title: 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-administered subcutaneously (3 x 2000 micrograms 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.
authors.affiliation: City Hospital Soest, Department of Surgery, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Sulkowski
authors.forename: M
authors.initials: M
authors.lastname: Büchler
authors.forename: P
authors.initials: P
authors.lastname: Pederzoli
authors.forename: R
authors.initials: R
authors.lastname: Arnold
authors.forename: P
authors.initials: P
authors.lastname: Dinse
authors.forename: A
authors.initials: A
authors.lastname: Kay
authors.forename: U
authors.initials: U
authors.lastname: Haus
authors.forename: H G
authors.initials: HG
authors.lastname: Beger
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000008:administration & dosage*; D010190:Pancreatic Neoplasms / Q000188:drug therapy*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D015282:Octreotide