PMID- 25395378
OWN - NLM
STAT- MEDLINE
DCOM- 20150624
LR  - 20221207
IS  - 1559-131X (Electronic)
IS  - 1357-0560 (Linking)
VI  - 31
IP  - 12
DP  - 2014 Dec
TI  - A randomized phase II study of everolimus for advanced pancreatic neuroendocrine 
      tumors in Chinese patients.
PG  - 251
LID - 10.1007/s12032-014-0251-x [doi]
AB  - Everolimus, an oral inhibitor of mammalian target of mTOR, has been recently 
      shown to have antitumor effect in a phase III, double-blind, randomized trial 
      (RADIANT-3) of 410 patients with advanced pancreatic neuroendocrine tumors 
      (PNETs). The purpose of this study was to investigate the specific efficacy and 
      safety of everolimus in the Chinese patient with PNETs. In this randomized phase 
      II study, the analysis on Chinese patients was performed comparing efficacy and 
      safety between everolimus 10 mg/day orally (n = 44) and matching placebo (n = 
      35). The primary endpoint was progression-free survival (PFS). Adverse events 
      were also examined. The median PFS was 15.47 months with everolimus [95% 
      confidence interval (CI) 10.52-26.37], as compared to 4.29 months with placebo 
      (95% CI 2.22-10.75), representing a 72% reduction in the risk of progression or 
      death (hazard ratio 0.27; 95% CI 0.13-0.59; P < 0.001). Drug-associated adverse 
      events (AEs) were mostly grade 1 or 2, observed in all 44 (100%) patients 
      receiving everolimus and in 29 (83%) patients receiving placebo. The most common 
      AEs (grade 1-4) associated with everolimus were rash (n = 38; 86%), stomatitis (n 
      = 30; 68%), infections (n = 33; 75%), epistaxis (n = 32; 73%), pneumonitis (n = 
      27; 61%) and anemia (n = 22; 50%). Everolimus when compared with placebo is 
      effectively in improving PFS in Chinese patients with PNETs.
FAU - Yao, Jun
AU  - Yao J
AD  - Department of Gastroenterology, Shenzhen Municipal People's Hospital, Jinan 
      University of Medical Sciences, 1017 East Gate Road, Shenzhen, 518020, Guangdong 
      Province, China.
FAU - Wang, Jian-yao
AU  - Wang JY
FAU - Liu, Yi
AU  - Liu Y
FAU - Wang, Bin
AU  - Wang B
FAU - Li, Ying-xue
AU  - Li YX
FAU - Zhang, Ru
AU  - Zhang R
FAU - Wang, Li-sheng
AU  - Wang LS
FAU - Liu, Lei
AU  - Liu L
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PT  - Retracted Publication
DEP - 20141114
PL  - United States
TA  - Med Oncol
JT  - Medical oncology (Northwood, London, England)
JID - 9435512
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Immunosuppressive Agents)
RN  - 9HW64Q8G6G (Everolimus)
RN  - W36ZG6FT64 (Sirolimus)
SB  - IM
RIN - Med Oncol. 2015 Aug;32(8):221. PMID: 26195291
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*therapeutic use
MH  - *Asian People
MH  - Double-Blind Method
MH  - Everolimus
MH  - Female
MH  - Humans
MH  - Immunosuppressive Agents/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Neuroendocrine Tumors/diagnosis/*drug therapy/mortality
MH  - Pancreatic Neoplasms/diagnosis/*drug therapy/mortality
MH  - Sirolimus/*analogs & derivatives/therapeutic use
MH  - Survival Rate/trends
EDAT- 2014/11/15 06:00
MHDA- 2015/06/25 06:00
CRDT- 2014/11/15 06:00
PHST- 2014/08/19 00:00 [received]
PHST- 2014/09/12 00:00 [accepted]
PHST- 2014/11/15 06:00 [entrez]
PHST- 2014/11/15 06:00 [pubmed]
PHST- 2015/06/25 06:00 [medline]
AID - 10.1007/s12032-014-0251-x [doi]
PST - ppublish
SO  - Med Oncol. 2014 Dec;31(12):251. doi: 10.1007/s12032-014-0251-x. Epub 2014 Nov 14.