PMID- 25466382
OWN - NLM
STAT- MEDLINE
DCOM- 20160621
LR  - 20211203
IS  - 1776-260X (Electronic)
IS  - 1776-2596 (Linking)
VI  - 10
IP  - 3
DP  - 2015 Sep
TI  - Everolimus in patients with metastatic renal cell carcinoma previously treated 
      with bevacizumab: a prospective multicenter study CRAD001LRU02T.
PG  - 423-7
LID - 10.1007/s11523-014-0347-4 [doi]
AB  - Everolimus is an orally administered inhibitor of the mammalian target of 
      rapamycin (mTOR) recommended for patients with metastatic renal cell carcinoma 
      (mRCC) who progressed on previous vascular endothelial growth factor (VEGF) 
      receptor-tyrosine kinase inhibitor therapy. Efficacy of everolimus in patients 
      who progressed on anti-VEGF monoclonal antibody bevacizumab is unknown. We did a 
      multicenter prospective trial of everolimus in patients with mRCC whose disease 
      had progressed on bevacizumab +/- interferon alpha (IFN). Patients with clear-cell 
      mRCC which had progressed on bevacizumab +/- IFN received everolimus 10 mg once 
      daily. The primary end point was the proportion of patients remaining 
      progression-free for 56 days, and a two-stage Simon design was used, with 80% 
      power and an alpha risk of 5%. This study is registered with ClinicalTrials.gov, 
      number NCT02056587. From December 2011 to October 2013, a total of 37 patients 
      (28 M, 9 F) were enrolled. Median age was 60.5 years (range 41-66), 1% had 
      Eastern Cooperative Oncology Group Performance Status (ECOG PS) >2, and Memorial 
      Sloan-Kettering Cancer Center (MSKCC) favorable/intermediate risk was 38/62%. 
      Five (14%) patients had a confirmed partial response and 26 (70%) patients had a 
      stable disease. Median progression-free survival was 11.5 months (95% CI, 
      8.8-14.2). Median overall survival was not reached. No grade 3 or 4 
      treatment-related toxicities were observed. The most common grade 2 adverse 
      events were fatigue (19%) and pneumonitis (8%). Everolimus demonstrated a 
      favorable toxicity profile and promising anti-tumor activity as a second-line 
      therapy in metastatic renal cell carcinoma (RCC) patients previously treated with 
      bevacizumab +/- IFN.
FAU - Tsimafeyeu, Ilya
AU  - Tsimafeyeu I
AD  - Kidney Cancer Research Bureau, Bazovskaya ul. 4/1 off. 15, Moscow, Russia, 
      125635, tsimafeyeu@gmail.com.
FAU - Snegovoy, Anton
AU  - Snegovoy A
FAU - Varlamov, Sergei
AU  - Varlamov S
FAU - Safina, Sufia
AU  - Safina S
FAU - Varlamov, Ilya
AU  - Varlamov I
FAU - Gurina, Ludmila
AU  - Gurina L
FAU - Manzuk, Ludmila
AU  - Manzuk L
LA  - eng
SI  - ClinicalTrials.gov/NCT02056587
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20141204
PL  - France
TA  - Target Oncol
JT  - Targeted oncology
JID - 101270595
RN  - 0 (Antineoplastic Agents)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - 9HW64Q8G6G (Everolimus)
RN  - EC 2.7.1.1 (MTOR protein, human)
RN  - EC 2.7.11.1 (TOR Serine-Threonine Kinases)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*therapeutic use
MH  - Bevacizumab/*therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/mortality
MH  - Disease-Free Survival
MH  - Everolimus/*therapeutic use/toxicity
MH  - Female
MH  - Humans
MH  - Kidney Neoplasms/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Prospective Studies
MH  - TOR Serine-Threonine Kinases/metabolism
MH  - Treatment Outcome
EDAT- 2014/12/04 06:00
MHDA- 2016/06/22 06:00
CRDT- 2014/12/04 06:00
PHST- 2014/09/23 00:00 [received]
PHST- 2014/11/19 00:00 [accepted]
PHST- 2014/12/04 06:00 [entrez]
PHST- 2014/12/04 06:00 [pubmed]
PHST- 2016/06/22 06:00 [medline]
AID - 10.1007/s11523-014-0347-4 [doi]
PST - ppublish
SO  - Target Oncol. 2015 Sep;10(3):423-7. doi: 10.1007/s11523-014-0347-4. Epub 2014 Dec 
      4.