title: Phase III evaluation of octreotide versus chemotherapy with 5-fluorouracil or 5-fluorouracil plus leucovorin in advanced exocrine pancreatic cancer: a North Central Cancer Treatment Group study.
abstract: There continues to be a need for new systemic approaches for the treatment of advanced pancreatic cancer. The purpose of this study was to compare the antitumor activity of the somatostatin analogue octreotide to 5-fluorouracil chemotherapy in a Phase III setting. Eighty-four patients with an Eastern Cooperative Oncology Group performance status of 0 or 1 and limited tumor volume were randomized to receive octreotide 200 microg three times daily or 5-fluorouracil with or without leucovorin. After the first 12 patients had been randomized to octreotide, we increased the dose in the remaining patients to 500 microg three times daily. This change was based on early reports in other studies, suggesting that our original dose may not have been effective and that higher doses of octreotide were well tolerated. A planned interim analysis performed after 84 patients were enrolled demonstrated inferior time to progression and survival for the patients randomized to octreotide. Further accrual to the octreotide arm of this protocol was therefore terminated. Octreotide in doses of 200-500 microg three times daily does not delay progression or extend survival in patients with advanced pancreatic cancer compared with treatment with 5-fluorouracil with or without leucovorin.
authors.affiliation: Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA.
authors.forename: P A
authors.initials: PA
authors.lastname: Burch
authors.forename: M
authors.initials: M
authors.lastname: Block
authors.forename: G
authors.initials: G
authors.lastname: Schroeder
authors.forename: J W
authors.initials: JW
authors.lastname: Kugler
authors.forename: D J
authors.initials: DJ
authors.lastname: Sargent
authors.forename: T A
authors.initials: TA
authors.lastname: Braich
authors.forename: J A
authors.initials: JA
authors.lastname: Mailliard
authors.forename: J C
authors.initials: JC
authors.lastname: Michalak
authors.forename: A K
authors.initials: AK
authors.lastname: Hatfield
authors.forename: K
authors.initials: K
authors.lastname: Wright
authors.forename: S A
authors.initials: SA
authors.lastname: Kuross
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D015996:Survival Rate
chemical_list: D000964:Antimetabolites, Antineoplastic; D018931:Antineoplastic Agents, Hormonal; D002955:Leucovorin; D015282:Octreotide; D005472:Fluorouracil