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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’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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  1. 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

  2. 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

  3. Surgery is the mainmechanismforcure in colo-rectalcancer

  4. neo-adjuvantchemoradiation preferredstrategy to furtherimprovelocalcontrol Sauer R et al. N Engl J Med2004; 351:1731-40.

  5. Currentstrategy neoadjuvantchemoradiation radicalsurgery (TME) - risk for permanent stoma - deterioration of bowel function • increased risk surgicalcomplications • increased postop deathrate (elderly) • longterm impact anorectal/sexualfunction

  6. 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

  7. Effect of neoadjuvantchemoradiation • - improvelocal tumor control • tumor downsizing • cancer,nodal sterilization : 12 – 24%

  8. Complete pathological response (pR) to neoadjuvantchemoradiotherapy

  9. 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

  10. Late recurrences overall : 21% (n=15) Habr-Gama A et al. SeminRadiatOncol2011;21:234-239.

  11. Nodalmetastasis in relation to ypT

  12. 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

  13. Actual series onnon-operativetreatmentafterchemoradiation and cCR

  14. “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

  15. 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

  16. 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:

  17. 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

  18. Canbiopsiesrule out persistingcancerin incomplete clinical response ? PPV = 100% NPV = 21% accuracy = 71% Perez RO et al. Colorectal Dis 2012

  19. TransanalEndoscopicMicrosurgery (TEM) Buess G et al. SurgEndosc1988; 2: 245- 250

  20. Pooled data on TEM afterneo-adjuvant chemoradiotherapy 6 retrospective studies, 1 prospectivestudy Borschitz T et al. Ann SurgOncol2008;15:712-720

  21. Morbidity TEM afterneoadjuvantchemoradiationtherapy Perez RO et al. Dis Colon Rectum 2011; 54: 545-551

  22. 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

  23. T2 – weighted MRI DWI- MRI pre post CRT post CRT patientnoteligibleforwait and see

  24. diagnostic performance of MRI for the prediction of complete response (ypT0) Lambregts D et al. Ann SurgOncol 2011

  25. Pet-CT and clinicalassessment 6 w 12w Perez RO et al. Cancer 2011

  26. Radiationinduced tumor downsizingis time-dependent Dhadda A.S. ClinicalOncology2009; 21:23-31

  27. -S Radio-chemotherapy restingperiod Improvinglocalcontrol in rectalcancer -S Radio-chemotherapy restingperiod -S Radio-chemotherapy restingperiod chemotherapy restingperiod HigherradiationdoseIncreasing interval to surgery EffectiveradiationsensitizationNeoadjuvantchemotherapy

  28. Increasing the interval ? Tulchinsky H et al. SurgOncol2008;15:2661-2667

  29. 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

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

  31. 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

  32. Timing of tumor assessmentat 12 w foreveryone ? Prediction? bad good Perez RO et al. Int J RadiationOncolBiolPhys2012

  33. 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)

  34. 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

  35. Conclusion non-operativetreatmentnotacceptedparadigmyet (butappealing) multimodal-defined cCR improves accuracy patientsshouldbeenrolled in prospectiveregistries Europeannetworkforwatchfulwaiting Kfe.onk@slb.regionsyddanmark.dk longer follow-up needed (>5 yrs.)

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