Table 4 Trajectory-adjusted mean change (95% CI)^a in HRQoL outcomes by type of first SRE in AFFIRM

Outcome measure	Any SRE		Radiation or surgery to bone		Pathologic bone fracture		Spinal cord compression
	n	TAMC (95% CI)	n	TAMC (95% CI)	n	TAMC (95% CI)	n	TAMC (95% CI)
FACT-P total score	139	–6.94 (–9.93, –3.95) ^b	96	–6.69 (–10.26, –3.12) ^b	23	–7.62 (–16.80, 1.56)	26	–9.69 (–16.10, –3.27) ^b
FACT-P PCS	139	–1.79 (–2.91, –0.68)^b	96	–1.37 (–2.60, –0.13)^b	23	–2.80 (–6.82, 1.22)	26	–2.66 (–5.01, –0.32) ^b
FACT-G	142	–5.46 (–7.55, –3.36) ^b	99	–5.57 (–8.13, –3.01) ^b	23	–5.18 (–10.88, 0.51)	26	–6.96 (–11.97, –1.94) ^b

Abbreviations: CI, confidence interval; FACT-G, Functional Assessment of Cancer Therapy-General; FACT-P, Functional Assessment of Cancer Therapy-Prostate; HRQoL, health-related quality of life; PCS, prostate cancer subscale; SRE, skeletal-related event; TAMC, trajectory-adjusted mean change.
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 time, baseline average pain score, baseline Eastern Cooperative Oncology Group Performance Status, baseline fatigue severity, age and number of prior chemotherapy regimens.
^aEstimates of change reflect difference between predicted and actual scores after SRE.
^b95% CI excludes zero, indicating a statistically significant change in TAMC.

Quick links

Search