Table 3 Trajectory-adjusted mean change (95% CI)a in HRQoL outcomes by category of first SRE in PREVAIL

From: Skeletal-related events significantly impact health-related quality of life in metastatic castration-resistant prostate cancer: data from PREVAIL and AFFIRM trials

Outcome measure

Any SRE (n=162)

Radiation or surgery to bone (n=107)

Pathologic bone fracture (n=31)

Spinal cord compression (n=23)

 

n

TAMC (95% CI)

n

TAMC (95% CI)

n

TAMC (95% CI)

n

TAMC (95% CI)

FACT-P

 Physical wellbeing

162

–1.70 (–2.42, –0.98)b

106

–1.28 (–2.06, –0.49)b

31

–1.15 (–3.09, 0.79)

23

–4.42 (–6.86, –1.98) b

 Social wellbeing

161

0.77 (0.23, 1.32)

106

1.26 (0.60, 1.91)b

30

0.84 (–0.50, 2.17)

23

–0.34 (–1.86, 1.17)

 Emotional wellbeing

160

–0.57 (–1.12, –0.01)b

107

–0.38 (–1.05, 0.30)

29

–0.15 (–1.23, 0.92)

23

–1.42 (–3.21, 0.37)

 Functional wellbeing

159

–1.81 (–2.54, –1.09)b

106

–1.51 (–2.37, –0.64)b

29

–1.21 (–3.03, 0.60)

23

–4.27 (–6.35, –2.19) b

 PCS

161

–1.92 (–2.91, –0.94)b

106

–0.72 (–1.77, 0.33)

30

–2.45 (–5.04, 0.13)

23

–6.00 (–9.30, –2.69) b

 FAPSI

162

–1.38 (–2.14, –0.61)b

107

–0.72 (–1.51, 0.06)

30

–1.42 (–3.70, 0.86)

23

–3.70 (–6.36, –1.05) b

 FACT-TOI

156

–5.20 (–7.39, –3.01) b

103

–2.83 (–5.15, –0.52)b

29

–4.67 (–10.37, 1.03)

23

–14.85 (–22.15, –7.55)b

 FACT-G total score

158

–3.41 (–5.30, –1.52)b

105

–1.85 (–3.92, 0.23)

29

–1.49 (–5.99, 3.00)

23

–10.72 (–17.14, –4.29) b

 FACT-P total score

156

–5.11 (–7.85, –2.37)b

103

–2.00 (–4.86, 0.85)

29

–4.07 (–10.93, 2.80)

23

–16.95 (–26.47, –7.44) b

 EQ-5D utility index

156

–0.11 (–0.15, –0.06) b

104

–0.06 (–0.10, –0.02) b

28

–0.20 (–0.36, –0.04)b

22

–0.24 (–0.39, –0.08) b

  1. Abbreviations: CI, confidence interval; FACT-G, Functional Assessment of Cancer Therapy-General; FACT-P, Functional Assessment of Cancer Therapy-Prostate; FACT-TOI, Functional Assessment of Cancer Therapy-Trial Outcome Index; FAPSI, Functional Assessment of Cancer Therapy Advanced Prostate Symptom Index; HRQoL, health-related quality of life; PCS, prostate cancer subscale; SRE, skeletal-related event; TAMC, trajectory-adjusted mean change.
  2. Negative values indicate decline in health. Values in bold indicate clinically meaningful changes (versus established minimal clinically important difference; Table 1). Linear mixed-effects model with intercept for time as random effects; fixed effects included region, baseline Eastern Cooperative Oncology Group performance status, baseline average pain score, baseline fatigue severity and age.
  3. aEstimates of change reflect difference between predicted and actual scores after SRE.
  4. b95% CI excludes zero, indicating a statistically significant change in TAMC.
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