Weekly pegylated liposomal doxorubicin and paclitaxel in patients with metastatic breast carcinoma: A phase II study

Pegylated liposomal doxorubicin (PLD) has the advantage of delivering active anthracycline directly to the tumor site, while exposing the patient to a lesser degree of doxorubicin-associated toxicities Recently, a regimen in which paclitaxel is infused weekly over 1 h produced substantial antitumor activity with little myelosuppression We designed a phase II trial to study the efficacy and toxicity of 10 mg/m(2) PLD on Days 1, 8 and 15, plus 70 mg/m2 paclitaxel weekly in patients with untreated metastatic breast cancer and a high risk of cardiotoxicity The study included 35 patients, with 31 (88 5%) evaluable for efficacy and 35 (100%) for toxicity A total of 28 patients (80%) had two or more sites of disease Overall, 4 complete and 16 partial responses were noted with an overall response rate of 64 5%, with 6 cases of stable and 5 cases of progressive disease Toxicity was found to be manageable in that the only grade 3-4 side effects recorded were palmar-plantar erythrodysesthesia, 8 5%, mucositis, 2 8%, leucopenia, 12 5%, anemia, 2 8% and AST/ALT, 2 8% No cardiotoxicity was observed In conclusion, weekly PLD plus paclitaxel appears to be a well-tolerated and effective approach for metastatic breast cancer patients with a high risk of cardiotoxicity