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Pegylated liposomal doxorubicin in combination with gemcitabine: a phase II study in anthracycline-naïve and anthracycline pretreated metastatic breast cancer patients

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Abstract

Background: The aim of the study was to assess the toxicity profile, activity in terms of response rate, time to progression, overall survival, and quality of life of pegylated liposomal doxorubicin (PLD) and gemcitabine combination in chemo-naïve and pretreated metastatic breast cancer (MBC) women. Methods: Patients were eligible if they had disease progression to prior chemotherapy (anthracycline-including or not) for early breast cancer or MBC. Patients received PLD 25 mg/m2 intravenously on day 1 plus gemcitabine 800 mg/m2 intravenously on days 1 and 8 of each 21-day cycle. Results: Of 50 patients enrolled, 37 had received prior adjuvant chemotherapy (24 with an anthracycline) and 23 prior chemotherapy for metastatic disease (6 with an anthracycline). Two complete responses and 20 partial responses were achieved in 46 assessable patients (overall response rate: 47.8%). Responses were observed in 14 (46.6%) of 30 patients with previous anthracycline exposure. Median response duration was 7 months, median duration of clinical benefit 8 months, time to progression 7 months. At a median follow-up of 10 months, 79.4% patients were alive at 1 year. No neutropenic complication was observed. Non-hematological toxicities were mild. One patient previously treated with an anthracycline developed a transient decrease (26%) in the left ventricular ejection fraction, with cardiac function recovering within 6 months. Conclusion: Because of the non-overlapping toxicity profiles of both PLD and gemcitabine, this combination can be regarded as a reliable therapeutic option for patients who have failed previous treatments, including anthracycline, for MBC.

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Acknowledgements

Partially supported by Eli-Lilly and Schering Plough

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Authors and Affiliations

  1. Division of Medical Oncology “A”, Regina Elena Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy

    Alessandra Fabi, Gianluigi Ferretti, Paola Papaldo, Nello Salesi, Mariangela Ciccarese, Paolo Carlini, Alessandra Felici & Francesco Cognetti

  2. Division of Medical Oncology, National Cancer Institute, Bari, Italy

    Vito Lorusso

  3. Cardiology Unit, Regina Elena Cancer Institute, Rome, Italy

    Armando Carpino

  4. Department of Pathology, Regina Elena Cancer Institute, Rome, Italy

    Marcella Mottolese

  5. Department of Clinical Pathology, Cytogenetic Unit, Rome, Italy

    Anna Maria Cianciulli

  6. Biostatistics Unit, Regina Elena Cancer Institute, Rome, Italy

    Diana Giannarelli & Isabella Sperduti

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  1. Alessandra Fabi
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  2. Gianluigi Ferretti
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  14. Francesco Cognetti
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Correspondence to Alessandra Fabi.

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Fabi, A., Ferretti, G., Papaldo, P. et al. Pegylated liposomal doxorubicin in combination with gemcitabine: a phase II study in anthracycline-naïve and anthracycline pretreated metastatic breast cancer patients. Cancer Chemother Pharmacol 57, 615–623 (2006). https://doi.org/10.1007/s00280-005-0116-2

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