%0 Generic
%A H., Tanioka
%A Y., Miyamoto
%A A., Tsuji
%A M., Asayama
%A T., Shiraishi
%A S., Yuki
%A M., Kotaka
%A A., Makiyama
%A M., Shimokawa
%A T., Shimose
%A S., Masuda
%A T., Yamaguchi
%A Y., Komatsu
%A H., Saeki
%A Y., Emi
%A H.
%A E., Oki
%A Y., Maehara
%A Cancer, Kyushu Study Group of Clinical
%D 2018
%T Supplementary Material for: 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)
%U https://karger.figshare.com/articles/dataset/Supplementary_Material_for_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_/5955847
%R 10.6084/m9.figshare.5955847.v1
%2 https://ndownloader.figshare.com/files/10667551
%2 https://ndownloader.figshare.com/files/10667554
%K Colorectal cancer
%K Regorafenib
%K Fatigue
%K Malaise
%K Dexamethasone
%X 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 incidence 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.
%I Karger Publishers