Taxol paclitaxel for adjuvant treatment of node positive breast cancer
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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

Oncologic Drugs Advisory Committee

September 17, 1999


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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


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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


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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

  • 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


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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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