Epidemiologic study to evaluate the treatment of palmar-plantar erythrodysesthesia (PPE) in patients (pts) with ovarian cancer (OC) or metastatic breast cancer (MBC) treated with pegylated liposomal doxorubicin (PLD).

Abstract

e12014 Background: PLD is a highly active agent for OC and MBC. Liposome encapsulation and pegylation of PLD alters the pharmacokinetic and side effect (SE) profiles of conventional doxorubicin, improving its therapeutic ratio. PPE is a common SE of PLD and may be related to the pressure-dependent extravasation of liposomes into the skin. Methods: Pts with OC or MBC being treated with PLD were observed. The primary objectives were frequency of PPE as well as the curative pharmacologic and/or prophylactic treatment for PPE. Secondary objectives were numbers of pts that required change in PLD treatment dose/schedule due to PPE and pts compliance to PPE treatment. Results: 154 pts from 16 Spanish hospitals were evaluable. The mean age was 62.4 y (range: 39-83). 73 pts had MBC and 81 had OC. 140 pts (90.9%) received PLD monotherapy with a mean of 3.9 cycles. The mean accumulated dose and dose intensity of PLD were 95.4 mg/m2 (15-331.5) and 9.7 mg/m2/week (4.4-23.3), respectively. At time of study enrollment, 65 pts presented with PPE (grade 1 n = 42; grade 2 n = 15; grade 3 n = 8; no grade 4). The median duration of PPE was 23 days (0-226). PLD treatment was adjusted in 18 pts (11.7%): delayed in 10 pts and dose reduced (to mean of 35 mg/m2 [30-40]) in 8 pts. PLD had to be interrupted in 4 pts. 14 pts (9.1%) received curative therapy for PPE, 52 (33.8%) received prophylaxis, and 6 (3.9%) received both. Most pts (n=55, 76.4%) received one treatment for PPE. Common pharmacologic strategies were oral dexamethasone (n = 10; 71.4%), pyridoxine (n = 8, 57.1%), topical corticosteroids (n = 8, 57.1%), and topical DMSO 99% (n = 3, 21.4%). Nonpharmacologic strategies were avoid excessive heat/water (n = 14, 100%), keep skin hydrated (n = 12, 85.7%), avoid sweating and physical activity (n = 7, 50%), avoid tight fitting clothing (n = 12, 85.7%), and local cooling of hands/feet (n = 6, 42.9%). Compliance with each educational recommendation was low (< 45%). Conclusions: While PPE was an observed SE of PLD in these MBC and OC pts, it was manageable. Patient education to ensure compliance with PPE preventive measures and treatments is important in controlling this SE. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Schering-Plough