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Sorafenib‐associated hand–foot syndrome in Japanese patients
Author(s) -
IIJIMA Masafumi,
FUKINO Koichi,
ADACHI Masatoshi,
TSUKAMOTO Taiji,
MURAI Masaru,
NAITO Seiji,
MINAMI Hironobu,
FURUSE Junji,
AKAZA Hideyuki
Publication year - 2011
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/j.1346-8138.2010.01059.x
Subject(s) - sorafenib , medicine , tolerability , renal cell carcinoma , discontinuation , adverse effect , common terminology criteria for adverse events , hepatocellular carcinoma , oncology , incidence (geometry) , response evaluation criteria in solid tumors , hazard ratio , surgery , gastroenterology , phases of clinical research , toxicity , confidence interval , physics , optics
Abstract Sorafenib (Nexavar) is an oral multi‐kinase inhibitor that targets tumor growth and angiogenesis, having encouraging efficacy and tolerability in patients with metastatic renal cell carcinoma (RCC) and other tumors. However, hand–foot syndrome (HFS), a frequently reported adverse event under sorafenib treatment, sometimes causes interruption of the treatment or dose reduction. This study was conducted to review sorafenib‐associated HSF in Japanese patients, to facilitate improvement of the management of HFS in clinical practice. We reviewed the combined results on HFS in three sorafenib studies in Japanese patients: (A) a phase II study of metastatic renal cell carcinoma; (B) a phase I study of solid tumor; and (C), phase I study of hepatocellular carcinoma. Severity of HFS was graded as 1–3 based on the modified grading scale of National Cancer Institute – Common Toxicity Criteria version 2.0 and Common Terminology Criteria for Adverse Events version 3.0. A total of 189 patients were included for analyses. The incidence of all‐grade HFS was 51% (55% in A, 39% in B and 44% in C), and the incidence of grade 3 HFS was 7% (9% in A, 0% in B and 7% in C). Incidence of HFS seemed dose‐dependent. These events were observed within 3–9 weeks after initiation of sorafenib treatment. The majority of HFS was manageable with symptomatic treatment and HFS caused permanent discontinuation of sorafenib in only one patient (in study A). The incidence of sorafenib‐associated HFS is high compared to other adverse events. However, the present analyses showed that HFS under sorafenib treatment is well manageable in Japanese patients.