PMID- 25036572
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20141013
LR  - 20240321
IS  - 1598-2998 (Print)
IS  - 2005-9256 (Electronic)
IS  - 1598-2998 (Linking)
VI  - 46
IP  - 4
DP  - 2014 Oct
TI  - Efficacy and safety of everolimus in korean patients with metastatic renal cell 
      carcinoma following treatment failure with a vascular endothelial growth factor 
      receptor-tyrosine kinase inhibitor.
PG  - 339-47
LID - 10.4143/crt.2013.154 [doi]
AB  - PURPOSE: The purpose of this study is to assess the efficacy and safety of 
      everolimus in Korean patients with metastatic renal cell carcinoma (mRCC) for 
      whom initial treatment with a vascular endothelial growth factor 
      receptor-tyrosine kinase inhibitor (VEGFr-TKI) has failed. MATERIALS AND METHODS: 
      Eligible patients with mRCC (any histology) who had progressed on or were 
      intolerant of VEGFr-TKI therapy received oral everolimus (10 mg dose once daily). 
      Tumor response was reassessed according to Response Evaluation Criteria in Solid 
      Tumors (RECIST). RESULTS: This study included 100 patientswith a median follow-up 
      duration of 10.2 months, a median progression-free survival (PFS) of 4.2 months 
      (95% confidence interval [CI], 3.4 to 5.0 months), and an overall survival of 
      10.1 months (95% CI, 6.9 to 13.3 months). The most common grade 3 or greater 
      adverse events (AEs) overall were anemia (13%), pneumonitis (9%), hyperglycemia 
      (8%), and stomatitis (6%). While the incidence of pneumonitis was similar (26 
      cases, 26%) to the reported incidence in Western patients, the Korean 
      presentations were more severe: 10 patients permanently discontinued everolimus 
      due to pneumonitis, including two deaths on treatment. Statistically significant 
      relationships were established between biologic toxicities, hyperglycemia and 
      anemia, and PFS (hyperglycemia vs. non-hyperglycemia: hazard ratio [HR], 0.61; 
      p=0.055 and anemia vs. non-anemia: HR, 0.51; p=0.021). CONCLUSION: Everolimus was 
      effective in Korean patients with mRCC who had failed initial VEGFr-TKI therapy. 
      While everolimus was well tolerated in general and the AE incidence of this study 
      was similar to those of previous reports, severe pneumonitis was common. 
      Hyperglycemia and anemia showed significant correlation with PFS and thus may be 
      potentially useful as prognostic indicators.
FAU - Park, Kwonoh
AU  - Park K
AD  - Departments of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea ; Department of Hematology-Oncology, KEPCO Medical Center, 
      Seoul, Korea ; Department of Urology, Asan Medical Center, University of Ulsan 
      College of Medicine, Seoul, Korea.
FAU - Lee, Jae-Lyun
AU  - Lee JL
AD  - Departments of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea ; Department of Hematology-Oncology, KEPCO Medical Center, 
      Seoul, Korea.
FAU - Ahn, Jin-Hee
AU  - Ahn JH
AD  - Departments of Oncology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea ; Department of Hematology-Oncology, KEPCO Medical Center, 
      Seoul, Korea.
FAU - Lee, Kyoo Hyung
AU  - Lee KH
AD  - Department of Internal Medicine, Asan Medical Center, University of Ulsan College 
      of Medicine, Seoul, Korea ; Department of Hematology-Oncology, KEPCO Medical 
      Center, Seoul, Korea.
FAU - Jeong, In-Gab
AU  - Jeong IG
AD  - Departments of Hematology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Song, Cheryn
AU  - Song C
AD  - Departments of Hematology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Hong, Bumsik
AU  - Hong B
AD  - Departments of Hematology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Hong, Jun Hyuk
AU  - Hong JH
AD  - Departments of Hematology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
FAU - Ahn, Hanjong
AU  - Ahn H
AD  - Departments of Hematology, Asan Medical Center, University of Ulsan College of 
      Medicine, Seoul, Korea.
LA  - eng
PT  - Journal Article
DEP - 20140716
PL  - Korea (South)
TA  - Cancer Res Treat
JT  - Cancer research and treatment
JID - 101155137
PMC - PMC4206076
OTO - NOTNLM
OT  - Everolimus
OT  - Renal cell carcinoma
OT  - Safety
OT  - Treatment outcome
COIS- Conflict of interest relevant to this article was not reported.
EDAT- 2014/07/19 06:00
MHDA- 2014/07/19 06:01
PMCR- 2014/10/01
CRDT- 2014/07/19 06:00
PHST- 2013/08/23 00:00 [received]
PHST- 2013/10/15 00:00 [accepted]
PHST- 2014/07/19 06:00 [entrez]
PHST- 2014/07/19 06:00 [pubmed]
PHST- 2014/07/19 06:01 [medline]
PHST- 2014/10/01 00:00 [pmc-release]
AID - crt.2013.154 [pii]
AID - crt-2013-154 [pii]
AID - 10.4143/crt.2013.154 [doi]
PST - ppublish
SO  - Cancer Res Treat. 2014 Oct;46(4):339-47. doi: 10.4143/crt.2013.154. Epub 2014 Jul 
      16.