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Article

Phase II Trial of a Metronomic Schedule of Docetaxel and Capecitabine with Concurrent Celecoxib in Patients with Prior Anthracycline Exposure for Metastatic Breast Cancer

1
Regional Cancer Program, Sudbury Regional Hospital, Sudbury, ON, Canada
2
Division of Medical Sciences, Northern Ontario School of Medicine, Sudbury, ON, Canada
3
Department of Medicine, The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, Canada
*
Author to whom correspondence should be addressed.
Curr. Oncol. 2012, 19(2), 75-83; https://doi.org/10.3747/co.19.879
Submission received: 6 January 2012 / Revised: 4 February 2012 / Accepted: 2 March 2012 / Published: 1 April 2012

Abstract

Background: This phase II clinical trial examined the activity of a metronomic dosing schedule of docetaxel and capecitabine chemotherapy in patients with advanced breast cancer. Patients also received daily oral celecoxib in an effort to improve outcome measures and to ameliorate some of the common side effects of chemotherapy. Methods: Patients received docetaxel at a starting dose of 15 mg/m2 weekly, oral capecitabine 1250 mg/m2 once daily, and oral celecoxib 200 mg twice daily. The primary endpoint was clinical benefit: percentage of patients experiencing either an objective response or stable disease (SD) for more than 6 months. In the absence of significant neutropenia, the dose of docetaxel was escalated after 4 and 8 weeks of treatment. Therapy was given until disease progression or development of unacceptable toxicity. The level of thymidine phosphorylase expression in peripheral white blood cells of patients was measured before and during treatment to determine the effect on this capecitabine-activating enzyme. Results: Of 47 patients enrolled, 38 (81%) completed treatment to a disease endpoint. No complete responses were achieved, but 13 of the 38 patients (34%) experienced a partial response, and another 3 patients (8%) experienced SD for more than 6 months. The clinical benefit rate was therefore 42% (95% confidence interval: 27% to 57%). The median time to disease progression for all evaluable patients was 3.6 months (range: 0.9–21.7 months). The most common nonhematologic toxicities were diarrhea, plantar– palmar erythrodysesthesia, fatigue, mucositis, and vomiting. Most patients (89%) received combination chemotherapy until disease progression. Conclusions: The present study demonstrates that metronomic docetaxel–capecitabine chemotherapy with daily celecoxib can produce significant anticancer activity, with predictable toxicity. Efficacy fell short of expectations, with outcome measures being similar to those obtained when the study agents are given in conventional dosing. Furthermore, there is mounting evidence to indicate that a low dose of taxanes fails to induce thymidine phosphorylase expression, an effect believed to be important in achieving therapeutic synergism when taxanes are given concurrently with capecitabine.
Keywords: metastatic breast cancer; metronomic chemotherapy; docetaxel; capecitabine metastatic breast cancer; metronomic chemotherapy; docetaxel; capecitabine

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MDPI and ACS Style

Young, S.D.; Lafrenie, R.M.; Clemons, M.J. Phase II Trial of a Metronomic Schedule of Docetaxel and Capecitabine with Concurrent Celecoxib in Patients with Prior Anthracycline Exposure for Metastatic Breast Cancer. Curr. Oncol. 2012, 19, 75-83. https://doi.org/10.3747/co.19.879

AMA Style

Young SD, Lafrenie RM, Clemons MJ. Phase II Trial of a Metronomic Schedule of Docetaxel and Capecitabine with Concurrent Celecoxib in Patients with Prior Anthracycline Exposure for Metastatic Breast Cancer. Current Oncology. 2012; 19(2):75-83. https://doi.org/10.3747/co.19.879

Chicago/Turabian Style

Young, S.D., R.M. Lafrenie, and M.J. Clemons. 2012. "Phase II Trial of a Metronomic Schedule of Docetaxel and Capecitabine with Concurrent Celecoxib in Patients with Prior Anthracycline Exposure for Metastatic Breast Cancer" Current Oncology 19, no. 2: 75-83. https://doi.org/10.3747/co.19.879

APA Style

Young, S. D., Lafrenie, R. M., & Clemons, M. J. (2012). Phase II Trial of a Metronomic Schedule of Docetaxel and Capecitabine with Concurrent Celecoxib in Patients with Prior Anthracycline Exposure for Metastatic Breast Cancer. Current Oncology, 19(2), 75-83. https://doi.org/10.3747/co.19.879

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