Pegylated liposomal doxorubicin and gemcitabine in the front-line treatment of recurrent/metastatic breast cancer: A multicentre phase II study

V. Adamo, V. Lorusso, R. Rossello, B. Adamo, G. Ferraro, D. Lorusso, G. Condemi, D. Priolo, L. Di Lullo, A. Paglia, S. Pisconti, G. Scambia, G. Ferrandina

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Abstract

This multicentre phase II study was aimed at investigating the activity and safety of pegylated liposomal doxorubicin (PLD) and gemcitabine (GEM) as front-line therapy in a large series of chemotherapy-naïve recurrent/metastatic breast cancer patients. From June 2003 to December 2006, a total of 71 recurrent/metastatic breast cancer patients were enrolled. Median age was 63 years (range=37-79), and 31 patients (43.7%) were ≥65 years old. Patients received PLD, 25 mg m -2, day 1, followed by GEM, 800 mg m -2, days 1 and 8, q21. Response was evaluable in 64 cases. Eight complete (12.5%) and 17 partial responses (26.6%) were registered, with an overall response rate of 39.1%. Thirty patients (46.9%) experienced stable disease, with an overall clinical benefit of 85.9%. Median time to progression (TTP) was 11 months, whereas median overall survival (OS) was not reached. The rate of 1- and 2-year OS was 79 and 61%, respectively. A total of 443 courses were evaluable for toxicity: grade 3 and 4 neutropaenia affected 14 patients (20.3%) and 3 patients (4.3%), respectively. Grade 3 and 4 palmar-plantar erythrodysesthesia syndrome was documented in five cases (7.2%) and one case (1.4%), whereas grade 3 and 4 mucositis occurred in six cases (8.7%) and two cases (2.9%), respectively. Grade 2 cardiac toxicity was observed in only one case. Interestingly enough, there was no difference in the percentage and severity of either haematological or non-haematological toxicity according to the age of the patients (

Original languageEnglish
Pages (from-to)1916-1921
Number of pages6
JournalBritish Journal of Cancer
Volume98
Issue number12
DOIs
Publication statusPublished - Jun 17 2008

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Keywords

  • Gemcitabine
  • Metastatic breast cancer
  • Pegylated liposomal doxorubicin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Adamo, V., Lorusso, V., Rossello, R., Adamo, B., Ferraro, G., Lorusso, D., Condemi, G., Priolo, D., Di Lullo, L., Paglia, A., Pisconti, S., Scambia, G., & Ferrandina, G. (2008). Pegylated liposomal doxorubicin and gemcitabine in the front-line treatment of recurrent/metastatic breast cancer: A multicentre phase II study. British Journal of Cancer, 98(12), 1916-1921. https://doi.org/10.1038/sj.bjc.6604409