Medical Oncology

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  • Local failure: the war we are winning
    SX only: 30% norvegese
    25% NSABP R-01
    24% GITSG 1*
    SX + RT:25% Mayo-NCCTG*
    20% GITSG 1*
    16% NSABP R-01
    SX + CMT:16% GITSG 2*
    13% Mayo-NCCTG*
    12% norvegese
    11% GITSG 1*
    11% INT 0114 3-y (media)
    8% NSABP R02*
    7% INT-PVI (media)
    TME +RT :3% Dutch
  • Local failure: the war we are winning
    SX only: 30% norvegese
    25% NSABP R-01
    24% GITSG 1*
    SX + RT:25% Mayo-NCCTG*
    20% GITSG 1*
    16% NSABP R-01
    SX + CMT:16% GITSG 2*
    13% Mayo-NCCTG*
    12% norvegese
    11% GITSG 1*
    11% INT 0114 3-y (media)
    8% NSABP R02*
    7% INT-PVI (media)
    TME +RT :3% Dutch
  • <number>
  • Medical Oncology

    1. 1. Multidisciplinary treatment of rectal cancer. Medical oncology Carlo Aschele E.O. Ospedali Galliera – Genova - Italy ESMO CONFERENCE - LUGANO July 5-8 2007
    2. 2. Multidisciplinary treatment of rectal cancer extraperitoneal rectal cancer locally advanced rectal cancer Rigid rectoscopy - TRUS - CT scan - MRI
    3. 3. Standard treatment of locally advanced rectal cancer T M E 45-50.4 Gy CT RT
    4. 4. Role of chemotherapy PRE-OP RT +/- CONCOMITANT CT pCR, % RT RT + CT EORTC 5 14 FFCD 3 10 Bosset, NEJM 2006; Gerard, JCO 2006
    5. 5. Role of chemotherapy PRE-OP RT +/- CONCOMITANT CT 5-y LR, % RT RT + CT EORTC 17 8 FFCD 16 8 Bosset, NEJM 2006; Gerard, JCO 2006
    6. 6. Standard treatment of locally advanced rectal cancer T M E 45-50.4 Gy CT RT
    7. 7. Dutch TME trial vs German trialDutch TME trial vs German trial 5-year overall survival Pre-op CMTPre-op CMT Post-op CMTPost-op CMT Years since surgeryYears since surgery 66 % vs 65 %66 % vs 65 % p = 0.98p = 0.98 Marijnen et al, GIASCO 2005, Abstr 166; Sauer et al NEJM 2004 00 11 22 33 44 55 66 77 88 99 00 0.20.2 0.60.6 1.01.0 00 11 22 33 44 55 66 77 88 99 00 0.20.2 0.60.6 1.01.0 Years since surgeryYears since surgery RT + TMERT + TME TME aloneTME alone 76 % vs 74 %76 % vs 74 % p = 0.80p = 0.80
    8. 8. Gunderson, L. L. et al. J Clin Oncol; 22:1785-1796 2004 (NCCTG 794751, 864751; NSABP R01, R02; INT 0114) n=3791 ROLE OF CHEMOTHERAPYROLE OF CHEMOTHERAPY POST-OP COMBINED-MODALITYPOST-OP COMBINED-MODALITY TREATMENTTREATMENT CT No CT
    9. 9. PRE-OP CHEMORADIATION: ORAL FP’s studies patients pCR (%) g 3-4 tox (%) Capecitabine 14 668 4-31 6-40 UFT 11 538 8-25 6-32 Eniluracile 1 22 6 nr
    10. 10. NSABP R-04NSABP R-04 RTRT ++ CapecitabineCapecitabine +/- oxaliplatin+/- oxaliplatin S RT +RT + CI 5-FUCI 5-FU +/- oxaliplatin+/- oxaliplatin R N=1460
    11. 11. Norway NSABP-R01 GITSG-1 Mayo-NCCTG GITSG-2 INT-0114 NSABP-R02 INT-PVI Dutch-TME Ulsan CAO/ARO/AIO Decline in the rates of local failure: 1980s–2000s 35 30 25 20 15 10 5 0 Localfailure(%) sx only sx  RT sx  CTRT TME + RT/CTRT
    12. 12. NSABP-R02 INT-0114 Norway GITSG-1 NSABP-R01 Mayo-NCCTG INT-PVI GITSG-2 Dutch-TME Ulsan CAO/ARO/AIO Proportion of patients with distant metastases: 1980s–2000s 40 35 30 25 20 15 10 5 0 Distantmetastases(%) sx only sx  RT sx  CTRT TME + RT/CTRT
    13. 13. ONGOING STUDIES OF COMBINATION CHEMOTHERAPY IN LARC Post-op E3201 E5204 Chronicle Pre-op STAR NASBP R-04 Pre and post-op PETACC-6 OXALIPLATIN + FP’s
    14. 14. % of patients FU/RT FU/OXA/RT Grade III-IV toxicity (mainly diarrhoea) 10 24 Ability to complete radiotherapy (> 80 %) 98 95 Ability to perform surgery 98 96 Preliminary safety findings: toxicity (n=313) Aschele, ASCO GI & ASCO 2007
    15. 15. PRE-OP CHEMORADIATION INCORPORATION OF BIOLOGICS Cetuximab + FU (1) pCR=12% + cape (1) pCR=5% + cape/ox (1) pCR=8% + cape/iri (2) pCR=25-20% ??: adk=squamous - ras - arrest of cell cycle progression Bevacizumab + FU (1) no pCR at the RD / surrogate markers + cape/oxa (1) pcR: 18% ??: toxicity - normalization vs antivascular effect - timing 2004-2007
    16. 16. MULTIDISCIPLINARY TREATMENT OF RECTAL CANCER
    17. 17. PRE-OP CHEMORADIATION INCORPORATION OF BIOLOGICS Better understanding of underlying biology Definition of optimal timing and duration (induction vs concomitant or both) Definition of an appropriate back- bone regimen Patient selection
    18. 18. Studio Terapia Adiuvante Retto 2 (PAN-STAR) Oxa Oxa Oxa Oxa Oxa Oxa 5-FLUOROURACIL RT RTRT RT RT RT PAN PAN PAN PAN - T4 and/or- T4 and/or - cN2 (> than 3 radiologically involved nodes) and/or- cN2 (> than 3 radiologically involved nodes) and/or - MRI prediction of +CRM- MRI prediction of +CRM Phase II n=70
    19. 19. INDUCTION CHEMOTHERAPYINDUCTION CHEMOTHERAPY D1 D22 …x4 Patients with MRI defined poor-risk rectal cancer T M E R D1 D22 …x4 D1 D22 …x4 D1 D22 …x4 Oxa: 130 mg/m2 /d Cape: 2000 mg/m2 /d Cetuximab: 400 mg/m2 D1 than 250 mg/m2 weekly Cape: 1650 mg/m2 /d RT:45 Gy+ 9Gy boost Oxa: 130 mg/m2 /d Cape: 2000 mg/m2 /d Phase II n=164 EXPERT-C

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