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Organ sparing-strategy in rectal cancer Importance – How can we progress ?. A.D’Hoore MD PhD , A. Wolthuis MD, F. Penninckx MD PhD K. Haustermans MD PhD*, E. Van Cutsem MD PhD** V. Vandecaveye MD PhD*** Department of Abdominal Surgery, Radiation Oncology*, GI Oncology** and Radiology***

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A d hoore md phd a wolthuis md f penninckx md phd

Organ sparing-strategy in rectal cancer

Importance – How can we progress ?

A.D’HooreMD PhD, A. Wolthuis MD, F. Penninckx MD PhD

K. Haustermans MD PhD*, E. Van Cutsem MD PhD**

V. Vandecaveye MD PhD***

Department of Abdominal Surgery, Radiation Oncology*,

GI Oncology** and Radiology***

Catholic University of Leuven


Actual treatment in rectal cancer
Actualtreatment in rectalcancer




≥ T3, TxN1

Neoadjuvant (chemo)radiotherapy

T1sm1 < 3 cm


absence LV-invasion



(TME +/- proctectomy)


A d hoore md phd a wolthuis md f penninckx md phd

Surgery is the mainmechanismforcure

in colo-rectalcancer

A d hoore md phd a wolthuis md f penninckx md phd


preferredstrategy to furtherimprovelocalcontrol

Sauer R et al. N Engl J Med2004; 351:1731-40.

Current strategy


radicalsurgery (TME)

- risk for permanent stoma

- deterioration of bowel function

  • increased risk surgicalcomplications

  • increased postop deathrate (elderly)

  • longterm impact anorectal/sexualfunction

Appeal of organ preservation
Appeal of organpreservation

  • Minimal perioperativemorbidity and mortality

  • - bleeding

  • - anastomoticleak

  • Rapidrecovery

  • Sphinctersavingoperation

  • Preservation of bowelfunction

  • - ‘anteriorresection’ syndrome

  • - permanent colostomy

  • Preservation of urogentialfunction

  • ImprovedQoL

  • Reduction in Health care cost

Effect of neoadjuvant chemo radiation
Effect of neoadjuvantchemoradiation

  • - improvelocal tumor control

  • tumor downsizing

  • cancer,nodal sterilization : 12 – 24%

Complete pathological response pr to neoadjuvant chemoradiotherapy

Complete pathological response (pR) to neoadjuvantchemoradiotherapy

A d hoore md phd a wolthuis md f penninckx md phd

n= 265 pts, distal rectalcancer


Local Excision:

n = 22 pts

(8.3%) pT0

stratification at 8-10 weeks


__ radical surgery


wait and see

n = 71 pts (26.8%) sustainedcCR

Ann Surg 2004;240(4):711-7

Late recurrences
Late recurrences

overall : 21% (n=15)

Habr-Gama A et al. SeminRadiatOncol2011;21:234-239.

Nodal metastasis in relation to ypt
Nodalmetastasis in relation to ypT

Background risk for untreated nodal disease

male, 57 yr.

uT1 , 2 cm aboveanalverge

TAE : pT1 sm3, G2-3

LV+, PN –

Adjuvantchemoradiation :

50.4 Gy, infusional 5 FU

Intensive FU : 5 years


at 9 years: sciatic pain +++

Background risk foruntreatednodaldisease

Actual series on non operative treatment after chemoradiation and ccr

Actual series onnon-operativetreatmentafterchemoradiation and cCR

Wait and see protocols
wait and seeprotocols”

  • lack of clarity to defineclinical complete response (cCR)

  • - clinical criteria

  • - imaging

  • - punch biopsy – TEM (excisionalbiopsy)

  • 20% fail the firstyear (earlyfailure)

  • - outcome early salvage

  • uncertainty in regard to long-termefficacy (late failure)

    • - rational, consistent follow-up programme

    • - selection of patients

    • - outcome late salvage

C omplete clinical response habr gama inter observer variablity
Complete clinical response (Habr Gama)inter observer variablity ?

  • careful digital examination

  • proctoscopy

  • - whitening of mucosa

  • - teleangiectasia

  • - loss of plicability of rectalwall

  • Habr-Gama et al. Dis of Colon Rectum 2010;53:1692-1698

Predictive value of clinical complete response ccr
Predictivevalue of clinical complete response (ccR)

n= 488 patients


ccR = 19%

cpR = 10%

ccR = predictive factor forcpR

but :

75% of ccR : residual foci of tumor:

Significance of residual mucosal abnormalities
Significance of residualmucosalabnormalities ?

61% (19/31) withcPR had anincomplete cR





Smith FM et al. Br J Surg 2012; 99:993-1001

Can biopsies rule out persisting cancer in incomplete clinical response

Canbiopsiesrule out persistingcancerin incomplete clinical response ?

PPV = 100% NPV = 21%

accuracy = 71%

Perez RO et al. Colorectal Dis 2012

Transanal endoscopic microsurgery tem
TransanalEndoscopicMicrosurgery (TEM)

Buess G et al. SurgEndosc1988; 2: 245- 250

Pooled data on tem after neo adjuvant chemoradiotherapy
Pooled data on TEM afterneo-adjuvant chemoradiotherapy

6 retrospective studies, 1 prospectivestudy

Borschitz T et al. Ann SurgOncol2008;15:712-720

Morbidity tem after neoadjuvant chemoradiation therapy
Morbidity TEM afterneoadjuvantchemoradiationtherapy

Perez RO et al. Dis Colon Rectum 2011; 54: 545-551

Maastricht dutch criteria for multimodal assessment of response
Maastricht (Dutch) criteria formultimodal assessment of response

  • substantialdownsizing: noresidual tumor, onlyfibrosis

  • (low signalon high b-valueDW- MRI)

  • -nosuspiciouslymphnodesonMRI

  • (USPIO, gadofosveset) contrast enhanced MRI

  • -noresidual tumor at endoscopy (residualscar)

  • normalbiopsiesfrom the scar

  • nopalpable tumor

Maas M. et al. J ClinOncol2011; 29:4633-4640

A d hoore md phd a wolthuis md f penninckx md phd

T2 – weighted MRI DWI- MRI

pre post CRT post CRT

patientnoteligibleforwait and see

Diagnostic performance of mri for the prediction of complete response ypt0
diagnostic performance of MRI for the prediction of complete response (ypT0)

Lambregts D et al. Ann SurgOncol 2011

Pet ct and clinical assessment
Pet-CT and clinicalassessment

6 w


Perez RO et al. Cancer 2011

Radiation induced tumor downsizing is time dependent
Radiationinduced tumor downsizingis time-dependent

Dhadda A.S. ClinicalOncology2009; 21:23-31

Improving local control in rectal cancer




Improvinglocalcontrol in rectalcancer









HigherradiationdoseIncreasing interval to surgery


Increasing the interval
Increasing the interval ?

Tulchinsky H et al. SurgOncol2008;15:2661-2667

Retrospective cohort analysis length of interval and cpr and dfs leuven rectal cancer database

Retrospective cohort analysis :length of interval and cPR and DFS(Leuven rectalcancer database)

Interval (days)

≤ 7 weeks : median 44.0 d

n=201 ypT0N0 : 16%

> 7 weeks : median 54.0 d

n=155 ypT0N0 : 28% (p=0.006)

AcceptedAnn SurgOncol2012

Additional chemotherapy during resting period

Habr-Gama A. Dis Colon Rectum 2009;52(12):1927-1934

Advanced rectal cancer nonrandomized phase ii prospective trial n 144


Advancedrectalcancer: nonrandomizedphase II prospective trialn=144

-S 18%



-S 25%




Garcia-Anguilar J. Ann Surg2011; 254:97-102

Timing of tumor assessment at 12 w for every one
Timing of tumor assessmentat 12 w foreveryone ?




Perez RO et al. Int J RadiationOncolBiolPhys2012

Multimodal defined complete clinical response
multimodal defined complete clinical response

“wait and see” TAE/TEM



sustainedcCR ypT0 yp≥T1

late failures


stringent and prolonged FU


(after 8 weeks)

Completion radical after tae tem does not compromise oncological results
Completionradicalafter TAE/TEM does notcompromiseoncologicalresults

safe at 6-8 weeks (adequate scar)

Mayo data

Stage –matched cohort (n=52)

Completionradical = primary RR

Mainz data

CompletionradicalforpT2 = primary RR

Hahnloser D, DCR 2005 ; Borschitz T, DCR 2007




multimodal-defined cCR improves accuracy

patientsshouldbeenrolled in prospectiveregistries


longer follow-up needed (>5 yrs.)