1. Survival analysis of Local excision versus Radical resection for Early-stage Middle and Low Rectal cancer
早期中低位直腸癌的治療：
局部切除與根治性切除之預後分析
賴以立 唐瑞平 陳進勛 游正府 江支銘 陳繹中 葉建裕 游耀東 謝寶秀 蔡文司 洪欣園 蔣昇甫 賴正洲 林耕平 林岳辰 許祐仁
林口長庚紀念醫院
大腸直腸肛門外科

2. Background
NCCN guidelines for rectal cancer, Version

3. Background Radical resection (RR) CCRT
NCCN guidelines for rectal cancer, Version

4. Background
Clancy C, et al: transanal endoscopic microsurgery is oncologically superior to transanal excision for the excision of rectal neoplasms.
You YN, et al: 5-year local recurrence after LE vs. Standard resection was 12.5 vs. 6.9% (P = 0.003) for T1 tumors, and 22.1 versus 15.1% (P = 0.01) for T2 tumors.
Kidane B, et al: Local excision does not offer oncologic control comparable to radical surgery.
Karyn B. Stitzenberg, et al: For T2N0 disease, patients treated with LE alone had significantly poorer adjusted OS than those treated with proctectomy alone or multimodality therapy.
Dis Colon Rectum. 2015;58:254–261.
Ann Surg May;245(5):
Dis Colon Rectum Jan;58(1):
J Clin Oncol Dec 1; 31(34): 4276–4282.

5. Material and Methods - Patients
Low risk
Moderate risk
High risk
pT1:
tumor < 3 cm in size
No LVI or PNI
Well to moderately differentiated
pT1:
tumor < 3 cm in size
With poor differentiation and/or LVI and/or PNI
pT1:
tumor > 5 cm in size
pT2
tumor > 3 cm in size
No LVI or PNI
And/or poor differentiation and/or LVI and/or PNI
pT1:
3 < tumor < 5 cm in size
With any other histological characteristics
pT2:
tumor < 3 cm in size
No LVI or PNI
Well to moderately differentiated
The TESAR-Trial, Borstlap et al. BMC Cancer (2016) 16:513

6. Material and Methods - Patients
Low risk
Moderate risk
High risk
pT1:
tumor < 3 cm in size
No LVI or PNI
Well to moderately differentiated
pT1:
tumor < 3 cm in size
With poor differentiation and/or LVI and/or PNI
pT1:
tumor > 5 cm in size
pT2
tumor > 3 cm in size
No LVI or PNI
And/or poor differentiation and/or LVI and/or PNI
pT1:
3 < tumor < 5 cm in size
With any other histological characteristics
pT2:
tumor < 3 cm in size
No LVI or PNI
Well to moderately differentiated
CCRT
Radical resection
The TESAR-Trial, Borstlap et al. BMC Cancer (2016) 16:513

7. Material and Methods
Tracing back the data from 1998 to 2016, 173 patients who matched Pathology: rectal adenocarcinoma, pT1 or pT2, Distance from anal verge (DAV) ≤ 8cm, and Moderate risk were enrolled.

8. Material and Methods - data
Basic data, Lab data, Pathologic data, Adjuvant therapy, OP style (LAR/APR vs. LE), Intra-operative diverting ileostomy or colostomy, Post-operative morbidity (early, late, total)
Outcome: Overall survival (OS), Disease-free survival (DFS), Loco-recurrence free survival (LFS).
Statistics methods: Fisher's exact test, Mann-Whitney U Test, Log-rank test

9. Results- RR vs LE Variable RR, N = 134 (%) LE, N = 39 (%) P value
Age (years), mean ± SD
63.0 ± 12.9
59.7 ± 13.9
0.178
BMI, mean ± SD
24.3 ± 3.5
25.3 ± 4.4
0.226
Sex
1.000
Male
68 (50.7)
20 (51.3)
Female
66 (49.3)
19 (48.7)
Family cancer history
43 (32.1)
16 (41.0)
0.339
CEA, mean ± SD
2.89 ± 3.49
2.14 ± 1.06
0.757
Albumin, mean ± SD
4.28 ± 0.42
4.43 ± 0.39
0.075
Hemoglobin, mean ± SD
13.12 ± 1.73
13.45 ± 1.71
0.350

10. Results- RR vs LE Variable RR, N = 134 (%) LE, N = 39 (%) P value
Intra-operative ileostomy or colostomy*
59 (48.0)
0.0001
Adjuvant therapy
21 (15.7)
17 (43.6)
Chemotherapy
20 (14.9)
1 (2.6)
CCRT
1 (0.7)
16 (41.0)
Morbidity
early
25 (18.7)
2 (5.1)
0.045
late
22 (16.4)
0.005
Total
38 (28.4)
0.002
* loss data: 11 cases

11. Results- RR vs LE Variable RR, N = 134 (%) LE, N = 39 (%) P value
Tumor diameter, mean ± SD (cm)
2.55 ± 0.75
2.75 ± 0.98
0.193
Distance from anal verge, mean ± SD (cm)
5.93 ± 1.83
4.59 ± 1.92
0.0001
Resection margin, mean ± SD (cm)
1.54 ± 0.98
0.14 ± 0.25
Differentiation
Well
31 (23.1)
13 (33.3)
0.214
Moderate
98 (73.1)
25 (64.1)
0.317
Poor
5 (3.7)
1 (2.6)
1.000

12. Results- RR vs LE Variable RR, N = 134 (%) LE, N = 39 (%) P value
Lymphovascular invasion
11 (8.2)
7 (17.9)
0.131
Perineural invasion
4 (3.0)
0.576
T stage
0.0001 T1
48 (35.8)
31 (79.5) T2
86 (64.2)
8 (20.5)
N stage
N0 (Nx)
112 (83.6)
(unknown) N1
22* (16.4)
*One 76-year-old male, refused adjuvant therapy due to old age.

13. Results- OS Overall Survival (OS) RR (N = 134) LE (N = 39) 94% 97% 89%
3-year
94%
97%
5-year
89%
88%
P = 0.456
OS complete number: 24 / 9

14. Results- DFS Disease-Free Survival (DFS) RR (N = 134) LE (N = 39)
1-year
100%
97%
3-year
95%
5-year
92%
88%
P = 0.595
DFS complete number: 10 / 4

15. Results- LFS Locorecurrence-Free Survival (LFS) RR (N = 134) LE
1-year
100%
97%
3-year
99%
5-year
98%
91%
P = 0.104
LFS complete number: 3 / 3

16. Conclusion
Whether RR or LE, patients with early stage mid-low rectal cancer at moderate histologic risk had similar oncological outcome. However, The RR group had higher morbidity rate (28.4% vs. 5.1%, p = 0.002), and 48% patients of this group had stomy.
In this selected group, there is 16.4% positive rate of lymph node metastasis in final pathologic diagnosis.

17. 林口長庚紀念醫院 直腸肛門科
賴以立

18. Results- DFS Disease-Free Survival (DFS) LAR / APR (N = 113)
No adjuvant therapy
With adjuvant CCRT
Disease-Free Survival (DFS)
LAR / APR
(N = 113)
Local excision
(N = 17)
1-year
100%
3-year
94%
5-year
91%
P = 0.670
DFS complete number: 10 / 1