Nardone Beatrice, Hensley Jennifer R, Kulik Laura, West Dennis P, Mulcahy Mary, Rademaker Alfred, Lacouture Mario E
Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
J Drugs Dermatol. 2012 Nov;11(11):e61-5.
The multikinase inhibitors sorafenib (SO) and sunitinib (SU) have shown benefit in a wide range of solid tumors. Although these agents are generally well tolerated, they may be associated with dermatologic adverse events, particularly hand-foot skin reaction (HFSR). The aim of this study is to evaluate the impact of HFSR associated with these multikinase inhibitors on patient health-related quality of life (HRQOL).
Twenty-three patients with HFSR related to SO or SU were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 for clinical severity and for impact on HRQOL through completion of the patient self-administered Skindex-16 (SK-16). Clinical severity scores were compared to HRQOL assessments.
Of the 23 patients with HFSR, clinical severity was grade 1 in 17.4%, grade 2 in 74%, and grade 3 in 8.6%. Median SK-16 scores were reported for symptoms (53.3), emotions (30.6), and functioning subscales (33.3). Median symptoms and emotions scores positively correlated with HFSR clinical severity grade.
These findings demonstrate that HFSR related to SO or SU negatively impacts HRQOL, with the symptoms domain being most significantly affected. In addition, CTCAE toxicity grading correlates with HRQOL.
多激酶抑制剂索拉非尼(SO)和舒尼替尼(SU)已在多种实体瘤中显示出疗效。尽管这些药物通常耐受性良好,但它们可能与皮肤不良事件有关,尤其是手足皮肤反应(HFSR)。本研究的目的是评估与这些多激酶抑制剂相关的HFSR对患者健康相关生活质量(HRQOL)的影响。
使用美国国立癌症研究所的不良事件通用术语标准(CTCAE)第3.0版对23例与SO或SU相关的HFSR患者进行临床严重程度分级,并通过患者自行填写的Skindex-16(SK-16)评估其对HRQOL的影响。将临床严重程度评分与HRQOL评估结果进行比较。
在23例HFSR患者中,临床严重程度为1级的占17.4%,2级的占74%,3级的占8.6%。症状、情绪和功能分量表的SK-16评分中位数分别为53.3、30.6和33.3。症状和情绪评分中位数与HFSR临床严重程度分级呈正相关。
这些发现表明,与SO或SU相关的HFSR对HRQOL有负面影响,其中症状领域受影响最为显著。此外,CTCAE毒性分级与HRQOL相关。