Jung S, Sehouli J, Chekerov R, Kluschke F, Patzelt A, Fuss H, Knorr F, Lademann J
Department of Dermatology, Venerology and Allergology, Center of Experimental and Applied Cutaneous Physiology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Department of Gynaecology and Obstetrics, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Support Care Cancer. 2017 Nov;25(11):3545-3549. doi: 10.1007/s00520-017-3781-x. Epub 2017 Jun 26.
Palmoplantar erythrodysesthesia (PPE) is one of the most frequent side effects during systemic treatment with pegylated liposomal doxorubicin (PLD, Caelyx®). PPE lesions show a range of symptoms, from numbness to painful erosions, and can have a major impact on the quality of life in affected patients. Previously, a possible pathomechanism of PPE was found in doxorubicin-treated patients based on radical formation in the skin. Here, a preventive strategy using a topically applied ointment with a high radical protection factor was investigated.
In this randomized placebo-controlled double-blind study the antioxidant-containing ointment was compared with a placebo ointment regarding PPE grade III occurrence, overall PPE grade I-III occurrence and PPE severity in PLD patients. The verum or placebo cream was topically applied for a period of 16 weeks, starting 3 days prior to the first cycle of chemotherapy. Clinical evaluations were carried out by a dermatologist prior to the first cycle of chemotherapy and every 4 weeks for the duration of 16 weeks.
Thirty-two patients were enrolled in total, of which 17 (66%) completed the study. No PPE grade III was found in the verum group, while five out of seven patients (71%) had to be unblinded in the placebo arm due to PPE grade III (p = 0.003). General PPE occurrence of all grades was 60% under verum and 86% under placebo treatment.
The preventive application of an antioxidant-containing ointment was shown to be significantly more effective in the prevention of PPE grade III compared to placebo treatment.
手足红斑性感觉异常（PPE）是聚乙二醇化脂质体阿霉素（PLD，凯素）全身治疗期间最常见的副作用之一。PPE病变表现出一系列症状，从麻木到疼痛性糜烂，可对受影响患者的生活质量产生重大影响。此前，在接受阿霉素治疗的患者中，基于皮肤中自由基的形成发现了PPE可能的发病机制。在此，研究了一种使用具有高自由基保护因子的局部应用软膏的预防策略。
在这项随机、安慰剂对照、双盲研究中，将含抗氧化剂的软膏与安慰剂软膏在PLD患者的PPE III级发生率、总体PPE I - III级发生率和PPE严重程度方面进行了比较。从化疗第一周期前3天开始，将试验用乳膏或安慰剂乳膏局部应用16周。在化疗第一周期前由皮肤科医生进行临床评估，并在16周的时间内每4周进行一次评估。
共纳入32例患者，其中17例（66%）完成了研究。试验组未发现PPE III级，而安慰剂组7例患者中有5例（71%）因PPE III级而揭盲（p = 0.003）。试验组所有等级的PPE总体发生率为60%，安慰剂治疗组为86%。
与安慰剂治疗相比，含抗氧化剂软膏的预防性应用在预防PPE III级方面显示出显著更高的有效性。
