Reduced Incidence of Severe Palmar-Plantar Erythrodysesthesia and Mucositis in a Prospective Multicenter Phase II Trial with Pegylated Liposomal Doxorubicin at 40 mg/m² Every 4 Weeks in Previously Treated Patients with Metastatic Breast Cancer

Purpose: The aim of this study was to assess whether the reduction in the total dose of pegylated liposomal doxorubicin (PLD) per cycle from 50 mg/m² every 4 weeks to 40 mg/m² every 4 weeks can effectively lower the incidence of treatment-related palmar-plantar erythrodysesthesia (PPE) and mucositis. Methods: Patients received PLD 40 mg/m² every 4 weeks, and were evaluated for toxicity prior to each treatment and for response every 8 weeks. Results: All patients were previously treated with at least one chemotherapy regimen for metastatic disease, and 72% of the patients had a prior exposure to an anthracycline. Forty-six evaluable patients received a median of four PLD cycles, with a median dose intensity of 10 mg/m²/week and a median cumulative dose of 160 mg/m². No National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade 3 or 4 PPE was observed in these patients. NCI-CTC grade 3 or 4 mucositis occurred in 4.3% of patients, only. Response rates and survival results observed here were comparable to those observed with PLD 50 mg/m² every 4 weeks in a matched patient population. However, patients treated with PLD 40 mg/m² every 4 weeks experienced less PPE and mucositis and required clearly less dose reductions and treatment delays. Conclusion: The favorable safety profile observed in this study leads us to recommend the use of PLD 40 mg/m² every 4 weeks for patients with advanced breast cancer.