A phase II study of high-dose octreotide in patients with unresectable pancreatic carcinoma
Abstract
This report describes the results of a phase II trial to evaluate the safety, feasibility and response of patients with irresectable, histologically proven, stage II–IV adenocarcinoma of the pancreas receiving high-dose octreotide treatment.
Octreotide was self-adminstered subcutaneously (3×2000 μg per day) by 49 patients. Therapy was discontinued after progression of the disease. Due to the subseqment diagnosis of bile duct carcinoma and stage I disease, 2 patients were excluded, leaving 47 evaluable patients with measurable disease.
The median Karnofsky score was 80%. 3 patients had stage II (6%), 19 stage III (40%), and 25 (53%) stage IV disease. Octreotide treatment resulted in stable disease in 9 patients (19%) for more than 12 weeks. No complete or partial response was observed. The median overall survival was 21.4 weeks and the median progression-free survival 9.0 weeks.
Therapy with high-dose octreotide is feasible, well tolerated and might prolong survival. In a placebo-controlled phase III study the effects of octreotide in patients with pancreatic cancer will be confirmed.
See also:
- Somatostatin in oncology, the overlooked evidences;
- Pancreatic Adenocarcinoma: clinical records on 17 patients treated with Di Bella's Method;