Phase II study of panobinostat and bortezomib in patients with pancreatic cancer progressing on gemcitabine-based therapy

Background: This single-arm, phase II study was designed to determine the efficacy and safety of panobinostat and bortezomib in patients with advanced pancreatic cancer. Patients and Methods: Patients had to have a histological diagnosis of pancreatic cancer and progression on a standard gemcitabine-based therapy. Treatment cycles consisted of 21 days, with bortezomib given twice weekly at 1.3 mg/m ² and panobinostat three times weekly at 20 mg during the first two weeks, followed by a 9-day rest period. Results: Seven patients (3 female, 4 male) were treated with at least one cycle, but the study was suspended after the enrollment of these patients because of a complete lack of treatment responses and early treatment-related toxicity. Median progression-free survival was 2.1 months (95% Confidence interval: 1.7-2.3 months). The most common grade 3 or 4 adverse events were thrombocytopenia (57%) and diarrhea (29%). Conclusion: Treatment of advanced pancreatic cancer with bortezomib in combination with panobinostat is not supported by our clinical study.