Sorafenib-associated hand-foot syndrome in Japanese patients

Area of Science:

• Oncology
• Pharmacology
• Clinical Medicine

Background:

• Sorafenib (Nexavar) is an oral multi-kinase inhibitor used for metastatic renal cell carcinoma (RCC) and other cancers.
• Hand-foot syndrome (HFS) is a common adverse event associated with sorafenib treatment, potentially leading to dose reduction or interruption.
• Effective management strategies for sorafenib-induced HFS are crucial for maintaining treatment adherence and efficacy.

Purpose of the Study:

• To review the incidence and characteristics of sorafenib-associated HFS in Japanese patients.
• To evaluate the manageability of HFS in this patient population.
• To inform clinical practice for improved HFS management during sorafenib therapy.

Main Methods:

• Pooled analysis of HFS data from three sorafenib studies in Japanese patients (metastatic RCC, solid tumors, hepatocellular carcinoma).
• HFS severity graded using modified National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v2.0 and Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
• Inclusion of 189 patients for analysis of HFS incidence, severity, onset, and treatment outcomes.

Main Results:

• The overall incidence of all-grade HFS was 51% (ranging from 39% to 55% across studies).
• Grade 3 HFS occurred in 7% of patients, with a dose-dependent relationship observed.
• HFS onset typically occurred within 3-9 weeks; most cases were managed with symptomatic treatment, and only one patient permanently discontinued sorafenib due to HFS.

Conclusions:

• Sorafenib-associated HFS occurs frequently in Japanese patients but is generally manageable with symptomatic treatment.
• The incidence of HFS appears to be dose-dependent.
• Proactive management of HFS can help maintain treatment continuity and efficacy in patients receiving sorafenib.