PMID- 24332573
OWN - NLM
STAT- MEDLINE
DCOM- 20140414
LR  - 20220318
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 50
IP  - 4
DP  - 2014 Mar
TI  - Efficacy and toxicity of sunitinib in patients with metastatic renal cell 
      carcinoma with renal insufficiency.
PG  - 746-52
LID - S0959-8049(13)01025-3 [pii]
LID - 10.1016/j.ejca.2013.11.029 [doi]
AB  - BACKGROUND: Patients with metastatic renal cell carcinoma (mRCC) with renal 
      insufficiency are generally excluded from clinical trials, despite their 
      increasing numbers. Thus, we evaluated the efficacy and toxicity of sunitinib in 
      such patients. PATIENTS AND METHODS: Korean patients with mRCC with renal 
      insufficiency who had received sunitinib as first-line treatment between January 
      2008 and May 2012 were included. Patient characteristics, clinical outcomes and 
      toxicities were evaluated. Overall survival (OS) and progression-free survival 
      (PFS) were determined according to the degree of renal impairment. RESULTS: The 
      median age of the 34 patients evaluated was 66 years, 90% had an Eastern 
      Cooperative Oncology Group performance status of 0 or 1 and the median glomerular 
      filtration rate was 46.5 mL min(-1) . 1.73 m(-2) (range, 21.1-59.5). The starting 
      sunitinib dose was 37.5 and 50mg for 12 and 22 patients, respectively. A 
      4-weeks-on-2-weeks-off regimen was followed for 31 patients; a 
      2-weeks-on-2-weeks-off regimen, for one patient; and a daily regimen, for two 
      patients. The best response was partial response in eight patients and stable 
      disease in 12. Median OS and PFS times were 26.3 months (95% confidence interval 
      [CI]: 17.1-35.3) and 12.2 months (95% CI: 10.2-13.2), respectively. Common 
      non-haematologic adverse events (AEs) were stomatitis, rash, general oedema and 
      fatigue. The most common AEs of ⩾ grade 3 severity were fatigue, neutropenia and 
      thrombocytopenia. CONCLUSIONS: In patients with mRCC with renal insufficiency, 
      sunitinib was efficacious and did not cause increased toxicity. Thus, clinicians 
      should not hesitate to treat patients with mRCC with renal insufficiency with 
      sunitinib.
CI  - Copyright (c) 2013 Elsevier Ltd. All rights reserved.
FAU - Kim, Ki Hyang
AU  - Kim KH
AD  - Division of Hematology-Oncology, Department of Internal Medicine, Busan Paik 
      Hospital, Inje University College of Medicine, Busan, South Korea.
FAU - Kim, Ho Young
AU  - Kim HY
AD  - Division of Hematology-Oncology, Department of Internal Medicine, Hallym 
      University Medical Center, Hallym University College of Medicine, Seoul, South 
      Korea.
FAU - Kim, Hye Ryun
AU  - Kim HR
AD  - Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer 
      Research Institute, Yonsei Cancer Center, Yonsei University College of Medicine, 
      Seoul, South Korea.
FAU - Sun, Jong-Mu
AU  - Sun JM
AD  - Division of Hematology-Oncology, Department of Internal Medicine, Samsung Medical 
      Center, Sungkyunkwan University College of Medicine, Seoul, South Korea.
FAU - Lim, Ho Yeong
AU  - Lim HY
AD  - Division of Hematology-Oncology, Department of Internal Medicine, Samsung Medical 
      Center, Sungkyunkwan University College of Medicine, Seoul, South Korea.
FAU - Lee, Hyo Jin
AU  - Lee HJ
AD  - Division of Hematology-Oncology, Department of Internal Medicine, College of 
      Medicine, Chungnam National University, Daejeon, South Korea.
FAU - Lee, Suee
AU  - Lee S
AD  - Division of Hematology-Oncology, Department of Internal Medicine, Dong-A 
      University Medical Center, Busan, South Korea.
FAU - Bae, Woo Kyun
AU  - Bae WK
AD  - Division of Hematology-Oncology, Department of Internal Medicine, Chonnam 
      National University Hwasun Hospital, Hwasun-gun, Jeollanamdo, South Korea.
FAU - Rha, Sun Young
AU  - Rha SY
AD  - Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer 
      Research Institute, Yonsei Cancer Center, Yonsei University College of Medicine, 
      Seoul, South Korea. Electronic address: rha7655@yuhs.ac.
CN  - Korean Cancer Study Group
CN  - Genitourinary & Gynecology Cancer Committee
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20131211
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Indoles)
RN  - 0 (Pyrroles)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Carcinoma, Renal Cell/*complications/*drug therapy/epidemiology
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology
MH  - Female
MH  - Glomerular Filtration Rate/drug effects
MH  - Humans
MH  - Indoles/adverse effects/*therapeutic use
MH  - Kidney Neoplasms/*complications/*drug therapy/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Pyrroles/adverse effects/*therapeutic use
MH  - Registries
MH  - Renal Insufficiency/epidemiology/*etiology/physiopathology
MH  - Retrospective Studies
MH  - Sunitinib
MH  - Survival Analysis
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Metastatic renal cell carcinoma
OT  - Renal insufficiency
OT  - Sunitinib
EDAT- 2013/12/18 06:00
MHDA- 2014/04/15 06:00
CRDT- 2013/12/17 06:00
PHST- 2013/06/28 00:00 [received]
PHST- 2013/11/22 00:00 [revised]
PHST- 2013/11/25 00:00 [accepted]
PHST- 2013/12/17 06:00 [entrez]
PHST- 2013/12/18 06:00 [pubmed]
PHST- 2014/04/15 06:00 [medline]
AID - S0959-8049(13)01025-3 [pii]
AID - 10.1016/j.ejca.2013.11.029 [doi]
PST - ppublish
SO  - Eur J Cancer. 2014 Mar;50(4):746-52. doi: 10.1016/j.ejca.2013.11.029. Epub 2013 
      Dec 11.