Search Results - "Fernandes, Laura L."

Analysis of the Association Between Adverse Events and Outcome in Patients Receiving a Programmed Death Protein 1 or Programmed Death Ligand 1 Antibody by Maher, V Ellen, Fernandes, Laura L, Weinstock, Chana, Tang, Shenghui, Agarwal, Sundeep, Brave, Michael, Ning, Yang-Min, Singh, Harpreet, Suzman, Daniel, Xu, James, Goldberg, Kirsten B, Sridhara, Rajeshwari, Ibrahim, Amna, Theoret, Marc, Beaver, Julia A, Pazdur, Richard

“…To assess the relationship among tumor response rate, overall survival, and the development of related adverse events of special interest (AESIs) or related…”
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Rendering the 3 + 3 Design to Rest: More Efficient Approaches to Oncology Dose-Finding Trials in the Era of Targeted Therapy by Nie, Lei, Rubin, Eric H, Mehrotra, Nitin, Pinheiro, José, Fernandes, Laura L, Roy, Amit, Bailey, Stuart, de Alwis, Dinesh P

“…Selection of the maximum tolerated dose (MTD) as the recommended dose for registration trials based on a dose-escalation trial using variations of an MTD/3 + 3…”
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Review of patient-reported outcomes in multiple myeloma registrational trials: highlighting areas for improvement by Fernandes, Laura L., Zhou, Jiaxi, Kanapuru, Bindu, Horodniceanu, Erica, Gwise, Thomas, Kluetz, Paul G., Bhatnagar, Vishal

“…Over the past 13 years, there have been advances in characterizing the patient experience in oncology trials, primarily using patient-reported outcomes (PROs)…”
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Parotid Glands Dose–Effect Relationships Based on Their Actually Delivered Doses: Implications for Adaptive Replanning in Radiation Therapy of Head-and-Neck Cancer by Hunter, Klaudia U., MD, Fernandes, Laura L., MS, Vineberg, Karen A., MS, McShan, Daniel, PhD, Antonuk, Alan E., BS, Cornwall, Craig, DDS, Feng, Mary, MD, Schipper, Mathew J., PhD, Balter, James M., PhD, Eisbruch, Avraham, MD

“…Purpose Doses actually delivered to the parotid glands during radiation therapy often exceed planned doses. We hypothesized that the delivered doses correlate…”
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Real‐world patient characteristics, treatment patterns, and treatment outcomes of patients with diffuse large B‐cell lymphoma by line of therapy by Sineshaw, Helmneh M., Zettler, Christina M., Prescott, Jennifer, Garg, Mahek, Chakraborty, Samhita, Sarpong, Eric M., Bai, Claire, Belli, Andrew J., Fernandes, Laura L., Wang, Ching‐Kun

“…Background Although initial treatment of diffuse large B‐cell lymphoma (DLBCL) with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone…”
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Exploring racial disparities in treatment patterns and outcomes for patients with multiple myeloma using real world data by Maignan, Kathleen, Fashoyin-Aje, Lola A., Torres, Aracelis Z., Fernandes, Laura L., Gwise, Thomas, Baxi, Shrujal B., Roose, James P., Rivera, Donna R., Shen, Yuan Li, Kluetz, Paul G., Gormley, Nicole J.

“…This retrospective observational study evaluated racial disparities among Black and White patients with multiple myeloma (MM). We included patients from a…”
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Real-world study of disease-free survival & patient characteristics associated with disease-free survival in early-stage non-small cell lung cancer: A retrospective observational study by Shah, Anne, Apple, Jon, Belli, Andrew J., Barcellos, Anna, Hansen, Eric, Fernandes, Laura L., Zettler, Christina M., Wang, Ching-Kun

“…•Recurrence rates for patients with resectable early-stage non-small cell lung cancer (NSCLC) remain high in the real-world.•Stage at diagnosis and adjuvant…”
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Preoperative topical antimicrobial decolonization in head and neck surgery by Shuman, Andrew G., Shuman, Emily K., Hauff, Samantha J., Fernandes, Laura L., Light, Emily, Chenoweth, Carol E., Bradford, Carol R.

“…Objectives/Hypothesis: Surgical site infections (SSIs) are an important cause of morbidity and mortality after head and neck surgery. Our primary objective was…”
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FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy by Suzman, Daniel L., Agrawal, Sundeep, Ning, Yang‐min, Maher, V. Ellen, Fernandes, Laura L., Karuri, Stella, Tang, Shenghui, Sridhara, Rajeshwari, Schroeder, Jason, Goldberg, Kirsten B., Ibrahim, Amna, McKee, Amy E., Pazdur, Richard, Beaver, Julia A.

“…The U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab and pembrolizumab in April and May 2017, respectively, for the…”
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FDA Approval Summary: Alpelisib Plus Fulvestrant for Patients with HR-positive, HER2-negative, PIK3CA-mutated, Advanced or Metastatic Breast Cancer by Narayan, Preeti, Prowell, Tatiana M, Gao, Jennifer J, Fernandes, Laura L, Li, Emily, Jiang, Xiling, Qiu, Junshan, Fan, Jianghong, Song, Pengfei, Yu, Jingyu, Zhang, Xinyuan, King-Kallimanis, Bellinda L, Chen, Wei, Ricks, Tiffany K, Gong, Yutao, Wang, Xing, Windsor, Katherine, Rhieu, Steve Y, Geiser, Gerlie, Banerjee, Anamitro, Chen, Xiaohong, Reyes Turcu, Francisca, Chatterjee, Deb K, Pathak, Anand, Seidman, Jeffrey, Ghosh, Soma, Philip, Reena, Goldberg, Kirsten B, Kluetz, Paul G, Tang, Shenghui, Amiri-Kordestani, Laleh, Theoret, Marc R, Pazdur, Richard, Beaver, Julia A

“…On May 24, 2019, the FDA granted regular approval to alpelisib in combination with fulvestrant for postmenopausal women, and men, with hormone receptor…”
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Eligibility criteria and enrollment of a diverse racial and ethnic population in multiple myeloma clinical trials by Kanapuru, Bindu, Fernandes, Laura L., Baines, Andrea, Ershler, Rachel, Bhatnagar, Vishal, Pulte, Elizabeth, Gwise, Thomas, Theoret, Marc R., Pazdur, Richard, Fashoyin-Aje, Lola, Gormley, Nicole

“…•Ineligibility rates were higher among Black patients and racial subgroups classified as Other.•Black patients were more likely to be ineligible for a trial…”
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FDA Approval Summary: Rucaparib for the Treatment of Patients with Deleterious BRCA Mutation-Associated Advanced Ovarian Cancer by Balasubramaniam, Sanjeeve, Beaver, Julia A, Horton, Sara, Fernandes, Laura L, Tang, Shenghui, Horne, Hisani N, Liu, Jinzhong, Liu, Chao, Schrieber, Sarah J, Yu, Jingyu, Song, Pengfei, Pierce, William, Robertson, Kim J, Palmby, Todd R, Chiu, Haw-Jyh, Lee, Eunice Y, Philip, Reena, Schuck, Robert, Charlab, Rosane, Banerjee, Anamitro, Chen, Xiao Hong, Wang, Xing, Goldberg, Kirsten B, Sridhara, Rajeshwari, Kim, Geoffrey, Pazdur, Richard

“…On December 19, 2016, the FDA granted accelerated approval to rucaparib (RUBRACA; Clovis Oncology, Inc.) for the treatment of patients with deleterious…”
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Reply to H. McLeod et al by Weinstock, Chana, Fernandes, Laura L, Theoret, Marc, Tang, Shenghui, Sridhara, Rajeshwari, Beaver, Julia A, Pazdur, Richard

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Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies by Brewer, Jamie R, Chang, Elaine, Agrawal, Sundeep, Singh, Harpreet, Suzman, Daniel L, Xu, James, Weinstock, Chana, Fernandes, Laura L, Cheng, Joyce, Zhang, Lijun, Xie, Diqiong, Goldberg, Kirsten B, Bloomquist, Erik W, Tang, Shenghui, Sridhara, Rajeshwari, Theoret, Marc R, Pazdur, Richard, Ibrahim, Amna, Beaver, Julia A

“…The development and review of combination drug regimens in oncology may present unique challenges to investigators and regulators. For regulatory approval of…”
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Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials by Kanapuru, Bindu, Fernandes, Laura L., Fashoyin-Aje, Lola A., Baines, Andrea C., Bhatnagar, Vishal, Ershler, Rachel, Gwise, Thomas, Kluetz, Paul, Pazdur, Richard, Pulte, Elizabeth, Shen, Yuan-Li, Gormley, Nicole

“…African Americans (AAs) have a higher incidence of multiple myeloma (MM) than White patients. Mortality is also higher in AAs compared with White patients. AAs…”
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Asian representation in clinical trials of new drugs for the treatment of cancer by Fashoyin-Aje, Lola A., Fernandes, Laura L., Lemery, Steven, Keegan, Patricia, Sridhara, Rajeshwari, Bull, Jonca C., Pazdur, Richard

“…Abstract only 6564 Background: In the US, statistics for Asians are often aggregated with other racial groups. This poses challenges in estimating the cancer…”
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Evaluation of Real-World Tumor Response Derived From Electronic Health Record Data Sources: A Feasibility Analysis in Patients With Metastatic Non-Small Cell Lung Cancer Treated With Chemotherapy by McKelvey, Brittany A, Garrett-Mayer, Elizabeth, Rivera, Donna R, Alabaster, Amy, Andrews, Hillary S, Bond, Elizabeth G, Brown, Thomas D, Bruno, Amanda, Damato, Lauren, Espirito, Janet L, Fernandes, Laura L, Hansen, Eric, Kluetz, Paul, Ma, Xinran, McCracken, Andrea, Mishra-Kalyani, Pallavi S, Natanzon, Yanina, Potter, Danielle, Robert, Nicholas J, Schwartz, Lawrence, Schwind, Regina, Sweetnam, Connor, Wagner, Joseph, Stewart, Mark D, Allen, Jeff D

“…Real-world data (RWD) holds promise for ascribing a real-world (rw) outcome to a drug intervention; however, ascertaining rw-response to treatment from RWD can…”
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Adaptive Phase I clinical trial design using Markov models for conditional probability of toxicity by Fernandes, Laura L., Taylor, Jeremy M. G., Murray, Susan

“…Many Phase I trials in oncology involve multiple-dose administrations on the same patient over multiple cycles, with a typical cycle lasting 3 weeks and having…”
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Multivariate Markov models for the conditional probability of toxicity in phase II trials by Fernandes, Laura L., Murray, Susan, Taylor, Jeremy M. G.

“…In addition to getting a preliminary assessment of efficacy, phase II trials can also help to determine dose(s) that have an acceptable toxicity profile over…”
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Validation of a Composite Real-World Mortality Variable Among Patients with Hematologic Malignancies Treated in the United States by Dong, Sharlene, Kansagra, Ankit J., Kaur, Gurbakhash, Barcellos, Anna, Belli, Andrew J., Fernandes, Laura L., Hansen, Eric, Ambrose, Jacob, Bai, Claire, Zettler, Christina M., Wang, Ching-Kun

“…Introduction: Real-world data (RWD) is being increasingly used to support clinical and regulatory decisions where utilization of clinical trial data is…”
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