A phase II study of high-dose octreotide in patients with unresectable pancreatic carcinoma

This report describes the results of a phase II trial to evaluate the safet y, feasibility and response of patients with irresectable, histologically p roven, stage II-IV adenocarcinoma of the pancreas receiving high-dose octre otide treatment. Octreotide was self-adminstered subcutaneously (3 x 2000 m u g per day) by 49 patients. Therapy was discontinued after progression of the disease. Due to the subsequent diagnosis of bile duct carcinoma and sta ge 1 disease, 2 patients were excluded, leaving 47 evaluable patients with measurable disease. The median Karnofsky score was 80%. 3 patients had stag e II (6%), 19 stage III (40%), and 25 (53%) stage IV disease. Octreotide tr eatment resulted in stable disease in 9 patients (19%) for more than 12 wee ks. No complete or partial response was observed. The median overall surviv al was 21.4 weeks and the median progression-free survival 9.0 weeks. Thera py 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. (C) 1999 Published b y Elsevier Science Ltd. All rights reserved.