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Published byAmberly Martin Modified over 8 years ago
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PHASE II RANDOMIZED STUDY OF TRASTUZUMAB EMTANSINE VERSUS TRASTUZUMAB PLUS DOCETAXEL IN PATIENTS WITH HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 – POSITIVE METASTATIC BREAST CANCER R2 김형오 J Clin Oncol 31:1157-1163. © 2013 by American Society of Clinical Oncology
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Introduction HER-2 overexpression in 20% of breast cancers Increased mortality in early stage disease Decreased time to relapse Increased incidence of metastases Trastuzumab + taxane based chemotherapy demonstrated significantly improved overall survival and progression free survival Trastuzumab containing regimen : 1 st line therapy for HER2 (+) metastatic breast cancer(MBC)
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Introduction MBC will eventrually progress in most patients Chemotherapy associated toxicity Source of morbidity Severe myelosuppression in docetaxel Tx Trastuzumab emtansine(T-DM1) Cytotoxic microtubule polymerization inhibitor DM1 conjugated to the humanized monoclonal Ab trastuzumab Ab-drug conjugate by stable thioether linker Selectively delivers a cytotoxic agent to tumor cells
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Purpose To compare T-DM1’s(DM1 conjugated trastuzumab) effects / side effects with HT’s (Trastuzumab + docetaxel) in HER2(+) MBC patients
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Patients and Methods Patients 18 years of age or more Hitologically or cytologically confirmed HER2(+) immunohistochemistry 3+, >10% cell staining Fluorescent in situ hybridization (+) Unresectable Locally advanced breast cancer or MBC w/o prior chemotherapy or trastuzumab for metastatic disease
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Patients and Methods Exclusion criteria Less than 6 months from completion of CTx Untreated / symptomatic brain metastases Treatment for brain metastases ≤ 60 days Cumulative anthracycline dose equivalent to doxorubicin more than 500mg/m2 History of significant cardiovascular or other severe uncontrolled systemic disease
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Patients and Methods Study design Patients randomly assigned 1:1 T-DM1 3.6mg/kg IV q3wks Trastuzumab 8mg/kg IV loading dose followed by 6mg/kg q3wks and docetaxel 75 or 100mg/m2 (HT) Progression free survival Adverse events Objective Response rate QOL
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Efficacy ORR in HT : 58.0% ORR in T-DM1 : 64.2%
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Safety
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T-DM1HT Grade ≥ 346.4%90.9% Grade 45.8%57.6% Treatment stopped d/t adverse event 7.2%40.9% Decreased LVEF Grade 1 : 2 Grade 3 : 1 Grade 2 : 2 Grade 3 : 1
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QOL
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Discussion T-DM 1 and HT Median PFS 14.2 months and 9.2 months Grade 4 AE 5.8% and 57.6% Adverse event Headache, thrombocytopenia, AST, ALT elevation in T-DM 1, and alopecia, neutropenia, peripheral edema, diarrhea in HT group AE leading to treatment discontinuation 7.2% and 40.9%
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Discussion QOL FACT-B Favorable safety profile in T-DM1
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Conclussion In this study, T-DM1 was superior to 1 st line HT therapy in terms of PFS, safety and QOL in HER2(+), metastatic breast cancer patients
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