Paclitaxel and liposomal doxorubicin (Caelyx) combination in advanced breast cancer patients: a phase II study

Due to the cumulative cardiotoxicity of doxorubicin in cancer treatment, the tendency of the physician to find a substitute has led to the use of liposomal encapsulated doxorubicin, as well as other similar compounds. Doxorubicin and paclitaxel, two of the most active agents for breast cancer, have often been used in combination for this condition. In the present study we combined liposomal doxorubicin with paclitaxel with the intention of diminishing the toxicity of the cardiac muscle. Twenty-three patients were evaluated for response rate, survival and toxicity. All patients had metastatic disease and were chemotherapy-naïve after generalization of the disease. Liposomal doxorubicin was infused at a dose of 30 mg/m(2) and paclitaxel at a dose of 175 mg/m(2) once every 3 weeks. The response rate was complete in 2 patients (8.70%) and partial in 14 patients (60.87%) totalling 69.57%. The median duration of response was 6 months (range 2-13+) and median survival was 10 months (range 4-20+). Cardiotoxicity, myelotoxicity and gastrointestinal toxicity were well-tolerated. The high hand-foot adverse reaction (47.83%) inhibited the continuation of treatment in half of the patients and due to this toxicity the trial was terminated after the 23rd patient.