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TAXOL® ( paclitaxel ) for Adjuvant Treatment of Node Positive Breast Cancer

TAXOL® ( paclitaxel ) for Adjuvant Treatment of Node Positive Breast Cancer. Oncologic Drugs Advisory Committee September 17, 1999. TAXOL® ( paclitaxel ) for Adjuvant Treatment of Node Positive Breast Cancer Oncologic Drug Advisory Committee INTRODUCTION. David Tuck, M.D.

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TAXOL® ( paclitaxel ) for Adjuvant Treatment of Node Positive Breast Cancer

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  1. TAXOL® (paclitaxel) for Adjuvant Treatment of Node Positive Breast Cancer Oncologic Drugs Advisory Committee September 17, 1999

  2. TAXOL® (paclitaxel) for Adjuvant Treatment of Node Positive Breast CancerOncologic Drug Advisory Committee INTRODUCTION David Tuck, M.D. Bristol-Myers Squibb Company Pharmaceutical Research Institute Wallingford, Connecticut

  3. PRESENTATIONS • Introduction D. Tuck, M.D. BMS - PRI • Adjuvant Chemotherapy L. Norton, M.D.ForBreast Cancer MSKCC • Pivotal Trial I.C. Henderson, M.D.Intergroup Study 0148 UCSF • Concluding Remarks R. Canetta, M.D. BMS - PRI

  4. 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

  5. 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

  6. 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 • Coordinating Group: Cancer and Leukemia Group B (CALGB) • Participating Groups: Eastern Cooperative Oncology Group (ECOG) North Central Cancer Treatment Group (NCCTG) Southwest Oncology Group (SWOG) • Enrollment: 3,170 patients accrued from • May 1, 1994 - April 15, 1997

  7. 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

  8. 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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