A randomized phase II study of everolimus for advanced pancreatic neuroendocrine
tumors in Chinese patients.
Author(s): Yao J(1), Wang JY, Liu Y, Wang B, Li YX, Zhang R, Wang LS, Liu L.
Affiliation(s): Author information:
(1)Department of Gastroenterology, Shenzhen Municipal People's Hospital, Jinan
University of Medical Sciences, 1017 East Gate Road, Shenzhen, 518020, Guangdong
Province, China.
Publication date & source: 2014, Med Oncol. , 31(12):251
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.
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