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2015 ; 94
(34
): e1361
Nephropedia Template TP
gab.com Text
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English Wikipedia
Retrospective Analysis of the Efficacy and Safety of Sorafenib in Chinese
Patients With Metastatic Renal Cell Carcinoma and Prognostic Factors Related to
Overall Survival
#MMPMID26313773
Yu X
; Guo G
; Li X
; Zhang C
; Huang L
; Fang D
; Song Y
; Zhang X
; Zhou L
Medicine (Baltimore)
2015[Aug]; 94
(34
): e1361
PMID26313773
show ga
Sorafenib has been recommended as first- or second-line treatment for metastatic
renal cell carcinoma (mRCC) by several guidelines. The objective of this study is
to evaluate the efficacy of sorafenib monotherapy in Chinese patients with mRCC
and determine the prognostic clinicopathologic factors associated with survival
in these patients.This is a single-arm retrospective study conducted in 2
tertiary medical centers; 140 mRCC patients were enrolled between January 2007
and June 2014. Sorafenib was administered at a dose of 400?mg twice daily, and
continued until disease progression, at which point the dose was increased to 600
or 800?mg twice daily, or the onset of an intolerable adverse drug event (ADE)
that required dose reduction or temporary suspension of treatment.The primary
endpoint was overall survival (OS), and the secondary endpoints included
progression-free survival (PFS), objective response rate (ORR), disease control
rate (DCR), and safety.The median follow-up time was 32 months. The median OS and
PFS were 24 months (range, 3-88 months) and 16 months (range, 0-88 months),
respectively. Patients with clear cell carcinoma had a greater OS (P=0.001)
whereas sarcomatoid differentiation (P=0.045) and disease progression (P=0.010)
negatively impacted OS; time from kidney surgery or biopsy to initiation of
sorafenib treatment was associated with PFS (P=0.027). Efficacy analysis revealed
that 3 (2.1%) patients achieved complete responses, 28 (20.0%) patients
experienced partial responses, 88 (62.9%) patients had stable disease, and 21
(15.0%) patients developed progressive disease. Moreover, the ORR was 22.1%, and
the DCR was 85.0%. Most ADEs were classified as grades 1 or 2 with only 14
(10.0%) patients experiencing a severe ADE (grade 3).Sorafenib monotherapy can
achieve promising OS and PFS for Chinese patients with mRCC, especially in those
with clear cell carcinoma, with manageable adverse events.