Prevention Of Palmoplantar Erythrodysesthesia (Ppe) With An Antiperspirant In Breast Cancer Patients Treated With Pegylated Liposomal Doxorubicin (Pld), A Placebo-Controlled, Double Blinded, Phase Iii 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 e...