS | - |
dc.citation.volume | 37 | - |
dc.citation.number | 6 | - |
dc.contributor.affiliatedAuthor | Park, Inkeun | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | Renal cell carcinoma | - |
dc.subject.keywordAuthor | Sarcomatoid | - |
dc.subject.keywordAuthor | Gemcitabine | - |
dc.subject.keywordAuthor | Axitinib | - |
dc.subject.keywordAuthor | Chemotherapy | - |
dc.subject.keywordPlus | BEVACIZUMAB | - |
dc.subject.keywordPlus | SORAFENIB | - |
dc.subject.keywordPlus | TRANSFORMATION | - |
dc.subject.keywordPlus | CHEMOTHERAPY | - |
dc.subject.keywordPlus | ANTIBODY | - |
dc.subject.keywordPlus | THERAPY | - |
dc.subject.keywordPlus | PD-1 | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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