%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