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Organ Sparing Treatments for Early Rectal Cancer The Oregon Gut Club

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Organ Sparing Treatments for Early Rectal Cancer The Oregon Gut Club. Mark H. Whiteford, MD, FACS, FASCRS Director, Colon and Rectal Surgery | Providence Cancer Center Clinical Associate Professor | Oregon Health & Science University

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slide1

Organ Sparing Treatments for EarlyRectal Cancer

The Oregon Gut Club

Mark H. Whiteford, MD, FACS, FASCRS

Director, Colon and Rectal Surgery | Providence Cancer Center

Clinical Associate Professor | Oregon Health & Science University

Gastrointestinal and Minimally Invasive Surgery Division | The Oregon Clinic, PC

slide2

Disclosure

  • Richard Wolf Medical Instruments
    • Research funding
    • Consultant
rectal cancer
Rectal Cancer
  • Colorectal Cancer is second most common cause of cancer related death in the US
  • Rectal cancer accounts for 40% of these
    • 36,400 new cases (56% male)
    • 8,600 deaths (55% male)
advancements in rectal cancer treatment
Advancements in Rectal Cancer Treatment
  • Improved tumor imaging:
    • Endoscopic ultrasound
    • Rectal MRI
advancements in rectal cancer treatment1
Advancements in Rectal Cancer Treatment
  • Improved tumor imaging:
    • Endoscopic ultrasound
    • Rectal MRI
  • Advantages of neoadjuvantchemoradiation
    • Stage 2 and 3
advancements in rectal cancer treatment2
Advancements in Rectal Cancer Treatment
  • Improved tumor imaging:
    • Endoscopic ultrasound
    • Rectal MRI
  • Advantages of neoadjuvantchemoradiation
    • Stage 2 and 3
  • Better understanding of surgical technique:
    • 1-2 cm distal margin = Sphincter sparing techniques
    • Total mesorectal excision
total mesorectal excision
Total Mesorectal Excision
  • Established gold standard for radical excision of rectal cancer
    • Nerve sparing technique
    • Lower local recurrence rates
    • Improved survival
what is a rectum
What is a rectum?
  • Anus to …
    • 15 cm?
    • Upper rectal fold?
    • “Rectosigmoid junction”?
    • Peritoneal reflection?
    • Top of S3?
the oncologic rectum

Gordon PH, 2nd Ed, 1999

The Oncologic Rectum

15 cm

12 cm

Anal Verge

NCI Guidelines 2000 for Colon and Rectal Cancer Surgery, JNCI 2001

clinical evaluation
Clinical Evaluation
  • History
    • Family history
    • Continence history
    • Evaluation of operative risk
  • Physical
    • Abdomen
    • Digital Rectal Examination
    • Rigid proctoscopy
rectal cancer work up
Rectal Cancer Work Up
  • Clearing colonoscopy
  • CBC
  • CMP
  • CEA
  • CT Scan Abdomen / Pelvis
  • Chest imaging (CXR or CT)
  • Endoscopic Ultrasound (MRI)
the early rectal cancer dilemma
The early rectal cancer dilemma
  • Stage 1 rectal cancer is a curable disease with radical surgery

But…

the early rectal cancer dilemma the cost for cure
The early rectal cancer dilemmaThe cost for cure
  • Total mesorectal excision associated with
    • Long hospital stay and convalescence
    • Infectious complications
    • Urinary dysfunction
    • Sexual dysfunction
    • Defecatory dysfunction
    • Some need permanent ostomy
sexual dysfunction radical surgery for rectal cancer
Sexual DysfunctionRadical surgery for rectal cancer

Activity:

Pre Op

Post Op

Loss Spont

Embarrassed

APR

91%

55%

53%

44%

LAR

94%

74%

27%

24%

TAE

80%

87%

13%

0%

Hendren et al, Ann Surg 2005

full thickness local excision
Full Thickness Local Excision
  • “Total Biopsy”
    • Thorough histologic evaluation
    • Polyp vs Cancer?
    • Tumor differentiation
    • Depth of invasion
    • Completeness of excision
local excision is appealing
Local Excision is Appealing
  • Low morbidity
  • Quick recovery
  • Minimal effect on long term bowel function
  • Organ sparing technique
local excision in an ideal world
Local Excision: In an Ideal World
  • If …
    • we know that there is no tumor in the lymph nodes
    • and technically a FTLE can be done,
    • the surgery should be curative!
  • And if there is a recurrence …
    • we can always perform salvage surgery!
predicting success
Predicting success?
  • How to predict which tumors are confined to the rectal wall ?
  • What tumor characteristics predict node positivity?
local treatment of rectal cancer t stage relates to lymph node metastasis
Local Treatment of Rectal CancerT-stage relates to Lymph Node Metastasis

Morson BC Proc R Soc Med 1966

Hojo K Am J Surg 1982

Minsky BD Cancer 1989

Huddy SPJ BJS 1993

T1

10.9%

17.9%

0%

11%

T2

12.1%

37.8%

28%

23%

T3

58.3%

>50%

36%

ns

favorable features of early rectal cancers
Favorable Features of Early Rectal Cancers
  • T1
  • Moderate to well differentiated
  • Negative margins
  • No LVI
  • < 4cm greatest dimension
  • < 40% circumference
  • < 8-10 cm from anal verge
case series of ftle
Case series of FTLE

Morson, et al. GUT 1977

calgb 8984 trial
CALGB 8984 Trial
  • Full Thickness Local Excision

Steele, et al, Ann Surg Oncol 1999

calgb 8984 trial1
CALGB 8984 Trial

Steele, et al, Ann Surg Oncol 1999

local treatments for rectal cancer
Local Treatments for Rectal Cancer
  • Transanal excision of rectal neoplasmsbecame standard practice:
slide30

Unfortunately . . .

the oncologic results have been disappointing

favorable t1 cancers parks trans anal excision tae
Favorable T1 CancersParks Trans Anal Excision (TAE)

Mellgren (2000)

n=TAE 69 OS 30

Paty (2002)

n=TAE 74

Nascimbeni (2004)

n=TAE 70 OS 74

Madbouly (2005)

n=52

Local Recurrence

TAE 18%Rsxn 4%

(TME)

TAE 14%

TAE 7%Rsxn 3%

(TME)

TAE 17%

Survival (CSS/Overall)

TAE 72%Rsxn80%

TAE 92%

TAE 89%(72%)Rsxn90%

TAE 89%(75%)

“Transanal excision equals total mesorectal neglect”

- David Rothenberger

salvage surgery for recurrence ftle
Salvage Surgery for Recurrence FTLE
  • Recurrent stages (n=29)
    • stage 1: 2
    • stage 2: 13
    • stage 3: 12
    • stage 4: 2
  • Mean time to recurrence = 26 months
  • 23/29 underwent curative surgery
  • Mean follow up = 39 months

Friel, et al. Dis Colon Rectum 2002

salvage surgery for recurrence ftle1
Salvage Surgery for Recurrence FTLE

Patients DFS

Overall 29 12(59%)

T1 10 7(70%)

T2 19 10(53%)

Good histol 22 15(68%)

Bad histol 7 2(29%)

Friel, et al. Dis Colon Rectum 2002

salvage surgery for recurrence ftle2
Salvage Surgery for Recurrence FTLE
  • 49/50 patients underwent curative surgery
    • 31 Abdomioperineal
    • 11 Low anterior
    • 4 Pelvic exenteration
    • 1 Transanal excision
  • 27 (55%) multivisceral resections
  • 47/49 underwent R0 resection

Weiser, et al. Dis Colon Rectum 2005

salvage surgery for recurrence ftle3
Salvage Surgery for Recurrence FTLE

5 year

Survival

53%

Weiser, et al. Dis Colon Rectum 2005

why the high failure rates
Why the high failure rates?
  • Progression of occult lymphatic tumor
  • Implantation of viable tumor cells
  • Better histologic predictors
  • Remove deeper en bloc section of mesorectum
  • More precise instrumentation
  • Less traumatic tissue handling
  • Better visualization
better histologic predictors
Better Histologic Predictors
  • Routine use of EUS
  • Submucosal Depth of Invasion

Kikuchi Classification:

1-3% 8-10% 23-25%

  • Eventually: molecular markers
why the high failure rates1
Why the high failure rates?
  • Progression of occult lymphatic tumor
  • Implantation of viable tumor cells
  • Better histologic predictors
  • Remove deeper en bloc section of mesorectum
  • More precise instrumentation
  • Less traumatic tissue handling
  • Better visualization
origins of tem
Origins of TEM

Standard transanal excision:

  • Limited to lesions:
    • distal rectum
    • small tumors (<3 cm)
  • However…
    • lighting and exposure is poor
    • surgical field collapses

“short reach, poor visibility”

origins of tem1
Origins of TEM

Professor Gerhard Buess

transanal endoscopic microsurgery
Transanal Endoscopic Microsurgery

4 cm x 10-20 cm proctoscope, airtight faceplate, insufflation, telescope, and laparoscopic instruments

other requirements for tem
Other requirements for TEM
  • Need correct equipment
  • Need staff familiar with equipment
  • Need a surgeon skilled in TEM
where can tem help
Where can TEM help?
  • Progression of occult lymphatic tumor
  • Implantation of viable tumor cells
  • Better histologic predictors
  • Remove deeper en bloc section of mesorectum
  • More precise instrumentation
  • Less traumatic tissue handling
  • Better visualization
tem results adenomas
TEM ResultsAdenomas

RCT:

OR Times:

Complications:

Recurrence:

TEM

n=98

84 min

10%

6%

TAE

n=90

38 min

17%

22%

Winde, et al 1996

tem results adenomas1
TEM ResultsAdenomas

Case series:

Polyp size:

Fragmentation:

Clear Margins:

Recurrence:

TEM

n=82

14 cm2

12%*

83%*

3%*

TAE

n=89

15 cm2

26%

61%

32%

Moore, et al 2008

tem results adenomas case series
TEM ResultsAdenomas: Case series

Recurrence

7%

2%

3.6%

1.7%

5.9%

5%

13%

4.8%

5.4 %

F/U (mo)

60

24

67

24

29

30

24

39

35

Said 1995

Mentges1996

Morschel1998

Buess2001

Lloyd 2002

Palma 2004

Endreseth2005

Whitehouse 2006

Ramirez 2009

pt1 rectal cancer tem case series
pT1 Rectal CancerTEM case series
  • 1991-2003, single surgeon, n=53 (75)
  • Age 65 y (31-89) (65y)
  • Average 7 cm (0-13) from verge (7cm)
  • F/U: 2.8 y
  • 7.5% (4/53) recurrence (9%)
  • No cancer related deaths (0%)

Floyd and Saclarides DCR 2006

(Abarca and Saclarides ASCRS 2010)

ut1n0 rectal cancer rct tem vs low anterior rsxn
uT1N0 Rectal Cancer RCT: TEM vs Low Anterior Rsxn

TEM

24

63.7

7/12/5

41

20.8%

1 (4%)

96%

LAR

26

60.9

8/11/7

46

34.5%

0

96%

Patients:

Age (y):

Location L/M/U:

Follow-up (m):

Complications:

Local Recur:

Survival:

Winde et al, DCR 1996

ut2n0 low rectal cancer rct chemoxrt followed by tem vs laparoscopic tme minimum 5 year follow up
uT2N0 Low Rectal CancerRCT: ChemoXRT followed byTEM vs Laparoscopic TMEminimum 5 year follow-up

Patients:

Local Recur:

Distant Recur:

Prob of any Recur:

DFS:

TEM

35

2 (5.7%)

2 (5.7%)

9%

94%

LAC-TME

35

1 (2.8%)

2 (5.7%)

6%

94%

Lezoche et al Surg Endosc 2007

slide59
ACOSOG Z6041A Phase II Trial of NeoadjuvantChemoradiation and Local Excision for uT2uN0 Rectal Cancer
slide60

Pathologic complete response (pCR) to neoadjuvantchemoradiation (CRT) of uT2uN0 rectal cancer (RC) treated by local excision (LE): Results of the ACOSOG Z6041 trial.

J. Garcia-Aguilar, ASCO Annual Meeting 2010

  • 90 pts enrolled, 9 excluded
  • n=81
  • Tumor characteristics
    • Size 2.9 cm
    • Distance from anal verge 5 cm
slide61

Pathologic complete response (pCR) to neoadjuvantchemoradiation (CRT) of uT2uN0 rectal cancer (RC) treated by local excision (LE): Results of the ACOSOG Z6041 trial.

J. Garcia-Aguilar, ASCO Annual Meeting 2010

  • Results:
    • 98.7% resection margins negative
    • 64% tumors down staged (ypT0-T1)
    • 44% pathologic complete response (ypY0)
    • 5 specimens had LN
tem no loss of function
TEMNo loss of function
  • Mean LOS: 0.9 days
  • Average distance

to prox margin 11.4 cm

  • Mean tumor size 8.75 cm2

BM’s qD

FISI

FIQOL no change

Pre Op

2.0

2.4

Post Op

2.0

2.4

Cataldoet al, DCR 2005

conclusion
Conclusion
  • Local excision must still be considered an oncologic compromise.
  • Once fully informed, many patients may find this compromise acceptable.
  • However, for patients interested in curative intent, radical surgery, despite its associated morbidity, remains the oncologic standard.
early rectal neoplasia unwilling unable to tolerate tme

Surveillance

Radical Surgery

Early Rectal Neoplasia(unwilling / unable to tolerate TME)

Favorable

uT2

Adenoma

&

Favorable

uT1

Chemo

radiation

TEM

Pathologic

evaluation

early rectal neoplasia unwilling unable to tolerate tme1

Surveillance

Radical Surgery

Early Rectal Neoplasia(unwilling / unable to tolerate TME)

Favorable

uT2

Adenoma

&

Favorable

uT1

Chemo

radiation

TEM

Pathologic

evaluation

ad