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A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Effect of Topical Urea for Secondary Prophylaxis of Hand Foot Skin Reaction in Renal Cell Cancer Patients on Sunitinib Therapy.
Clin Genitourin Cancer
June 2024
Ocular Pharmacology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
Introduction: Hand foot skin reaction (HFSR) is a common dose-limiting adverse effect of multi kinase inhibitors (MKI) whose mechanism is not fully understood, and the prophylaxis is inadequate.
Objective: In this pilot study, a double-blind, randomized placebo-controlled trial was conducted to evaluate the effect of topical urea in secondary prevention of sunitinib-induced HFSR in renal cell cancer patients.
Methods: Out of 55 screened patients, 14 were randomized to receive topical urea or placebo for four weeks.
Safety and Efficacy of Bis-Glyceryl Ascorbate as Prophylaxis for Hand-Foot Skin Reaction: A Single-Arm, Open-Label Phase I/II Study (DGA Study).
Oncologist
May 2022
Department of Pharmacy, Kobe University Hospital, Kobe, Japan.
Article Synopsis
- The study investigated the effectiveness of a cream containing bis-glyceryl ascorbate (DGA cream) to prevent hand-foot skin reactions (HFSR) caused by sunitinib treatment in patients with metastatic renal cell carcinoma (mRCC).
- It was a phase I/II trial where 24 patients used DGA cream during sunitinib therapy, with phase I focusing on safety and phase II assessing the effectiveness of preventing HFSR.
- Results showed that only 12.5% of participants developed HFSR, significantly lower than the expected threshold of 33.3%, indicating that DGA cream may provide a protective benefit.
Meta-Analysis of ABCG2 and ABCB1 Polymorphisms With Sunitinib-Induced Toxicity and Efficacy in Renal Cell Carcinoma.
Front Pharmacol
March 2021
Department of Pharmacy, The First Affiliated Hospital of Third Military Medical University (Army Medical University), Chongqing, China.
ABCG2 and ABCB1 are genes related to the pharmacokinetics of sunitinib and have been associated with its toxicity and efficacy. However, the results have been controversial. This study aimed to evaluate the associations of ABCG2 and ABCB1 polymorphisms with sunitinib-induced toxicity and efficacy in renal cell carcinoma (RCC) by meta-analysis.
View Article and Find Full Text PDFSunitinib decreases the expression of KRT6A and SERPINB1 in 3D human epidermal models.
Exp Dermatol
March 2021
Department of Pharmacy, Kobe University Hospital, Kobe, Japan.
Hand-foot skin reaction (HFSR) is a common side effect caused by several tyrosine kinase inhibitors, including sunitinib. However, the nature of the cornifying factors related to the molecular biological mechanisms underlying HFSR remains poorly understood. We used human keratinocyte models to investigate the key cornifying factors for dermatological and biological abnormalities induced by sunitinib.
View Article and Find Full Text PDFSafety and Efficacy of Bis-Glyceryl Ascorbate (Amitose DGA) to Prevent Hand-Foot Skin Reaction in Patients With Renal Cell Carcinoma Receiving Sunitinib Therapy: Protocol for a Phase I/II, Uncontrolled, Single-Arm, Open-Label Trial.
JMIR Res Protoc
August 2019
Department of Pharmacy, Kobe University Hospital, Kobe, Japan.
Background: Hand-foot skin reaction (HFSR) is a serious side effect induced by multiple-tyrosine kinase inhibitors (TKIs). HFSR can cause treatment interruption or decreased dosing. HFSR also markedly decreases quality of life and is associated with the therapeutic efficacy of multiple-TKIs.
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