gms | German Medical Science

27th German Cancer Congress Berlin 2006

German Cancer Society (Frankfurt/M.)

22. - 26.03.2006, Berlin

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Adjuvant chemotherapy with gemcitabine vs. observation in patients with resected pancreatic cancer - a randomised, prospective, multicenter phase III study (CONKO-001)

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  • corresponding author presenting/speaker Helmut Oettle - Charité Universitätsmedizin, Berlin, Deutschland
  • Lars Roll - Charité Universitätsmedizin, Berlin
  • Peter Neuhaus - Charité Universitätsmedizin, Berlin
  • Stefan Post - Ruprecht-Karls-Universität, Mannheim
  • Klaus Gellert - Paritätisches Krankenhaus Lichtenberg, Berlin
  • Karsten Ridwelski - Otto-von-Guericke-Universität, Magdeburg
  • Harald Schramm - Wald-Klinikum, Gera
  • Carl Zülke - Universität Regensburg, Regensburg
  • Jörg Ziske - Universitätsklinik, Bonn
  • Christof Burkart - Eberhard-Karls-Universität, Tübingen
  • Marco Niedergethman - Ruprecht-Karls-Universität, Mannheim
  • Jörg Fahlke - Otto-von-Guericke-Universität, Magdeburg
  • Jan Langrehr - Charité Universitätsmedizin, Berlin
  • Hanno Riess - Charité Universitätsmedizin, Berlin

27. Deutscher Krebskongress. Berlin, 22.-26.03.2006. Düsseldorf, Köln: German Medical Science; 2006. DocOP120

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dkk2006/06dkk230.shtml

Published: March 20, 2006

© 2006 Oettle et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

Text

Background: Gemcitabine (G) is the standard chemotherapy in locally advanced and metastasised inoperable PC. No standard adjuvant therapy has been defined yet. So far no prospective, randomised trial with G in adjuvant situation is available.

Methods: The aim of this study was to evaluate the efficacy and side effects of adjuvant G in patients (pts) with resected pancreatic cancer. After stratification for tumor status, lymph nodes status and status of resection margins pts were randomised within 6 weeks after standard operation procedure to receive G or observation (O) only. G was administered at a dosage of 1g/m² days 1, 8 and 15 monthly for 6 months. Pts in the O group were followed equivalent to the G group, but received no specific postoperative therapy. Primary endpoint was disease free survival (DFS), secondary endpoints were overall survival (OS) and side effects.

Results: In December 2004 the recruitment goal of 368 pts was reached. 12 ineligible pts where excluded. 179 pts were randomised to G and 177 to O. Pts characteristics were well balanced (G/O) with regard to median age (62/61y), tumor status (T3+T4 86/86%), nodal status (N neg: 29/27%; N pos: 71/73%), resection margin (R0: 81/84%; R1: 19/16%). Until March 2005 243 events (68%) have occurred for DFS and 182 events (51%) for OS. Analysis demonstrated a difference in median DFS [G:14.2 months (m), O: 7.5m, p< 0.05] and in OS [G:24.1m, O: 22.3m] Subgroup analysis showed increased DFS in pts with positive (n=62) or negative (n=294) microscopic resection margin involvement and in those with (n= 256) or w/o (n= 100) lymph nodes involvement. The toxicities where low with grade 3/4 (per cycle analysis) (G/O): leucocytes (2.6/0%), platelets (0.9/0%), diarrhea (1.2/0.5%), nausea (1.6/0.2%).

Conclusion: Preliminary data demonstrate an increased DFS in pts with resected PC when treated with G for 6 months after resection.