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Ultra-Low Sphincter Saving Procedures Re-defining the inferior resection limit
4th East – West
Colorectal Days
Hungary
Oct. 16-18, 2008
W. Douglas Wong, M.D.
Chief,Colorectal Service
Memorial Sloan Kettering Cancer Center
Professor of Surgery
Cornell University Medical School
Sphincter preserving surgery
should be considered the
standard for the majority of low
rectal cancers
How much distal margin do you need?
• 5 cm rule*
• 2 cm rule**
• “end of the 2 cm rule”
*Williams et al. Reappraisal of the 5cm rule of distal excision for carcinoma of the rectum. Br. J
Surg. 1983;70:150-154.
**Pollett et al. The relationship between the extent of distal clearance and survival and local
recurrence rates after curative anterior resection for carcinoma of the rectum. Ann Surg.
1983;198:159-163
What is an adequate distal margin for
sphincter sparing rectal resection?
MSKCC Studies
1.
2.
3.
Whole Mount Pathologic Analysis
Distal Margin Analysis Study
Coloanal / Intersphincteric Study
( Annals of Surgery 2007)
( Unpublished 2008 )
( Submitted 2008 )
Study # 1
A Prospective Pathologic Analysis Using WholeMount Sections of Rectal Cancer Following
Preoperative Combined Modality Therapy
Implications for Sphincter Preservation
Jose Guillem, David Chessin, Jinru Shia,
Arief Suriawinata, Elyn Riedel, Harvey Moore,
Bruce Minsky, and W. Douglas Wong
Annals of Surgery 2007;245(1):88-93
Aims of the Study
• To use whole mount pathologic analysis
to characterize microscopic patterns of
residual disease
• Circumferential margins
• Distal resection margins
• To identify clinicopathologic factors
associated with residual disease
Methodology
• 109 patients prospectively accrued with ERUS
staged locally advanced rectal cancer (T2-T4 and
/or N1)
• Median distance of 7 cm. from anal verge
• Preoperative chemoradiation followed by TME
based resection
• Comprehensive whole mount pathologic analysis
was performed
Results
• Sphincter preserving resection was feasible in 87 patients
(80%)
• Distal margins negative in all 109 pts
– Median 2.1 cm; range 0.4 – 10 cm
• Intramural extension beyond gross mucosal edge of
residual tumor was only in 2 patients (1.8 %)
– Both < .95 cm
• No positive circumferential margins although 6 were less
that 1 mm
– Median 10 mm; range 1 - 28 mm
• On multivariate analysis, residual disease was observed
more frequently in distally located tumors < 5 cm from the
anal verge (p=.03)
Distal Margin Rectal Cancer
Impact of distal margin
 MSK1: Whole mount analysis of 87 locally advanced
RC after neoadjuvant CMT and LAR
 No positive margins
 2.2% had intramural extension
beyond mucosal edge of tumor
9.5mm
3mm
1. Guillem JG, Ann Surg. 2007 Jan;245(1):88-93
Conclusions
• Following preoperative chemoradiation and TME, distal
margins of 1 cm seems adequate
• Occult tumor beneath the mucosal edge was rare and when
present was limited to less that 1 cm
• These results extend the indications for sphincter
preservation as distal resection margins of only 1 cm may
be acceptable for locally advanced rectal cancer treated
with preoperative chemoradiation
Study # 2
Distal Margin Analysis
Nash G, Paty P, Guillem J, Temple L,
Weiser M, and Wong D
( Unpublished Data 2008 )
Distal margin rectal cancer
Study Hypotheses
 Margin of less than 8mm is associated
with higher risk of local recurrence (LR)
 Mucosal recurrence (MR) is the
mechanism of higher LR
Distal margin rectal cancer
Study Cohort
• 627 patients with primary rectal cancer
• Study period: 1991-2004
• Curative resection
• No involvement of adjacent organs
• Low anterior resection
– Stapled anastomosis
– Hand-sewn coloanal anastomosis (HSCAA)
• Median follow up 5.8 years
Distal margin rectal cancer
Patient and Tumor Characteristics - LAR
Group
1
2
3
<8mm
8-19mm
20-60mm
n
103
230
294
Age ≤60 years
59%
53%
47%
0.07
Female
46%
39%
40%
0.40
2-6cm from AV
81%
57%
17%
<0.001
pT3/4
16%
34%
54%
<0.001
pN1/2
23%
29%
25%
0.48
M1
1%
2%
3%
0.47
LVI
9%
9%
10%
0.97
Preop CMT
58%
61%
60%
0.87
Any adjuvant rx
72%
76%
74%
0.73
DSS at 6 years
90%
87%
87%
0.76
OS at 6 years
84%
85%
83%
0.67
Distal margin
P value
Distal margin rectal cancer
Local recurrence
Distal margin
LR events
Absolute LR
<8mm
13/103
12.6%
8-19mm 20-60mm P-value
13/230
15/294
5.7%
5.1%
0.006
DM = 20-60mm
DM = 8-19mm
DM < 8mm *
* P = 0.008
103
230
294
95
217
281
78
167
220
45
99
133
23
47
71
13
21
35
5
9
15
Distal margin rectal cancer
Mucosal recurrence
Distal margin
<8mm
8-19mm 20-60mm P value
MR events
8/103
4/230
4/294
Absolute MR
7.8%
1.7%
1.4%
DM = 20-60mm
DM = 8-19mm
DM < 8mm *
* P = 0.001
103
230
294
97
222
283
81
170
222
46
99
134
25
47
71
13
21
35
5
9
16
<0.001
Distal margin rectal cancer
Pelvic recurrence (excludes iMR)
Distal margin
PR events
Absolute PR
<8mm
7/103
6.8%
8-19mm 20-60mm P value
11/230
13/294
4.8%
4.4%
0.63
DM = 20-60mm
DM = 8-19mm
DM < 8mm
P = 0.62
103
230
294
95
217
281
78
167
220
45
99
133
23
47
71
13
21
35
5
9
15
Distal margin rectal cancer
Changes over time:
1991-1997 and 1998-2004
Distal margin rectal cancer
Variation of LR
n
1991-97
n
98-2004
P value
<8 mm
41
22%
62
6.5%
0.02
8-19 mm
74
6.8%
156
5.1%
0.62
20-60 mm
127
7.9%
167
3.0%
0.06
All patients
242
9.9%
385
4.4%
0.007
Distal margin rectal cancer
Variation of LR
n
1991-97
n
98-2004
P value
<8 mm
41
22%
62
6.5%
0.02
8-19 mm
74
6.8%
156
5.1%
0.62
20-60 mm
127
7.9%
167
3.0%
0.06
All patients
242
9.9%
385
4.4%
0.007
Use of adjuvant therapy
n
1991-7
n
98-2004
P value
Preop CMT
286
46%
462
67%
<0.001
Any adjuvant
286
65%
462
78%
<0.001
Distal margin rectal cancer
Conclusions
• Sphincter sparing techniques do not
compromise local control or survival
• Careful surveillance for MR is
warranted in patients with close DM
• Salvage is feasible for most MR
Rationale for ultralow LAR/CAA
Ultralow LAR/CAA with
Intersphincteric Dissection
1. We need less distal
margin than we
once thought
2. Internal sphincter is
an extension of the
rectal wall
Weiser et al. Adenocarcinoma of the Colon and Rectum. In Shackelford’s Surgery
of the Alimentary Tract6th ed, 2007
Oncologic Outcome of Coloanal
Anastomosis
Author
Year
n
FollowLocal
up
recurrence
Tiret et al
2003
26
39 mo
3.4%
Portier et al
2007
173
67 mo
10.6%
Saito et al
2006
228
41 mo
5.8%
Rullier et al
2005
92
>24 mo
2.0%
Tilney et al* 2007
612
*literature review
9.5%
Study # 3
Sphincter Preservation in low rectal cancer is
facilitated by preoperative chemoradiation
and intersphincteric dissection
Weiser M, Quah HM, Shia J, Guillem J,
Paty P, Temple L, Goodman K,
Minsky B and Wong D
( Submitted paper 2008 )
Aim of the Study
• To evaluate oncologic outcome in patients
with locally advanced distal rectal cancer
treated with preoperative chemoradiation
followed by:
– LAR with stapled coloanal anastomosis
– LAR with intersphincteric dissection and hand
sewn coloanal anastomosis
– APR
Background Data
• From a cohort of 601 consecutive patients
from 1998 – 2004 :
– 148 patients were identified with Stage II and III
rectal cancers (ERUS Staged uT3-4 and/or N1)
at or below 6 cm from the anal verge
– All treated with preoperative long course
chemoradiation and TME
Median Distal Margin
Median Distal Margin
• LAR Stapled Coloanal
• LAR Handsewn Intersphincteric
• APR
1.1 cm ( 0.9 – 1.3 cm)
1.0 cm ( 0.9 – 1.3 cm)
4.0 cm ( 3.5 – 4.6 cm)
Oncologic Outcome (MSKCC data)
LAR
n = 41
Intersphincteric
dissection
n = 44
n = 63
Age
60
54
67
Male
44%
57%
52%
ns
6 (3-6)
5 (3-6)
3 (0-6)
0.0001
Pathologic CR
24%
25%
6%
0.018
Poor differentiation
7%
5%
28%
0.003
+ circumferential margin
0%
5%
13%
0.11
Coloanal
Distance from anal verge
MSKCC 2008
APR
p-value
Oncologic Outcome (MSKCC data)
LAR
Intersphincteric
dissection
Coloanal
n = 44
n = 41
Crude recurrence rate
APR
n = 63
6(15%)
7(16%)
26(41%)
Local
1(2%)
0(0)
6(9%)
Distant
5(12%)
7(16%)
22(35%)
5 yr RFS (95% CI)
85%
83%
47%
5 yr DSS (95% CI)
97%
96%
59%
MSKCC 2008
Oncologic Outcome of Coloanal
Anastomosis
N=149
MSKCC 2008
Conclusions
• In low rectal cancer, sphincter preservation
is facilitated by significant response to
chemoradiation and intersphincteric
dissection without oncologic compromise
• APR is more likely required in those
patients with lesser response to
neoadjuvant therapy and is associated with
poorer outcome
Functional outcome of ultralow LAR
with coloanal anastomosis
Functional Outcome after LAR/CAA
• 81 patients
• Median 2 BM / day
• Continence
complete
51%
incontinent gas
21%
minor leak
23%
significant leak
5%
• 56% excellent or good composite function
(continence, evacuation, #BMs)
• 74% of patients were satisfied
Paty et al. Long-term functional results of coloanal anastomosis for rectal cancer. Am J
Surg. 1994;167:90-95.
QOL: Anal Sphincter
Preservation or Sacrifice
• Despite LAR patients suffering defecation problems, they had better QOL
than APR patient
• Bowel function did not significantly impact on overall QOL
• Stoma patients
– More limited everyday work and hobby activities (role functioning)
– More disrupted social and family life (social functioning)
– Less able to get about and look after themselves (physical
functioning)
– Felt less attractive (body image)
• These changes persisted over time (4 years)
• LAR scores improved with time while APR did not.
• Greatest improvement in QOL was when temporary stomas were
reversed.
Engel et al. Quality of life in Rectal Cancer Patients. Ann Surg 2003;238:203-213.
LAR vs APR
Quality of Life:
Stoma vs Sphincter Preservation
• “Meta-analysis”
– Validated instruments
– Studies including APR and LAR
• Study included data from 11 studies
– 1443 patients
– 486 patients with APR
– All retrospective
– Validated instruments
• 4 SF-36, 7 EORTC 30, 8 EORTC – CRC38
Cornish et al. Ann Surg Onc, 2007; 14: 2056-2068
QOL: SPS vs APR
Overall when comparing APR
to LAR, no differences in
general QOL were identified
Cornish et al. Ann Surg Onc, 2007; 14: 2056-2068
Conclusions
• A 1 cm distal margin is acceptable in patients
undergoing neoadjuvant tx
• Ultra-low LAR/COLOANAL is oncologically
sound
• Restores body image
• Majority of patients are satisfied with their QOL