Table of Contents
Potential Use of Biomarkers or QoL Parameters in Colorectal Cancer Drug Approval
Biomarkers and QOL in CRC Drug Approval
CEA: Background
CEA Background (cont.)
Changes in CEA with Cytotoxic Chemotherapy
CEA in CRC: Translation
Additional Caveat: Hepatotoxicity
Quality of Life: A multidimensional construct encompassing complete information on the impact of disease or its treatment on a patient’s usual or expected physical, psychological, and social well-being
How Symptomatic is the Average Advanced Disease CRC Patient?
How Do We Measure QOL in CRC Patients?
Generic Instruments
Cancer-Specific Instruments
Symptom-Focused Questionnaires
Clinical Benefit Response
Interpretation and Application of HRQoL Scores
Summary of HRQoL Data in CRC
IFL vs. FL: Front-Line
IFL vs. BSC: Second-Line
FOLFOX vs. LV5FU2: Front-Line
Problem: We Don’t Know that Palliative Chemotherapy Truly Improves QOL
Problem: Inconsistent Methodologies with HRQoL Assessment
Problems with HRQoL Assessment (cont.):
Problem: HRQoL Reflects Efficacy and Safety (Toxicity)
Problems with Use of CBR in CRC
Additional Problems with Using Symptom Assessment
Additional Problems with Using Symptom Assessment (cont.)
Colorectal Cancer Drug Approval
Biomarkers: Conclusions
HRQoL Assessment: Conclusions
HRQoL Assessment: Conclusions (cont.)
Clinical Benefit Response: Conclusions
DISCUSSION
|