Retrospective research of neoadjuvant therapy on tumor-downstaging, post-operative complications, and prognosis in locally advanced rectal cancer

Table 1 General data

	Case counts
Gender: Male/Female	62	15
Diabetes mellitus: Yes/No	11	66
Hypertension: Yes/No	19	58
Preoperative radiation: Yes/No	55	22

Table 2 General data comparison between neoadjuvant radiochemotherapy and neoadjuvant chemotherapy

	NRCT	NCT	P value
Median age in yr	60	62	0.64
Gender, n			1.00
Male	44	18
Female	11	4
Hypertension, n			0.80
Yes	14	5
No	41	17
Diabetes mellitus, n			0.80
Yes	7	4
No	48	18

NCT: Neoadjuvant chemotherapy; NRCT: Neoadjuvant radiochemotherapy.

Table 3 Baseline comparison of oncology data between neoadjuvant radiochemotherapy and neoadjuvant chemotherapy

	NRCT	NCT	P value
Pre-operative median distance of tumor lower edge in cm	5.0	6.0	0.37
T3	25	17	0.01
T4	30	5
Pre-operative N stage, n
N0	5	2	1.00
N+	50	20

NCT: Neoadjuvant chemotherapy; NRCT: Neoadjuvant radiochemotherapy.

Table 4 Effectiveness of neoadjuvant therapy

Neoadjuvant therapy	n
RECIST, n
CR	12
PR	45
SD	20
PD	0
TRG, n
0	15
1	12
2	23
3	27

CR: Complete response; PD: Progressive disease; PR: Partial response; RECIST: Response Evaluation Criteria in Solid Tumors; SD: Stable disease; TRG: Tumor regression grade.

Table 5 Effectiveness comparison between neoadjuvant radiochemotherapy and neoadjuvant chemotherapy

	NRCT	NCT	P value
Retraction of lower edge, n			0.72
Yes	30	9
No	25	13
Median retraction distance of lower edge in cm	1.0	1.0	0.97
T-downstaging, n			0.03
Yes	37	9
No	18	13
N-downstaging, n			0.50
Yes	37	13
No	18	9
CR, n			0.71
Yes	20	7
No	35	15
TRG-0, n			1.00
Yes	11	4
No	44	18

CR: Complete response; NCT: Neoadjuvant chemotherapy; NRCT: Neoadjuvant radiochemotherapy; TRG-0: Tumor regression grade 0.

Table 6 Comparison of operation data between neoadjuvant radiochemotherapy and neoadjuvant chemotherapy

	NRCT	NCT	P value
Organ-preservation, n			0.15
Yes	40	20
No	15	2
Defunctioning stoma1, n			0.61
Yes	32	16
No	4	4
Median operation duration in min	168	142	0.23
Intra-operation blood loss in mL	70	50	0.59
Anastomosis site2 in cm	5.0 ± 1.6	6.0 ± 1.4	0.03

¹Including cases receiving Dixon or Hartmann.

²Including cases receiving Dixon only. NCT: Neoadjuvant chemotherapy; NRCT: Neoadjuvant radiochemotherapy.

Table 7 Comparison of post-operation data between neoadjuvant radiochemotherapy and neoadjuvant chemotherapy

	NRCT	NCT	P value
Median hospitalization time in d	7	8	0.75
Liquid diet time in d	3	2	0.96
Re-operation, n			0.47
Yes	4	0
No	51	22
Complications, n			0.33
Yes	13	3
No	42	19
Anastomotic leakage1, n			0.56
Yes	5	1
No	31	19
Incision complications, n			0.47
Yes	4	0
No	51	22

¹Including cases receiving Dixon only. NCT: Neoadjuvant chemotherapy; NRCT: Neoadjuvant radiochemotherapy.

Table 8 Influence factors and assignments for neoadjuvant therapy effectiveness

Factor	Variable	Assignment
Gender	X1	M = 1, F = 0
Age	X2	≤ 60 yr = 1, > 60 yr = 0
Hypertension	X3	N = 1, Y = 0
Diabetes mellitus	X4	N = 1, Y = 0
Pre-operative radiation	X5	N = 1, Y = 0
Pre-T stage	X6	T3 = 1, T4 = 0
Tumor lower edge	X7	≤ 5 cm = 1, > 5 cm = 0
TRG-0 or 1	Y	Y = 1, N = 0

F: Female; TRG: Tumor regression grade; M: Meal; N: No; Y: Yes.

Table 9 Logistic regression analysis of predictors of neoadjuvant therapy effectiveness

Variable	β	Wals value, χ2	P value	OR	95%CI
					Lower limit		Upper limit
Gender	-1.381	5.609	0.02	0.251	0.08	0.788
Age	-1.183	4.34	0.04	0.306	0.101	0.932
Hypertension	0.725	1.245	0.26	2.065	0.578	7.385
Diabetes mellitus	0.527	0.622	0.43	1.694	0.457	6.273
Pre-operative radiation	-0.601	1.012	0.31	0.548	0.17	1.768
Pre-T stage	0.526	0.967	0.33	1.692	0.593	4.827
Tumor lower edge	0.073	0.021	0.89	1.075	0.401	2.884

CI: Confidence interval; OR: Odds ratio.

Table 10 Risk factors and assignments for anastomotic leakage

Factor	Variable	Assignment
Gender	X1	M = 1, F = 0
Age	X2	≤ 60 yr = 1, > 60 yr = 0
Comorbidities	X3	N = 1, Y = 0
Radiation	X4	N = 1, Y = 0
Stoma	X5	N = 1, Y = 0
TRG-0 or 1	X6	N = 1, Y = 0
Anastomosis site location	X7	≤ 5.4 cm = 1, > 5.4 cm = 0
Anastomotic leakage	Y	Y = 1, N = 0

F: Female; TRG: Tumor regression grade; M: Meal; N: No; Y: Yes.

Table 11 Logistic regression analysis of risk factors for anastomotic leakage after neoadjuvant therapy

Variable	β	Wals value, χ2	P value	OR	95%CI
					Lower limit	Upper limit
Gender	-0.777	0.971	0.32	0.46	0.098	2.156
Age	-0.349	0.136	0.71	0.706	0.11	4.514
Comorbidity	0.146	0.024	0.88	1.157	0.185	7.239
Radiation	-1.732	1.832	0.18	0.177	0.014	2.173
Stoma	1.176	0.917	0.34	3.241	0.292	35.961
TRG-0 or 1	-1.198	1.564	0.21	0.302	0.046	1.973
Anastomosis site	-1.46	2.386	0.12	0.232	0.036	1.481

CI: Confidence interval; OR: Odds ratio; TRG-0: tumor regression grade 0.