Development of Hand Foot Skin Reaction Is Associated with Good Prognosis for HCC Patients Treated with Sorafenib: A Prospective Cohort Study = Development of Hand Foot Skin Reaction Is Associated with Good Prognosis for HCC Patients Treated with Sorafenib: A Prospective Cohort Study

다국어 초록 (Multilingual Abstract)

Aims: Sorafenib is a standard first-line systemic therapy of advanced hepatocellular carcinoma (HCC). However there are few studies that have examined prognostic factors of sorafenib therapy in prospective cohort. We analyze prognostic factors of HCC patients who were treated with sorafenib.
Methods: Between May 2016 and May 2018, 288 advanced HCC patients treated with sorafenib were prospectively enrolled at 13 hospitals. Originally, this study has been performed to investigated the efficacy of Urea cream. We analyzed various prognostic factors of sorafenib for overall survival (OS) and progression free survival (PFS) by Univariate and Multivariate analyses using Cox proportional hazards regression model.
Results: We included 288 patients in the present analysis. The median age was 61 years. Among the 288 patients, 241 (83.7%) were male. Chronic hepatitis B (68.4%) was main etiologic factor in development of HCC. Most of the patients (85.4%) were in the advanced Barcelona Clinic Liver Cancer Stage. Hand-foot skin reactions (HFSR) were observed in 142 patients (49.2%). The univariate analysis identified presence of HFSR, serum albumin level as potential prognostic factor for PFS. In multivariate analysis for PFS, presence of HFSR (HR 0.212; 95% CI: 0.091-0.495, P<0.001) and serum albumin level (HR 0.30, 95% CI: 0.158-0.568, P<0.001) were significant factors of PFS. Prognostic factors for OS were analyzed in the same method. In univariate analysis, presence of ascites, serum albumin level and creatinine level, presence of HFSR were potential prognostic factors for OS. In multivariate analysis for OS, presence of HFSR (HR 0.144; 95% CI: 0.063-0.330, p 0.002), albumin level (HR ratio 0.283; 95% CI: 0.148-0.544, P<0.001), creatinine level (HR 1.395; 95% CI 1.133-1.717, p 0.002) were significant factors of OS. BCLC stage, presence of portal vein invasion, presence of distant metastasis were not statistically significant in the present analysis.
Conclusions: Developing HFSR from sorafenib therapy and high serum albumin level were independently associated with good OS and PFS. Developing HFSR have been suggested as valuable indicator of good sorafenib prognosis.