Celecoxib as an adjuvant to chemotherapy for patients with metastatic colorectal cancer: A randomized controlled clinical study

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Figure 1
- Consolidated standards of reporting trials (CONSORT) diagram showing the disposition of all subjects screened for the study.
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Figure 2
- One-year overall survival (OS) for the control group (FOLFIRI only) versus treated (FOLFIRI + celecoxib) group.

Table 1

- Demographic and clinical data of the study participants.

Parameters	Control group (n=28)	Celecoxib group (n=26)	P-value
	n (%)
Gender
Male	9 (32.1)	9 (34.6)	0.847
Female	19 (67.8)	17 (65.3)
Age (years), mean±SD	42.04±8.95	45.92±5.07	0.058
Weight (kg), mean±SD	72.39±4.13	72.26±4.29	0.915
Height (cm), mean±SD	161.34±1.49	162.96±4.56	0.084
BMI (kg/m²), mean±SD	27.8±1.49	27.25±1.84	0.227
Primary tumor
Colon	21 (75)	23 (88.5)	0.203
Rectum	7 (25)	3 (11.5)
Metastatic site
Liver	15 (53.6)	19 (73.1)	0.138
Others	13 (46.4)	7 (26.9)

Table 2

- Biological markers in the 2 study groups at baseline and after 6 cycles.

Parameters	Control group (n=28)		Celecoxib group (n=26)		P₁-value
Parameters	Mean±SD	P-value	Mean±SD	P-value	P₁-value
CEA
At baseline	103.02±31.22	0.097	112±35.23	<0.001*	0.338
After 6 cycles	90.09±32.62	0.097	28.8±9.76	<0.001*	<0.001*
CA19.9
At baseline	159.20±39.68	0.069	170.70±54.7	<0.001*	0.379
After 6 cycles	139.50±51.04	0.069	47.19±16.33	<0.001*	<0.001*
VEGF (ng/L)
At baseline	2220.95±427.04	0.669	2281.97±573.35	<0.001*	0.658
After 6 cycles	2261.15±310.08	0.669	1533.09±368.29	<0.001*	<0.001*
CXCL5 (pg/ml)
At baseline	76.39±10.86	0.002*	82.46±17.90	<0.001*	0.135
After 6 cycles	93.43±21.04	0.002*	51.19±13.79	<0.001*	<0.001*
sFAS (ng/ml)
At baseline	46.86±10.12	0.472	43.21±7.07	<0.001*	0.134
After 6 cycles	48.51±8.16	0.472	65.1±18.02	<0.001*	<0.001*
sFASL(ng/ml)
At baseline	15.22±3.89	0.155	15.37±4.09	<0.001*	0.892
After 6 cycles	16.51±3.79	0.155	9.24±2.94	<0.001*	<0.001*
sFAS/sFASL ratio
At baseline	3.169±0.63	0.309	3.059±1.28	<0.001*	0.892
After 6 cycles	3.03±0.61	0.309	8.17±4.77	<0.001*	<0.001*

SD: standard deviation, CEA: carcinoembryonic antigen, CA19.9: cancer antigen 19.9, VEGF: vascular endothelial growth factor, CXCL5: CXC motif chemokine 5, sFAS: soluble factor-related apoptosis, FASL: factor related apoptosis ligand, *significant difference (p<0.05), p-value: before versus after within the same group, p₁-value: p-value between the 2 groups after treatment

Table 3

- Objective response rates of the 2 groups after 6 cycles and follow up after one year.

Tumor response	Control group (n=28)	Celecoxib group (n=26)	P-value
	n (%)
CR	0 (0)	1 (3.9)
PR	5 (17.9)	15 (57.7)
SD	6 (21.4)	5 (19.2)	0.001*
PD	17 (60.7)	5 (19.2)
ORR	5 (17.9)	16 (61.6)	0.001*
DCR	11 (39.3)	21 (80.8)	0.002
Median progression free survival	23 week	30 week	0.004*
Median overall survival	8 months	12 months	0.042*
Precentage of one year overall survival	25%	57.7%	0.015*

CR: complete response, PR: partial response, SD: stable disease, PD: progressive disease, ORR: objective response rate, DCR: disease control rate, in CR disappearance of all target lesions, in PR at least a 30% decrease in the sum of the longest diameters of target lesions, in PD at least a 20% increase in the sum of diameters of target lesions, in SD neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, ORR is the sum of CR and PR, DCR is the sum of CR, PR, SD. *significant difference (p<0.05)

Table 4

- The reported adverse effects by the 2 study groups.

Side effects	Control group (n=28)					Celecoxib group (n=26)					P-value^†	P-value^‡
Side effects	Grades					Grades					P-value^†	P-value^‡
I	II	III	IV	Totaln (%)	I	II	III	IV	Totaln (%)
Neutropenia	3	3	3	2	11 (39)	3	2	1	1	7 (27)	0.487	0.396
Leukopenia	3	3	2	1	9 (32)	2	2	1	1	6 (23)	0.918	0.550
Nausea/vomiting	5	4	4	3	16 (57)	4	4	2	1	11 (42)	0.449	0.414
Diarrhea	3	4	3	2	12 (43)	2	1	0	0	3 (12)	0.130	0.015*
Mucositis	-	-	-	-	-	-	-	-	-	-		-
CVS	-	-	-	-	-	-	-	-	-	-		-
Infection	2	3	0	0	5 (18)	2	0	0	0	2 (8)	0.147	0.423

CVS: cardiovascular, ^†value to compare grades (Chi square for trend), ^‡value to compare totals (Fisher exact test), *significant difference (p<0.05)