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SWISS TUMOR BOARD Pancreatic Cancer March 26, 2009 Novotel Bern

SWISS TUMOR BOARD Pancreatic Cancer March 26, 2009 Novotel Bern. Prof. Dr. Mahmut Ozsahin. Lausanne University Medical Center (CHUV), Lausanne. Case #1 J. Metzger. Male patient, 55-yr-old G3, pT2pN1 (1+/16), R0 (close margin) Adjuvant ttt?, Cx alone?, Cx and RT?.

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SWISS TUMOR BOARD Pancreatic Cancer March 26, 2009 Novotel Bern

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  1. SWISS TUMOR BOARDPancreatic CancerMarch 26, 2009Novotel Bern Prof. Dr. Mahmut Ozsahin Lausanne University Medical Center (CHUV), Lausanne

  2. Case #1J. Metzger • Male patient, 55-yr-old • G3, pT2pN1 (1+/16), R0 (close margin) • Adjuvant ttt?, Cx alone?, Cx and RT?

  3. Case #1Short literature review on adjuvant CT/RT • GITSG study including 43 + 32 patients (Kalser, Arch Surg 1985; Cancer 1987) = RT/CT (40 Gy/5FU) better than observation (20 vs. 11 months median survival) • EORTC 40891 study including 114 patients (Klinkenbijl, Ann Surg 1999) = No difference RT/CT (split course 40 Gy/5FU) vs. observation (17 vs.13 months median survival) • ESPAC-1 study including 289 patients (pooled analysis 541 patients) (Neoptolemos, Lancet 2001, NEJM 2004) = 2x2 factorial design; CT vs. RT/CT vs. CT/RT+CT vs. observation. RT worsens the outcome whereas chemo. increases it (very complex study with a lot of criticism) • CONKO study including 368 R0/R1 patients (Oettle, JAMA 2007, ProcASCO 2008) = gemcitabine vs. observation (23 vs 20 months median survival; 21 vs. 9% OS; gemcitabine better). Very clean data. • RTOG 9704 including 388 pancreatic head patients (Regine, JAMA 2008) compared conventional RT/CT (5FU) vs. 3-wk gemcitabine + RT/CT (5FU) + 3 mo. gemcitabine. Gemcitabine arm better (20.5 vs. 17 months median survival). • Meta-analyses assessing the impact of chemotherapy (Stocken, BJC 2005; Butturini, Arch Surg 2008): Chemotherapy is better, and more pronounced in negative-margin patients. • NCCN guidelines and current evidence: waiting the ESPAC-3 results (observation vs. leucovorin/5FU vs. gemcitabine), the standard is CONKO or RTOG 9704 type treament

  4. EORTC 40891 study

  5. Case #1Short literature review on adjuvant CT/RT • GITSG study including 43 + 32 patients (Kalser, Arch Surg 1985; Cancer 1987) = RT/CT (40 Gy/5FU) better than observation (20 vs. 11 months median survival) • EORTC 40891 study including 114 patients (Klinkenbijl, Ann Surg 1999) = No difference RT/CT (split course 40 Gy/5FU) vs. observation (17 vs.13 months median survival) • ESPAC-1 study including 289 patients (pooled analysis 541 patients) (Neoptolemos, Lancet 2001, NEJM 2004) = 2x2 factorial design; CT vs. RT/CT vs. CT/RT+CT vs. observation. RT worsens the outcome whereas chemo. increases it (very complex study with a lot of criticism) • CONKO study including 368 R0/R1 patients (Oettle, JAMA 2007, ProcASCO 2008) = gemcitabine vs. observation (23 vs 20 months median survival; 21 vs. 9% OS; gemcitabine better). Very clean data. • RTOG 9704 including 388 pancreatic head patients (Regine, JAMA 2008) compared conventional RT/CT (5FU) vs. 3-wk gemcitabine + RT/CT (5FU) + 3 mo. gemcitabine. Gemcitabine arm better (20.5 vs. 17 months median survival). • Meta-analyses assessing the impact of chemotherapy (Stocken, BJC 2005; Butturini, Arch Surg 2008): Chemotherapy is better, and more pronounced in negative-margin patients. • NCCN guidelines and current evidence: waiting the ESPAC-3 results (observation vs. leucovorin/5FU vs. gemcitabine), the standard is CONKO or RTOG 9704 type treament

  6. ESPAC-1 study, Lancet 2001

  7. ESPAC-1 trial New Engl J Med 2004

  8. Case #1Short literature review on adjuvant CT/RT • GITSG study including 43 + 32 patients (Kalser, Arch Surg 1985; Cancer 1987) = RT/CT (40 Gy/5FU) better than observation (20 vs. 11 months median survival) • EORTC 40891 study including 114 patients (Klinkenbijl, Ann Surg 1999) = No difference RT/CT (split course 40 Gy/5FU) vs. observation (17 vs.13 months median survival) • ESPAC-1 study including 289 patients (pooled analysis 541 patients) (Neoptolemos, Lancet 2001, NEJM 2004) = 2x2 factorial design; CT vs. RT/CT vs. CT/RT+CT vs. observation. RT worsens the outcome whereas chemo. increases it (very complex study with a lot of criticism) • CONKO study including 368 R0/R1 patients (Oettle, JAMA 2007, ProcASCO 2008) = gemcitabine vs. observation (23 vs 20 months median survival; 21 vs. 9% OS; gemcitabine better). Very clean data. • RTOG 9704 including 388 pancreatic head patients (Regine, JAMA 2008) compared conventional RT/CT (5FU) vs. 3-wk gemcitabine + RT/CT (5FU) + 3 mo. gemcitabine. Gemcitabine arm better (20.5 vs. 17 months median survival). • Meta-analyses assessing the impact of chemotherapy (Stocken, BJC 2005; Butturini, Arch Surg 2008): Chemotherapy is better, and more pronounced in negative-margin patients. • NCCN guidelines and current evidence: waiting the ESPAC-3 results (observation vs. leucovorin/5FU vs. gemcitabine), the standard is CONKO or RTOG 9704 type treament

  9. CONKO study, JAMA 2007

  10. Neuhaus, ASCO 2008

  11. Case #1Short literature review on adjuvant CT/RT • GITSG study including 43 + 32 patients (Kalser, Arch Surg 1985; Cancer 1987) = RT/CT (40 Gy/5FU) better than observation (20 vs. 11 months median survival) • EORTC 40891 study including 114 patients (Klinkenbijl, Ann Surg 1999) = No difference RT/CT (split course 40 Gy/5FU) vs. observation (17 vs.13 months median survival) • ESPAC-1 study including 289 patients (pooled analysis 541 patients) (Neoptolemos, Lancet 2001, NEJM 2004) = 2x2 factorial design; CT vs. RT/CT vs. CT/RT+CT vs. observation. RT worsens the outcome whereas chemo. increases it (very complex study with a lot of criticism) • CONKO study including 368 R0/R1 patients (Oettle, JAMA 2007, ProcASCO 2008) = gemcitabine vs. observation (23 vs 20 months median survival; 21 vs. 9% OS; gemcitabine better). Very clean data. • RTOG 9704 including 388 pancreatic head patients (Regine, JAMA 2008) compared conventional RT/CT (50.4 Gy/5FU) vs. 3-wk gemcitabine + RT/CT (5FU) + 3 mo. gemcitabine. Gemcitabine arm better (20.5 vs. 17 months median survival). • Meta-analyses assessing the impact of chemotherapy (Stocken, BJC 2005; Butturini, Arch Surg 2008): Chemotherapy is better, and more pronounced in negative-margin patients. • NCCN guidelines and current evidence: waiting the ESPAC-3 results (observation vs. leucovorin/5FU vs. gemcitabine), the standard is CONKO or RTOG 9704 type treament

  12. RTOG 9704 study Regine, JAMA 2008

  13. Case #1J. Metzger • Male patient, 55-yr-old • G3, pT2pN1 (1+/16), R0 (close margin) • Adjuvant ttt?, Cx alone?, Cx and RT? • GITSG (RT/CT better than observation) • EORTC (RT/CT vs. Observation) = no difference • ESPAC-1 (CT vs. RT/CT vs. CT/RT+CT vs. observation) = RT group worse • CONKO (gemcitabine vs. observation) = gemcitabine better • RTOG 9704 (conventional RT/CT vs. gemcitabine + RT/CT + gemcitabine) = gemcitabine arm better (borderline significance) • Conlusion: pT2pN1 R0; therefore adjuvant gemcitabine would be the right decision (CONKO) (young patient = RTOG 9704? not accepted in Europe) • NCCN guidelines: RT/CT vs. gemcitabine, both OK

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