title: Weekly pegylated liposomal doxorubicin and paclitaxel in patients with metastatic breast carcinoma: A phase II study.
abstract: 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/m(2) 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.
authors.affiliation: Division Of Medical Oncology, Oncologic Department, Arnas Civico, Palermo, Italy.
authors.forename: Vita
authors.initials: V
authors.lastname: Leonardi
authors.forename: Valentina
authors.initials: V
authors.lastname: Palmisano
authors.forename: Alessio
authors.initials: A
authors.lastname: Pepe
authors.forename: Antonella
authors.initials: A
authors.lastname: Usset
authors.forename: Giovanna
authors.initials: G
authors.lastname: Manuguerra
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Savio
authors.forename: Manuela Tamburo
authors.initials: MT
authors.lastname: DE Bella
authors.forename: Agata
authors.initials: A
authors.lastname: Laudani
authors.forename: Massimo
authors.initials: M
authors.lastname: Alù
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Cusimano
authors.forename: Caterina
authors.initials: C
authors.lastname: Scianna
authors.forename: Armando
authors.initials: A
authors.lastname: Giresi
authors.forename: Biagio
authors.initials: B
authors.lastname: Agostara