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

Leonardi,Vita; Palmisano,Valentina; Pepe,Alessio; Usset,Antonella; Manuguerra,Giovanna; Savio,Giuseppina; Tamburo de Bella,Manuela; Laudani,Agata; Alù,Massimo; Cusimano,Maria P.; Scianna,Caterina; Giresi,Armando; Agostara,Biagio

doi:10.3892/ol_00000131

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

Authors:
- Vita Leonardi
- Valentina Palmisano
- Alessio Pepe
- Antonella Usset
- Giovanna Manuguerra
- Giuseppina Savio
- Manuela Tamburo de Bella
- Agata Laudani
- Massimo Alù
- Maria P. Cusimano
- Caterina Scianna
- Armando Giresi
- Biagio Agostara
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Affiliations: Division of Medical Oncology, Oncologic Department, Arnas Civico, 90127 Palermo, Italy. vitaleonardi@yahoo.it
Published online on: July 1, 2010 https://doi.org/10.3892/ol_00000131
Pages: 749-753

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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/m2 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.

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