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A prospective phase II trial of gemcitabine plus axitinib in patients with sarcomatoid type renal carcinoma

Journal of Clinical Oncology Mar 04, 2019

Park I, et al. - In 25 patients (median age 61; range 33-80) with recurrent or metastatic sarcomatoid renal cell carcinoma (SRCC), researchers assessed the effectiveness and safety of gemcitabine plus axitinib (GX) in a multicenter phase 2 trial. Participants were considered eligible if had histologically confirmed metastatic or recurrent RCC with sarcomatoid component of 25% or more on resected kidney or exclusive sarcomatoid carcinoma on needle biopsy, ECOG PS 0-2, measurable lesion by RECIST v1.1, and satisfactory cardiac, hepatic, renal and bone marrow function. Exclusion criteria included having uncontrolled hypertension, prior exposure to gemcitabine or vascular endothelial growth factor receptor tyrosine kinaase inhibitor. The treatment regimen was gemcitabine 1,000 mg/m2 given intravenously on days 1 and 8 by 3-week cycle and axitinib 5 mg twice daily. The observed objective response rate (ORR) was 56% and median duration of response was 2.5 months. Follow-up of 21.4 months revealed median progression-free survival (PFS) of 4.9 months and median overall survival of 8.4 months. Manageable adverse events and no unforeseen toxicities were found. GX displayed promising effectiveness and could be considered a treatment option for SRCC patients.

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