Non-pegylated liposomal doxorubicin plus capecitabine as first-line treatment in metastatic breast cancer

Purpose: To determine the toxicity and efficacy profile of non-pegylated doxorubicin in combination with capecitabine administered according to LipAX regimen. Materials and methods: The analysis included 5 female patients undergoing first-line treatment for metastatic breast cancer. Patients received non-pegylated doxorubicin intravenously and oral capecitabine at usual doses used for monotherapy, until disease progression or unacceptable toxicity. Results: Patients received a total of 26 complete treatment cycles according to LipAX regimen. During treatment, 15 toxicities occurred, including 7 adverse events with grade 3 severity. Only two haematological toxicities were observed, and the other 13 were of a non-haematological nature. Only one patient experienced no adverse events. Apart from symptomatic treatment, the capecitabine dose was reduced twice and the non-pegylated doxorubicin once. Positive clinical outcomes were observed in 4 patients, and disease progression was reported in the case of 1 patient in the course of the treatment. The median time to disease progression was 10.4 months, and the median overall survival was 34.2 months. During the 54-month follow-up, 4 of the patients died. The surviving patient continues treatment. Conclusions: Therapy according to the LipAX regimen was relatively well tolerated, however, since the majority of patients discontinued treatment due to adverse events, and not disease progression, an adequate reduction in the cytostatic doses should be considered. The use of the LipAX regimen may contribute to the achievement of long-term remission in some patients, a fact that encourages further studies on this form of therapy.