Prevention of palmoplantar erythrodysesthesia (PPE) with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (PLD), a placebo-controlled, double blinded, phase lll trial (SAKK 92/08).

9059 Background: PPE, also known as hand-foot syndrome, is a distinctive adverse drug reaction of PLD treatment. PLD has been detected in elevated concentrations in eccrine sweat glands in palms and soles. We postulated that prophylactic administration of an antiperspirant (F511 cream) prior and during treatment with PLD could decrease the incidence of PPE. Methods: Patients (pts) with metastatic breast cancer treated with PLD monotherapy ≥10mg/m2 per week applied an antiperspirant to the left or right hand and foot and a corresponding placebo to the opposite site with double-blinding for the content of the cream applied to either side (intra-patient randomization). The creams were applied once daily during the first week, then three times per week. The primary endpoint was the rate of PPE grade (G) ≥ 2 in the antiperspirant or placebo treated side. Pts were evaluable if they developed PPE G ≥ 2 or had received cumulatively at least 160mg/m2 PLD. Patient-reported extent of symptom burden was a secondary endpoint. Using McNemar’s matched pairs design 53 pts were needed to detect a difference of 20% between the sides with a significance level of 5% and power of 90%. Results: 52 of 90 pts from 11 Swiss centers included were evaluable. Median age was 64.5 years; median duration of PLD treatment was 12 weeks. 30 pts developed PPE G ≥ 2. In 3 pts PPE G ≥ 2 occurred on the placebo side but not on the antiperspirant side (p=0.097; table). PPE G ≥ 2 was borderline significantly more frequent in placebo foot than antiperspirant foot (p=0.048). Patient-reported extent of symptom burden showed a trend in favor of the antiperspirant side for skin problems (peeling, blistering, bleeding) in the group of pts with PPE G ≥ 2 (p=0.051). Conclusions: In this double-blind trial with intra-patient randomization we observed a trend towards less PPE G ≥ 2 with application of the antiperspirant cream F511 in pts treated with PLD as determined by the treating physician and reported by the pts. [Table: see text]