Antiangiogenese zur adjuvanten Therapie nach Resektion kolorektaler Lebermetastasen — Erste Ergebnisse einer Phase I/II-Studie mit einem monoklonalen anti-lntegrin- Antikörper

Abstract

Introduction: Liver resection offers the only chance of cure for patients with colorectal liver metastases. Nevertheless, recurrences occur in up to 80%. No adjuvant therapy is established. Methods: Within this study 16 patients with high risk of recurrence received an adjuvant treatment after resection of colorectal liver metastases with a chimeric monoclonal antibody against αvβ3 and αIIbβ3 integrins. Main criteria for evaluation were toxicity, tumour-free survival, and overall survival. Results: After a median follow-up of 18 months the only observed toxicity was severe thrombocytopenia in 3 of the 16 patients combined with an anaphylactic reaction in one of these. All recovered without complications, especially without bleeding. Recurrences and deaths were observed in 25% and 6% respectively. Considering the high-risk situation, this was at most half of the expected rate in this group. Discussion and Conclusion: With this regimen acute toxicity in terms of thrombocytopenia was high. Nevertheless, oncologic results are encouraging to further follow up that path.