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STAR Patient-Reported Outcomes

STAR Patient-Reported Outcomes. Patricia A. Ganz, M.D. Behavioral and Health Outcomes Protocol Officer for STAR. P-2 BAHO Assessment Strategy. From P-1 we learned that women recruited in early, middle and late parts of trial had similar QOL and symptoms

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STAR Patient-Reported Outcomes

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  1. STAR Patient-Reported Outcomes Patricia A. Ganz, M.D. Behavioral and Health Outcomes Protocol Officer for STAR

  2. P-2 BAHO Assessment Strategy • From P-1 we learned that women recruited in early, middle and late parts of trial had similar QOL and symptoms • Therefore, P-2 QOL study could be limited to a smaller sample • Patient reported symptom assessment was retained for entire study sample

  3. Quality of Life Assessment • Quality of life (QOL) in subset of ~2000 pts. • QOL was measured with • MOS SF-36, • CES-D, • MOS Sexual Activity Questionnaire. • Primary QOL endpoints: SF-36 Mental Component Summary (MCS) Physical Component Summary (PCS). These are the same questionnaires used in P-1.

  4. Patient-reported Symptoms Symptom information was collected on all STAR participants using a symptom checklist (SCL). Scales: • musculoskeletal: joint pain, muscle stiffness, general aches and pains • vasomotor: night sweats, hot flashes, cold sweats • gastrointestinal: vomiting, nausea • dyspareunia: vaginal dryness, pain with intercourse • bladder: difficulty with bladder control (when laughing or crying), difficulty with bladder control (at other times), • gynecological: vaginal discharge, genital itching/irritation, vaginal bleeding or spotting. Plus weight gain, forgetfulness and leg cramps.

  5. Questionnaire administration • Both the SCL and QOL questionnaires were adminstered at baseline (pre-treatment), every 6 months until 60 months, and at 72 months. • Present analysis is restricted to assessments performed through 60 months on study. • Questionnaires administered in office (phone, mail allowed as back-up)

  6. QOL Participants • All STAR participants entered at participating CCOP sites were QOL participants. • 1983 participants (973 TAM, 1010 Ralox) enrolled between 1/4/2000 and 5/31/2001 • Median follow-up time 5.4 years. • Comparable demographics with (concurrent) non-participants.

  7. SCL Forms Compliance

  8. Quality of Life Forms Compliance

  9. SF-36 Mental Component Summary better p=0.23 worse

  10. SF-36 Physical Component Summary better p=0.21 worse

  11. CES-D (Depressive Sxs) worse p=0.61 better

  12. Treatment Comparisons: Symptoms * Main effect † Mean difference / standard deviation

  13. SCL Forgetfulness Item Severity worse p=0.85 better

  14. SCL Musculoskeletal Scale Severity worse p=0.0018 Favors TAM better

  15. SCL Vasomotor Scale Severity worse p<0.0001 Favors RAL better

  16. Vasomotor Symptom Severity (1+ = at least slightly bothersome; 2+ = at least moderately bothersome; 3+ = at least quite a bit bothersome)

  17. SCL Gastrointestinal Scale Severity worse p=0.86 better

  18. SCL Dyspareunia Scale Severity worse p<0.0001 Favors TAM better

  19. SCL Weight Gain Item Severity worse p<0.0001 Favors TAM better

  20. SCL Gynecological Scale Severity p<0.0001 Favors RAL worse better

  21. SCL Bladder Scale Severity worse p<0.0001 Favors RAL better

  22. SCL Leg cramps Item Severity p<0.0001 Favors RAL worse better

  23. Bladder problems and leg cramps (1+ = at least slightly bothersome; 2+ = at least moderately bothersome; 3+ = at least quite a bit bothersome)

  24. Percent women with > 1 point change in symptom severity from baseline to 6 months % 42 32 24 18 15 13 15 12

  25. Sexual Activity p = 0.027 (treatment)

  26. Sexual Activity 7% difference p = 0.027 (treatment)

  27. Lack of Sexual Enjoyment worse p=0.03 Mean diff = 0.07 (favors TAM) better

  28. Lack of Sexual Interest worse p=0.009 Mean diff = 0.1 (favoring TAM) better

  29. Difficulty with Sexual Arousal worse p=0.028 Mean diff = 0.08 (favoring TAM) better

  30. Difficulty with Orgasm worse p=0.2 better

  31. Conclusions & Summary • No significant difference in primary QOL endpoints, with minimal symptom severity • Symptom profile: small differences slightly favoring raloxifene • Sexual function slightly favors tamoxifen • Both tamoxifen & raloxifene are effective in reducing invasive breast ca incidence • Decision to take one or the other can be based on patient-reported outcomes

  32. Acknowledgements • S. R. Land, PhD, BAHO Protocol Officer, M. Ritter, PhD, BAHO Compliance Officer, M. Lee, MS, Graduate Student Researcher • STAR PIs, Study Coordinators and Nurses • Most important—the STAR Participants! • Full report published in Land SR, et al., JAMA 2006

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