NON-TRADITIONAL ENDPOINTS IN LUNG CANCER - Patient Reported Outcomes -

10/10/2003


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Table of Contents

NON-TRADITIONAL ENDPOINTS IN LUNG CANCER - Patient Reported Outcomes -

ENDPOINTS IN DECISION-MAKING - Clinical Trials and Patient Management -

NON-SMALL CELL LUNG CANCER - Quality of Life at Baseline: Influence on Survival - - Prospective Analysis of 673 Patients at 30 Centers -

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PATIENT REPORTED OUTCOMES (“PROs”) - Rationale and Need -

SYMPTOMS OF LUNG CANCER - By Patient Reports (N = 121) -

NON-SMALL CELL LUNG CANCER - Number of Presenting Symptoms at Baseline -

PATIENT REPORTED OUTCOMES (“PROs”) - Clinical Benefit and Quality of Life -

QUALITY OF LIFE INSTRUMENTS - Dimensions -

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QUALITY OF LIFE - Questions -

QUALITY OF LIFE INSTRUMENTS - Instrument Focus -

QUALITY OF LIFE INSTRUMENTS - Lung Cancer Specific -

LUNG CANCER SPECIFIC INSTRUMENTS - Psychometrics (1) -

QUALITY OF LIFE INSTRUMENTS - Good reliability features include: -

QOL MEASURES FOR LUNG CANCER - Example: Reliability Coefficients -

LUNG CANCER SPECIFIC INSTRUMENTS - Psychometrics (2) -

QUALITY OF LIFE INSTRUMENTS - Additional Information -

PATIENT RESPONSE OUTCOME INSTRUMENTS IN LUNG CANCER TRIALS - Other Questionnaires -

NON-SMALL CELL LUNG CANCER - Clinical Benefit and Quality of Life –

RANDOMIZED PHASE II TRIAL OF IRESSA AT 2 DOSE LEVELS – “IDEAL 2” Quality of Life / Clinical Benefit: ASCO 2002 Abstract #1167

QUALITY OF LIFE EVALUATION IN CLINICAL TRIALS - Difficulties with Results Analysis: Phase II Trials -

NON-SMALL CELL LUNG CANCER - Clinical Benefit and Quality of Life –

PATIENT REPORTED OUTCOMES IN CLINICAL TRIALS - Problems in Evaluation and Analysis -

PROSPECTIVE CLINICAL TRIAL IN NSCLC - Causes of Patient Attrition -

PATIENT REPORTED OUTCOMES IN CLINICAL TRIALS - Prospective Emphasis on PRO: A Recent Study -

NON-SMALL CELL LUNG CANCER - Quality of Life at Baseline: Influence on Survival - - Prospective Analysis of 673 Patients at 30 Centers -

QUALITY OF LIFE - Baseline Values for Age and LCSS -

QUALITY OF LIFE IN LUNG CANCER - Evaluation Problems in Advanced Disease –

QUALITY OF LIFE EVALUATION IN CLINICAL TRIALS - Difficulties with Results Analysis: Phase III Trials -

PATIENT REPORTED OUTCOMES (“PROs”) - Conclusions -

PATIENT REPORTED OUTCOMES (“PROs”) - Conclusions -

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QUALITY OF LIFE AND LUNG CANCER - Conclusions -

QUALITY OF LIFE AND LUNG CANCER - Conclusions -

QUALITY OF LIFE INSTRUMENTS - Step #2: Compare Feasibility -

QUALITY OF LIFE INSTRUMENTS - Step #4: Examine Support for Validity -

QUALITY OF LIFE INSTRUMENTS - Step #4: Support for Validity (Cont.) -

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LUNG CANCER SYMPTOM SCALE (LCSS):

PSYCHOMETRICS "The Jargon"

QUALITY OF LIFE - Baseline Values of Prognostic Factors -

NON-SMALL CELL LUNG CANCER - Single Agent Vinorelbine vs Supportive Care - - In Patients > Age 70: A Prospective Randomized Trial -

NON-SMALL CELL LUNG CANCER - Single Agent Vinorelbine vs Supportive Care - - In Patients > Age 70: A Prospective Randomized Trial -

NON-SMALL CELL LUNG CANCER - SWOG 95-09 Randomized Trial in 410 Patients -

NON-SMALL CELL LUNG CANCER - SWOG Randomized Trial: Quality of Life -

STUDY DESIGN: Tax 326

NON-SMALL CELL LUNG CANCER - SWOG Randomized Trial in 415 Patients -

NSCLC: SECOND-LINE TRIAL (TAX 317) Survival: Docetaxel vs BSC - Intention to Treat

STUDY DESIGN: Tax 326 – First Line

TAX 326: Survival for DOCETAXEL + CISPLATIN vs. VINORELBINE + CISPLATIN

TAX 326: Survival for DOCETAXEL + CARBO vs. VINORELBINE + CISPLATIN

NON-SMALL CELL LUNG CANCER - Clinical Benefit and Quality of Life -

LCSS – Global QoL

EuroQoL Global Health Status

LCSS – Patient-Rated Pain Assessment

Weight Change (Kg) from Baseline to Last On-Treatment Assessment

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QUALITY OF LIFE - Conclusions from TAX 326 -

QUALITY OF LIFE MEASUREMENT - Uses in Lung Cancer -

QUALITY OF LIFE EVALUATION IN CLINICAL PRACTICE - Use in Routine Patient Evaluation -

QUALITY OF LIFE EVALUATION USE IN CLINICAL PRACTICE - Other Strategies for Improvement -

NON-SMALL CELL LUNG CANCER - Treatment Approaches -

WEIGHT LOSS DURING TREATMENT Percent of Patients with Weight Loss > 10%

NSCLC: SECOND-LINE TRIAL (TAX 317B) - Opioid Analgesic Use: Change from Baseline -

NSCLC: SECOND-LINE TRIAL (TAX 317B) - PERFORMANCE STATUS EVALUATION - Change from Baseline: Difference in Treatment Group Means

CLINICAL BENEFIT: PATIENTS WITH WEIGHT LOSS ᡂ% DURING TREATMENT (DC vs VC and DCb vs VC)

NON-SMALL CELL LUNG CANCER - Primary Endpoints for Determining Study Size -

KARNOFSKY PERFORMANCE STATUS CHANGE DURING TREATMENT Difference in Treatment Group Means: N = 812

LCSS BACKGROUND

QUALITY OF LIFE INSTRUMENTS - Instrument Focus -

Author: RJ Gralla

Home Page: http://www.fda.gov/cder/drug/cancer_endpoints/default.htm

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