Effects of omeprazole in improving concurrent chemoradiotherapy efficacy in rectal cancer

Table 1 Mean dose and duration of omeprazole administered orally and intravenously

OME	Cases	administered dose (mg)				OME administration (No. of days)
		Mean ± SD	95%CI	Max	Min	Mean ± SD	95%CI	Max	Min
Oral1	7	260.0 ± 143.2	127.6-392.4	546	182	11.0 ± 8.0	3.6-18.3	28	7
IV2	47	217.2 ± 184.8	162.8-271.3	940	40	3.8 ± 3.0	2.9-4.6	16	1
IV + Oral3	9	406.2 ± 184.9	264.1-548.4	756	151	13.7 ± 7.0	8.2-19.1	28	7

¹Oral OME multiplied by 65%;

²OME received intravenously;

³Oral OME multiplied by 65% plus OME received intravenously. OME: Omeprazole.

Table 2 Differences in the clinicopathological characteristics in eligible omeprazole users and non-eligible omeprazole users

Characteristics	Total	EOU		P value
		Non	Yes
Sex
Male	90	46	44	0.59
Female	35	16	19
Age (yr)
< 60	73	37	36	0.77
≥ 60	52	25	27
BMI
< 25	100	47	53	0.25
≥ 25	25	15	10
Tumor size (cm)
≤ 3	49	24	25	0.95
3-6	61	30	31
≥ 6	15	8	7
Tumor grade
1	28	14	14	0.23
2	88	46	42
3	9	2	7
cTNM
II	39	22	17	0.31
III	86	40	46
CEA (ng/mL)
< 5	62	28	34	0.47
≥ 5	58	30	28
CA19-9 (U/mL)
< 35	102	50	52	0.72
≥ 35	18	8	10
TGR
0	39	23	16	0.25
1	15	8	7
2	20	12	8
3	24	9	15
4	27	10	17
CRT efficacy
Poor	74	43	31	0.02
Good	51	19	32
ypTNM
ypcr	25	9	16	0.34
I	26	16	10
II	40	20	20
III	34	17	17
Adjuvant CT
No	21	9	12	0.5
Yes	104	53	51
Recurrence
No	92	46	46	0.66
Yes	33	16	17

EOU: Eligible OME users; non-EOU: Non-eligible OME users; BMI: Body mass index; TGR: Tumor regression grade; adjuvant CT: Adjuvant chemotherapy.

Table 3 Differences in clinicopathological characteristics of non-eligible omeprazole users and eligible omeprazole users

Characteristics	Total	EOG		P value
		Non	Yes
Sex
Male	90	71	19	0.380
Female	35	25	10
Age(yr)
< 60	73	58	15	0.410
≥ 60	52	38	14
BMI
< 25	100	77	23	0.920
≥ 25	25	19	4
Tumor size (cm)
≤ 3	49	37	12	0.940
3-6	61	47	14
≥ 6	15	12	3
Tumor grade
1	28	22	6	0.960
2	88	67	21
3	9	7	2
cTNM
II	39	30	9	0.980
III	86	66	20
CEA (ng/mL)
< 5	62	45	17	0.390
≥ 5	58	46	12
CA19-9 (U/mL)
< 35	102	76	26	0.420
≥ 35	18	15	3
TGR
0	39	34	5	0.330
1	15	11	4
2	20	16	4
3	24	17	7
4	27	18	9
CRT efficacy
Poor	74	61	13	0.072
Good	51	35	16
ypTNM
ypcr	25	16	9	0.380
I	26	21	5
II	40	31	9
III	34	28	6
Adjuvant CT
No	21	14	7	0.230
Yes	104	82	22
Recurrence
No	97	66	26	0.025
Yes	28	30	3

EOG: Effective OME group; non-EOG: Non-effective OME group; BMI: Body mass index; TGR: Tumor regression grade; adjuvant CT: Adjuvant chemotherapy.

Table 4 Univariate analysis of impact of various characteristics on patient survival

Characteristics	n	DFS			P value	OS			P value
		Mean (mo)1	3-yr2	5- yr2		Mean (mo)1	3- yr2	5- yr2
Sex
Male	90	61.8 ± 25.9	81.1%	74.4%	0.803	65.5 ± 22.2	84.4%	79.9%	0.855
Female	35	65.6 ± 24.6	82.9%	76.9%		69.5 ± 20.1	88.6%	79.8%
Age (yr)
< 60	73	63.3 ± 26.3	80.1%	71.1%	0.533	68.4 ± 22.0	86.3%	80.7%	0.908
≥ 60	52	62.4 ± 24.6	82.7%	80.7%		64.2 ± 21.5	84.6%	78.7%
Tumor size (cm)
≤ 3	48	62.5 ± 26.1	81.2%	77.0%	0.571	65.0 ± 22.4	83.3%	79.2%	0.962
> 3	77	63.2 ± 25.3	81.8%	74.0%		67.7 ± 21.6	87.0%	80.3%
BMI
< 25	100	60.5 ± 26.8	77.0%	69.9%	0.024	65.3 ± 22.7	82.0%	76.9%	0.050
≥ 25	25	72.7 ± 16.6	96.0%	96.0%		72.1 ± 17.0	96.0%	92.0%
Tumor grade
1	28	64.7 ± 28.0	78.6%	75.0%	0.852	69.4 ± 22.5	85.7%	78.6%	0.931
2, 3	97	62.4 ± 25.0	82.5%	75.2%		65.6 ± 21.7	85.6%	80.2%
cTNM
II	39	69.2 ± 23.2	87.2%	84.6%	0.067	71.9 ± 18.8	92.3%	87.2%	0.137
III	86	60.0 ± 26.2	79.1%	70.7%		64.2 ± 22.8	82.6%	76.4%
CEA (ng/mL)
< 5	62	77.0 ± 4.1	69.2%	69.2%	0.789	79.6 ± 3.7	80.6%	73.9%	0.384
≥ 5	58	80.4 ± 4.3	82.8%	74.0%		86.1 ± 3.4	89.7%	84.5%
CA19-9 (U/mL)
< 35	102	81.3 ± 3.1	83.3%	75.4%	0.174	84.2 ± 2.7	86.3%	80.2%	0.597
≥ 35	18	68.1 ± 9.2	72.2%	66.7%		78.3 ± 7.8	77.8%	72.2%
CRT efficacy
Poor	74	60.7 ± 27.2	78.4%	67.5%	0.031	66.2 ± 23.2	83.8%	75.6%	0.144
Good	51	66.1 ± 23.0	90.2%	86.0%		67.3 ± 19.9	88.2%	86.1%
ypTNM
ypcr,I, II	91	66.1 ± 24.0	85.7%	82.3%	0.005	68.5 ± 20.1	89.0%	84.4%	0.041
III	34	54.3 ± 28.0	70.6%	55.6%		61.6 ± 25.5	76.5%	67.6%
Adjuvant CT
No	21	60.2 ± 31.5	71.4%	71.4%	0.385	63.5 ± 26.5	76.2%	66.3%	0.229
Yes	104	63.5 ± 24.3	83.7%	75.8%		67.3 ± 20.8	87.5%	82.7%
OME
Non- EOU	62	70.0 ± 25.8	85.5%	75.6%	0.658	73.9 ± 21.9	90.3%	82.0%	0.754
EOU	63	55.9 ± 23.5	77.8%	74.6%		59.5 ± 19.5	82.5%	77.6%
OME (200 mg)
Non-EOG	96	62.0 ± 28.2	77.1%	69.6%	0.032	66.9 ± 24.1	82.3%	76.9%	0.092
EOG	29	65.9 ± 13.3	96.6%	46.7%		65.8 ± 12.0	96.6%	89.5%

¹Mean ± SD (mo);

²Three or 5 years survival rate. EOU: Eligible OME users; Non-EOU: Non-eligible OME users; EOG: Effective OME group; Non-EOG: Non-effective OME group; BMI: Body mass index; adjuvant CT: Adjuvant chemotherapy.

Table 5 Univariate Cox analysis of the impact of various characteristics on patient survival

Characteristics	DFS		P value	OS		P value
	HR	95%CI		HR	95%CI
Sex
Male vs Female	0.91	0.42-1.65	0.800	0.93	0.41-2.09	0.860
Age (yr)
< 60 vs ≥ 60	0.80	0.40-1.62	0.530	1.05	0.50-2.19	0.910
BMI
< 25 vs ≥ 25	0.22	0.05-0.93	0.039	0.26	0.06-1.11	0.069
Tumor size (cm)
≤ 3 vs > 3	1.23	0.60-2.51	0.570	0.98	0.46-2.08	0.960
Tumor grade
1 vs 2, 3	1.08	0.47-2.50	0.850	0.96	0.41-2.26	0.930
cTNM
II vs III	2.23	0.92-5.41	0.075	1.96	0.80-4.80	0.144
CEA (ng/mL)
< 5 vs ≥ 5	0.91	0.46-1.81	0.790	0.72	0.34-1.51	0.390
CA199 (U/mL)
< 35 vs ≥ 35	1.77	0.77-4.08	0.180	1.30	0.50-3.40	0.600
CRT efficacy
Poor vs good	0.43	0.19-0.95	0.036	0.55	0.24-1.24	0.150
ypTNM
ypcr, I,II vs III	1.61	1.14-2.27	0.006	1.46	1.01-2.11	0.045
Adjuvant CT
Non vs yes	0.69	0.30-1.60	0.390	0.60	0.25-1.40	0.240
EOU
Non vs yes	1.17	0.59-2.31	0.660	1.13	0.54-2.37	0.750
EOG
Non vs yes	0.30	0.90-0.97	0.044	0.37	0.11-1.23	0.110

EOU: Eligible OME users; Non-EOU: Non-eligible OME users; EOG: Effective OME group; Non-EOG: Non-effective OME group; BMI: Body mass index; Adjuvant CT: Adjuvant chemotherapy.