A multicenter, prospective phase II trial of gemcitabine plus axitinib in patients with renal cell carcinoma with a predominant sarcomatoid component
- Authors
- Park, Inkeun; Lee, Hyo Jin; Bae, Woo Kyoon; Yoon, Shinkyo; Lee, Jae Lyun
- Issue Date
- Dec-2019
- Publisher
- SPRINGER
- Keywords
- Renal cell carcinoma; Sarcomatoid; Gemcitabine; Axitinib; Chemotherapy
- Citation
- INVESTIGATIONAL NEW DRUGS, v.37, no.6, pp.1239 - 1246
- Journal Title
- INVESTIGATIONAL NEW DRUGS
- Volume
- 37
- Number
- 6
- Start Page
- 1239
- End Page
- 1246
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/17887
- DOI
- 10.1007/s10637-019-00817-0
- ISSN
- 0167-6997
- 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.
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