Efficacy and safety of sorafenib therapy on metastatic renal cell carcinoma in Korean patients: Results from a retrospective multicenter study

Sung Han Kim, Sohee Kim, Byung Ho Nam, Sang Eun Lee, Choung Soo Kim, Ill Young Seo, Tae Nam Kim, Sung Hoo Hong, Tae Gyun Kwon, Seong Il Seo, Kwan Joong Joo, Kanghyon Song, Cheol Kwak, Jinsoo Chung, Jung Weon Lee

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Abstract

Objective: To evaluate the efficacy and safety of sorafenib for Korean patients with metastatic renal cell carcinoma (mRCC). Methods: A total of 177 mRCC patients using sorafenib as first- (N = 116), second- (N = 43), and third-line (N = 18) therapies were enrolled from 11 Korean centers between 2006 and 2012. The patient characteristics, therapy duration, tumor response, disease control rate, and tolerability were assessed at baseline and at routine follow-ups, and the progression-free survival (PFS) and overall survival (OS) times and rates were analyzed. Results: Among all patients, 18 (10.2%) stopped sorafenib treatment for a median of 1.7 weeks, including 15 (8.5%) who discontinued the drug, while 40 (22.6%) and 12 (6.8%) patients required dose reductions and drug interruptions, respectively. Severe adverse events (AEs) or poor compliance was observed in 64 (36.2%) patients, with 118 (7.4%) ≥grade 3 AEs. During the treatment, one myocardial infarction was observed. The number of ≥grade 3 AEs in the first-line sorafenib group was 71 (6.8% of the total 1048 AEs). During a median follow-up of 17.2 months, the radiologically confirmed best objective response rate, disease control rate, median PFS, and median OS were 22.0%, 53.0%, 6.4 months (95% confidence interval [CI], 5.2-8.9), and 32.6 months (95% CI, 27.3-63.8) for the total 177 sorafenib-treated patients, respectively, and 23.2%, 56.0%, 7.4 months (95% CI, 5.5-10.5), and not reached yet (95% CI, 1.0-31.1) for the first-line sorafenib group, respectively. Conclusions: Sorafenib produced tolerable safety, with a ≥grade 3 AE rate of 7.4% and an acceptable disease control rate (53.0%) in Korean mRCC patients.

Original languageEnglish
Article numbere0135165
JournalPLoS ONE
Volume10
Issue number8
DOIs
StatePublished - 26 Aug 2015

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Kim, S. H., Kim, S., Nam, B. H., Lee, S. E., Kim, C. S., Seo, I. Y., Kim, T. N., Hong, S. H., Kwon, T. G., Seo, S. I., Joo, K. J., Song, K., Kwak, C., Chung, J., & Lee, J. W. (2015). Efficacy and safety of sorafenib therapy on metastatic renal cell carcinoma in Korean patients: Results from a retrospective multicenter study. PLoS ONE, 10(8), [e0135165]. https://doi.org/10.1371/journal.pone.0135165