未登录 The Food and Drug Administration pooled analysis of overall survival according to depth of response in frontline advanced immune-oncology renal cell carcinoma trials 美国食品药品监督管理局对一线晚期免疫肿瘤学肾细胞癌试验中根据缓解深度进行的总生存期合并分析 Chang, Elaine; Gittleman, Haley; Song, Chi; Bloomquist, Erik; Fernandes, Laura; Weinstock, Chana; Agrawal, Sundeep; Gormley, Nicole; Tang, Shenghui; Suzman, Daniel L.; Amiri-Kordestani, Laleh; Pazdur, Richard; Kluetz, Paul G.; McDermott, David F.; Regan, Meredith M.; Rini, Brian, I 分享 收藏
Cardiovascular Safety in Oncology Clinical Trials JACC: CardioOncology Primer 肿瘤学临床试验中的心血管安全性 JACC: CardioOncology Primer Bonaca, Marc P.; Lang, Ninian N.; Chen, Alice; Amiri-Kordestani, Laleh; Lipka, Leslie; Zwiewka, Michal; Strnadova, Colette; Klaar, Sigrid; Dent, Susan; Janicijevic, Tijana Krnjeta; Herrmann, Joerg; Barac, Ana; Boer, Rudolf A. de; Deswal, Anita; Schou, Morten; Neilan, Tomas G.; van der Meer, Peter; Moslehi, Javid; Kondapalli, Lavanya; Ky, Bonnie; Fernandez, Teresa Lopez; Cornell, R. Frank; Flaig, Thomas W.; Hsia, Judith; Sharon, Elad; de Azambuja, Evandro; Seltzer, Jonathan; Januzzi, James L.; Petrie, Mark C. 分享 收藏
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RE: Is it time to reconsider the role of upfront cytoreductive nephrectomy in metastatic renal cell carcinoma? Fallah, Jaleh; Gittleman, Haley; Weinstock, Chana; Chang, Elaine; Agrawal, Sundeep; Tang, Shenghui; Pazdur, Richard; Kluetz, Paul G.; Suzman, Daniel L.; Amiri-Kordestani, Laleh 分享 收藏
Cytoreductive nephrectomy in the era of immune checkpoint inhibitors: a US Food and Drug Administration pooled analysis Fallah, Jaleh; Gittleman, Haley; Weinstock, Chana; Chang, Elaine; Agrawal, Sundeep; Tang, Shenghui; Pazdur, Richard; Kluetz, Paul G.; Suzman, Daniel L.; Amiri-Kordestani, Laleh 分享 收藏
Methodology for Good Machine Learning with Multi-Omics Data Coroller, Thibaud; Sahiner, Berkman; Amatya, Anup; Gossmann, Alexej; Karagiannis, Konstantinos; Moloney, Conor; Samala, Ravi K.; Santana-Quintero, Luis; Solovieff, Nadia; Wang, Craig; Amiri-Kordestani, Laleh; Cao, Qian; Cha, Kenny H.; Charlab, Rosane; Cross, Frank H.; Hu, Tingting; Huang, Ruihao; Kraft, Jeffrey; Krusche, Peter; Li, Yutong; Li, Zheng; Mazo, Ilya; Paul, Rahul; Schnakenberg, Susan; Serra, Paolo; Smith, Sean; Song, Chi; Su, Fei; Tiwari, Mohit; Vechery, Colin; Xiong, Xin; Zarate, Juan Pablo; Zhu, Hao; Chakravartty, Arunava; Liu, Qi; Ohlssen, David; Petrick, Nicholas; Schneider, Julie A.; Walderhaug, Mark; Zuber, Emmanuel 分享 收藏
Highlights of FDA Oncology Approvals in 2023: Bispecific T-cell Engagers, Pediatric Indications, and Inclusive Drug Development Donaldson, Joshua M.; Seddiq, Marjilla; Fusco, Michael J.; Singla, Shyamli; Pamuk, Gulsum E.; Lee-Alonso, Rosa J.; Mixter, Bronwyn D.; Goldberg, Kirsten B.; Amiri-Kordestani, Laleh; De Claro, R. Angelo; Drezner, Nicole; Gormley, Nicole J.; Kanapuru, Bindu; Lemery, Steven J.; Fashoyin-Aje, Lola A.; Richardson, Nicholas C.; Singh, Harpreet; Suzman, Daniel L.; Theoret, Marc R.; Kluetz, Paul G.; Pazdur, Richard 分享 收藏
A US Food and Drug Administration-pooled Analysis of Frontline Combination Treatment Survival Benefits by Risk Groups in Metastatic Renal Cell Carcinoma Lee, Daniel; Gittleman, Haley; Weinstock, Chana; Suzman, Daniel; Bloomquist, Erik; Agrawal, Sundeep; Brave, Michael; Brewer, Jamie; Fallah, Jaleh; Singh, Harpreet; Tang, Shenghui; Ibrahim, Amna; Pazdur, Richard; Beaver, Julia A.; Amiri-Kordestani, Laleh 分享 收藏
Feasibility of generating an external control comparator using RWD by matching with previously conducted RCTs: CDK4/6 Inhibitors for the treatment of Metastatic Breast Cancer Osgood, Christy; Fan, Jiaxin; Gao, Xin; Keane, Catherine; Bryan, Jonathan; Roose, James P.; Bloomquist, Erik; Torres, Aracelis; Baxi, Shrujal; Nussbaum, Nathan; Rizvi, Fatima; Tang, Shenghui; Nunes, Irene; Beaver, Julia; Rivera, Donna R.; Howie, Lynn; Paliwal, Prashni; Amiri-Kordestani, Laleh 分享 收藏
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Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria (vol 32, pg 950, 2021) Gao, J. J.; Krol, D.; Narayan, P.; Cardoso, F.; Regan, M. M.; Goetz, M. P.; Hurvitz, S. A.; Mauro, L.; Hodgdon, C.; Miller, C. P.; Booth, B.; Bloomquist, E.; Ison, G.; Osgood, C.; Bhatnagar, V.; Fashoyin-Aje, L.; Pazdur, R.; Amiri-Kordestani, L.; Beaver, J. A. 分享 收藏
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Generating real-world external comparators for randomized clinical trials (RCTs) in metastatic breast cancer (mBC) using electronic health records (EHRs) Amiri-Kordestani, Laleh; Gao, Xin; Baxi, Shrujal; Bloomquist, Erik; Bryan, Jonathan; Howie, Lynn; Keane, Catherine; Kluetz, Paul G.; Osgood, Christy; Paliwal, Prashni; Rivera, Donna R.; Roose, James; Schneider, Julie; Singh, Harpreet; Tang, Shenghui; Zhang, Lijun; Beaver, Julia A. 分享 收藏
Model Development of CDK4/6 Predicted Efficacy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer Mason, Jeremy; Gong, Yutao; Amiri-Kordestani, Laleh; Wedam, Suparna; Gao, Jennifer J.; Prowell, Tatiana M.; Singh, Harpreet; Amatya, Anup; Tang, Shenghui; Pazdur, Richard; Kuhn, Peter; Blumenthal, Gideon M.; Beaver, Julia A. 分享 收藏
Survival outcomes in older men with non-metastatic castration-resistant prostate cancer treated with androgen receptor inhibitors: a US Food and Drug Administration pooled analysis of patient-level data from three randomised trials Fallah, Jaleh; Zhang, Lijun; Amatya, Anup; Gong, Yutao; King-Kallimanis, Bellinda; Bhatnagar, Vishal; Weinstock, Chana; Suzman, Daniel L.; Agrawal, Sundeep; Chang, Elaine; Anscher, Mitchell S.; Chi, Dow-Chung; Xu, James X.; Brewer, Jamie R.; Brave, Michael H.; Hadadi, Mehrnoosh; Theoret, Marc R.; Kluetz, Paul G.; Goldberg, Kirsten B.; Ibrahim, Amna; Tang, Shenghui; Pazdur, Richard; Beaver, Julia A.; Amiri-Kordestani, Laleh; Singh, Harpreet 分享 收藏
Bringing safe and effective therapies to premenopausal women with breast cancer: efforts to broaden eligibility criteria Gao, J. J.; Krol, D.; Narayan, P.; Cardoso, F.; Regan, M. M.; Goetz, M. P.; Hurvitz, S. A.; Mauro, L.; Hodgdon, C.; Miller, C. P.; Booth, B.; Bloomquist, E.; Ison, G.; Osgood, C.; Bhatnagar, V.; Fashoyin-Aje, L.; Pazdur, R.; Amiri-Kordestani, L.; Beaver, J. A. 分享 收藏
US Food and Drug Administration regulatory updates in neuro-oncology 美国食品和药物管理局在神经肿瘤学方面的监管更新 Mehta, Gautam U.; Barone, Amy K.; Bradford, Diana; Larkins, Erin; Kim, Janice; Pai-Scherf, Lee; Jaigirdar, Adnan; Shah, Mirat; Wedam, Suparna; Amiri-Kordestani, Laleh; Theoret, Marc R.; Pazdur, Richard; Beaver, Julia A.; Singh, Harpreet 分享 收藏
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A Food and Drug Administration analysis of survival outcomes comparing the Adjuvant Paclitaxel and Trastuzumab trial with an external control from historical clinical trials Amiri-Kordestani, L.; Xie, D.; Tolaney, S. M.; Bloomquist, E.; Tang, S.; Ibrahim, A.; Goldberg, K. B.; Theoret, M. R.; Pazdur, R.; Sridhara, R.; Winer, E. P.; Beaver, J. A. 分享 收藏
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