Multicenter Phase II Study of Capecitabine in Paclitaxel-Refractory Metastatic Breast Cancer

Joanne L Blum; Stephen E Jones; Aman U Buzdar; Patricia Mucci LoRusso; Irene Kuter; Charles Vogel; Bruno Osterwalder; Hans-Ulrich Burger; Cheryl Stoner Brown; Tom Griffin

doi:10.1200/JCO.1999.17.2.485

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$Multicenter Phase II Study of Capecitabine in Paclitaxel-Refractory Metastatic Breast Cancer$

Journal article

Peer reviewed

Multicenter Phase II Study of Capecitabine in Paclitaxel-Refractory Metastatic Breast Cancer

Joanne L Blum, Stephen E Jones, Aman U Buzdar, Patricia Mucci LoRusso, Irene Kuter, Charles Vogel, Bruno Osterwalder, Hans-Ulrich Burger, Cheryl Stoner Brown and Tom Griffin

Journal of clinical oncology, Vol.17(2), pp.485-485

1999-02

DOI: https://doi.org/10.1200/JCO.1999.17.2.485

PMID: 10080589

Abstract

PURPOSE: Capecitabine is a novel, oral, selectively tumor-activated fluoropyrimidine carbamate. This large multicenter phase II trial tested the efficacy and safety of twice-daily oral capecitabine at 2,510 mg/m2/d given for 2 weeks followed by a 1-week rest period and repeated in 3-week cycles, in patients with paclitaxel-refractory metastatic breast cancer. PATIENTS AND METHODS: Patients were to have received at least two but not more than three prior chemotherapeutic regimens, one of which had to have contained paclitaxel given for metastatic disease. One hundred sixty-three patients were entered onto the study at 25 centers, and 162 patients received capecitabine. One hundred thirty-five patients had bidimensionally measurable disease, and 27 patients had assessable disease. RESULTS: The overall response rate was 20% (95% confidence interval, 14% to 28%). All responding patients were resistant to or had failed paclitaxel, and all had received an anthracycline. Three complete responses were seen, with complete response durations of 106, 109, and 194+ days. Median duration of response was 8.1 months, median survival time was 12.8 months, and the median time to disease progression was 93 days. The most common treatment-related adverse events were hand-foot syndrome, diarrhea, nausea, vomiting, and fatigue. Diarrhea (14%) and hand-foot syndrome (10%) were the only treatment-related adverse events that occurred with grade 3 or 4 intensity in more than 10% of patients. CONCLUSION: Capecitabine is an active drug in the treatment of paclitaxel-refractory metastatic breast cancer. It has a favorable toxicity profile with the added advantage of being an oral drug administered at home.

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Collaboration types: Industry collaboration; Domestic collaboration
Citation topics: 1 Clinical & Life Sciences; 1.119 Breast Cancer Scanning; 1.119.259 HER2
Web Of Science research areas: Oncology
ESI research areas: Clinical Medicine

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Title: Multicenter Phase II Study of Capecitabine in Paclitaxel-Refractory Metastatic Breast Cancer
Creators: Joanne L Blum - From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ
Stephen E Jones - From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ
Aman U Buzdar - From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ
Patricia Mucci LoRusso - From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ
Irene Kuter - From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ
Charles Vogel - From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ
Bruno Osterwalder - From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ
Hans-Ulrich Burger - From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ
Cheryl Stoner Brown - From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ
Tom Griffin - From the Physician Reliance Network (PRN) Research, Baylor-Charles A. Sammons Cancer Center, Baylor University Medical Center, Dallas, and M.D. Anderson Cancer Center, Houston, TX; Harper Hospital, Detroit, MI; Massachusetts General Hospital, Boston, MA; Cancer Center, North Miami Beach, FL; and Hoffman-LaRoche, Inc, Nutley, NJ
Publication Details: Journal of clinical oncology, Vol.17(2), pp.485-485
Academic Unit: Miller School of Medicine; UMMG Dept of Medicine - Hematology/Oncology
Language: English
Resource Type: Journal article
PMID: 10080589
Record Identifier: 991031614079402976