Everolimus for advanced pancreatic neuroendocrine tumours: A subgroup analysis evaluating japanese patients in the radiant-3 trial

Tetsuhide Ito, Takuji Okusaka, Masafumi Ikeda, Hisato Igarashi, Chigusa Morizane, Kohei Nakachi, Takeshi Tajima, Akio Kasuga, Yoshie Fujita, Junji Furuse

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

Objective: Everolimus, an inhibitor of the mammalian target of rapamycin, has recently demonstrated efficacy and safety in a Phase III, double-blind, randomized trial (RADIANT-3) in 410 patients with low- or intermediate-grade advanced pancreatic neuroendocrine tumours. Everolimus 10 mg/day provided a 2.4-fold improvement compared with placebo in progression-free survival, representing a 65% risk reduction for progression. The purpose of this analysis was to investigate the efficacy and safety of everolimus in the Japanese subgroup enrolled in the RADIANT-3 study. Methods: Subgroup analysis of the Japanese patients was performed comparing efficacy and safety between everolimus 10 mg/day orally (n = 23) and matching placebo (n = 17). The primary endpoint was progression-free survival. Safety was evaluated on the basis of the incidence of adverse drug reactions. Results: Progression-free survival was significantly prolonged with everolimus compared with placebo. The median progression-free survival was 19.45 months (95% confidence interval, 8.31-not available) with everolimus vs 2.83 months (95% confidence interval, 2.46-8.34) with placebo, resulting in an 81% risk reduction in progression (hazard ratio, 0.19; 95% confidence interval, 0.08-0.48; P< 0.001). Adverse drug reactions occurred in all 23 (100%) Japanese patients receiving everolimus and in 13 (77%) patients receiving placebo; most were grade 1/2 in severity. The most common adverse drug reactions in the everolimus group were rash (n = 20; 87%), stomatitis (n = 17; 74%), infections (n = 15; 65%), nail disorders (n = 12; 52%), epistaxis (n = 10; 44%) and pneumonitis (n = 10; 44%). Conclusions: These results support the use of everolimus as a valuable treatment option for Japanese patients with advanced pancreatic neuroendocrine tumours.

Original languageEnglish
Article numberhys123
Pages (from-to)903-911
Number of pages9
JournalJapanese journal of clinical oncology
Volume42
Issue number10
DOIs
Publication statusPublished - Oct 1 2012

Fingerprint

Neuroendocrine Tumors
Placebos
Disease-Free Survival
Drug-Related Side Effects and Adverse Reactions
Safety
Confidence Intervals
Risk Reduction Behavior
Everolimus
Stomatitis
Epistaxis
Sirolimus
Nails
Exanthema
Pneumonia
Incidence

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Everolimus for advanced pancreatic neuroendocrine tumours : A subgroup analysis evaluating japanese patients in the radiant-3 trial. / Ito, Tetsuhide; Okusaka, Takuji; Ikeda, Masafumi; Igarashi, Hisato; Morizane, Chigusa; Nakachi, Kohei; Tajima, Takeshi; Kasuga, Akio; Fujita, Yoshie; Furuse, Junji.

In: Japanese journal of clinical oncology, Vol. 42, No. 10, hys123, 01.10.2012, p. 903-911.

Research output: Contribution to journalArticle

Ito, T, Okusaka, T, Ikeda, M, Igarashi, H, Morizane, C, Nakachi, K, Tajima, T, Kasuga, A, Fujita, Y & Furuse, J 2012, 'Everolimus for advanced pancreatic neuroendocrine tumours: A subgroup analysis evaluating japanese patients in the radiant-3 trial', Japanese journal of clinical oncology, vol. 42, no. 10, hys123, pp. 903-911. https://doi.org/10.1093/jjco/hys123
Ito, Tetsuhide ; Okusaka, Takuji ; Ikeda, Masafumi ; Igarashi, Hisato ; Morizane, Chigusa ; Nakachi, Kohei ; Tajima, Takeshi ; Kasuga, Akio ; Fujita, Yoshie ; Furuse, Junji. / Everolimus for advanced pancreatic neuroendocrine tumours : A subgroup analysis evaluating japanese patients in the radiant-3 trial. In: Japanese journal of clinical oncology. 2012 ; Vol. 42, No. 10. pp. 903-911.
@article{ab26fbdb0d1d4a90804099cc61ed8e0d,
title = "Everolimus for advanced pancreatic neuroendocrine tumours: A subgroup analysis evaluating japanese patients in the radiant-3 trial",
abstract = "Objective: Everolimus, an inhibitor of the mammalian target of rapamycin, has recently demonstrated efficacy and safety in a Phase III, double-blind, randomized trial (RADIANT-3) in 410 patients with low- or intermediate-grade advanced pancreatic neuroendocrine tumours. Everolimus 10 mg/day provided a 2.4-fold improvement compared with placebo in progression-free survival, representing a 65{\%} risk reduction for progression. The purpose of this analysis was to investigate the efficacy and safety of everolimus in the Japanese subgroup enrolled in the RADIANT-3 study. Methods: Subgroup analysis of the Japanese patients was performed comparing efficacy and safety between everolimus 10 mg/day orally (n = 23) and matching placebo (n = 17). The primary endpoint was progression-free survival. Safety was evaluated on the basis of the incidence of adverse drug reactions. Results: Progression-free survival was significantly prolonged with everolimus compared with placebo. The median progression-free survival was 19.45 months (95{\%} confidence interval, 8.31-not available) with everolimus vs 2.83 months (95{\%} confidence interval, 2.46-8.34) with placebo, resulting in an 81{\%} risk reduction in progression (hazard ratio, 0.19; 95{\%} confidence interval, 0.08-0.48; P< 0.001). Adverse drug reactions occurred in all 23 (100{\%}) Japanese patients receiving everolimus and in 13 (77{\%}) patients receiving placebo; most were grade 1/2 in severity. The most common adverse drug reactions in the everolimus group were rash (n = 20; 87{\%}), stomatitis (n = 17; 74{\%}), infections (n = 15; 65{\%}), nail disorders (n = 12; 52{\%}), epistaxis (n = 10; 44{\%}) and pneumonitis (n = 10; 44{\%}). Conclusions: These results support the use of everolimus as a valuable treatment option for Japanese patients with advanced pancreatic neuroendocrine tumours.",
author = "Tetsuhide Ito and Takuji Okusaka and Masafumi Ikeda and Hisato Igarashi and Chigusa Morizane and Kohei Nakachi and Takeshi Tajima and Akio Kasuga and Yoshie Fujita and Junji Furuse",
year = "2012",
month = "10",
day = "1",
doi = "10.1093/jjco/hys123",
language = "English",
volume = "42",
pages = "903--911",
journal = "Japanese Journal of Clinical Oncology",
issn = "0368-2811",
publisher = "Oxford University Press",
number = "10",

}

TY - JOUR

T1 - Everolimus for advanced pancreatic neuroendocrine tumours

T2 - A subgroup analysis evaluating japanese patients in the radiant-3 trial

AU - Ito, Tetsuhide

AU - Okusaka, Takuji

AU - Ikeda, Masafumi

AU - Igarashi, Hisato

AU - Morizane, Chigusa

AU - Nakachi, Kohei

AU - Tajima, Takeshi

AU - Kasuga, Akio

AU - Fujita, Yoshie

AU - Furuse, Junji

PY - 2012/10/1

Y1 - 2012/10/1

N2 - Objective: Everolimus, an inhibitor of the mammalian target of rapamycin, has recently demonstrated efficacy and safety in a Phase III, double-blind, randomized trial (RADIANT-3) in 410 patients with low- or intermediate-grade advanced pancreatic neuroendocrine tumours. Everolimus 10 mg/day provided a 2.4-fold improvement compared with placebo in progression-free survival, representing a 65% risk reduction for progression. The purpose of this analysis was to investigate the efficacy and safety of everolimus in the Japanese subgroup enrolled in the RADIANT-3 study. Methods: Subgroup analysis of the Japanese patients was performed comparing efficacy and safety between everolimus 10 mg/day orally (n = 23) and matching placebo (n = 17). The primary endpoint was progression-free survival. Safety was evaluated on the basis of the incidence of adverse drug reactions. Results: Progression-free survival was significantly prolonged with everolimus compared with placebo. The median progression-free survival was 19.45 months (95% confidence interval, 8.31-not available) with everolimus vs 2.83 months (95% confidence interval, 2.46-8.34) with placebo, resulting in an 81% risk reduction in progression (hazard ratio, 0.19; 95% confidence interval, 0.08-0.48; P< 0.001). Adverse drug reactions occurred in all 23 (100%) Japanese patients receiving everolimus and in 13 (77%) patients receiving placebo; most were grade 1/2 in severity. The most common adverse drug reactions in the everolimus group were rash (n = 20; 87%), stomatitis (n = 17; 74%), infections (n = 15; 65%), nail disorders (n = 12; 52%), epistaxis (n = 10; 44%) and pneumonitis (n = 10; 44%). Conclusions: These results support the use of everolimus as a valuable treatment option for Japanese patients with advanced pancreatic neuroendocrine tumours.

AB - Objective: Everolimus, an inhibitor of the mammalian target of rapamycin, has recently demonstrated efficacy and safety in a Phase III, double-blind, randomized trial (RADIANT-3) in 410 patients with low- or intermediate-grade advanced pancreatic neuroendocrine tumours. Everolimus 10 mg/day provided a 2.4-fold improvement compared with placebo in progression-free survival, representing a 65% risk reduction for progression. The purpose of this analysis was to investigate the efficacy and safety of everolimus in the Japanese subgroup enrolled in the RADIANT-3 study. Methods: Subgroup analysis of the Japanese patients was performed comparing efficacy and safety between everolimus 10 mg/day orally (n = 23) and matching placebo (n = 17). The primary endpoint was progression-free survival. Safety was evaluated on the basis of the incidence of adverse drug reactions. Results: Progression-free survival was significantly prolonged with everolimus compared with placebo. The median progression-free survival was 19.45 months (95% confidence interval, 8.31-not available) with everolimus vs 2.83 months (95% confidence interval, 2.46-8.34) with placebo, resulting in an 81% risk reduction in progression (hazard ratio, 0.19; 95% confidence interval, 0.08-0.48; P< 0.001). Adverse drug reactions occurred in all 23 (100%) Japanese patients receiving everolimus and in 13 (77%) patients receiving placebo; most were grade 1/2 in severity. The most common adverse drug reactions in the everolimus group were rash (n = 20; 87%), stomatitis (n = 17; 74%), infections (n = 15; 65%), nail disorders (n = 12; 52%), epistaxis (n = 10; 44%) and pneumonitis (n = 10; 44%). Conclusions: These results support the use of everolimus as a valuable treatment option for Japanese patients with advanced pancreatic neuroendocrine tumours.

UR - http://www.scopus.com/inward/record.url?scp=84866751750&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84866751750&partnerID=8YFLogxK

U2 - 10.1093/jjco/hys123

DO - 10.1093/jjco/hys123

M3 - Article

C2 - 22859827

AN - SCOPUS:84866751750

VL - 42

SP - 903

EP - 911

JO - Japanese Journal of Clinical Oncology

JF - Japanese Journal of Clinical Oncology

SN - 0368-2811

IS - 10

M1 - hys123

ER -