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Kolon Kanserinde Adjuvan Tedavi Prof. Dr. N. Faruk AYKAN TOD Kursu Gaziantep 24 Ekim 2003.

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... konulu sunumlar: "Kolon Kanserinde Adjuvan Tedavi Prof. Dr. N. Faruk AYKAN TOD Kursu Gaziantep 24 Ekim 2003."— Sunum transkripti:

1 Kolon Kanserinde Adjuvan Tedavi Prof. Dr. N. Faruk AYKAN TOD Kursu Gaziantep 24 Ekim 2003

2 Prognosis by Stage StageTNMDukes5-yr survival IT1 N0 M0A>90% IT2 N0 M0B185% IIT3/4 N0 M0B2/370-80% III T2 N1/2 M0 T3 N1/2 M0 T4 N1 M0 C1 C2 C % IVAny T/N M1D5-30% ESMO Guidelines 2001

3 Kolon Kanserinde Tedavi Primer Tedavi : Cerrahi Rezeksiyon (Hastaların % 50’si kürabl) NCI-PDQ Statement March 2002

4 Kanser Tedavisinde Kanıt Düzeyleri (NCI-2002) A.Total mortalite (GSK) B.Nedene özgül mortalite C.Yaşam kalitesi D.Dolaylı veriler i.Hastalıksız sağkalım ii.Progresyonsuz sağkalım iii.Tümör cevap oranı 1.Randomize, kontrollü klinik çalışmalar, metaanalizler i.Çift kör ii.Şemaya göre 2.Randomize olmayan klinik çalışmalar 3.Olgu sunumları i.Popülasyon, ardışık seri ii.Ardışık seri iii.Ardışık olmayan olgular Source: US NCI / Cancer information PDQ Çalışma Dizaynı Hedef

5 Level Of Evidence: How Is It Recorded? MAY BE USED FOR PRIMARY AND SECONDARY ENDPOINTS Non-randomized (2) Non-blinded (ii) Disease-free survival (Di) Randomized, controlled (1) Non-blinded (ii) Overall survival (A) 1iiA END POINTSDESIGN 2iiDi Example 1 Example 2

6 Kolon Ca – Adjuvan KT Evre III (Dukes’ C)

7 NIH ASCO 5-FU/LEV 5-FU/FA (12 ay) (6 ay) ?

8 Kolon Ca – Adjuvan KT Evre III (Dukes’ C)  Cerrahi 5-FU/Lev (12 ay) > Cerrahi (1iiA) (n:304) (n:315) NCCTG 1989, INT – 1995 Toplam vaka sayısı: yıl HSK:% 45 vs % 63p< yıl GSK:% 54 vs % 65p<0.007 Moertel CG et al: Ann Intern Med 122: , 1995

9 Kolon Ca – Adjuvan KT Önerilen KT rejimi (1991)

10 Kolon Ca – Adjuvan KT Evre III (Dukes’ C)  Cerrahi 5-FU/FA (6 ay) > Cerrahi (1iiA) n:158n:151 IMPACT 1995, INT Toplam vaka sayısı: yıl HSK:% 58 vs % 74p< yıl GSK:% 63 vs % 74 p<0.01 O’Connell et al: J Clin Oncol, 15: , 1997

11  Cerrahi 5-FU/FA (6 ay) = Cerrahi 5-FU/Lev (12 ay) (1iiA)n: ?n: ? INT ve 1998 Toplam vaka sayısı: yıl HSK:% 59 vs % 56 p: yıl GSK:% 66 vs % 63p:0.09 (5-FU/FA/Lev 6 ay FU/FA’dan üstün değil !) Haller DG et al: Pro ASCO, 17:256a, 1998 (abstr.982) Kolon Ca – Adjuvan KT Evre III (Dukes’ C)

12 Kolon Ca – Adjuvan KT Standart KT rejimleri (ASCO 1997) Mayo rejimi

13 Kolon Ca – Adjuvan KT Standart KT rejimleri Dublin

14 Adjuvant Chemotherapy For Stage III Colon Cancer •The oxaliplatin MOSAIC trial of LV5FU2 vs. FOLFOX4 recruited 1123 pts/arm 40% stage II patients •3-year DFS results were presented at ASCO 2003: MOSAIC 3-year DFS OverallStage IIStage III LV5FU272.9%83.9%65.5% FOLFOX477.8%86.6%71.8% P-value P<.01 HR=.77 - HR=.82 - HR=0.76 De Gramont A, et al: Pro ASCO, abstr.1015, 2003

15 Oxaliplatin + 5-FU/FA Adjuvan KT •NSABP C-01 : MOF ≥ Cerrahi (1988) •NSABP C-02 : PortalVİ 5-FU (7 gün) ≥ Cerrahi (1990) •NSABP C-03 : 5-FU/FA (12 ay) > MOF (1993) •NSABP C-04 : 5-FU/FA (6 ay) = 5-FU/Lev (12 ay) (1996) •NSABP C-05 : 5-FU/FA (6 ay) = 5-FU/FA/INFα-2a •NSABP C-06 : UFT/FA vs 5-FU/FA (6 ay) •NSABP C-07 : OXA/5-FU/FA vs 5-FU/FA

16 Irinotecan Adjuvant Clinical Development Programme: Main Trials In Stage III Colon Cancer TrialRegimenPtsEndpoints ACCORD 2 CPT-11+LV5FU2 LV5FU yr DFS Safety Overall survival PETACC-3 (V-307) CPT-11+ inf 5-FU/FA (LV5FU2 or AIO) Inf 5-FU/FA yr DFS Safety Overall survival Translational res QUASAR II CPT-11+ capecitabine Bolus 5-FU/FA yr DFS Safety Overall survival Translational res

17 Adjuvan KT’de infüzyonal 5-FU PETACC-2 çalışması LV5FU2, AIO 5-FU/FA* * : Mayo klinik şeması

18 Irinotecan/5-FU/FA Adjuvan KT’de PETACC-3 çalışması CPT-11/5-FU/FA* 5-FU/FA* * : De Gramont, AIO şeması

19 Group A1 (AIO, every wk) Folinic acid 500 mg/m² 60min 2 hours 5-FU IV 2000 mg/m 2 24 hours CPT mg/m 2 PETACC-3 (V-307) Group A2 (LV5FU2, every 2 wks) Folinic acid 200 mg/m² 60min 2 hours 5-FU IV 600 mg/m 2 22 hours CPT mg/m mg/m 2 D1 & D2 D1 5-FU bolus

20 Xeloda ® as adjuvant treatment for colon cancer: X-ACT study  Open-label, randomised, multicentre, phase III trial  Recruitment of 1,956 Dukes’ C colon cancer patients is on target for completion in 2001  Xeloda 1,250mg/m 2 twice daily, days 1–14 every 21 days x 8 versus 4-weekly Mayo Clinic regimen x 6  Disease-free survival as 1° endpoint  2° endpoints: overall survival, safety, quality of life, health economics, measurement of biochemical markers in selected centres

21 Kolon Ca – Adjuvan KT Evre II (Dukes’ B)

22  Cerrahi 5-FU/FA (6 ay) ≥ Cerrahi (1iiDi) % 2 HSK avantajı; NSABP ve Meta-analiz 1999  Riskli sub-gruplar;  Perforasyon  Tam Obstrüksiyon  Anöploidi  Yüksek S-faz fraksiyonu  18q delesyonu  MSS Kontrollü klinik çalışma !

23 Irinotecan Adjuvant Clinical Development Programme: Other Studies •CALGB C89803 •Irinotecan + bolus 5-FU/FA weekly vs bolus 5-FU/FA weekly •1263 patients, includes stage II + III and PS-2 patients •3-yr DFS, safety, overall survival, translational research •AERO •Irinotecan + LV5FU2 vs 5-FU/FA (Mayo Clinic or LV5FU2) •600 patients with stage II and III rectal cancer •5-yr DFS, safety, overall survival •PETACC-4 •Irinotecan + 5-FU/FA (TTD, LV5FU2, AIO) vs 5-FU/FA •1976 patients with stage II colon cancer •5-yr DFS, safety, overall survival, translational research

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