TAXOL® (paclitaxel) for Adjuvant Treatment of Node Positive Breast Cancer
Oncologic Drugs Advisory Committee September 17, 1999
Bristol-Myers Squibb Company
TAXOL® (paclitaxel) for Adjuvant Treatment of Node Positive Breast Cancer Oncologic Drug Advisory Committee
INTRODUCTION
David Tuck, M.D. Bristol-Myers Squibb Company Pharmaceutical Research Institute Wallingford, Connecticut
Bristol-Myers Squibb Company
PRESENTATIONS
• Introduction D. Tuck, M.D. BMS - PRI L. Norton, M.D. MSKCC I.C. Henderson, M.D. UCSF R. Canetta, M.D. BMS - PRI
• Adjuvant Chemotherapy For Breast Cancer • Pivotal Trial Intergroup Study 0148 • Concluding Remarks
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CALGB PARTICIPANTS
• Don Berry, Ph.D. Faculty Statistician CALGB Breast Committee M.D. Anderson Cancer Center - Houston, Texas • Stephen George, Ph.D. Director CALGB Statistical Center Duke University - Durham, North Carolina
• I. Craig Henderson, M.D. Study Chair CALGB University of California at San Francisco, California
• Larry Norton, M.D. Chair CALGB Breast Committee Memorial Sloan-Kettering Cancer Center - New York, New York
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ACTIVITY IN BREAST CANCER
• TAXOL showed high response rates in Phase II trials in heavily pretreated patients, including anthracycline refractory patients • One randomized trial (n=471) led to FDA approval of TAXOL (175 mg/m2 over 3 hours) for the second line treatment of metastatic breast cancer in 1994 • One randomized trial (n=469) led to the approval of Herceptin, in combination with TAXOL (175 mg/m2 over 3 hours), for the first line treatment of HER2+ metastatic breast cancer in 1998
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TAXOL IN NODE POSITIVE BREAST CANCER PIVOTAL TRIAL: INT-0148
A Phase III Intergroup Study
• Trial: Doxorubicin Dose Escalation, With or Without TAXOL, As Part Of the Cyclophosphamide/ Doxorubicin Adjuvant Chemotherapy Regimen For Node Positive Breast Cancer
Cancer and Leukemia Group B (CALGB)
• Coordinating Group:
• Participating Groups:
Eastern Cooperative Oncology Group (ECOG) North Central Cancer Treatment Group (NCCTG) Southwest Oncology Group (SWOG) 3,170 patients accrued from May 1, 1994 - April 15, 1997
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• Enrollment:
TAXOL IN NODE POSITIVE BREAST CANCER PIVOTAL TRIAL: INT-0148
A Phase III Intergroup Study
• The pivotal study is the largest randomized trial of chemotherapy in the adjuvant treatment of node positive breast cancer ever submitted to the FDA • TAXOL (175 mg/m2 over 3 hours) given sequentially to standard chemotherapy demonstrates significant disease-free and overall survival advantages • The safety profile of TAXOL in this setting is consistent with the large experience accumulated at this approved dose and schedule
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PROPOSED INDICATION
TAXOL® (paclitaxel) administered sequential to standard combination chemotherapy is indicated for the adjuvant treatment of node positive breast cancer
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