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*C HARITÉ ONKO LOGIE:Clinical studies in GI cancers

Preliminary Results: A randomised, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resected pancreatic cancer - CONKO*-001 -.

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*C HARITÉ ONKO LOGIE:Clinical studies in GI cancers

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  1. Preliminary Results:A randomised, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resected pancreatic cancer- CONKO*-001- P. Neuhaus, H. Oettle, S. Post, K. Gellert, K. Ridwelski, H. Schramm, C. Zülke, G. Fahlke, J. Langrehr, L. Roll, H. RiessCharitè - Universitätsmedizin Berlin - Campus Virchow Klinikum;Ruprecht-Karls-Universität, Mannheim; Oskar-Ziethen-Krankenhaus, Berlin; Otto-von-Guericke-Universität, Magdeburg; Wald-Klinikum, Gera; Universität Regensburg, Regensburg; AIO; CAO; Deutsche Krebsgesellschaft e.V. *CHARITÉ ONKOLOGIE:Clinical studies in GI cancers

  2. CONKO-001Rationale • Prognosis in disease free survival with pancreatic cancer is still poor • Median survival after resection is 11 - 25 months • Long term survival (>5 years) is 8 - 21percent Bakkevold (1993); Klinkenbijl (1999); Gastrointestinal Study Group (1985, 1987); Neoptolemos (2004)

  3. CONKO-001 Study Design Resected pancreatic cancer 368 patients Stratification: R; T; N Observation for 6 months Gemcitabine for 6 months Follow up every 8 weeks

  4. CONKO-001 Disease Monitoring Randomisation Ultrasound after week 16 CT Scan after week 32 Ultrasound after week 8 Gem Gem Gem Gem Gem Gem Follow up every 8 weeks Obs Obs Obs Obs Obs Obs 4 weeks 4 weeks 4 weeks 4 weeks 4 weeks 4 weeks CA 19-9 CA 19-9 CA 19-9 CA 19-9 CA 19-9 CA 19-9 CA 19-9 Gem Gemcitabine 1000 mg/m²: d1, 8, 15; q 4 weeks Obs Observation: d1; q 4 weeks

  5. CONKO-001 Endpoints • Primary Endpoint • Disease free survival (DFS) • Secondary Endpoint • Overall survival (OS) • Toxicity

  6. CONKO-001 Entry Criteria • Histologically proven resected pancreatic carcinoma • Standard operation • No measurable disease • No prior chemo- or radiotherapy • No active infection • Karnofsky performance status  50% • Adequate hematologic, renal and hepatic function • CA 19-9, CEA < 2.5 ULN • Start with adjuvant therapy within 6 weeks after resection • Written informed consent

  7. CONKO-001 Statistics • Hypothesis: • Significant increase in disease free survival (DFS) of at least 6 months due to chemotherapy with gemcitabine • Statistics: • Kaplan-Meier estimates und two-tailed log-rank test with significance level of 0.05 and a power of 90% • Sample size: • 368 pts – 184 pts per treatment arm (1:1 ratio) • including an estimated drop out rate of up to 20%

  8. CONKO-001 Recruitment and Analysis • Time of recruitment: 7/98 - 12/04 • Recruited patients: 368 • Recruiting centres: 88 (Germany, Austria) Date of Analysis: March 2005

  9. CONKO-001 Recruitment Patients Patients per month

  10. CONKO-001 Patient Disposition 368 patients enrolled 7/98 - 12/04 186 pts. for Gemcitabine 182 pts. for Observation 177 eligible* pts. (97%) 179 eligible* pts. (96%) * 7 excluded Patients: 4 pts. lost to follow up 1 pt. without histological proven pc 1 pt. with persistent disease after resection 1 pt. with another tumor disease * 5 excluded Patients: 3 pts. lost to follow up 2 pts. with another tumor disease

  11. CONKO-001 Patient Characteristic

  12. CONKO-001 Tumor Characteristic

  13. CONKO-001 Toxicities WHO Grade III+IV

  14. CONKO-001 Toxicities WHO Grade III+IV

  15. CONKO-001 Toxicities WHO Grade III+IV

  16. CONKO-001 Kaplan Meier Disease Free Survival Chemotherapy with gemcitabine median: 14.21 months (95% CI, 12.86; 15.57)41 % patients censored (+) Observation median: 7.46 months (95% CI, 6.80; 8.11)22 % patients censored (+) Log Rank: p=0.001

  17. CONKO-001 Disease Free Survival

  18. CONKO-001 Kaplan Meier Survival Chemotherapy with gemcitabine53 % patients censored (+) Observation45 % patients censored (+)

  19. CONKO-001 Preliminary Data Summary • Toxicity of gemcitabine in adjuvant therapy is low • Treatment with gemcitabine results in an improvement in disease free survival • Favourable overall survival with chemotherapy (no comparative calculations done; 49% of patients censored) • Improved longterm (3- and 5-year) survival expected

  20. CONKO-001 Conclusions • Treatment with gemcitabine in patients with resected pancreatic cancer results in improved disease free survival as compared to observation • Gemcitabine may become the standard of care for adjuvant treatment of pancreatic cancer

  21. CONKO-001 Top recruiting centres • Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum - Germany • Klinikum Mannheim gGmbH, Universitätsklinikum, Fakultät für Klinische Medizin Mannheim - Germany • Paritätisches Krankenhaus Lichtenberg, Oskar-Ziethen-Krankenhaus, Berlin - Germany • Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät - Germany • SRH Wald-Klinikum Gera gGmbH - Germany • Klinikum der Universität Regensburg - Germany • Eberhard-Karls-Universität Tübingen, Universitätsklinikum Tübingen - Germany • Universitätsklinikum Bonn, Medizinische Fakultät der Rheinischen Friedrich-Wilhelms-Universität - Germany • Klinikum Bremen Mitte gGmbH - Germany • Städtisches Klinikum Magdeburg, Standort Altstadt - Germany • Klinikum der Friedrich-Schiller-Universität zu Jena - Germany • Klinikum Nürnberg Nord - Germany • Klinikum und Fachbereich Medizin der Johann-Wolfgang-Goethe Universität Frankfurt am Main - Germany • Praxis Dr. Schlag, Würzburg - Germany • Universitätsklinikum Freiburg - Germany • DRK Krankenhaus Luckenwalde - Germany • Praxis Drs. med. Mayr & Strohbach, Berlin - Germany • Praxis Drs. med. Günther & Sauer, Potsdam - Germany • Praxis Dr. Hauch, Erfurt - Germany • Humaine Klinikum Bad Saarow - Germany • Henriettenstiftung Hannover - Germany • Charité, Universitätsmedizin Berlin, Campus Berlin-Buch - Germany • Diakoniekrankenhaus Rotenburg (Wümme) - Germany • Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH - Austria • Israelitisches Krankenhaus in Hamburg - Germany • Städtisches Krankenhaus Hildesheim GmbH - Germany • Praxis Dr. von Grünhagen, Cottbus - Germany • Städtisches Klinikum Dessau - Germany

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