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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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


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


Surgery is the mainmechanismforcure

in colo-rectalcancer


neo-adjuvantchemoradiation

preferredstrategy to furtherimprovelocalcontrol

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


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 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 neoadjuvantchemoradiation

  • - improvelocal tumor control

  • tumor downsizing

  • cancer,nodal sterilization : 12 – 24%


Complete pathological response (pR) to neoadjuvantchemoradiotherapy


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

overall : 21% (n=15)

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


Nodalmetastasis in relation to ypT


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 onnon-operativetreatmentafterchemoradiation and cCR


“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


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


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 residualmucosalabnormalities ?

61% (19/31) withcPR had anincomplete cR

ypT0N0

ypT0N0

ypT3N1

ypT0N0

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


Canbiopsiesrule out persistingcancerin incomplete clinical response ?

PPV = 100%NPV = 21%

accuracy = 71%

Perez RO et al. Colorectal Dis 2012


TransanalEndoscopicMicrosurgery (TEM)

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


Pooled data on TEM afterneo-adjuvant chemoradiotherapy

6 retrospective studies, 1 prospectivestudy

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


Morbidity TEM afterneoadjuvantchemoradiationtherapy

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


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


T2 – weighted MRI DWI- MRI

pre post CRT post CRT

patientnoteligibleforwait and see


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

Lambregts D et al. Ann SurgOncol 2011


Pet-CT and clinicalassessment

6 w

12w

Perez RO et al. Cancer 2011


Radiationinduced tumor downsizingis time-dependent

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


-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 ?

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


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


Additionalchemotherapyduringrestingperiod

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


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 assessmentat 12 w foreveryone ?

Prediction?

bad

good

Perez RO et al. Int J RadiationOncolBiolPhys2012


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)


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

non-operativetreatmentnotacceptedparadigmyet

(butappealing)

multimodal-defined cCR improves accuracy

patientsshouldbeenrolled in prospectiveregistries

Europeannetworkforwatchfulwaiting

[email protected]

longer follow-up needed (>5 yrs.)


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