gms | German Medical Science

27. Deutscher Krebskongress

Deutsche Krebsgesellschaft e. V.

22. - 26.03.2006, Berlin

A randomized, prospective, multicenter, phase III trial of gemcitabin (g), 5-fluorouracil (5-fu), folinic acid (fa) vs. gemcitabine alone in patients with advanced pancreatic cancer (CONKO 002)

Meeting Abstract

  • corresponding author presenting/speaker Uwe Pelzer - Universitätsmedizin - Charité, Berlin, Deutschland
  • A. Helm - Universitätsmedizin - Charité
  • M. Niedergehtmann - Universitätsklinikum Heidelberg
  • I. Schmidt-Wolf - Universitätsklinikum Bonn
  • M. Moik - Klinikum Salzburg
  • C. Hammer - Humaine Klinikum Bad Saarow
  • K. Zippel - Päritätisches Krankenhaus Lichtenberg
  • K. Weigang-Köhler - Klinikum Nürnberg Nord
  • M. Stauch - Onkologische Schwerpunktpraxis - Kronach
  • H. Riess - Universitätsmedizin - Charité
  • H. Oettle - Universitätsmedizin - Charité

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocPO135

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/dkk2006/06dkk245.shtml

Veröffentlicht: 20. März 2006

© 2006 Pelzer et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Gemcitabin as 1st line treatment in patients with advanced pancreatic cancer (apc) is associated with a low toxicity profile. So it can be combinated with other drugs and may be bring a benefit for these patients. Gemcitabine 1g/m² (30min.) and 5-fu 750mg/m² (24h) modulated by folinic acid 200mg/m² (2h) given on days 1, 8, 15 and 22 every six weeks (GFF) showed encouraging results in our multicenter phase II study. So we started this randomized phase III trial to confirm these results. Methods: Pts were stratificated for stage (III vs. IVa vs. IVb) and karnofsky performance status (KPS; 60%-80%; 90%-100%). Then they were randomized to receive GFF or G. Eligibility criteria included KPS > 60%, histlogical confirm local advanced inoperable or metastatic disease, no prior chemotherapy, adequate renal and liver function. Primary endpoint was median overall survival (mOS). Secondary endpoints included time to progression (TTP) and toxicities. The trial was powered to detect a significant difference with 80% probability at a significance level of 0.05 when 392 death were observed. Results: 473 pts. were randomized between 08/00 and 11/03. 7 pts. were ineligible. 230 pts. were allocated to GFF and 236 pts. to G. Both arms (G/GFF) were well balanced with median age (63/64y), KPS (60-80% (56%/53%) and stage IVb (76%/77%). At cut off 445 events had occured. There were no difference in mOS (GFF:5.85 month, G: 6.2 month; p=0.68, 1-year survival (GFF 21%, G: 22%; p=0.68), TTP (GFF/G 3.5month; p=0.44). Stage IVb pts with KPS>90 (n=150) tended to have better OS with GFF (8.5month vs. 6.2 month; p=0,62); those with KPS < 90% (n=192) tended to better on G (4.9 month vs. 3.4 month; p=0.17). Toxicities was mild for both arms with grade III°/IV° tox. (per pt. analysis). GFF/G: leucocytes (12%/12%); platelets (13%/7%); diarrhea (4%/4%); nausea (14%/7%). Conclusion: Gemcitabin in combination with 5-fu/fa did not result in increased survival as compared to standard therapy with G in pts with advanced pancreatic cancer.