Instruments: EORTC QLQ-C30 EORTC QLQ-OV28 FOSI Number of - - PowerPoint PPT Presentation

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Instruments: EORTC QLQ-C30 EORTC QLQ-OV28 FOSI Number of - - PowerPoint PPT Presentation

TRIAS Quality of Life Instruments: EORTC QLQ-C30 EORTC QLQ-OV28 FOSI Number of questionnaires: Sorafenib Placebo 83 89 65 67 Baseline (78.3%) (75.3%) 40 40 End of therapy (48.2%) (44.9%) TRIAS Quality of Life EORTC


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SLIDE 1

TRIAS Quality of Life

Instruments:

  • EORTC QLQ-C30
  • EORTC QLQ-OV28
  • FOSI

Number of questionnaires:

Sorafenib Placebo 83 89 Baseline 65 (78.3%) 67 (75.3%) End of therapy 40 (48.2%) 40 (44.9%)

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SLIDE 2

EORTC QLQ-C30 Baseline to end of therapy

TRIAS Quality of Life

  • 30
  • 25
  • 20
  • 15
  • 10
  • 5

5 10 15

Social Emotional Role Physical Global QoL

Changes in mean scores of global quality of life and functional scales

Sorafenib Placebo ▬ 95% CI Worsening Improvement

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SLIDE 3

EORTC QLQ-C30 Baseline to end of therapy

TRIAS Quality of Life

  • 20
  • 10

10 20 30

Changes in mean scores of symptom scales

Sorafenib Placebo Fatigue Nausea/vomiting Dyspnea Appetite loss Constipation Diarrhea ▬ 95% CI Improvement Worsening

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SLIDE 4

EORTC QLQ-OV28 Baseline to end of therapy

TRIAS Quality of Life

  • 20
  • 10

10 20 30

Changes in mean scores of symptom scales

Sorafenib Placebo Abdominal/gastrointestinal Peripheral neuropathy Other chemotherapy- related side effects Hormonal Body image Attitude to disease and treatment ▬ 95% CI Improvement Worsening

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SLIDE 5

FOSI Baseline to end of therapy

TRIAS Quality of Life

  • 20
  • 10

10 20

Changes in mean scores

Sorafenib Placebo FOSI

▬ 95%

▬ 95% CI Improvement Worsening

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SLIDE 6

TRIAS Quality of Life

Significant worsening from baseline to end of therapy:

  • Role functioning, dyspnea, constipation, and diarrhea with CID
  • Physical functioning, fatigue, nausea/vomiting, peripheral neuropathy, and

body image without CID

Summary

Significant difference between arms in change from baseline to end of therapy:

  • Attitude to disease and treatment (p=0.038)
  • Sorafenib arm improvement (8.2 points) and placebo arm worsening (1.7 points)

CID: Clinical important difference (>10 points)

Non-significant difference between arms in change from baseline to end of therapy:

  • Favoring Sorafenib: Global QoL (8.6 points), constipation (8.1 points)
  • Favoring placebo: Dyspnea (12.2 points), diarrhea (9.4 points)