Different Resection Margin Status of the Patient Cohort from Pathological Report
Patients whose resection margins were not clearly indicated in the pathological report were excluded. There were a total of 228 patients performed PD between 2015 and 2019 in this study. (FIGURE 2)According to the Pathological report: there were no cancer cells in anterior margin, posterior margin, proximal gastric margin, distal jejunum margin, common bile duct margin and gallbladder, corpus/neck margin of the all the 228 patients. 62 (27%) patients had histologically positive which there were cancer cells within 1 mm (<1 mm) in PV/SMV and SMA margins and were R1 PV/SMV, SMA resections group. The others 166(73%) patients which there were no cancer cells within 1 mm (>1 mm) were R0 PV/SMV, SMA resections group.
Clinico-pathologic Characteristics Of Different Resection Margin Status Groups
In this study, tumor grade is categorized into poorly differentiated tumors, poorly- moderately differentiated tumors, moderately differentiated tumors, moderately-well differentiated tumors and well differentiated tumors. All patients were tumor stage T1, T2 or T3. And the AJCC criteria of TNM staging were applied. The clinico-pathologic characteristics of the different resection margin status groups are summarized in Table 1.
Table 1
Clinico-Pathologic Characteristics of Different Resection Margin Status Groups
|
|
Total patients
228 (100%)
|
R0PV/SMV, SMA
166 (73%)
|
R1 PV/SMV, SMA
62 (27%)
|
χ2/t/Z
|
P
|
Age, year
|
M (P25,P75)
|
60.5
(53, 68.25)
|
61
(53, 69)
|
57
(52,66.25)
|
-1.467
|
0.142
|
Gender
|
|
|
|
|
0.006
|
0.938
|
Male
|
n (%)
|
137(60)
|
100(60)
|
37(60)
|
|
|
Female
|
n (%)
|
91(40)
|
66(40)
|
25(40)
|
|
|
BMI, kg/m2
|
M (P25,P75)
|
21.495
(19.53,23.83)
|
21.53
(19.38,23.72)
|
21.485
(19.99,23.97)
|
-0.661
|
0.509
|
Diameter, cm
|
M (P25,P75)
|
3
(2.5,3.825)
|
3
(2.475,4)
|
3
(2.5,3.8)
|
-0.890
|
0.373
|
CA19-9, U/ml
|
M (P25,P75)
|
102.75
(16.14,309.35)
|
106.3
(18.83,334.9)
|
83.785
(6.125,271.55)
|
-0.605
|
0.545
|
HGB, g/L
|
M (P25,P75)
|
123.5
(113,133.25)
|
124
(113,135)
|
123
(113,132)
|
-0.143
|
0.887
|
TBIL, µmol/L
|
M (P25,P75)
|
106.9
(12.75,223.08)
|
95.4
(12.75,209)
|
139.95
(11.75,232.95)
|
-0.818
|
0.413
|
ALT, U/L
|
M (P25,P75)
|
86(26,187)
|
82
(23.5,209)
|
97
(41,160.75)
|
-0.407
|
0.684
|
AST, U/L
|
M (P25,P75)
|
59
(28,140.5)
|
57.5
(24,142.75)
|
59
(38.75,132.5)
|
-0.451
|
0.652
|
ALB, g/L
|
M (P25,P75)
|
40.05
(37.08,43.43)
|
39.9
(37.13,43.25)
|
40.55
(37.08,43.98)
|
-0.690
|
0.490
|
GLU, mmol/L
|
M (P25,P75)
|
5.81
(5.09,7.10)
|
5.845
(5.25,7.44)
|
5.65
(4.94,6.71)
|
-1.390
|
0.165
|
Adjuvant Chemotherapy
|
|
|
|
|
0.063
|
0.801
|
Yes
|
n(%)
|
95(42)
|
70(42)
|
25(40)
|
|
|
No
|
n(%)
|
133(58)
|
96(58)
|
37(60)
|
|
|
Grade
|
|
|
|
|
1.410
|
0.842
|
poorly
|
n (%)
|
28(12)
|
22(13)
|
6(10)
|
|
|
poorly-moderately
|
n (%)
|
101(44)
|
70(42)
|
31(50)
|
|
|
moderately
|
n (%)
|
81(36)
|
61(37)
|
20(32)
|
|
|
moderately-well
|
n (%)
|
15(7)
|
11(7)
|
4(6)
|
|
|
well
|
n (%)
|
3(1)
|
2(1)
|
1(2)
|
|
|
T
|
|
|
|
|
1.346
|
0.510
|
1
|
n (%)
|
40(18)
|
31(19)
|
9(15)
|
|
|
2
|
n (%)
|
153(67)
|
112(67)
|
41(66)
|
|
|
3
|
n (%)
|
35(15)
|
23(14)
|
12(19)
|
|
|
N
|
|
|
|
|
2.645
|
0.448
|
x
|
n (%)
|
42(18)
|
28(17)
|
14(23)
|
|
|
0
|
n (%)
|
108(47)
|
84(51)
|
24(39)
|
|
|
1
|
n (%)
|
62(28)
|
43(26)
|
19(31)
|
|
|
2
|
n (%)
|
16(7)
|
11(6)
|
5(7)
|
|
|
TNM
|
|
|
|
|
2.923
|
0.571
|
IA
|
n (%)
|
27(12)
|
22(13)
|
5(8)
|
|
|
IB
|
n (%)
|
71(31)
|
53(32)
|
18(29)
|
|
|
IIA
|
n (%)
|
12(5)
|
10(6)
|
2(10)
|
|
|
IIB
|
n (%)
|
69(31)
|
48(29)
|
21(34)
|
|
|
III
|
n (%)
|
49(21)
|
33(20)
|
16(19)
|
|
|
BMI = Body Mass Index, HGB = Hemoglobin, TBIL = Total bilirubin, ALT = Alanine aminotransferase, AST = Aspartate aminotransferase, ALB = Albumin, GLU = Glucose
|
Table 2
A. Result of Log-Rank in Prognostic Factors
Characteristics
|
N
|
Survival Rate%
|
χ2
|
P
|
1-Year
|
2-Year
|
3-Year
|
Resection margin
|
7.871
|
0.005
|
R0PV/SMV, SMA
|
166
|
73%
|
37%
|
25%
|
|
|
R1PV/SMV, SMA
|
62
|
61%
|
13%
|
10%
|
|
|
Adjuvant Chemotherapy
|
12.759
|
0.000
|
Yes
|
95
|
83%
|
56%
|
31%
|
|
|
No
|
133
|
65%
|
30%
|
14%
|
|
|
Gender
|
0.607
|
0.436
|
Male
|
137
|
72%
|
44%
|
20%
|
|
|
Female
|
91
|
75%
|
44%
|
20%
|
|
|
Age
|
0.418
|
0.518
|
≤ 60 year
|
111
|
74%
|
31%
|
24%
|
|
|
༞60 year
|
117
|
71%
|
41%
|
16%
|
|
|
BMI
|
0.376
|
0.540
|
Normal
|
139
|
74%
|
36%
|
18%
|
|
|
Abnormal
|
89
|
68%
|
32%
|
20%
|
|
|
CA19-9
|
1.159
|
0.282
|
Normal
|
59
|
71%
|
43%
|
25%
|
|
|
Abnormal
|
169
|
69%
|
39%
|
19%
|
|
|
HGB
|
1.407
|
0.236
|
Normal
|
183
|
74%
|
38%
|
23%
|
|
|
Anemia
|
45
|
69%
|
21%
|
8%
|
|
|
TBIL
|
0.125
|
0.724
|
Normal
|
82
|
75%
|
38%
|
19%
|
|
|
Jaundice
|
146
|
68%
|
35%
|
17%
|
|
|
ALT
|
0.636
|
0.425
|
Normal
|
82
|
71%
|
37%
|
23%
|
|
|
Abnormal
|
146
|
68%
|
30%
|
10%
|
|
|
AST
|
2.247
|
0.134
|
Normal
|
73
|
77%
|
38%
|
26%
|
|
|
Abnormal
|
155
|
71%
|
33%
|
15%
|
|
|
ALB
|
1.239
|
0.266
|
Normal
|
194
|
71%
|
36%
|
21%
|
|
|
Hypoalbuminemia
|
34
|
64%
|
26%
|
14%
|
|
|
GLU
|
1.375
|
0.241
|
Normal
|
168
|
71%
|
36%
|
22%
|
|
|
Hyperglycemia
|
60
|
70%
|
26%
|
15%
|
|
|
Maximum Diameter of Tumor
|
1.364
|
0.505
|
≤ 2 cm
|
98
|
76%
|
39%
|
19%
|
|
|
>2cm,≤4 cm
|
81
|
70%
|
38%
|
18%
|
|
|
>4 cm
|
49
|
68%
|
32%
|
16%
|
|
|
Grade
|
4.199
|
0.380
|
poorly
|
28
|
70%
|
41%
|
0
|
|
|
poorly-moderately
|
101
|
65%
|
31%
|
16%
|
|
|
moderately
|
81
|
79%
|
39%
|
17%
|
|
|
moderately-well
|
15
|
79%
|
63%
|
47%
|
|
|
well
|
3
|
99%
|
0
|
0
|
|
|
TNM
|
3.064
|
0.547
|
IA
|
27
|
80%
|
46%
|
25%
|
|
|
IB
|
71
|
75%
|
43%
|
7%
|
|
|
IIA
|
12
|
61%
|
61%
|
30%
|
|
|
IIB
|
69
|
64%
|
32%
|
15%
|
|
|
III
|
49
|
68%
|
21%
|
17%
|
|
|
Table 2B. Result of Multivariate Analysis in Prognostic Factors
|
Characteristics
|
HR
|
95%C.I
|
P
|
Resection Margin
|
1.649
|
1.126
|
2.415
|
0.010
|
Adjuvant Chemotherapy
|
1.896
|
1.303
|
2.758
|
0.001
|
Survival Prognostic Factors By Univariate And Multivariate Analysis
The results of the Log-rank test showed that resection margins status (P = 0.005) and adjuvant chemotherapy (P = 0.000) were associated with survival prognosis (Table 2A). The results of Cox regression showed that resection margins status (P = 0.010) and adjuvant chemotherapy (P = 0.001) were independent risk factors for survival prognosis (Table 2B).
Relationship Between Survival And Resection Margin Status
In a total of 228 patients, 215(94.3%) patients were followed up after surgical. 152(91.6%) patients were followed up in the R0 PV/SMV, SMA group. And 57(91.9%) patients were followed up in the R1 PV/SMV, SMA group. The follow-up time ranged 6–60 months, and the median follow-up time was 20 months (Table 3)
Table 3
Survival Analysis between Resection Margin Status and Adjuvant Chemotherapy
|
Survival time (M)
|
Median survival time (M)
|
Mean survival time (M)
|
1-Year
|
2-Year
|
3-Year
|
P
|
Total patients
228 (100%)
|
0.3–52
|
21
|
15.75 ± 8.90
|
73%
|
40%
|
19%
|
-
|
Resection margin (228)
|
R0PV/SMV, SMA
166 (73%)
|
0.3–52
|
22
|
16.98 ± 8.99
|
73%
|
37%
|
25%
|
0.005
|
R1 PV/SMV, SMA
62 (27%)
|
0.6–42
|
15
|
13.22 ± 8.21
|
61%
|
13%
|
10%
|
Adjuvant chemotherapy (228)
|
Yes 95(42%)
|
6–43
|
24
|
17.28 ± 8.48
|
83%
|
56%
|
31%
|
0.000
|
No 133(58%)
|
0.3–52
|
17
|
14.59 ± 9.08
|
65%
|
30%
|
14%
|
None-adjuvant chemotherapy group (133)
|
R0PV/SMV, SMA
96 (72%)
|
0.3–52
|
19
|
15.7 ± 9.53
|
69%
|
36%
|
15%
|
0.074
|
R1 PV/SMV, SMA
37 (28%)
|
0.6–35
|
15
|
12.66 ± 8.00
|
54%
|
11%
|
0%
|
Adjuvant chemotherapy group (95)
|
R0PV/SMV, SMA
70 (74%)
|
6–43
|
26
|
18.42 ± 8.22
|
84%
|
63%
|
35%
|
0.025
|
R1 PV/SMV, SMA
25 (26%)
|
2–42
|
16
|
14.11 ± 8.61
|
79%
|
25%
|
13%
|
The Relationship between R0PV/SMV, SMA Patients and Adjuvant chemotherapy (166)
|
Adjuvant chemotherapy
|
Yes 70(42%)
|
6–43
|
26
|
18.42 ± 8.22
|
84%
|
63%
|
35%
|
0.001
|
No 96(58%)
|
0.3–52
|
19
|
15.7 ± 9.53
|
69%
|
36%
|
15%
|
The Relationship between R1PV/SMV, SMA Patients and Adjuvant chemotherapy (62)
|
Adjuvant chemotherapy
|
Yes 25(40%)
|
2–42
|
16
|
14.11 ± 8.61
|
79%
|
25%
|
13%
|
0.208
|
No 37(60%)
|
0.6–35
|
15
|
12.66 ± 8.00
|
54%
|
11%
|
0%
|
In a total of 228 patients, the survival time ranged 0.3–52 months, the median survival time was 21 months, the mean survival time was 15.75 ± 8.90 months and the 1-year, 2-year, and 3-year survival rates were 73%, 40%, and 19%, respectively. In the R0 PV/SMV, SMA group, the survival time ranged 0.3–52 months, the median survival time was 22 months, the mean survival time was 16.98 ± 8.99 months and the 1-year, 2-year, and 3-year survival rates were 73%, 37%, and 25%, respectively. In the R1 PV/SMV, SMA group, the survival time ranged 0.6–42 months, the median survival time was 15 months, the mean survival time was 13.22 ± 8.21 months, and the 1-year, 2-year, and 3-year survival rates were 61%, 13%, and 10%, respectively. There was statistical significance of survival time between R1 PV/SMV, SMA group and R0 PV/SMV, SMA group (P = 0.005)(Table 3)(FIGURE 3 A).
Survival Relationship Between Adjuvant Chemotherapy And Resection Margin Status
Postoperatively, 95 (42%) patients had received adjuvant chemotherapy. 24 patients were treated with Gemcitabine, 57 patients were treated with Tegafur Gimeracil Oteracil Potassium Capsule, 4 patients were treated with Tegafur Gimeracil Oteracil Potassium Capsule combined Gemcitabine. 4 patients were treated with FOLFIRINOX and 6 with Doxifluridine. In addition to this, 133 (58%) patients had not received any adjuvant therapy.
There was the statistical significance of survival time between the adjuvant chemotherapy group and the none-adjuvant chemotherapy group (P = 0.000), (Table 3)(FIGURE 3B). In the none-adjuvant chemotherapy group, there was no statistical significance of survival time between R0 PV/SMV, SMA patients and R1 PV/SMV, SMA patients( P = 0.074) (Table 3) (FIGURE 3C). In the adjuvant chemotherapy group, there was statistical significance of survival time between R0 PV/SMV, SMA group and R1 PV/SMV, SMA group(P = 0.025). (Table 3) (FIGURE 3D)
In the R0 PV/SMV, SMA group, there was the statistical significance of survival time between the adjuvant chemotherapy patients and the none-adjuvant chemotherapy patients (P = 0.001) (Table 3) (FIGURE 3E). In the R1 PV/SMV, SMA group, there was no statistical significance of survival time between the adjuvant chemotherapy patients and the none-adjuvant chemotherapy patients (P = 0.208) (Table 3) (FIGURE 3F).