Adding Adjuvant Erlotinib to Gemcitabine After R0 Resection of Pancreatic Cancer


Key Points

  • The addition of erlotinib to gemcitabine after R0 resection in patients with pancreatic ductal adenocarcinoma did not improve disease-free survival.
  • No significant difference in overall survival was observed.

The German phase III CONKO-005 trial has shown no significant benefit of adding adjuvant erlotinib (Tarceva) to gemcitabine after R0 resection in patients with pancreatic ductal adenocarcinoma. The findings were reported in the Journal of Clinical Oncology by Sinn et al.

Study Details

In the open-label trial, 436 patients from 57 sites in Germany were randomized between April 2008 and July 2013 to receive gemcitabine at 1,000 mg/m2 on days 1, 8, and 15 every 4 weeks plus erlotinib at 100 mg once daily (n = 219) or gemcitabine alone (n = 217) for 6 cycles. The primary endpoint was disease-free survival.

Survival Outcomes

The median follow-up was 54 months. Median disease-free survival was 11.4 months in the erlotinib/gemcitabine group vs 11.4 months in the gemcitabine group (hazard ratio [HR] = 0.94, P = .26). Median overall survival was 24.5 vs 26.5 months (P = .61). Overall survival at 1, 2, and 5 years was 77% vs 79%, 53% vs 54%, and 25% vs 20%, respectively.


The most common grade 3 or 4 adverse events in both groups were neutropenia (27% vs 28%), leukopenia (10% vs 15%), and increased gamma-glutamyltransferase (9% vs 9%). Grade 3 or 4 rash occurred in 7% vs < 1% of patients; the occurrence or the grade of rash was not associated with better outcome in the erlotinib/gemcitabine group.

The investigators concluded: “To the best of our knowledge, CONKO-005 is the first study to investigate the combination of chemotherapy and a targeted therapy in the adjuvant treatment of [pancreatic ductal adenocarcinoma]. [Gemcitabine/erlotinib] for 24 weeks did not improve [disease-free survival] or overall survival over [gemcitabine].”

The study was supported in part by a grant from Roche Pharma AG and by the German Cancer Society.

Marianne Sinn, MD, of Charité-Universitätsmedizin Berlin, is the corresponding author of the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.