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CLO22-068: An Assessment of Extended Pembrolizumab Dosing and Outcomes in Advanced Non-Small Cell Lung Cancer Patients During the COVID-19 Pandemic

Gordon Taylor Moffat, Lilian Hanna, Wilma Hopman, Andrea S. Fung, and Pierre-Olivier Gaudreau

to the cancer center. Pembrolizumab ED has been evaluated through pharmacokinetic studies and simulated model-based analyses, however clinical data are lacking. The aim of this study is to evaluate real-world outcomes and safety of ED vs standard

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HSR21-050: Access to Gastroenterology and Internal Medicine Physicians is Associated With Improved Outcomes in Colorectal Cancer: A Nation-Wide Analysis

Udhayvir Singh Grewal, Subhash Chandra Garikipati, Parth Rajeshbhai Shah, Shiva Jashwanth Gaddam, Aakash Rajendra Sheth, and Ghanshyam Mudigonda

conducted the current analysis to study the impact of access to various specialties on the overall outcomes in CRC patients. Materials and Methods: The National Provider Identifier (NPI) database was interrogated to identify the number of gastroenterology

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HSR22-180: Real-World Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy in BRAF+ Cutaneous Melanoma Patients Treated in the Adjuvant Setting

Sanjay Chandrasekaran, You-Li Ling, Jackson Tang, Deborah Norton, and Rohan Shah

use in the real-world setting is scarce. Objective : To examine treatment patterns and outcomes among BRAF+ cutaneous melanoma patients treated with adjuvant IO or DT in the United States. Methods: This was a retrospective cohort study using

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HSR23-101: Characteristics and Outcomes of Patients Treated With Selpercatinib in the Real-World: A Retrospective Study Using US Claims Databases

Naleen Raj Bhandari, Neha Bansal, Chi-Wei Duann, Anasofia Afonso, and Shen Zheng

and associated outcomes (time to treatment discontinuation [TTD] and treatment adherence) in selpercatinib-treated US patients. Methods: This retrospective cohort study used de-identified data from two administrative real-world claims databases

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Associations With Definitive Outcomes and Clinical Benefit of Cancer Drugs at the Time of Marketing Approval and in the Postmarketing Period

Aida Bujosa, Consolación Moltó, Thomas J. Hwang, José Carlos Tapia, Kerstin N. Vokinger, Arnoud J. Templeton, Ignasi Gich, Agustí Barnadas, Eitan Amir, and Ariadna Tibau

Background The FDA defines clinical benefit as an improvement in either the duration or the quality of life (QoL). 1 FDA criteria allow cancer drugs to be approved based on surrogate measures that will reasonably predict definitive outcomes

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CLO23-042: Clinical Outcomes of Radical Radiotherapy With or Without Chemotherapy in Inoperable Locally Advanced Squamous Cell Carcinoma of Oral Cavity

Maria Philip, Jomon Raphael Chalissery, Febin Antony, Rajkrishna B, and Mathew Varghese K

to determine the benefits and overall survival in these patients treated with definitive radiotherapy with or without concurrent chemotherapy. Methods: We conducted a retrospective analysis to evaluate the clinical outcomes in patients with

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HSR22-166: Patient Demographic and Socioeconomic Differences in Non-Small Cell and Small Cell Lung Cancers: Impact on Outcomes. A National Cancer Database Analysis.

Logan Roof, Wei Wei, and James P Stevenson

communities, distance to an academic center, income, insurer, and education level. The goal of this study was to determine whether the same disparities exist in non-small cell lung cancer (NSCLC), and how the patient demographics and outcomes compare to those

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EPR22-111: Outcomes and Utilization of Adjuvant Chemotherapy With and Without an Anthracycline in Node-Positive, Triple-Negative Breast Cancer: Analysis of SEER-Medicare Data

Stephanie Lakritz, Anna Schreiber, Elizabeth Molina, Elisabeth Meyer, Cathy J Bradley, and Jennifer R Diamond

therapy (ATAX) regimens shown to be more efficacious compared to non-anthracycline-containing, taxane-based regimens (TAX) in node-positive disease. However, data investigating outcomes and utilization of adjuvant chemotherapy in older women with node

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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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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