PMID- 28039705
OWN - NLM
STAT- MEDLINE
DCOM- 20170620
LR  - 20181202
IS  - 1107-0625 (Print)
IS  - 1107-0625 (Linking)
VI  - 21
IP  - 6
DP  - 2016 Nov-Dec
TI  - Safety profile of temsirolimus in patients with metastatic renal cell carcinoma.
PG  - 1442-1448
AB  - PURPOSE: Various targeted disease-specific therapeutics are currently approved, 
      demonstrating a survival benefit over therapy with interferon-alpha (IFN-alpha) in 
      patients with metastatic renal cell carcinoma (mRCC). Temsirolimus, a highly 
      specific inhibitor of the mammalian target of rapamycin (mTOR), improves the 
      overall and progression-free survival of high-risk patients with mRCC. The 
      purpose of this study was to estimate the effects of temsirolimus on several 
      laboratory parameters and to report the potential adverse events (AEs) in 
      patients with mRCC. METHODS: This research was a controlled, open, prospective 
      and partly retrospective randomized study that included 60 patients up to 65 
      years of age, divided into the experimental and control group, each containing 30 
      patients. Patients in the experimental group were treated with temsirolimus. The 
      control group comprised patients in the same stage of disease, treated with 
      IFN-alpha. The effect of therapy in both groups was monitored during the first year 
      of administration. RESULTS: The overall incidence of AEs was 40% in both groups. 
      Sixteen laboratory parameters were analyzed and the total number of deviations 
      from the reference range was 263 in the experimental group and 229 in the control 
      group. The total number of AEs regarding patient general clinical condition in 
      the experimental group was 193 (asthenia 53.3%, urinary infection 43.3% and 
      pyrexia 40%) and 175 in the control group (pyrexia 76.7%, asthenia 50% and tremor 
      50%). CONCLUSION: Monitoring the renal function parameters during the 
      temsirolimus administration has proved that the therapy had no significant 
      influence on the remaining kidney function. By evaluating the AEs we concluded 
      that there was no significant difference in the number of AEs of all grades 
      between the groups, while the laboratory parameters and physical status 
      deterioration differed qualitatively.
FAU - Levakov, Ivan
AU  - Levakov I
AD  - Urology Clinic, Clinical Center of Vojvodina, Novi Sad, Serbia.
FAU - Vojinov, Sasa
AU  - Vojinov S
FAU - Marusic, Goran
AU  - Marusic G
FAU - Popov, Milan
AU  - Popov M
FAU - Levakov, Olivera
AU  - Levakov O
FAU - Popov, Mladen
AU  - Popov M
FAU - Jeremic, Dimitrije
AU  - Jeremic D
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Cyprus
TA  - J BUON
JT  - Journal of B.U.ON. : official journal of the Balkan Union of Oncology
JID - 100883428
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Interferon alpha-2)
RN  - 0 (Interferon-alpha)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 0 (Recombinant Proteins)
RN  - 624KN6GM2T (temsirolimus)
RN  - W36ZG6FT64 (Sirolimus)
SB  - IM
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/secondary
MH  - Humans
MH  - Interferon alpha-2
MH  - Interferon-alpha/adverse effects/*therapeutic use
MH  - Kidney Neoplasms/*drug therapy/pathology
MH  - Prospective Studies
MH  - Protein Kinase Inhibitors/adverse effects/*therapeutic use
MH  - Recombinant Proteins/adverse effects/therapeutic use
MH  - Retrospective Studies
MH  - Serbia
MH  - Sirolimus/adverse effects/*analogs & derivatives/therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2017/01/01 06:00
MHDA- 2017/06/21 06:00
CRDT- 2017/01/01 06:00
PHST- 2017/01/01 06:00 [entrez]
PHST- 2017/01/01 06:00 [pubmed]
PHST- 2017/06/21 06:00 [medline]
PST - ppublish
SO  - J BUON. 2016 Nov-Dec;21(6):1442-1448.