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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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slide1

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

slide4

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

slide9

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.

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

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

slide24

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

-S 25%

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 ypT0 yp≥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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