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Drug Treatment of Metastatic Breast Cancer;Drugs approved for Metastatic Breast Cancer;
Paclitaxel 1994
Docetaxel 1996
Trastuzumab 1998
Capecitabine 1998
Capecitabine + Docetaxel 2001
Abraxane 2005
Lapatinib 2006
Ixabepilone 2007
;Paclitaxel; Paclitaxel 135 mg/m2 3-hour infusion
;TAXOL Efficacy ResultsFull Approval;Docetaxel;DocetaxelAccelerated Approval 1996; Mytomicin 12 mg/m2 Q 6 weeks
Vinblastine 6 mg/m2
Q 3 weeks ;TAX304 Efficacy ResultsFull Approval;Trastuzumab;Trastuzumab 4 mg/kg loading dose
2 mg/kg wkly maintenance;Herceptin monotherapy Full Approval;Capecitabine;Capecitabine monotherapy Accelerated Approval;Capecitabine;Docetaxel 100 mg/m2
Q 3 weeks;Capecitabine Efficacy ResultsFull Approval;Overall Survival;Lapatinib;
Capecitabine 2500 mg/m2 daily for 14 days
;Lapatinib Efficacy ResultsFull Approval;Efficacy of Combination Therapy:Kaplan-Meier Curves of TTP;Ixabepilone; Capecitabine 1250 mg/m2 BID Days 1 to 14 q 21 days
;Ixabepilone Efficacy ResultsFull Approval;Efficacy of Combination Therapy:Kaplan-Meier Curves of PFS;Ixabepilone; Single-arm Monotherapy Studies (n=126);1st line Metastatic Breast Cancer;Drugs approved in 1st line Metastatic Breast Cancer;Trastuzumab;Chemotherapy Alone;;Herceptin Full Approval
Survival All Patients;;Gemcitabine;Paclitaxel 175 mg/m2
Days 1 and 8 q 21 days ;Survival;;ENDPOINTS ;Survival: Basis of cytotoxic drug approval in 1st line MBC;Efficacy Reasons for using Survival as basis of approval in 1st line MBC;Survival as a basis of approval: Examples;Cross-over therapy confounds survival effect: truth or myth?;SUMMARY;See ODAC transcript for Monday June 7, 1999, posted on the FDA website;TTP as the basis of approval: Examples;Progression Free Survival;Problems with PFS;;NDA submissions based on PFS will affect survival data;1、有时候读书是一种巧妙地避开思考的方法。5月-205月-20Sunday, May 31, 20
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