Autier Julien, Escudier Bernard, Wechsler Janine, Spatz Alain, Robert Caroline
Dermatology Unit, Gustave Roussy Institute, 39 rue Camille Desmoulins, 94805 Villejuif Cedex, France.
Arch Dermatol. 2008 Jul;144(7):886-92. doi: 10.1001/archderm.144.7.886.
To provide an accurate description and to evaluate the incidence and severity of cutaneous reactions induced by sorafenib tosylate, a new oral multikinase inhibitor.
Double-blind, prospective dermatologic substudy performed on all consecutive patients included in our center in a large phase 3 trial.
Institutional practice at the Gustave Roussy Institute.
Eighty-five patients with renal cell cancer treated between November 1, 2003, and February 28, 2005. Interventions Patients were randomized to receive either sorafenib (n = 43) or placebo (n = 42). Dermatologic examination was performed before treatment, every 3 weeks during the first 4 cycles, and every 4 weeks thereafter.
Incidence and severity of cutaneous reactions to sorafenib.
Thirty-nine patients (91%) experienced at least 1 cutaneous reaction in the sorafenib group vs 3 (7%) in the placebo group. A hand-foot skin reaction that appeared to be clinically distinct from the well-known chemotherapy-induced hand-foot syndrome was observed in 26 patients receiving sorafenib (60%). Reversible grade 3 hand-foot skin reaction was documented in 2 patients receiving sorafenib and led to a dose reduction. Other cutaneous reactions were facial erythema, scalp dysesthesia, alopecia, and subungual splinter hemorrhages.
Sorafenib induces frequent cutaneous adverse events, some of which may lead to a dose reduction. Close collaboration between oncologists and dermatologists is needed to improve both the characterization and the management of these side effects. Appropriate patient education before the initiation of therapy and the introduction of early symptomatic measures may improve management.
准确描述并评估新型口服多激酶抑制剂甲苯磺酸索拉非尼引起的皮肤反应的发生率和严重程度。
在一项大型3期试验中，对本中心纳入的所有连续患者进行双盲、前瞻性皮肤病学亚研究。
古斯塔夫·鲁西研究所的机构实践。
2003年11月1日至2005年2月28日期间接受治疗的85例肾细胞癌患者。干预措施：患者被随机分为接受索拉非尼组（n = 43）或安慰剂组（n = 42）。在治疗前、前4个周期中每3周以及此后每4周进行一次皮肤科检查。
对索拉非尼的皮肤反应的发生率和严重程度。
索拉非尼组39例患者（91%）经历了至少1次皮肤反应，而安慰剂组为3例（7%）。在接受索拉非尼的26例患者（60%）中观察到一种手足皮肤反应，在临床上似乎与众所周知的化疗引起的手足综合征不同。2例接受索拉非尼的患者记录到可逆的3级手足皮肤反应，并导致剂量减少。其他皮肤反应包括面部红斑、头皮感觉异常、脱发和甲下裂片样出血。
索拉非尼经常引起皮肤不良事件，其中一些可能导致剂量减少。肿瘤学家和皮肤科医生需要密切合作，以改善这些副作用的特征描述和管理。在治疗开始前进行适当的患者教育并引入早期对症措施可能会改善管理。
