Publications by authors named "E H Horodniceanu"
Article Synopsis
- The study emphasizes the importance of incorporating patient-reported outcomes (PROs) to evaluate symptomatic adverse events in cancer clinical trials, which is crucial for understanding treatment tolerability.
- Researchers analyzed safety data from cancer drug approvals between 2015-2021, focusing on the most common symptomatic adverse reactions reported in clinical trials for lung, breast, and hematologic cancers.
- Findings revealed that fatigue, diarrhea, and nausea were the most frequently reported adverse reactions, indicating these should be prioritized when developing PRO strategies for assessing treatment tolerability in future trials.
Purpose: Successful patient-focused drug development involves selecting and measuring outcomes in clinical trials that are important to patients. The U.S.
View Article and Find Full Text PDFPurpose: The U.S. Food & Drug Administration has identified physical functioning (PF) as a core patient-reported outcome (PRO) in cancer clinical trials.
View Article and Find Full Text PDFPatient-reported frailty phenotype (PRFP) vs. International Myeloma Working Group frailty index (IMWG FI) proxy: A comparison between two approaches to measuring frailty.
J Geriatr Oncol
March 2024
Introduction: Frailty assessments may help to identify patients at highest risk for treatment-related toxicity, early treatment discontinuation due to toxicity, and death in Multiple Myeloma. We aimed to compare the patient-reported frailty phenotype (PRFP) and a modified version of the International Myeloma Working Group frailty index (IMWG FI) in terms of their strengths, limitations, and classification of frailty in a cohort of patients with relapsed/refractory multiple myeloma (RRMM).
Materials And Methods: Data were pooled from six RRMM Phase 3 randomized clinical trials submitted to the Food and Drug Administration for regulatory review between 2010 and 2021.
Purpose: The objective of this retrospective study was to determine the feasibility of measuring frailty using patient responses to relevant EORTC QLQ-C30 items as proxy criteria for the Fried Frailty Phenotype, in a cohort of patients with Relapsed/Refractory Multiple Myeloma (RRMM).
Methods: Data were pooled from nine Phase III randomized clinical trials submitted to the FDA for regulatory review between 2010 and 2021, for the treatment of RRMM. Baseline EORTC QLQ-C30 responses were used to derive a patient-reported frailty phenotype (PRFP), based on the Fried definition of frailty.