Weekly paclitaxel and Pegylated liposomal doxorubicin as first line treatment in metastatic breast cancer patients

Background: Paclitaxel-Doxorubicin combination chemotherapy is highly active in metastatic breast cancer patients (pts) but may be cardiotoxic in a small percentage of cases. PLD is a new formulation of Doxorubicin with significant reduced cardiac toxicity and for this reason PLD can be given safe in elderly patients with cardiac risk factors or in younger patients with prior exposure to anthracycline-containing regimens. The main side effect of PLD is Hand-Foot syndrome but when given in intervals not below 4 weeks and with a dose intensity not exceeding 10 mg/sqm per week, this side effects is clearly reduced. Methods: : We carried out a phase 2 study to verify the activity of P 70 mg/sm weekly day 1–8-15 and PLD 30 mg/mq every four weeks. Inclusion Criteria were: age <75, Performance Status (PS)<=2, normal kidney and liver function, absence of brain symptomatic metastases, adjuvant chemotherapy with anthracyclines (relapse free survival>12months) or patients with LVEF beetween 40–50%, informed consent. Results: Out of the 11 patients so far included, 9 were evaluable for toxicity and response. Five patients (55.5%) showed a response including 4 PR and 1 CR, 1 patients (11.1 %) obtained SD and 2 pts (33.3%) progressed. Median time to progression and median survival have to be reached. Haematological side effects were: Neutropenia G1–2 in 4 pts (44.4%), thrombocytopenia G1–2 in 3 pts (33.3%). The non-haematological side effects were mild with the total absence of grade 3–4 toxicities. Only 3 patients (33.3%) experienced grade 2 nausea and stomatitis. G1–2 peripheral sensory neuropathy was seen in 1 pt (11.1%). Hand-Foot syndrome G1–2 occurred in 2 pts (22.2%). Conclusions: The treatment with weekly Paclitaxel and PLD with this schedule appears to be a well tolerated therapy with an interesting activity in this subset of patients.