The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform
A.m. Russell - One of the best experts on this subject based on the ideXlab platform.
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fda approval ado trastuzumab emtansine for the Treatment of Patients with her2 positive metastatic breast cancer
Clinical Cancer Research, 2014Co-Authors: Laleh Amirikordestani, L Ha, R Candauchacon, Wendy C. Weinberg, S. W. Tang, Gideon M Blumenthal, P Hughes, Lijun Zhang, Qing Xu, A.m. RussellAbstract:On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent for the Treatment of Patients with human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. The clinical basis for licensure was a phase III trial in 991 Patients with HER2-positive MBC that randomly allocated Patients to receive ado-trastuzumab emtansine ( n = 495) or lapatinib in combination with capecitabine ( n = 496). The coprimary endpoints were progression-free survival (PFS) based on tumor assessments by an independent review committee and overall survival (OS). Statistically significant improvements in PFS and OS were observed in Patients receiving ado-trastuzumab emtansine compared with Patients receiving lapatinib plus capecitabine [difference in PFS medians of 3.2 months, HR, 0.65 (95% confidence interval, CI, 0.55–0.77), P P = 0.0006]. The most common adverse reactions in Patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation. Other significant adverse reactions included hepatobiliary disorders and left ventricular dysfunction. Given the PFS and OS results, the benefit–risk profile was considered favorable. Clin Cancer Res; 20(17); 4436–41. ©2014 AACR .
Sarah Pope Miksinski - One of the best experts on this subject based on the ideXlab platform.
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fda approval ado trastuzumab emtansine for the Treatment of Patients with her2 positive metastatic breast cancer
Clinical Cancer Research, 2014Co-Authors: Laleh Amirikordestani, Wendy C. Weinberg, S. W. Tang, Gideon M Blumenthal, Lijun Zhang, Bo Chi, Reyes Candauchacon, Patricia Hughes, Anne Marie Russell, Sarah Pope MiksinskiAbstract:On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent for the Treatment of Patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. The clinical basis for licensure was a phase III trial in 991 Patients with HER2-positive MBC that randomly allocated Patients to receive ado-trastuzumab emtansine (n=495) or lapatinib in combination with capecitabine (n=496). The coprimary endpoints were progression-free survival (PFS) based on tumor assessments by an independent review committee and overall survival (OS). Statistically significant improvements in PFS and OS were observed in Patients receiving ado-trastuzumab emtansine compared with Patients receiving lapatinib plus capecitabine [difference in PFS medians of 3.2 months, HR, 0.65 (95% confidence interval, CI, 0.55-0.77), P<0.0001 and difference in OS medians of 5.8 months, HR, 0.68 (95% CI, 0.55-0.85), P=0.0006]. The most common adverse reactions in Patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation. Other significant adverse reactions included hepatobiliary disorders and left ventricular dysfunction. Given the PFS and OS results, the benefit-risk profile was considered favorable.
Gideon M Blumenthal - One of the best experts on this subject based on the ideXlab platform.
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fda approval ado trastuzumab emtansine for the Treatment of Patients with her2 positive metastatic breast cancer
Clinical Cancer Research, 2014Co-Authors: Laleh Amirikordestani, L Ha, R Candauchacon, Wendy C. Weinberg, S. W. Tang, Gideon M Blumenthal, P Hughes, Lijun Zhang, Qing Xu, A.m. RussellAbstract:On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent for the Treatment of Patients with human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. The clinical basis for licensure was a phase III trial in 991 Patients with HER2-positive MBC that randomly allocated Patients to receive ado-trastuzumab emtansine ( n = 495) or lapatinib in combination with capecitabine ( n = 496). The coprimary endpoints were progression-free survival (PFS) based on tumor assessments by an independent review committee and overall survival (OS). Statistically significant improvements in PFS and OS were observed in Patients receiving ado-trastuzumab emtansine compared with Patients receiving lapatinib plus capecitabine [difference in PFS medians of 3.2 months, HR, 0.65 (95% confidence interval, CI, 0.55–0.77), P P = 0.0006]. The most common adverse reactions in Patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation. Other significant adverse reactions included hepatobiliary disorders and left ventricular dysfunction. Given the PFS and OS results, the benefit–risk profile was considered favorable. Clin Cancer Res; 20(17); 4436–41. ©2014 AACR .
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fda approval ado trastuzumab emtansine for the Treatment of Patients with her2 positive metastatic breast cancer
Clinical Cancer Research, 2014Co-Authors: Laleh Amirikordestani, Wendy C. Weinberg, S. W. Tang, Gideon M Blumenthal, Lijun Zhang, Bo Chi, Reyes Candauchacon, Patricia Hughes, Anne Marie Russell, Sarah Pope MiksinskiAbstract:On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent for the Treatment of Patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. The clinical basis for licensure was a phase III trial in 991 Patients with HER2-positive MBC that randomly allocated Patients to receive ado-trastuzumab emtansine (n=495) or lapatinib in combination with capecitabine (n=496). The coprimary endpoints were progression-free survival (PFS) based on tumor assessments by an independent review committee and overall survival (OS). Statistically significant improvements in PFS and OS were observed in Patients receiving ado-trastuzumab emtansine compared with Patients receiving lapatinib plus capecitabine [difference in PFS medians of 3.2 months, HR, 0.65 (95% confidence interval, CI, 0.55-0.77), P<0.0001 and difference in OS medians of 5.8 months, HR, 0.68 (95% CI, 0.55-0.85), P=0.0006]. The most common adverse reactions in Patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation. Other significant adverse reactions included hepatobiliary disorders and left ventricular dysfunction. Given the PFS and OS results, the benefit-risk profile was considered favorable.
Wendy C. Weinberg - One of the best experts on this subject based on the ideXlab platform.
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fda approval ado trastuzumab emtansine for the Treatment of Patients with her2 positive metastatic breast cancer
Clinical Cancer Research, 2014Co-Authors: Laleh Amirikordestani, L Ha, R Candauchacon, Wendy C. Weinberg, S. W. Tang, Gideon M Blumenthal, P Hughes, Lijun Zhang, Qing Xu, A.m. RussellAbstract:On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent for the Treatment of Patients with human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. The clinical basis for licensure was a phase III trial in 991 Patients with HER2-positive MBC that randomly allocated Patients to receive ado-trastuzumab emtansine ( n = 495) or lapatinib in combination with capecitabine ( n = 496). The coprimary endpoints were progression-free survival (PFS) based on tumor assessments by an independent review committee and overall survival (OS). Statistically significant improvements in PFS and OS were observed in Patients receiving ado-trastuzumab emtansine compared with Patients receiving lapatinib plus capecitabine [difference in PFS medians of 3.2 months, HR, 0.65 (95% confidence interval, CI, 0.55–0.77), P P = 0.0006]. The most common adverse reactions in Patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation. Other significant adverse reactions included hepatobiliary disorders and left ventricular dysfunction. Given the PFS and OS results, the benefit–risk profile was considered favorable. Clin Cancer Res; 20(17); 4436–41. ©2014 AACR .
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fda approval ado trastuzumab emtansine for the Treatment of Patients with her2 positive metastatic breast cancer
Clinical Cancer Research, 2014Co-Authors: Laleh Amirikordestani, Wendy C. Weinberg, S. W. Tang, Gideon M Blumenthal, Lijun Zhang, Bo Chi, Reyes Candauchacon, Patricia Hughes, Anne Marie Russell, Sarah Pope MiksinskiAbstract:On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent for the Treatment of Patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. The clinical basis for licensure was a phase III trial in 991 Patients with HER2-positive MBC that randomly allocated Patients to receive ado-trastuzumab emtansine (n=495) or lapatinib in combination with capecitabine (n=496). The coprimary endpoints were progression-free survival (PFS) based on tumor assessments by an independent review committee and overall survival (OS). Statistically significant improvements in PFS and OS were observed in Patients receiving ado-trastuzumab emtansine compared with Patients receiving lapatinib plus capecitabine [difference in PFS medians of 3.2 months, HR, 0.65 (95% confidence interval, CI, 0.55-0.77), P<0.0001 and difference in OS medians of 5.8 months, HR, 0.68 (95% CI, 0.55-0.85), P=0.0006]. The most common adverse reactions in Patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation. Other significant adverse reactions included hepatobiliary disorders and left ventricular dysfunction. Given the PFS and OS results, the benefit-risk profile was considered favorable.
S. W. Tang - One of the best experts on this subject based on the ideXlab platform.
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fda approval ado trastuzumab emtansine for the Treatment of Patients with her2 positive metastatic breast cancer
Clinical Cancer Research, 2014Co-Authors: Laleh Amirikordestani, L Ha, R Candauchacon, Wendy C. Weinberg, S. W. Tang, Gideon M Blumenthal, P Hughes, Lijun Zhang, Qing Xu, A.m. RussellAbstract:On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent for the Treatment of Patients with human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. The clinical basis for licensure was a phase III trial in 991 Patients with HER2-positive MBC that randomly allocated Patients to receive ado-trastuzumab emtansine ( n = 495) or lapatinib in combination with capecitabine ( n = 496). The coprimary endpoints were progression-free survival (PFS) based on tumor assessments by an independent review committee and overall survival (OS). Statistically significant improvements in PFS and OS were observed in Patients receiving ado-trastuzumab emtansine compared with Patients receiving lapatinib plus capecitabine [difference in PFS medians of 3.2 months, HR, 0.65 (95% confidence interval, CI, 0.55–0.77), P P = 0.0006]. The most common adverse reactions in Patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation. Other significant adverse reactions included hepatobiliary disorders and left ventricular dysfunction. Given the PFS and OS results, the benefit–risk profile was considered favorable. Clin Cancer Res; 20(17); 4436–41. ©2014 AACR .
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fda approval ado trastuzumab emtansine for the Treatment of Patients with her2 positive metastatic breast cancer
Clinical Cancer Research, 2014Co-Authors: Laleh Amirikordestani, Wendy C. Weinberg, S. W. Tang, Gideon M Blumenthal, Lijun Zhang, Bo Chi, Reyes Candauchacon, Patricia Hughes, Anne Marie Russell, Sarah Pope MiksinskiAbstract:On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent for the Treatment of Patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination. The clinical basis for licensure was a phase III trial in 991 Patients with HER2-positive MBC that randomly allocated Patients to receive ado-trastuzumab emtansine (n=495) or lapatinib in combination with capecitabine (n=496). The coprimary endpoints were progression-free survival (PFS) based on tumor assessments by an independent review committee and overall survival (OS). Statistically significant improvements in PFS and OS were observed in Patients receiving ado-trastuzumab emtansine compared with Patients receiving lapatinib plus capecitabine [difference in PFS medians of 3.2 months, HR, 0.65 (95% confidence interval, CI, 0.55-0.77), P<0.0001 and difference in OS medians of 5.8 months, HR, 0.68 (95% CI, 0.55-0.85), P=0.0006]. The most common adverse reactions in Patients receiving ado-trastuzumab emtansine were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased aminotransferase levels, and constipation. Other significant adverse reactions included hepatobiliary disorders and left ventricular dysfunction. Given the PFS and OS results, the benefit-risk profile was considered favorable.
