Originally published as JCO Early Release 10.1200/JCO.2005.05.1383 on August 22 2006

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Phase II Trial of Capecitabine and Weekly Paclitaxel As First-Line Therapy for Metastatic Breast Cancer

Joanne L. Blum, E. Claire Dees, Aparna Chacko, Lisa Doane, Sukumar Ethirajan, Judith Hopkins, Richard McMahon, Suzan Merten, Angel Negron, Marcus Neubauer, Des Ilegbodu, Kristi A. Boehm, Lina Asmar, Joyce A. O'Shaughnessy

From the US Oncology Research Inc, Houston; Baylor–Charles A. Sammons Cancer Center, Dallas; Texas Oncology, PA, TX; and the University of North Carolina at Chapel Hill, Chapel Hill, NC

Address reprint requests to Joanne L. Blum, MD, PhD, Baylor–Charles A. Sammons Cancer Center, 3535 Worth St, Dallas, TX 75246; e-mail: joanne.blum{at}usoncology.com

PURPOSE: The taxanes and capecitabine have synergistic antitumor activity in preclinical models. This trial was designed to determine the efficacy and tolerability of weekly paclitaxel plus capecitabine as first-line treatment for metastatic breast cancer (MBC).

PATIENTS AND METHODS: Participants had histologically proven breast cancer, with measurable metastatic disease by Response Evaluation Criteria in Solid Tumors Group. Exclusion criteria included prior taxane therapy or any prior capecitabine or infusional fluorouracil. Participants received capecitabine 825 mg/m²/dose orally bid (1,650 mg/m²/d) for days 1 to 14. Paclitaxel 80 mg/m² was administered intravenously weekly on days 1 and 8. Cycles were repeated every 3 weeks. Responders (complete or partial) or those with stable disease were treated until progression of disease or intolerable toxicity.

RESULTS: Fifty-five women were enrolled; 94% received study therapy as first-line treatment for MBC. In the intent-to-treat population, objective responses (partial) were achieved in 30 patients (55%; 95% CI, 40% to 69%), and six additional patients had stable disease for 6 months or longer (clinical benefit rate of 65%). The median duration of response was 10 months (range, 2.5 to 18.7 months). Dose modifications and reductions were common, particularly for capecitabine, leading to a delivered dose-intensity of 75% for capecitabine and 91% for paclitaxel. The most frequent grade 3 to 4 treatment-related adverse events were hand-foot skin reaction (n = 10); neutropenia (n = 7); fatigue (n = 4); and leukopenia, diarrhea, and pain (n = 3 each).

CONCLUSION: Capecitabine in combination with weekly paclitaxel is an active and tolerable regimen as first-line therapy for women with MBC.

published online ahead of print at www.jco.org on August 21, 2006.

Supported by Roche Laboratories, Nutley, NJ.

Presented in part in poster format at the 2004 San Antonio Breast Cancer Symposium, San Antonio, TX, December 10, 2004.

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

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