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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.
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.
Abstracts by Marianne Sinn:
- Meeting: 2016 Gastrointestinal Cancers Symposium | Abstract No: 441
Nabpaclitaxel plus gemcitabine in subjects with advanced pancreatic cancer who have cholestatic hyperbilirubenemia secondary to bile duct obstruction.Meeting: 2016 ASCO Annual Meeting | Abstract No: e15717
Population pharmacokinetics of CAP7.1 and the effect on total target lesion size in adult patients with biliary tract cancer.Meeting: 2016 ASCO Annual Meeting | Abstract No: e15602