Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 10618
© 2006 American Society of Clinical Oncology

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Silva, O. E. Articles by Hurley, J. Search for Related Content PubMed Articles by Silva, O. E. Articles by Hurley, J.

Abstract

Split, low-dose docetaxel (D) and low-dose capecitabine (C) is an active regimen in metastatic breast cancer with minimal toxicity

University of Miami, Miami, FL

10618

Background: Successful therapeutic regimens in metastatic breast cancer must balance efficacy and tolerability. D and C is an active and commonly used doublet in this setting. D upregulates thymidine phosphorylase and thus potentiates the anti-tumor effects of C. A schedule with split, low-dose D in combination with low dose C could improve the therapeutic index of this regimen without compromising its clinical activity. Methods: Patients with previously untreated her2-neu negative metastatic breast cancer were included. A Simon 2-stage Phase II clinical trial was designed to assess the response rate (primary end-point), and toxicity of docetaxel 25 mg/m² on days 1 and 8 in combination with capecitabine 750 mg/m² bid on days 1–14 of a 21-day cycle. RECIST criteria were used for response assessment, which was performed every 2 cycles. Results: Thirty-one women have been enrolled. Median age was 55. Twenty patients had hormone receptor positive disease. Sites of metastasis were as follows: bone, 24 patients; liver, 14; lungs or pleura 14. A total of 189 cycles have been delivered (median: 4 cycles, range 1–33). Grade 3 and 4 toxicities were as follows: peripheral neuropathy, 2 patients; edema, 1 patient; skin, 1 patient. Two women had fever without neutropenia. Another patient had a gastric perforation but recovered without sequela. Twenty-two patients are available for response evaluation. One patient with a single bone metastasis had a complete response after chemotherapy followed by radiation. Partial responses were seen in 10 patients, for an overall response rate of 50% (95% CI, 30 to 70). Four women had stable disease and 7 had progressed at the time of first assessment. With a median follow-up of 15 months (range 1–26), the median time to treatment failure (all patients) was 7 months (range 1–26+). Median survival has not yet been reached. Out of 8 patients older than 65, seven were evaluable and 4 had a partial response. Conclusions: Split, low-dose Docetaxel and low-dose Capecitabine is an effective combination in the first-line treatment of patients with metastatic breast cancer. Toxicity with this schedule was minimal, making it an attractive regimen for further study.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen, Eli Lilly, Genentech, Millennium Pharmaceuticals, Novartis, Pfizer, sanofi-aventis Millennium Pharmaceuticals Amgen, sanofi-aventis