Randomized double-blind controlled trial of the pre-emptive steroid treatment on Hand-foot skin reaction with sorafenib (PRESSO)
演題番号 : P52-1
1:Patient Safety Unit, Hospital, Kyoto University、2:Department of Surgery, Graduate School of Medicine, Kyoto University、3:Institute for Advancement of Clinical and Translational Science, Hospital, Kyoto University、4:National Hospital Organization Kyoto Medical Center、5:Division of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center、6:Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University、7:Second Department of Surgery, Faculty of Medicine, Hamamatsu University School of Medicine、8:Department of Hepato-Biliary-Pancreatic Surgery, Graduate School of Medicine, Osaka City University、9:Kyoto Katsura Hospital、10:Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East、11:Department of Surgery, School of Medicine, Fujita Health University、12:Department of Hepatobiliary and Pancreatic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases
To assess whether steroid ointment has prophylactic benefits on sorafenib-induced hand-foot skin reaction (HFSR) in patients with advanced hepatocellular carcinoma (HCC).
Patients and Methods
In this randomized double-blind controlled trial, patients with advanced HCC were randomly assigned to receive treatment with steroid ointment (betamethasone) or placebo ointment (petrolatum), starting on day-1 of sorafenib treatment, for up to 6 weeks. HFSR was assessed at about 2 weeks, 4 weeks, and 6 weeks for patients completing the study. The primary end point of the study was proportion of developing ≧ grade 2 HFSR within 6 weeks of starting sorafenib. Secondary outcomes include 6-month mortality and proportion of the patients with dose reduction. Fisher's exact test was used for univariate analysis.
Of 76 enrolled patients, 39 received pre-emptive topical betamethasone treatment, and 37 received placebo treatment. The proportions of developing ≧ grade 2 HFSR were 37.5% and 35.1% for betamethasone group and placebo group, respectively (P=0.82). Mortality rates at 6-months were 12.8% and 13.5% (P=1.00), and the proportions with dose reduction of sorafenib were 48.7% and 32.4% (P=0.17) for betamethasone and placebo group, respectively.
Pre-emptive topical steroid treatment has no significant prophylactic benefits on sorafenib-induced HFSR than treatment with petrolatum.