WALT TRIAL (PHASE III): WEEKLY NON PEGYLATED LIPOSOMAL ANTHRACYCLINE AND TAXANE COMBINATION IN FIRSTLINE BREAST CANCER CHEMOTHERAPY

Object: We evaluated the toxicity of liposomal-doxorubicin (LD) and paclitaxel (P) in patients (pts) with MBC. Patients and methods: From December 2003 to March 2004, 15 consecutive pts with MBC have received LD 25 mg/mq and P 50mg/mq both i.v., days 1, 8, 15 every 3 weeks for six cycles. Cardiac function was assessed with ECG and FEV measurement at the beginning and after six cycles of treatment. Pts characteristics were: median age 57 years (range 30–72), PS ECOG 0/1 9/6. Dominant sites of metastasis were: liver 8/15, lung 5/15, nodes 3/15, bone 4/15, brain 1/15, skin 1/15. A single metastatic site was present 6/15 (40%), two or 2 metastatic sites in 9/15. All pts received adjuvant chemotherapy, 5/15 pts received first-line chemotherapy for advanced disease and 4/15 pts a second-line chemotherapy. In total, 9/15 pts previously received anthracycline-containing regimens. Results: Toxicity was assessed on a total of 55 courses. The median number of cycles administered per patient was 3.6 (range 1–6). Myelosuppression and alopecia were the most common adverse events (see Table). In total, 9/15 pts were assessed for response with 6 SD, 1 PR, 2 PD. Any significant variation of ECG parameters and FEV was detected. Conclusions: Our results