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Preliminary Results: A randomised, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with.

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Presentation on theme: "Preliminary Results: A randomised, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with."— Presentation transcript:

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. Riess Charitè - 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 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Rationale n Prognosis in disease free survival with pancreatic cancer is still poor Median survival after resection is months Long term survival (>5 years) is percent Bakkevold (1993); Klinkenbijl (1999); Gastrointestinal Study Group (1985, 1987); Neoptolemos (2004)

3 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Study Design Resected pancreatic cancer 368 patients Stratification: R; T; N Follow up every 8 weeks Gemcitabine for 6 months Observation for 6 months

4 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Disease Monitoring Gem Obs Gemcitabine 1000 mg/m²: d1, 8, 15; q 4 weeks Observation: d1; q 4 weeks R an do mi sa t i on Follow up every 8 weeks Gem Ultrasound after week 8 Ultrasound after week 16 CT Scan after week 32 Obs Gem Obs Gem Obs Gem Obs Gem Obs Gem Obs CA weeks CA 19-9

5 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Endpoints n Primary Endpoint Disease free survival (DFS) n Secondary Endpoint Overall survival (OS) Toxicity

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

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

8 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Recruitment and Analysis Time of recruitment:7/ /04 Recruited patients:368 Recruiting centres:88 (Germany, Austria) Date of Analysis:March 2005

9 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Recruitment Patients Patients per month

10 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Patient Disposition 368 patients enrolled 7/ / pts. for Observation 179 eligible* pts. (96%) 177 eligible* pts. (97%) * 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 186 pts. for Gemcitabine

11 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Patient Characteristic

12 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Tumor Characteristic

13 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Toxicities WHO Grade III+IV

14 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Toxicities WHO Grade III+IV

15 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Toxicities WHO Grade III+IV

16 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Kaplan Meier Disease Free Survival Chemotherapy with gemcitabine median: 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 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Disease Free Survival

18 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Kaplan Meier Survival Chemotherapy with gemcitabine 53 % patients censored (+) Observation 45 % patients censored (+)

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

20 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Conclusions n Treatment with gemcitabine in patients with resected pancreatic cancer results in improved disease free survival as compared to observation n Gemcitabine may become the standard of care for adjuvant treatment of pancreatic cancer

21 Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum CONKO-001 Top recruiting centres n Charité, Universitätsmedizin Berlin, Campus Virchow-Klinikum - Germany n Klinikum Mannheim gGmbH, Universitätsklinikum, Fakultät für Klinische Medizin Mannheim - Germany n Paritätisches Krankenhaus Lichtenberg, Oskar-Ziethen-Krankenhaus, Berlin - Germany n Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät - Germany n SRH Wald-Klinikum Gera gGmbH - Germany n Klinikum der Universität Regensburg - Germany n Eberhard-Karls-Universität Tübingen, Universitätsklinikum Tübingen - Germany n Universitätsklinikum Bonn, Medizinische Fakultät der Rheinischen Friedrich-Wilhelms-Universität - Germany n Klinikum Bremen Mitte gGmbH - Germany n Städtisches Klinikum Magdeburg, Standort Altstadt - Germany n Klinikum der Friedrich-Schiller-Universität zu Jena - Germany n Klinikum Nürnberg Nord - Germany n 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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