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

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Presentation transcript:

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 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

PRESENTATIONS IntroductionD. Tuck, M.D. BMS - PRIIntroductionD. Tuck, M.D. BMS - PRI Adjuvant ChemotherapyL. Norton, M.D. For Breast CancerMSKCCAdjuvant ChemotherapyL. Norton, M.D. For Breast CancerMSKCC Pivotal Trial I.C. Henderson, M.D. Intergroup Study 0148 UCSFPivotal Trial I.C. Henderson, M.D. Intergroup Study 0148 UCSF Concluding RemarksR. Canetta, M.D. BMS - PRIConcluding RemarksR. Canetta, M.D. BMS - PRI

CALGB PARTICIPANTS Don Berry, Ph.D. Faculty Statistician CALGB Breast CommitteeDon Berry, Ph.D. Faculty Statistician CALGB Breast Committee M.D. Anderson Cancer Center - Houston, Texas Stephen George, Ph.D.Stephen George, Ph.D. Director CALGB Statistical Center Duke University - Durham, North Carolina I. Craig Henderson, M.D. Study Chair CALGBI. Craig Henderson, M.D. Study Chair CALGB University of California at San Francisco, California Larry Norton, M.D. Chair CALGB Breast CommitteeLarry Norton, M.D. Chair CALGB Breast Committee Memorial Sloan-Kettering Cancer Center - New York, New York

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/m 2 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/m 2 over 3 hours), for the first line treatment of HER2+ metastatic breast cancer in 1998

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, April 15, 1997

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/m 2 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

PROPOSED INDICATION TAXOL® (paclitaxel) administered sequential to standard combination chemotherapy is indicated for the adjuvant treatment of node positive breast cancer