![]() PFS was ≥12 months in five patients, three of whom attained a PFS of ≥23 months. Progression-free survival (PFS) was 10 months compared with the 9.6 months of the EMILIA trial and the 6.2 months of the TH3RESA trial, overall survival was 34 months compared with the 29.9 months of the EMILIA trial and the 22.7 months of the TH3RESA trial. We have retrospectively analyzed outcomes in these patients and compared our findings with those of the two clinical trials. From 2012 to 2016, 15 patients with HER2-positive breast cancer who had progressed to prior treatment received T-DM1 at our center. We have performed a real-world study to complement the findings of the clinical trials. In two phase III clinical trials, EMILIA and TH3RESA, T-DM1 was shown to be effective in HER2-positive metastatic breast cancer patients who had progressed to taxanes and trastuzumab. ICESP - Instituto do Cancer do Estado de São Paulo Octavio Frias de OliveiraĬlínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda.T-DM1 is an antibody drug conjugate that combines trastuzumab with emtansine via a stable thioether linker. Santo André, Sao Paulo, Brazil, 09060-650 ![]() Itajaí, Santa Catarina, Brazil, 88301-220ĬEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200 Subiaco, Western Australia, Australia, 6008 Peninsula and South Eastern Haematology & Oncology Group Woolloongabba, Queensland, Australia, 4102 ![]() Tweed Heads, New South Wales, Australia, 2485 MultiCare Health System Institute for Research and Innovation The University of Texas Health Science Center at Tyler Houston Methodist Hospital / Houston Methodist Cancer Center Nashville, Tennessee, United States, 37232 Vanderbilt Breast Center at One Hundred Oaks Nashville, Tennessee, United States, 37205 Pittsburgh, Pennsylvania, United States, 15213 Winston-Salem, North Carolina, United States, 27157 Wake Forest University Baptist Medical Center Rochester, New York, United States, 14642 North Shore Hematology Oncology Associates, PCĮast Setauket, New York, United States, 11733 Louisville, Kentucky, United States, 40207īoston, Massachusetts, United States, 02215 Saint Petersburg, Florida, United States, 33705 Washington, District of Columbia, United States, 20010įort Myers, Florida, United States, 33916 Whittier, California, United States, 90603 San Francisco, California, United States, 94115 San Diego, California, United States, 92123 Los Angeles, California, United States, 90095 A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.Participants with clinically inactive brain metastases may be included in the study.Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.Has uncontrolled or significant cardiovascular disease.Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy Has previously been treated with an anti-HER2 antibody drug conjugate (ADC) in the metastatic setting.Has adequate renal and hepatic function.If of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for 7 months after the last dose of DS-8201a (females) 4.5 months after last dose of DS-8201a (males) or 7 months after the last dose of T-DM1.If archived tissue is not available, agrees to provide a fresh biopsy. Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available.Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy).was previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane.has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory.Has pathologically documented breast cancer that: Is the age of majority in their country.Why Should I Register and Submit Results?.
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