Phase II study of pegylated liposomal doxorubicin in heavily pretreated epithelial ovarian cancer patients: May a new treatment schedule improve toxicity profile?

Objective: Pegylated liposomal doxorubicin (PLD) has shown promising activity in the treatment of recurrent ovarian cancer but skin toxicity remains the dose-limiting toxicity of the drug. The aim of this study was to investigate whether a different treatment schedule may improve the toxicity profile, especially in terms of dermatological and mucosal toxicity. Methods: It is an openlabel phase II study in a population of heavily pretreated ovarian cancer patients. PLD was administered at the dose of 35 mg/m² q21 until disease progression or unacceptable toxicity. Results: Thirty-seven heavily pretreated (median number of previous chemotherapy regimens 2, range 1-6) ovarian cancer patients were enrolled. All patients received at least two courses of chemotherapy and all were evaluated for response. No one showed complete response, while five partial responses (13.5%), 16 stabilizations of disease (48.6%) and 14 progressions of disease (37.8%) were observed. The median time to response was 12 weeks (range 8-16). The median duration of response was 22.8 weeks (range 4-68), the median duration of stabilization of disease was 17.6 weeks (range 4-28). Palmar plantar erythrodysesthesia (PPE) occurred in 8 patients (21.6%) and was of grade 3 in one patient (2.8%). Grade 1 stomatitis occurred in 3 patients (8.1%). Grade 3-4 neutropenia occurred in only 4 patients (10.8%). Conclusions: PLD at the dose of 35 mg/m² q21 seems to translate into an acceptable skin toxicity profile with a response rate comparable to others obtained with a standard schedule.