Baseline physical functioning status of metastatic colorectal cancer patients predicts the overall survival but not the activity of a front-line oxaliplatin-fluoropyrimidine doublet

Figures & data

Table I. Demographic and clinical characteristics of patients enrolled in the SICOG trial 0401 and assessable for baseline QoL.

Arm	OXAFAFU		OXXEL		TOTAL
Characteristics	No.	%	No.	%	No.	%
Assessable patients	160	100	150	100	310	100
Males	86	54	100	67	186	60
Females	74	46	50	33	124	40
Median age (range)	65 (37-79)		64 (39-84)		63 (37-84)
Aged > 70 years	63	39	49	32	112	36
Primary tumor: colon	113	71	108	72	221	71
rectum	47	29	42	28	89	29
Grading: well differentiated	14	9	9	6	23	7
moderately differentiated	90	56	97	65	187	61
poorly differentiated	30	19	28	18	58	19
unknown	26	16	16	11	42	13
Previous surgery	124	77	110	73	234	75
Previous adjuvant chemotherapy	41	25	39	26	80	26
ECOG Performance Status: 0	97	61	92	61	189	61
1	56	35	54	36	110	36
2	6	4	5	3	11	3
No. disease sites: 1	73	45	75	50	148	48
2	52	33	42	28	94	30
3+	35	22	33	22	68	22
Liver involved	121	75	125	83	246	79
Liver only metastases	48	30	62	41	110	35
Synchronous metastases	93	58	86	57	179	57
Weigh loss > 5%	38	24	42	28	80	26
Alkaline phosphatase > UNL^¶	59	37	51	34	110	35
CEA value > UNL^¶	141	88	113	75	254	81
CEA value > 100 ng/mL	38	24	32	21	70	22

¶UNL = upper normal limit

Table II. Cox analysis of biomedical factors independently affecting OS.

Factors	Wald	HR	95% CI of HR		p-value
Number disease sites	22.18	1.422	1.228	1.647	0.0001
Alkaline phosphatase	9.835	1.300	1.103	1.532	0.0017
Performance status	5.23	1.350	1.046	1.743	0.0123
Surgery of primary	4.29	0.674	0.464	0.979	0.038

Table III. Cox analysis of factors (including PF score) independently affecting OS.

Factors	Wald	HR	95% CI of HR		p-value
Number disease sites	26.07	1.462	1.264	1.691	0.0001
Alkaline phosphatase	7.66	1.262	1.070	1.489	0.0057
Physical functioning	11.5	0.988	0.981	0.995	0.0007

Figure 1. OS curves according to PF score groups: circles, high score (n = 111); squares, intermediate score (n = 99); triangles, low score (n = 100). Log-rank test, p = 0.0012.

Figure 2. PFS curves according to PF score groups: circles, high score (n = 111); squares, intermediate score (n = 99); triangles, low score (n = 100). Log-rank test, p = 0.1055.

Table IV. Relationship between PF grouping and response rate.

Physical functioning group	Responders
Patients	No.	%	Total
≥ highest quartile	37	33.3	111
< highest and > lowest quartile	36	36.4	99
≤ lowest quartile	31	31.0	100
Total	104	33.5	310

Table V. Relationship between the PF groups and the ECOG PS score.

Physical functioning group	Performance status score
	0		1		2		Total
Patients	No.	%	No.	%	No.	%	No.
> highest quartile	94	84.7	14	12.6	3	2.7	111
< highest and >	57	57.6	41	41.4	1	1.0	99
lowest quartile
< lowest quartile	38	38.0	55	55.0	7	7.0	100
Total	189	61.0	110	35.5	11	3.5	310