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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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Organ sparing treatments for early rectal cancer the oregon gut club

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


Organ sparing treatments for early rectal cancer the oregon gut club

  • 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 anatomic rectum

Gordon PH, 2nd Ed, 1999

The Anatomic Rectum

15 cm

Anal Verge


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)


Clinical stage

Clinical Stage


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


Bowel dysfunction radical surgery for rectal cancer

Bowel DysfunctionRadical surgery for rectal cancer

Temple et al, DCR 2005


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


So what about transanal full thickness local excision

So, what about transanal, full thickness local excision?


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


Organ sparing treatments for early rectal cancer the oregon gut club

Blumberg , et al, Dis Colon Rectum 1999


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:


Organ sparing treatments for early rectal cancer the oregon gut club

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


But don t worry we can perform salvage radical surgery

But, don’t worry, we can perform salvage radical surgery!


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 2912(59%)

T110 7(70%)

T21910(53%)

Good histol2215(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


Richard wolf medical instruments

Richard Wolf Medical Instruments


Transanal endoscopic microsurgery

Transanal Endoscopic Microsurgery

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


Tem instruments

TEM Instruments


Karl storz teo

Karl Storz (TEO)


Other requirements for tem

Other requirements for TEM

  • Need correct equipment

  • Need staff familiar with equipment

  • Need a surgeon skilled in TEM


Tem equipment set up

TEM Equipment Set Up


Organ sparing treatments for early rectal cancer the oregon gut club

TEM Set-up


Operative technique

Operative Technique


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):

LocationL/M/U:

Follow-up (m):

Complications:

Local Recur:

Survival:

Winde et al, DCR 1996


Organ sparing treatments for early rectal cancer the oregon gut club

Lezoche, et al 2005


Lezoche en bloc mesorectal excision

Lezoche en bloc mesorectal excision


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


Organ sparing treatments for early rectal cancer the oregon gut club

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


Organ sparing treatments for early rectal cancer the oregon gut club

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


Organ sparing treatments for early rectal cancer the oregon gut club

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 margin11.4 cm

  • Mean tumor size8.75 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


Predictive model for local recurrence following tems

Predictive model for local recurrence following TEMS

Bach SP, et al. Br J Surg 2009


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


Thank you

Thank you


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