Efficacy of different dosing schedules of capecitabine for metastatic breast cancer: a single-institution experience

Summary

Purpose Capecitabine is widely used as a single agent on a 21-day cycle in the management of metastatic breast cancer (MBC). Our primary objective was to compare the standard dosing of capecitabine (Arm A: days 1–14 on 21-day cycle) to biweekly dosing (Arm B: days 1–7 and 15–21 on 28-day cycle) using retrospective data analysis. Methods 166 patients with MBC treated with single agent capecitabine at The Ohio State University from 2002 to 2014 were considered eligible. Median time to treatment failure (TTF) and overall survival (OS) were estimated using Kaplan-Meier (KM) methods. KM curves were compared using log-rank tests with Holm’s correction for multiplicity. Results Patients were grouped by dose schedule into one of three arms: Arm A (21-day cycle; capecitabine given at 1000 mg/m2 orally, twice daily on days 1–14 of 21-day cycle); Arm B (28-day cycle; capecitabine given at 1000 mg/m2 orally, twice daily on days 1–7 and 15–21 of 28-day cycle); and Arm C (changeover regimen where patients started on the 21-day cycle, but changed to a 28-day cycle for tolerability). No difference was found in TTF or OS for patients with MBC between those who received capecitabine on either standard dosing (Arm A) and those on a biweekly cycle (Arm B or C). Overall, 41% of patients required dose reduction. Conclusions Our single institution experience showed that alternate dosing of capecitabine (biweekly, 28-day cycle) may be a reasonable alternative to standard 21-day cycle with similar efficacy and fewer dose reductions.

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

The project described was supported by the Stefanie Spielman Fund for Breast Cancer Research, the Award Number Grant UL1TR002733 from the National Center for Advancing Translational Sciences, and the National Cancer Institute and Cancer Clinical Investigator Team Leadership Award P30CA016058-42S2. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Sciences or the National Institutes of Health.

Funding

The project described was supported by the Stefanie Spielman Fund for Breast Cancer Research, the Award Number Grant UL1TR002733 from the National Center for Advancing Translational Sciences, and the National Cancer Institute and Cancer Clinical Investigator Team Leadership Award P30CA016058-42S2. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Sciences or the National Institutes of Health.

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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Anupama Suresh, Akannsha Ganju, Evan Morgan, Marilly Palettas, Julie A. Stephens, Joseph Liu, Michael Berger, Craig Vargo, Bhuvaneswari Ramaswamy and Nicole Williams. The first draft of the manuscript was written by Anupama Suresh and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

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Correspondence to Nicole Williams.

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The authors declare that they have no conflict of interest.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the Ohio State University Comprehensive Cancer Center (OSUCCC) Clinical Scientific Review Committee (CSRC), the Ohio State Cancer Institutional Review Board (OSU IRB 2015C0155), and with the 1964 Helsinki declaration and its later amendments.

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The Ohio State Cancer Institutional Review Board (OSU IRB 2015C0155) approved the full waiver of the informed consent process due to the retrospective nature of the study.

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Suresh, A., Ganju, A., Morgan, E. et al. Efficacy of different dosing schedules of capecitabine for metastatic breast cancer: a single-institution experience. Invest New Drugs 38, 1605–1611 (2020). https://doi.org/10.1007/s10637-020-00891-9

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Keywords

  • Capecitabine
  • Metastatic breast cancer
  • Dosing schedules
  • Survival analysis