Prophylactic Effect of Dexamethasone on Regorafenib-Related Fatigue and/or Malaise: A Randomized, Placebo-Controlled, Double-Blind Clinical Study in Patients with Unresectable Metastatic Colorectal Cancer (KSCC1402/HGCSG1402)

Hiroaki Tanioka, Yuji Miyamoto, Akihito Tsuji, Masako Asayama, Takeshi Shiraishi, Satoshi Yuki, Masahito Kotaka, Akitaka Makiyama, Mototsugu Shimokawa, Takayuki Shimose, Satohiro Masuda, Takuhiro Yamaguchi, Yoshito Komatsu, Hiroshi Saeki, Yasunori Emi, Hideo Baba, Eiji Oki, Yoshihiko Maehara

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Regorafenib is an oral multikinase inhibitor with a proven survival benefit for metastatic colorectal cancer patients. The KSCC1402/HGCSG1402 study investigated the prophylactic effect of oral dexamethasone (DEX) on regorafenib-related fatigue and/or malaise. Patients and Methods: Patients who progressed after standard chemotherapy were randomized 1: 1 to a DEX group (2 mg/day; days 1-28) with regorafenib or a placebo group with regorafenib. The primary endpoint was the incidence of fatigue and/or malaise, based on version 4.0 of the National Cancer Institute's CTCAE (Common Terminology Criteria for Adverse Events). One of the secondary endpoints was the in-cidence of fatigue and/or malaise based on the CTCAE assessed by patient-reported outcome (PRO). Results: The incidence of any grade of fatigue and/or malaise assessed by the investigators was 58.8% in the DEX group and 61.1% in the placebo group (p = 0.8101), and that assessed by PRO was 47.2 and 58.3%, respectively (p = 0.3450). The incidence of grade ≥2 fatigue and/or malaise, as assessed by the investigators, was 19.4% for the DEX group and 38.9% for the placebo group (p = 0.0695), and that assessed by PRO was 27.8 and 52.8%, respectively (p = 0.0306). Conclusion: Our results suggest that prophylactic oral DEX is clinically effective in improving regorafenib-related fatigue and/or malaise.

Original languageEnglish
Pages (from-to)289-296
Number of pages8
JournalOncology (Switzerland)
Volume94
Issue number5
DOIs
Publication statusPublished - Apr 1 2018

Fingerprint

Double-Blind Method
Dexamethasone
Fatigue
Colorectal Neoplasms
Placebos
Terminology
Incidence
Research Personnel
National Cancer Institute (U.S.)
Clinical Studies
regorafenib
Drug Therapy
Survival
Patient Reported Outcome Measures

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Prophylactic Effect of Dexamethasone on Regorafenib-Related Fatigue and/or Malaise : A Randomized, Placebo-Controlled, Double-Blind Clinical Study in Patients with Unresectable Metastatic Colorectal Cancer (KSCC1402/HGCSG1402). / Tanioka, Hiroaki; Miyamoto, Yuji; Tsuji, Akihito; Asayama, Masako; Shiraishi, Takeshi; Yuki, Satoshi; Kotaka, Masahito; Makiyama, Akitaka; Shimokawa, Mototsugu; Shimose, Takayuki; Masuda, Satohiro; Yamaguchi, Takuhiro; Komatsu, Yoshito; Saeki, Hiroshi; Emi, Yasunori; Baba, Hideo; Oki, Eiji; Maehara, Yoshihiko.

In: Oncology (Switzerland), Vol. 94, No. 5, 01.04.2018, p. 289-296.

Research output: Contribution to journalArticle

Tanioka, H, Miyamoto, Y, Tsuji, A, Asayama, M, Shiraishi, T, Yuki, S, Kotaka, M, Makiyama, A, Shimokawa, M, Shimose, T, Masuda, S, Yamaguchi, T, Komatsu, Y, Saeki, H, Emi, Y, Baba, H, Oki, E & Maehara, Y 2018, 'Prophylactic Effect of Dexamethasone on Regorafenib-Related Fatigue and/or Malaise: A Randomized, Placebo-Controlled, Double-Blind Clinical Study in Patients with Unresectable Metastatic Colorectal Cancer (KSCC1402/HGCSG1402)', Oncology (Switzerland), vol. 94, no. 5, pp. 289-296. https://doi.org/10.1159/000486624
Tanioka, Hiroaki ; Miyamoto, Yuji ; Tsuji, Akihito ; Asayama, Masako ; Shiraishi, Takeshi ; Yuki, Satoshi ; Kotaka, Masahito ; Makiyama, Akitaka ; Shimokawa, Mototsugu ; Shimose, Takayuki ; Masuda, Satohiro ; Yamaguchi, Takuhiro ; Komatsu, Yoshito ; Saeki, Hiroshi ; Emi, Yasunori ; Baba, Hideo ; Oki, Eiji ; Maehara, Yoshihiko. / Prophylactic Effect of Dexamethasone on Regorafenib-Related Fatigue and/or Malaise : A Randomized, Placebo-Controlled, Double-Blind Clinical Study in Patients with Unresectable Metastatic Colorectal Cancer (KSCC1402/HGCSG1402). In: Oncology (Switzerland). 2018 ; Vol. 94, No. 5. pp. 289-296.
@article{3c7c1719977143fc9e95dbfef079c05b,
title = "Prophylactic Effect of Dexamethasone on Regorafenib-Related Fatigue and/or Malaise: A Randomized, Placebo-Controlled, Double-Blind Clinical Study in Patients with Unresectable Metastatic Colorectal Cancer (KSCC1402/HGCSG1402)",
abstract = "Background: Regorafenib is an oral multikinase inhibitor with a proven survival benefit for metastatic colorectal cancer patients. The KSCC1402/HGCSG1402 study investigated the prophylactic effect of oral dexamethasone (DEX) on regorafenib-related fatigue and/or malaise. Patients and Methods: Patients who progressed after standard chemotherapy were randomized 1: 1 to a DEX group (2 mg/day; days 1-28) with regorafenib or a placebo group with regorafenib. The primary endpoint was the incidence of fatigue and/or malaise, based on version 4.0 of the National Cancer Institute's CTCAE (Common Terminology Criteria for Adverse Events). One of the secondary endpoints was the in-cidence of fatigue and/or malaise based on the CTCAE assessed by patient-reported outcome (PRO). Results: The incidence of any grade of fatigue and/or malaise assessed by the investigators was 58.8{\%} in the DEX group and 61.1{\%} in the placebo group (p = 0.8101), and that assessed by PRO was 47.2 and 58.3{\%}, respectively (p = 0.3450). The incidence of grade ≥2 fatigue and/or malaise, as assessed by the investigators, was 19.4{\%} for the DEX group and 38.9{\%} for the placebo group (p = 0.0695), and that assessed by PRO was 27.8 and 52.8{\%}, respectively (p = 0.0306). Conclusion: Our results suggest that prophylactic oral DEX is clinically effective in improving regorafenib-related fatigue and/or malaise.",
author = "Hiroaki Tanioka and Yuji Miyamoto and Akihito Tsuji and Masako Asayama and Takeshi Shiraishi and Satoshi Yuki and Masahito Kotaka and Akitaka Makiyama and Mototsugu Shimokawa and Takayuki Shimose and Satohiro Masuda and Takuhiro Yamaguchi and Yoshito Komatsu and Hiroshi Saeki and Yasunori Emi and Hideo Baba and Eiji Oki and Yoshihiko Maehara",
year = "2018",
month = "4",
day = "1",
doi = "10.1159/000486624",
language = "English",
volume = "94",
pages = "289--296",
journal = "Oncology",
issn = "0030-2414",
publisher = "S. Karger AG",
number = "5",

}

TY - JOUR

T1 - Prophylactic Effect of Dexamethasone on Regorafenib-Related Fatigue and/or Malaise

T2 - A Randomized, Placebo-Controlled, Double-Blind Clinical Study in Patients with Unresectable Metastatic Colorectal Cancer (KSCC1402/HGCSG1402)

AU - Tanioka, Hiroaki

AU - Miyamoto, Yuji

AU - Tsuji, Akihito

AU - Asayama, Masako

AU - Shiraishi, Takeshi

AU - Yuki, Satoshi

AU - Kotaka, Masahito

AU - Makiyama, Akitaka

AU - Shimokawa, Mototsugu

AU - Shimose, Takayuki

AU - Masuda, Satohiro

AU - Yamaguchi, Takuhiro

AU - Komatsu, Yoshito

AU - Saeki, Hiroshi

AU - Emi, Yasunori

AU - Baba, Hideo

AU - Oki, Eiji

AU - Maehara, Yoshihiko

PY - 2018/4/1

Y1 - 2018/4/1

N2 - Background: Regorafenib is an oral multikinase inhibitor with a proven survival benefit for metastatic colorectal cancer patients. The KSCC1402/HGCSG1402 study investigated the prophylactic effect of oral dexamethasone (DEX) on regorafenib-related fatigue and/or malaise. Patients and Methods: Patients who progressed after standard chemotherapy were randomized 1: 1 to a DEX group (2 mg/day; days 1-28) with regorafenib or a placebo group with regorafenib. The primary endpoint was the incidence of fatigue and/or malaise, based on version 4.0 of the National Cancer Institute's CTCAE (Common Terminology Criteria for Adverse Events). One of the secondary endpoints was the in-cidence of fatigue and/or malaise based on the CTCAE assessed by patient-reported outcome (PRO). Results: The incidence of any grade of fatigue and/or malaise assessed by the investigators was 58.8% in the DEX group and 61.1% in the placebo group (p = 0.8101), and that assessed by PRO was 47.2 and 58.3%, respectively (p = 0.3450). The incidence of grade ≥2 fatigue and/or malaise, as assessed by the investigators, was 19.4% for the DEX group and 38.9% for the placebo group (p = 0.0695), and that assessed by PRO was 27.8 and 52.8%, respectively (p = 0.0306). Conclusion: Our results suggest that prophylactic oral DEX is clinically effective in improving regorafenib-related fatigue and/or malaise.

AB - Background: Regorafenib is an oral multikinase inhibitor with a proven survival benefit for metastatic colorectal cancer patients. The KSCC1402/HGCSG1402 study investigated the prophylactic effect of oral dexamethasone (DEX) on regorafenib-related fatigue and/or malaise. Patients and Methods: Patients who progressed after standard chemotherapy were randomized 1: 1 to a DEX group (2 mg/day; days 1-28) with regorafenib or a placebo group with regorafenib. The primary endpoint was the incidence of fatigue and/or malaise, based on version 4.0 of the National Cancer Institute's CTCAE (Common Terminology Criteria for Adverse Events). One of the secondary endpoints was the in-cidence of fatigue and/or malaise based on the CTCAE assessed by patient-reported outcome (PRO). Results: The incidence of any grade of fatigue and/or malaise assessed by the investigators was 58.8% in the DEX group and 61.1% in the placebo group (p = 0.8101), and that assessed by PRO was 47.2 and 58.3%, respectively (p = 0.3450). The incidence of grade ≥2 fatigue and/or malaise, as assessed by the investigators, was 19.4% for the DEX group and 38.9% for the placebo group (p = 0.0695), and that assessed by PRO was 27.8 and 52.8%, respectively (p = 0.0306). Conclusion: Our results suggest that prophylactic oral DEX is clinically effective in improving regorafenib-related fatigue and/or malaise.

UR - http://www.scopus.com/inward/record.url?scp=85043492638&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85043492638&partnerID=8YFLogxK

U2 - 10.1159/000486624

DO - 10.1159/000486624

M3 - Article

C2 - 29514163

AN - SCOPUS:85043492638

VL - 94

SP - 289

EP - 296

JO - Oncology

JF - Oncology

SN - 0030-2414

IS - 5

ER -