Retrospective Study
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World J Hepatol. Sep 27, 2014; 6(9): 670-676
Published online Sep 27, 2014. doi: 10.4254/wjh.v6.i9.670
Skin toxicity predicts efficacy to sorafenib in patients with advanced hepatocellular carcinoma
Masako Shomura, Tatehiro Kagawa, Koichi Shiraishi, Shunji Hirose, Yoshitaka Arase, Jun Koizumi, Tetsuya Mine
Masako Shomura, Department of Nursing, Tokai University School of Health Sciences, Isehara, Kanagawa 2591193, Japan
Tatehiro Kagawa, Koichi Shiraishi, Shunji Hirose, Yoshitaka Arase, Tetsuya Mine, Division of Gastroenterology, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa 2591193, Japan
Jun Koizumi, Department of Radiology, Tokai University School of Medicine, Isehara, Kanagawa 2591193, Japan
Author contributions: Shomura M and Kagawa T contributed equally to this study; Shomura M, Kagawa T, Shiraisi K, Hirose S and Arase Y performed the majority of sorafenib therapy; Koizumi J and Kagawa T provided evaluation the efficacy of therapy; Shomura M and Kagawa T provided the collection of all the data in addition to performing a statistical analysis and were also involved in writing and editing the manuscript; Shomura M provided financial support for this work; Mine T designed and coordinated the study.
Supported by Japan Society for the Promotion of Science (JSPS) KAKENHI Grant-in-Aid for Young Scientists (B) 21792240
Correspondence to: Masako Shomura, RN, PhD, Associate Professor, Department of Nursing, Tokai University School of Health Sciences, 143 Shimokasuya, Isehara, Kanagawa 2591193, Japan. rocky36j@is.icc.u-tokai.ac.jp
Telephone: +81-463-902035 Fax: +81-463-902035
Received: May 16, 2014
Revised: July 16, 2014
Accepted: August 27, 2014
Published online: September 27, 2014
Processing time: 155 Days and 23.6 Hours
Abstract

AIM: To study the relationship between adverse events (AEs), efficacy, and nursing intervention for sorafenib therapy in patients with hepatocellular carcinoma (HCC).

METHODS: We enrolled 37 consecutive patients with advanced HCC who received sorafenib therapy. Relationships among baseline characteristics as well as AE occurrence and tumor response, overall survival (OS), and treatment duration were analyzed. The nursing intervention program consisted of education regarding self-monitoring and AEs management, and telephone follow-up was provided once in 1-2 wk.

RESULTS: A total of 37 patients were enrolled in the study, comprising 30 males (81%) with a median age of 71 years. The disease control rate at 3 mo was 41%, and the median OS and treatment duration were 259 and 108 d, respectively. Nursing intervention was given to 24 patients (65%). Every patient exhibited some kinds of AEs, but no patients experienced G4 AEs. Frequently observed AEs > G2 included anorexia (57%), skin toxicity (57%), and fatigue (54%). Factors significantly associated with longer OS in multivariate analysis demonstrated that age ≤ 70 years, presence of > G2 skin toxicity, and absence of > G2 hypoalbuminemia. The disease control rate in patients with > G2 skin toxicity was 13/20 (65%), which was significantly higher compared with that in patients with no or G1 skin toxicity. Multivariate analysis revealed that nursing intervention and > G2 skin toxicity were independent significant predictors for longer treatment duration.

CONCLUSION: Skin toxicity was associated with favorable outcomes with sorafenib therapy for advanced HCC. Nursing intervention contributed to better adherence, which may improve the efficacy of sorafenib.

Keywords: Hepatocellular carcinoma; Molecular targeted therapy; Drug toxicity; Surrogate marker; Nursing intervention

Core tip: Sorafenib therapy for advanced hepatocellular carcinoma (HCC) often causes adverse events (AEs), subsequently leading to dose reduction or discontinuation. Conversely, few studies have associated serious AEs with a favorable response to sorafenib. We aimed to elucidate the relationship between AEs occurrence, therapeutic efficacy, and the impact of nursing intervention on adherence to therapy. We observed that skin toxicity was associated with favorable outcomes in sorafenib therapy for advanced HCC. Furthermore nursing intervention contributed to better adherence, which may improve the efficacy of sorafenib therapy.