Construction of quality of life change patterns: example in oncology in a phase III therapeutic trial (FFCD 0307)

Table 2 Characteristics of patients’ QoL change patterns

	Pattern 1*	Pattern 2	Pattern 3	Pattern 4
					P^a
Number of patients	24	171	78	143
Gender
Men n(%)	15 (63)	128 (75)	58 (74)	108 (76)	0.596
Age (years)
md ± inq^b	63 ± 17	61 ± 15	65 ± 19	60 ± 17	0.370
Performance status at D₀
=0-1^c n (%)	20 (83.3)	151 (88.3)	56 (71.8)	126 (88.1)	0.004
=2 n (%)	4 (16.7)	20 (11.7)	22 (28.2)	17 (11.9)	0.004
Type of tumor
Diffuse n (%)	7 (29.2)	33(19.3)	22(28.2)	35(24.5)	0.369
Randomization arm
FOLFIRI n (%)	5 (20.8)	93 (54.4)	35 (44.9)	74 (51.8)	0.015
Quality of life Score
Score₇-Score₁ (p^**)	10.7 (0.520)	−13.4 (0.013)	−62.7 (0.038)	−67.6 (<10⁻³)
SAE^d
n(%)	13 (54)	67 (39)	62 (81)	86 (60)	<10⁻³
TTF^e (weeks)
md ± inq	15 ± 18	30 ± 24	4 ± 7	20 ± 12	<10⁻³
Death
n(%)	3 (13)	18 (11)	78 (100)	131 (92)	<10⁻³

^a : p for significance
^b :median ± inter-quartile range
^c Performance status
0 = Fully active, able to carry on all pre-disease performance / 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50 % of waking hours
^d Serious adverse events
^e time to therapeutic failure of the first-line treatment
^* x-axis: time (unit = weeks) and y-axis: the physical functioning scale scores (range [0–100])
^** p for significance of the slope predicted by a linear model

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