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

Table 1 Characteristics of patients included in the study

Variables	ECX^a/FOLFIRI arm	FOLFIRI/ECX arm
Variables	n = 209	n = 207
Gender
Men n (%)	154 (74)	155 (75)
Performance status at D₀
=0-1^b n (%)	175(83.7)	178(86.0)
=2 n (%)	34(16.3)	29(14.0)
Type of tumor
Diffuse n (%)	46(22.0)	51(24.6)
Age (years)
md^c ± inq	61 ± 16	61 ± 16
Follow-up (months)
md ± inq	9 ± 12	9 ± 10
SAE^d n(%)
After 7 evaluation time points	122 (58)	105 (51)
TTF^e (weeks)
md ± inq	17 ± 20	22 ± 25
Deaths n(%)
Global^f	175 (84)	180 (87)
After 7 evaluation time points	116 (56)	113 (55)

^a ECX: Epirubicin-Cisplatin-Capecitabine
^b 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
^c median ± inter-quartile range
^d Serious adverse events
^e Time to therapeutic failure of the first-line treatment
^f Proportion of deaths whatever the therapeutic line

ISSN: 1477-7525