Organ sparing-strategy  in rectal cancer
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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

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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

Belgium


Actual treatment in rectal cancer

Actualtreatment in rectalcancer

Earlyrectalcancer

(T1,T2,N0)

Advancedrectalcancer

≥ T3, TxN1

Neoadjuvant (chemo)radiotherapy

T1sm1 < 3 cm

good-moderatedifferentiation

absence LV-invasion

non-ulcerated

RadicalSurgery

(TME +/- proctectomy)

TEM/TAE


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

neo-adjuvantchemoradiation

preferredstrategy to furtherimprovelocalcontrol

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


Current strategy

Currentstrategy

neoadjuvantchemoradiation

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

0S

Local Excision:

n = 22 pts

(8.3%) pT0

stratification at 8-10 weeks

….observation

__ radical surgery

DFS

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

yearlyendoscopy

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

MemorialSloanKettering

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

ypT0N0

ypT0N0

ypT3N1

ypT0N0

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

12w

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

-S

Radio-chemotherapy

restingperiod

Improvinglocalcontrol in rectalcancer

-S

Radio-chemotherapy

restingperiod

-S

Radio-chemotherapy

restingperiod

chemotherapy

restingperiod

HigherradiationdoseIncreasing interval to surgery

EffectiveradiationsensitizationNeoadjuvantchemotherapy


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

Additionalchemotherapyduringrestingperiod

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


Advanced rectal cancer nonrandomized phase ii prospective trial n 144

pCR

Advancedrectalcancer: nonrandomizedphase II prospective trialn=144

-S 18%

Radio-chemotherapy

restingperiod

-S25%

p=0.0217

Radio-chemotherapy

mFOLFOX6

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 ?

Prediction?

bad

good

Perez RO et al. Int J RadiationOncolBiolPhys2012


Multimodal defined complete clinical response

multimodal defined complete clinical response

“wait and see”TAE/TEM

(full-thicknesslocalexcision)

earlyfailures

sustainedcCR ypT0yp≥T1

late failures

delayedradicalsurgery

stringent and prolonged FU

completionsurgery

(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


Conclusion

Conclusion

non-operativetreatmentnotacceptedparadigmyet

(butappealing)

multimodal-defined cCR improves accuracy

patientsshouldbeenrolled in prospectiveregistries

Europeannetworkforwatchfulwaiting

[email protected]

longer follow-up needed (>5 yrs.)


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