149689-156

CONKO-005: Adjuvant therapy in R0 resected pancreatic cancer patients with gemcitabine plus erlotinib versus gemcitabine for 24 weeks—A prospective randomized phase III study.

Subcategory: 
Category: 
Gastrointestinal (Noncolorectal) Cancer
Session Type and Session Title: 
Oral Abstract Session, Gastrointestinal (Noncolorectal) Cancer
Abstract Number: 

4007

Citation: 
J Clin Oncol 33, 2015 (suppl; abstr 4007)
Author(s): 
Marianne Sinn, Torsten Liersch, Klaus Gellert, Helmut Messmann, Wolf O. Bechstein, Dirk Waldschmidt, Lutz Jacobasch, Martin Wilhelm, Bettina M Rau, Robert Grützmann, Arndt Weinmann, Georg Maschmeyer, Uwe Pelzer, Jens Stieler, Jana Kaethe Striefler, B. Michael Ghadimi, Marcus Bahra, Helmut Oettle, Bernd Dörken, Hanno Riess; Charité - Universitätsmedizin Berlin, Medical Oncology, Berlin, Germany; Department of General, Visceral and Pediatric Surgery, University Medical Center, Georg-August-University, Göttingen, Germany; Department of General and Visceral Surgery, Sana Klinikum Lichtenberg, Berlin, Germany; Klinikum Augsburg, Department of Gastroenterology, Augsburg, Germany; Department of General and Visceral Surgery, University Hospital Frankfurt, Frankfurt Am Main, Germany; Department of Gastroenterology and Hepatology, University of Cologne, Cologne, Germany; Onkologische Schwerpunktpraxis, Dresden, Germany; Klinikum Nuernberg, Nuernberg, Germany; Universitätsmedizin Rostock, Department of General, Thoracic, Vascular and Transplantation Surgery, Rostock, Germany; Universitätsklinikum Carl Gustav Carus, Department of General, Thoracic and Vascular Surgery, Dresden, Germany; Klinikum der Johannes Gutenberg-Universität, Department of Gastroenterology, Mainz, Germany; Potsdam Klinikum, Potsdam, Germany; Charité Universitätsmedizin Berlin, Medical Oncology, Berlin, Germany; Department of General, Visceral and Transplantation Surgery, Charité, Berlin, Germany; Outpatient Department Hematology/Oncology, Friedrichshafen, Germany; Internistischen Onkologie/Campus Virchow-Klinikum, Charité-Universitätsmedizin, Berlin, Germany

Abstract Disclosures

Abstract: 

Background: Adjuvant chemotherapy with gemcitabine (Gem) for 6 months significantly improves survival of pancreatic cancer patients. CONKO-005 was designed to evaluate an additional effect of the EGFR-tyrosinkinase-inhibitor erlotinib (Erlo 100 mg p.o. daily) in combination with Gem (1000 mg/m² i.v. day 1,8,15, q29) for 24 weeks in pts after R0 resection. Methods: In an open-label multicenter design, pts were randomised within 8 weeks after operation to receive GemErlo or Gem; stratified by lymph node involvement, operation techniques, study centre. The primary endpoint was disease-free survival (DFS). The study was planned with a power of 80% at a significance level of 0.05 to detect an improvement of DFS from 14 to 18 months. Secondary objectives were median overall survival (OS) and treatment safety. Kaplan-Meier analyses were performed; survival data for the treatment arms compared using log-rank test. RESULTS: Between April 2008 and July 2013, 219 pts were randomized to GemErlo and 217 to Gem. Pts characteristics are well balanced (GemErlo/Gem): age (median 63/65 years), tumor status (T3/T4 88/86%), nodal status (N pos 64/66%), grading (G3 33/34%). After a median follow up of 41 months (March 2015), 350 events (80%) occurred. Median treatment duration was 22 weeks in both groups. Grade 3/4 toxicities were (GemErlo%/Gem%): rash 7/0.4, diarrhea 5/1, nausea 2/2, fatigue 5/2, hypertension 3/1,GGT 9/9, neutropenia 27/28, thrombopenia 5/2. There was no difference in DFS (median: GemErlo 11.6 months, Gem 11.6 months; HR 0.89, 95%CI 0.72-1.10) or OS (median: GemErlo 24.6 months, Gem 26.5 months; HR 0.90, 95%CI 0.71-1.15). There was no correlation between the grade of rash and an improved DFS in the GemErlo group (median: rash grade 0-1 vs > = grade 2 12.2 vs 11.0 months; HR 0.91, 95%CI 0.66-1.25). OS curves show a late divergence in favour of GemErlo (estimated survival after 2/3/4/5-years: 54/36/31/28% vs 53/33/22/19%). Conclusion: The combination therapy of GemErlo for 24 weeks did not improve DFS or OS. There is a trend in favour of long-term survival in pts treated with GemErlo. Clinical trial information: DRKS00000247.