PMID- 26320662
OWN - NLM
STAT- MEDLINE
DCOM- 20160919
LR  - 20220408
IS  - 1938-0682 (Electronic)
IS  - 1558-7673 (Linking)
VI  - 13
IP  - 6
DP  - 2015 Dec
TI  - Long-Term Safety With Axitinib in Previously Treated Patients With Metastatic 
      Renal Cell Carcinoma.
PG  - 540-7.e1-7
LID - S1558-7673(15)00174-3 [pii]
LID - 10.1016/j.clgc.2015.07.001 [doi]
AB  - BACKGROUND: Axitinib is an approved treatment for advanced renal cell carcinoma 
      (RCC) after failure of 1 systemic therapy. PATIENTS AND METHODS: Long-term safety 
      with single-agent axitinib was analyzed using pooled data from clinical trials in 
      672 previously treated patients with metastatic RCC (mRCC) and in 1304 patients 
      with different advanced solid tumors. In all studies, except the phase I 
      first-in-human, dose-finding study, the starting dose of oral axitinib was 5 mg 
      twice daily continuously. Common long-term treatment-emergent adverse events 
      (AEs) were identified in patients who received axitinib for >/= 2 years, then 
      evaluated in all patients, and assessed using interval, cumulative, and latency 
      analyses. RESULTS: In all, 108 (16%) previously treated patients with mRCC 
      received axitinib for >/= 2 years. In interval analysis, most AEs occurred during 
      the first 6 months of treatment, with rates stable or decreased over time; rates 
      increased for proteinuria, peripheral edema, and increased blood creatinine. 
      Common Grade >/= 3 AE rates declined or plateaued over time, except for increased 
      amylase and myocardial infarction. Results were similar in cumulative analysis in 
      this population, and in interval and cumulative analyses in all patients with 
      mRCC and those with advanced solid tumors. CONCLUSION: Declining or stable rates 
      of most AEs support an acceptable long-term safety profile for axitinib in 
      patients with mRCC. However, increases in the rates of some AEs warrant 
      monitoring. This analysis is limited in that it was retrospective and included a 
      relatively small patient population.
CI  - Copyright (c) 2015 Elsevier Inc. All rights reserved.
FAU - Rini, Brian I
AU  - Rini BI
AD  - Department of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute, 
      Cleveland, OH. Electronic address: rinib2@ccf.org.
FAU - Escudier, Bernard
AU  - Escudier B
AD  - Gustave Roussy/Medical Oncology Department, Villejuif, France.
FAU - Hariharan, Subramanian
AU  - Hariharan S
AD  - Pfizer Oncology, New York, NY.
FAU - Roberts, W Gregory
AU  - Roberts WG
AD  - Pfizer Oncology, New York, NY.
FAU - Tarazi, Jamal
AU  - Tarazi J
AD  - Pfizer Oncology, New York, NY.
FAU - Rosbrook, Brad
AU  - Rosbrook B
AD  - Pfizer Oncology, New York, NY.
FAU - Askerova, Zena
AU  - Askerova Z
AD  - Pfizer Safety Evaluation and Reporting, Peapack, NJ.
FAU - DeAnnuntis, Liza L
AU  - DeAnnuntis LL
AD  - Pfizer Oncology, New York, NY.
FAU - Motzer, Robert J
AU  - Motzer RJ
AD  - Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20150720
PL  - United States
TA  - Clin Genitourin Cancer
JT  - Clinical genitourinary cancer
JID - 101260955
RN  - 0 (Imidazoles)
RN  - 0 (Indazoles)
RN  - 0 (Protein Kinase Inhibitors)
RN  - C9LVQ0YUXG (Axitinib)
SB  - IM
MH  - Axitinib
MH  - Carcinoma, Renal Cell/*drug therapy
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Imidazoles/administration & dosage/*adverse effects
MH  - Indazoles/administration & dosage/*adverse effects
MH  - Kidney Neoplasms/*drug therapy
MH  - Male
MH  - Neoplasm Metastasis
MH  - Protein Kinase Inhibitors/administration & dosage/*adverse effects
MH  - Retrospective Studies
OTO - NOTNLM
OT  - adverse events
OT  - tyrosine kinase inhibitor
OT  - vascular endothelial growth factor receptor
EDAT- 2015/09/01 06:00
MHDA- 2016/09/20 06:00
CRDT- 2015/09/01 06:00
PHST- 2015/05/11 00:00 [received]
PHST- 2015/07/01 00:00 [revised]
PHST- 2015/07/11 00:00 [accepted]
PHST- 2015/09/01 06:00 [entrez]
PHST- 2015/09/01 06:00 [pubmed]
PHST- 2016/09/20 06:00 [medline]
AID - S1558-7673(15)00174-3 [pii]
AID - 10.1016/j.clgc.2015.07.001 [doi]
PST - ppublish
SO  - Clin Genitourin Cancer. 2015 Dec;13(6):540-7.e1-7. doi: 
      10.1016/j.clgc.2015.07.001. Epub 2015 Jul 20.