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Efficacy and safety of single agent capecitabine in pretreated metastatic breast cancer patients from the French compassionate use program

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Abstract

Background. A retrospective source review identifying predictive factors and assessing safety and efficacy in pretreated metastatic breast cancer (MBC) patients treated with capecitabine in a French compassionate-use program.

Patients and methods. 197 patients received capecitabine at an initial total dose 0.25–3.0g/m2/day, twice daily for 14 consecutive days, every 3weeks.

Results. Median patient age was 56years (range, 31–88), 19% had performance status (PS) 3–4. Prior palliative and adjuvant treatment was reported in 96 and 61% of patients respectively. Best overall response rate (ORR) was 15% (95% confidence interval [CI], 11–21%) and 49% had benefit (CR, PR or SD). Median time to progression (TTP) and overall survival were 4.8 and 14.7 months, respectively. Median TTP in responders was 8.9months (95%CI 6.1–11.7). Grade 3/4 neutropenia and grade 3 thrombocytopenia occurred in 8 and 3% of patients respectively. Hand-foot syndrome (grade 3/4 in 16% of patients), diarrhea, stomatitis and asthenia were prevalent. Multivariate analysis showed ORR was significantly influenced by PS≥2 (p=0.004), time from metastases diagnosis to capecitabine treatment (p=0.015) and presence of liver metastases at inclusion (p=0.047). Abnormal liver function tests at baseline were associated with severe thrombocytopenia and anemia. Four treatment-related deaths occurred.

Conclusion. Capecitabine is active in heavily pretreated MBC patients and has a favorable toxicity profile with the added advantage of being an oral drug administered in an outpatient setting.

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Authors and Affiliations

  1. Institut Curie, Paris, 75005, France

    J. Y. Pierga

  2. Centre René Gauducheau, St. Herblain

    P. Fumoleau

  3. Clinique St Catherine, Avignon

    Y. Brewer

  4. Institut Gustave Roussy, Villejuif

    L. Zelek

  5. Centre Mallet Proux, Laval

    D. Martin

  6. Centre René Huguenin, St Cloud

    F. L. Turpin

  7. Centre Hospitalier Bretagne Sud, Lorient

    M. J. Goudier

  8. Hôpital Pitié-Salpêtrière, Paris

    M. Gil-delgado

  9. Clinique St Roch, Montpellier

    J. L. Baticle

  10. Centre Antoine Lacassagne, Nice

    M. Namer

  11. Centre Jean Perrin, Clermont-Ferrand

    P. Chollet

  12. CAC, Kremlin Bicêtre; CAC, 18–20 rue Pasteur, Le Kremlin-Bicêtre, 94278, France

    W. Sutherland

  13. Hôpital Civil, Colmar, France

    J. C. Barats

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Pierga, J.Y., Fumoleau, P., Brewer, Y. et al. Efficacy and safety of single agent capecitabine in pretreated metastatic breast cancer patients from the French compassionate use program. Breast Cancer Res Treat 88, 117–129 (2004). https://doi.org/10.1007/s10549-004-1282-3

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  • DOI: https://doi.org/10.1007/s10549-004-1282-3

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