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 OUTCOMEINSTRUMENTS 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 TREATMENTPercent 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 -
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