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W. Douglas Wong, M.D.
Chief,Colorectal Service
Memorial Sloan Kettering Cancer Center
Professor of Surgery
Cornell University Medical School
4th East – West Colorectal Days
HungaryOct. 16-18, 2008
Ultra-Low Sphincter Saving Procedures -Re-defining the inferior resection limit
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. Whole Mount Pathologic Analysis ( Annals of Surgery 2007)2. Distal Margin Analysis Study ( Unpublished 2008 )3. Coloanal / Intersphincteric Study ( Submitted 2008 )
A Prospective Pathologic Analysis Using Whole-Mount 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
Study # 1
• 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
Aims of the Study
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)
Impact of distal margin
Distal Margin Rectal Cancer
1. Guillem JG, Ann Surg. 2007 Jan;245(1):88-93
MSK1: Whole mount analysis of 87 locally advanced RC after neoadjuvant CMT and LAR
No positive margins
2.2% had intramural extensionbeyond mucosal edge of tumor
9.5mm
3mm
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
Distal Margin Analysis
Nash G, Paty P, Guillem J, Temple L, Weiser M, and Wong D
( Unpublished Data 2008 )
Study # 2
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 - LARDistal margin rectal cancer
Group 1 2 3 P value
Distal margin <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
Local recurrenceDistal margin rectal cancer
Distal margin <8mm 8-19mm 20-60mm P-value
LR events 13/103 13/230 15/294
Absolute LR 12.6% 5.7% 5.1% 0.006
DM < 8mm *
DM = 8-19mm
DM = 20-60mm
* P = 0.008
103 95 78 45 23 13 5 230 217 167 99 47 21 9 294 281 220 133 71 35 15
103 97 81 46 25 13 5 230 222 170 99 47 21 9 294 283 222 134 71 35 16
Mucosal recurrenceDistal margin rectal cancer
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% <0.001
DM < 8mm *
DM = 8-19mm
DM = 20-60mm
* P = 0.001
Pelvic recurrence (excludes iMR)Distal margin rectal cancer
Distal margin <8mm 8-19mm 20-60mm P value
PR events 7/103 11/230 13/294
Absolute PR 6.8% 4.8% 4.4% 0.63
DM < 8mm
DM = 8-19mm
DM = 20-60mm
P = 0.62
103 95 78 45 23 13 5 230 217 167 99 47 21 9 294 281 220 133 71 35 15
Changes over time: 1991-1997 and 1998-2004
Distal margin rectal cancer
Variation of LRDistal margin rectal cancer
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
Variation of LRDistal margin rectal cancer
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
n 1991-7 n 98-2004 P value
Preop CMT 286 46% 462 67% <0.001
Any adjuvant 286 65% 462 78% <0.001
Use of adjuvant therapy
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
Distal margin rectal cancer
Rationale for ultralow LAR/CAA
Ultralow LAR/CAA with Intersphincteric Dissection
Weiser et al. Adenocarcinoma of the Colon and Rectum. In Shackelford’s Surgery of the Alimentary Tract6th ed, 2007
1. We need less distal margin than we once thought
2. Internal sphincter is an extension of the rectal wall
Author Year nFollow-
upLocal
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 9.5%
Oncologic Outcome of Coloanal Anastomosis
*literature review
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 )
Study # 3
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 1.1 cm ( 0.9 – 1.3 cm)• LAR Handsewn Intersphincteric 1.0 cm ( 0.9 – 1.3 cm)• APR 4.0 cm ( 3.5 – 4.6 cm)
Oncologic Outcome (MSKCC data)
LAR
Coloanal
n = 41
Intersphincteric dissection
n = 44
APR
n = 63
p-value
Age 60 54 67
Male 44% 57% 52% ns
Distance from anal verge 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
MSKCC 2008
Oncologic Outcome (MSKCC data)
LAR Coloanal
n = 41
Intersphincteric dissection
n = 44
APR
n = 63
Crude recurrence rate 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.
• “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
LAR vs APR
Quality of Life:Stoma vs Sphincter Preservation
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