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A retrospective study evaluating a fixed low dose capecitabine monotherapy in women with HER-2 negative metastatic breast cancer

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Abstract

To determine if a low fixed dosing strategy of capecitabine would produce comparable clinical activity with less adverse toxicities compared to published data with higher doses in the setting of metastatic breast cancer (mBC). We retrospectively analyzed patients treated with a low fixed dose of capecitabine (CAPE-L) at 1,000 mg twice daily for 14 days every 21 days. Outcomes included clinical benefit rate (CBR), overall response rates (ORR), time to progression (TTP), and overall survival (OS). A historical comparison group of mBC patients treated on 12 prior trials at the package-insert dose of capecitabine (n = 1,949) was utilized. Eighty-six patients were analyzed in our cohort. Positive hormone receptor status (79.1 vs. 50.6 %), and capecitabine as first-line chemotherapy (44.2 vs. 16.5 %) were more frequent in our cohort relative to the historical comparison. The median starting dose in our cohort was 633.5 mg/m2. The CBR was similar between the CAPE-L and the standard dose cohorts (55.8 vs. 49.5 %), as was ORR (24.3 vs. 24 %), and median TTP (7 mo, 95 % CI 5.5–8.5 vs. 5.1 mo, 95 % CI 4.5–5.7). Median OS was longer in our cohort (24 mo, 95 % CI 16.8–31.2) than the historic standard dose cohort (12.1 mo, 95 % CI 9.6–14.4), a difference that was likely explained by the higher proportion of patients in the CAPE-L cohort who received capecitabine as first-line chemotherapy and who had hormone receptor positive disease. As expected, adverse events were less frequent with CAPE-L. We found that CAPE-L, which translates into a dose of 600–650 mg/m2, appeared to have good clinical efficacy and acceptable toxicity.

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Conflict of interest

Dr. Mahtani has held consultant/advisory role for Genetech. Dr. Vogel has received remuneration from Roche and Genetech. Dr. Vogel has held consultant/advisory role for Roche. The remaining authors state that they have no conflict on interests.

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Authors and Affiliations

  1. Department of Hematology and Oncology, University of Pittsburgh Cancer Institute, 5150 Centre Avenue, Pittsburgh, PA, 15232, USA

    Tadeu Ambros

  2. Department of Internal Medicine, Mount Sinai Medical Center, 4300 Alton Rd., Miami Beach, FL, 33140, USA

    Simon B. Zeichner

  3. Department of Medicine, SUNY Downstate Medical Center, 450 Clarkson Ave., Brooklyn, NY, 11203, USA

    John Zaravinos

  4. Cleveland Clinic, Taussig Cancer Institute, 9500 Euclid Avenue R35, Cleveland, OH, 44195, USA

    Alberto J. Montero

  5. University of Miami/Sylvester Comprehensive Cancer Center, 1475 NW 12th Ave., Miami, FL, 33136, USA

    Eugene Ahn

  6. Memorial Breast Cancer Center, 603 North Flamingo Rd., Suite 151, Pembroke Pines, FL, 33026, USA

    Mani Aruna

  7. University of Miami/Sylvester Comprehensive Cancer Center, 1192 East Newport Center Drive Suite 100, Deerfield Beach, FL, 33442, USA

    Lori Kronish, Reshma L. Mahtani & Charles L. Vogel

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  1. Tadeu Ambros
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  9. Charles L. Vogel
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Correspondence to Tadeu Ambros.

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Ambros, T., Zeichner, S.B., Zaravinos, J. et al. A retrospective study evaluating a fixed low dose capecitabine monotherapy in women with HER-2 negative metastatic breast cancer. Breast Cancer Res Treat 146, 7–14 (2014). https://doi.org/10.1007/s10549-014-3003-x

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  • DOI: https://doi.org/10.1007/s10549-014-3003-x

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