PMID- 26308612
OWN - NLM
STAT- MEDLINE
DCOM- 20160519
LR  - 20181202
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 10
IP  - 8
DP  - 2015
TI  - Efficacy and Safety of Sorafenib Therapy on Metastatic Renal Cell Carcinoma in 
      Korean Patients: Results from a Retrospective Multicenter Study.
PG  - e0135165
LID - 10.1371/journal.pone.0135165 [doi]
LID - e0135165
AB  - 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.
FAU - Kim, Sung Han
AU  - Kim SH
AD  - Departments of Urology, Center for Prostate Cancer, National Cancer Center, 
      Goyang, Korea.
FAU - Kim, Sohee
AU  - Kim S
AD  - Biometric Research Branch, Center for Prostate Cancer, National Cancer Center, 
      Goyang, Korea.
FAU - Nam, Byung-Ho
AU  - Nam BH
AD  - Biometric Research Branch, Center for Prostate Cancer, National Cancer Center, 
      Goyang, Korea.
FAU - Lee, Sang Eun
AU  - Lee SE
AD  - Seoul National University Bundang Hospital, SeongNam, Korea.
FAU - Kim, Choung Soo
AU  - Kim CS
AD  - Asan Medical Center, Seoul, Korea.
FAU - Seo, Ill Young
AU  - Seo IY
AD  - Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
FAU - Kim, Tae Nam
AU  - Kim TN
AD  - Pusan National University Hospital, Busan, Korea.
FAU - Hong, Sung-Hoo
AU  - Hong SH
AD  - Seoul St. Mary's Hospital, Seoul, Korea.
FAU - Kwon, Tae Gyun
AU  - Kwon TG
AD  - School of Medicine, Kyungpook National University, Daegu, Korea.
FAU - Seo, Seong Il
AU  - Seo SI
AD  - Wonkwang University School of Medicine and Hospital, Iksan, Korea.
FAU - Joo, Kwan Joong
AU  - Joo KJ
AD  - Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, 
      Korea.
FAU - Song, Kanghyon
AU  - Song K
AD  - Korea Cancer Center Hospital, Seoul, Korea.
FAU - Kwak, Cheol
AU  - Kwak C
AD  - Seoul National University Hospital, Seoul, Korea.
FAU - Chung, Jinsoo
AU  - Chung J
AD  - Departments of Urology, Center for Prostate Cancer, National Cancer Center, 
      Goyang, Korea.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, Non-U.S. Gov't
DEP - 20150826
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Phenylurea Compounds)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Antineoplastic Agents/adverse effects/pharmacology/therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/*pathology
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Kidney Neoplasms/*drug therapy/*pathology
MH  - Korea
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Niacinamide/adverse effects/*analogs & derivatives/pharmacology/therapeutic use
MH  - Phenylurea Compounds/*adverse effects/*pharmacology/therapeutic use
MH  - Retrospective Studies
MH  - *Safety
MH  - Sorafenib
MH  - Treatment Outcome
PMC - PMC4550402
COIS- Competing Interests: This investigator-initiated research was supported with 
      funding by a grant from Bayer Healthcare Pharmaceuticals. Co-author Ill Young Seo 
      is employed by Samsung Medical Center. Co-author Kwan Joong Joo is employed by 
      Kangbuk Samsung Hospital. The corresponding author (Dr. Jinsoo Chung) and one of 
      the co-author named Dr Choung-Soo Kim have acted as consultants for Pfizer, 
      Bristol-Myers Squibb, and Taiho, and have received advisory and/or speaker fees 
      from Bayer, Bristol-Myers Squibb, and Taiho. There are no patents, products in 
      development or marketed products to declare. This does not alter the authors' 
      adherence to all the PLOS ONE policies on sharing data and materials. The other 
      authors declare that they do not have anything to disclose regarding funding or 
      conflicts of interests with respect to this manuscript.
EDAT- 2015/08/27 06:00
MHDA- 2016/05/20 06:00
PMCR- 2015/08/26
CRDT- 2015/08/27 06:00
PHST- 2015/04/06 00:00 [received]
PHST- 2015/07/18 00:00 [accepted]
PHST- 2015/08/27 06:00 [entrez]
PHST- 2015/08/27 06:00 [pubmed]
PHST- 2016/05/20 06:00 [medline]
PHST- 2015/08/26 00:00 [pmc-release]
AID - PONE-D-15-14243 [pii]
AID - 10.1371/journal.pone.0135165 [doi]
PST - epublish
SO  - PLoS One. 2015 Aug 26;10(8):e0135165. doi: 10.1371/journal.pone.0135165. 
      eCollection 2015.