This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Gradishar, W. J. Articles by Marcom, P. K. Search for Related Content PubMed PubMed Citation Articles by Gradishar, W. J. Articles by Marcom, P. K. Social Bookmarking                            What's this?

Capecitabine Plus Paclitaxel As Front-Line Combination Therapy for Metastatic Breast Cancer: A Multicenter Phase II Study

From the Northwestern University, Chicago, IL; SW Oncology Associates, Lafayette, LA; Mid Dakota Clinic, Bismark, ND; Roche Laboratories Inc, Nutley, NJ; University of Cincinnati Medical Center, Cincinnati, OH; and Duke University Medical Center, Durham, NC

Address reprint requests to William J. Gradishar, MD, Northwestern University, 676 N St. Clair, Suite 850, Chicago, IL, 60611; e-mail: w-gradishar{at}northwestern.edu

PURPOSE: The goal of this multicenter, open-label phase II study was the clinical evaluation of combination therapy with the oral fluoropyrimidine capecitabine and the taxane paclitaxel in patients with metastatic breast cancer (MBC).

PATIENTS AND METHODS: Forty-seven patients with MBC received oral capecitabine at 1,650 mg/m²/d (825 mg/m² twice daily) on days 1 through 14, and intravenous infusion of paclitaxel at 175 mg/m² on day 1 of each 21-day treatment cycle. Treatment continued until disease progression, intolerable toxicity, or patient's decision to discontinue. Patients (35 to 76 years old) had a median Karnofsky performance status of 90%. Forty-four patients (94%) received study treatment as first-line therapy for metastatic disease.

RESULTS: Objective responses occurred in 24 (51%) patients; seven (15%) complete responses and 17 (36%) partial responses. Stable disease lasting 180 days or more was observed in nine (19%); the clinical response rate was 70%. Median duration of response was 12.6 months, median time to disease progression was 10.6 months, and median overall survival time was 29.9 months. The most common treatment-related adverse events, regardless of severity, were alopecia, hand-foot syndrome, nausea, and fatigue. Neutropenia (15%), alopecia (13%), and hand-foot syndrome (11%) were the only grade 3 or 4 treatment-related adverse events that occurred in more than 10% of patients.

CONCLUSION: The combination of capecitabine plus paclitaxel is a highly active and generally well-tolerated regimen for first-line treatment of MBC.

This study was supported by Roche Laboratories Inc.

This study has been presented in part at the following conferences: The San Antonio Breast Cancer Symposium, San Antonio, TX, 2001, San Antonio Breast Cancer Symposium, 2002 and the European Cancer Conference, Copenhagen, Denmark, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				S. Chan, G. Romieu, J. Huober, T. Delozier, M. Tubiana-Hulin, A. Schneeweiss, A. Lluch, A. Llombart, A. du Bois, R. Kreienberg, et al. Phase III Study of Gemcitabine Plus Docetaxel Compared With Capecitabine Plus Docetaxel for Anthracycline-Pretreated Patients With Metastatic Breast Cancer J. Clin. Oncol., April 10, 2009; 27(11): 1753 - 1760. [Abstract] [Full Text] [PDF]

				F. Puglisi, G. G. Cardellino, D. Crivellari, C. Di Loreto, M. D. Magri, A. M. Minisini, M. Mansutti, C. Andreetta, S. Russo, D. Lombardi, et al. Thymidine phosphorylase expression is associated with time to progression in patients receiving low-dose, docetaxel-modulated capecitabine for metastatic breast cancer Ann. Onc., September 1, 2008; 19(9): 1541 - 1546. [Abstract] [Full Text] [PDF]

				D. Tripathy Capecitabine in Combination with Novel Targeted Agents in the Management of Metastatic Breast Cancer: Underlying Rationale and Results of Clinical Trials Oncologist, April 1, 2007; 12(4): 375 - 389. [Abstract] [Full Text] [PDF]

				M. Colozza, E. de Azambuja, N. Personeni, F. Lebrun, M. J. Piccart, and F. Cardoso Achievements in Systemic Therapies in the Pregenomic Era in Metastatic Breast Cancer Oncologist, March 1, 2007; 12(3): 253 - 270. [Abstract] [Full Text] [PDF]

				J. L. Blum, E. C. Dees, A. Chacko, L. Doane, S. Ethirajan, J. Hopkins, R. McMahon, S. Merten, A. Negron, M. Neubauer, et al. Phase II Trial of Capecitabine and Weekly Paclitaxel As First-Line Therapy for Metastatic Breast Cancer J. Clin. Oncol., September 20, 2006; 24(27): 4384 - 4390. [Abstract] [Full Text] [PDF]

				S. M Gressett, B. L Stanford, and F. Hardwicke Management of hand-foot syndrome induced by capecitabine Journal of Oncology Pharmacy Practice, September 1, 2006; 12(3): 131 - 141. [Abstract] [PDF]

				R Leonard, J O'Shaughnessy, S Vukelja, V Gorbounova, C. Chan-Navarro, D Maraninchi, N Barak-Wigler, J. McKendrick, W. Harker, A. Bexon, et al. Detailed analysis of a randomized phase III trial: can the tolerability of capecitabine plus docetaxel be improved without compromising its survival advantage? Ann. Onc., September 1, 2006; 17(9): 1379 - 1385. [Abstract] [Full Text] [PDF]

				D. Cameron, R. Bell, M. Aapro, and C. Zielinski What Are the Current Standards of Care and Recent Developments in the Management of Breast Cancer? Oncologist, September 1, 2006; 11(suppl_1): 1 - 3. [Full Text] [PDF]

				K. Gelmon, A. Chan, and N. Harbeck The Role of Capecitabine in First-Line Treatment for Patients with Metastatic Breast Cancer Oncologist, September 1, 2006; 11(suppl_1): 42 - 51. [Abstract] [Full Text] [PDF]