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HSR24-152: Patient-Reported Outcome (PRO) Data in Oncology NDAs Approved by the FDA (2018–2021): A Review of Criticism and Concerns in Comments From Regulators

Erin Comerford, Lindsey Norcross, Medha Sasane, Ying Zheng, and Ari Gnanasakthy

Background: Despite increasing inclusion of patient-reported outcomes (PROs) in pivotal trials, PRO data often do not make it into labeling for approved products. This is particularly true in the field of oncology, where assessment and

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HSR24-139: Patient-Reported Outcome Measures Used in Patients With Chronic Phase–Chronic Myeloid Leukemia: A Systematic Review of the Literature

Kathryn E. Flynn, Lovneet Saini, Aditi Kataria, Kejal Jadhav, Daisy Yang, and David Wei

for CML patients in survivorship. Patient-reported outcome (PRO) measures provide key evidence about patients’ experiences with TKIs, as TKIs differ in associated adverse events (AEs) and side effect profiles. What we understand about PROs depends on

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Counterpoint: Implementing Population Genetic Screening for Lynch Syndrome Among Newly Diagnosed Colorectal Cancer Patients—Will the Ends Justify the Means?

Michael J. Hall

with Lynch in the United States population and, more importantly, 2) to effectively improve health outcomes for patients with CRC and their relatives, because of a paucity of information on real-life access barriers, educational gaps, and patient

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Use of Circulating Tumor DNA for the Clinical Management of Metastatic Castration-Resistant Prostate Cancer: A Multicenter, Real-World Study

Baijun Dong, Liancheng Fan, Bin Yang, Wei Chen, Yonghong Li, Kaijie Wu, Fengbo Zhang, Haiying Dong, Huihua Cheng, Jiahua Pan, Yinjie Zhu, Chenfei Chi, Liang Dong, Jianjun Sha, Lei Li, Xudong Yao, and Wei Xue

alterations, especially those involving DDR genes, can predict the clinical outcomes of Chinese patients with mCRPC following specific treatments remains to be fully elucidated. Routine sampling of bone and other metastatic tissues in patients with mCRPC is

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Current Surveillance After Treatment is Not Sufficient for Patients With Rectal Cancer With Negative Baseline CEA

Dingcheng Shen, Xiaolin Wang, Heng Wang, Gaopo Xu, Yumo Xie, Zhuokai Zhuang, Ziying Huang, Juan Li, Jinxin Lin, Puning Wang, Meijin Huang, Yanxin Luo, and Huichuan Yu

sustained negative CEA during surveillance, whereas the other 26 (41.3%) in the CEA-turn group had elevated CEA during surveillance before the recurrent disease was confirmed. Interestingly, when we stratified the overall recurrence outcomes by local and

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The Role of Autologous and Allogeneic Hematopoietic Stem Cell Transplantation for Hodgkin Lymphoma

Leona Holmberg and David G. Maloney

complete remission, the disease may become life-threatening. For many patients, the current standard of care involves salvage chemotherapy and autologous hematopoietic stem cell transplantation (ASCT). Successful outcome depends on chemosensitivity at the

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BPI24-016: Clinical Behavior, Oncological Outcomes, and External Validation of the Gronchi Nomogram in Patients Diagnosed With Primary Retroperitoneal Sarcoma Treated at a Latin American Reference Center Between 2009–2018

Ivan Mariño-Lozano, Sandra Diaz-Casas, Mauricio Garcia-Mora, Carlos Lehmann-Mosquera, Javier Angel-Aristizabal, Sergio Cervera-Bonilla, Pablo Gutierrez, Ricardo Sanchez-Pedraza, and Carlos Duarte Torres

determination of each patient's individual survival. The objective of this study was to validate this nomogram and describe the demographic, clinical, and oncological outcomes of this pathology at a Latin American reference center. Methodology: This is a

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HSR24-154: Real-World Clinical Outcomes in Patients With Advanced/Metastatic Melanoma and Brain Metastases Treated With Pembrolizumab Monotherapy—An Analysis of the ADOReg German Skin Cancer Registry

Ruixuan Jiang, Michael Weichenthal, Cesar I. Fernandez-Lazaro, Anja Rudolph, Clemens Krepler, Peter Mohr, and on behalf of the ADOReg investigators

Background: Brain metastases are associated with poor clinical outcomes in advanced/metastatic melanoma, with median overall survival (OS), historically, of 3–6 months. The ADOReg German skin cancer registry provides an opportunity to evaluate

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HSR24-159: Relationship Between Durable Transfusion Independence (TI) and Survival Outcomes in Patients (Pts) With Lower-Risk Myelodysplastic Syndrome (LR-MDS): An Analysis From US Health Insurance Claims Data

Rami S. Komrokji, Nishan Sengupta, Dylan Supina, Shyamala Navada, Ravi Potluri, Rohit Tyagi, Timothy Werwath, Zhouer Xie, Eric Padron, and David Sallman

limited efficacy and durability. In this study, the association between RBC-TD and outcomes was assessed. Methods: A large US commercial health claims database (including ∼17–19M annual covered lives) identified LR-MDS pts using ICD-10 codes (D46.0, D46

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Chronic Myeloid Leukemia, Version 2.2021, NCCN Clinical Practice Guidelines in Oncology

Michael W. Deininger, Neil P. Shah, Jessica K. Altman, Ellin Berman, Ravi Bhatia, Bhavana Bhatnagar, Daniel J. DeAngelo, Jason Gotlib, Gabriela Hobbs, Lori Maness, Monica Mead, Leland Metheny, Sanjay Mohan, Joseph O. Moore, Kiran Naqvi, Vivian Oehler, Arnel M. Pallera, Mrinal Patnaik, Keith Pratz, Iskra Pusic, Michal G. Rose, B. Douglas Smith, David S. Snyder, Kendra L. Sweet, Moshe Talpaz, James Thompson, David T. Yang, Kristina M. Gregory, and Hema Sundar

associated with higher molecular response rates to imatinib. 17 – 20 While some studies have demonstrated a trend toward better survival outcomes with e14a2 transcript, 18 , 19 in other studies the type of transcript did not have any significant impact on