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Drug Treatment of Metastatic Breast CancerFDA Approval OverviewPatricia Cortazar, MD第一页，共五十三页。 Drugs approved for Metastatic Breast CancerMethotrexate 1953Cyclophosphamide 1959Thiotepa 1959Vinblastine 19615-Fluorouracil 1962Doxorubicin 1974第二页，共五十三页。 Paclitaxel 1994Docetaxel 1996Trastuzumab 1998Capecitabine 1998Capecitabine + Docetaxel 2001Abraxane 2005Lapatinib 2006Ixabepilone 2007Drugs approved in 2nd-3rd line Metastatic Breast Cancer第三页，共五十三页。 PaclitaxelTAXOL? is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated 第四页，共五十三页。 Paclitaxel 135 mg/m2 3-hour infusion TAXOL Study Design Paclitaxel 175 mg/m2 3-hour infusion 471Patients who failed one or two regimensof chemotherapy67% previous anthracyclines第五页，共五十三页。 TAXOL Efficacy ResultsFull ApprovalPaclitaxel 175235Paclitaxel 135236Response (months)28%22% P-value (log rank)p=0.135TTP median (months)4.23.0 P-value (log rank)p=0.027Survival (months)11.710.5 P-value (log rank)p=0.321第六页，共五十三页。 DocetaxelTAXOTERE? for Injection indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy第七页，共五十三页。 DocetaxelAccelerated Approval 19963 Phase II studies in total 134 patientsDose 100 mg/m2 q 3 weeksEndpoint: Overall RR 41% (95% CI: 33-49)PMC: Submit data from controlled clinical studies (TAX311, TAX304)第八页，共五十三页。 Mytomicin 12 mg/m2 Q 6 weeks Vinblastine 6 mg/m2 Q 3 weeks TAX304 Study Design Docetaxel 100 mg/m2 Q 3 weeks 392Patients with Prior anthracyclineregimens第九页，共五十三页。 TAX304 Efficacy ResultsFull ApprovalDocetaxel203Myt +Vinblastine189TTP (months)4.32.5 Risk Ratio 95% CI (RR)0.750.61-0.94 P-value (log rank)p=0.01Survi