A phase III evaluation of a somatostatin analogue (octreotide) in the treatment of patients with asymptomatic advanced colon carcinoma. North Central Cancer Treatment Group and the Mayo Clinic.
BACKGROUND
The purpose of this study was to determine by randomized, controlled, double-blind evaluation whether therapy with the somatostatin analogue, octreotide, would delay tumor progression and improve survival of patients with metastatic colorectal carcinomas who were ambulatory with no significant symptoms.


METHODS
Two hundred sixty patients with an Eastern Cooperative Oncology Group performance status of 0 or 1 and without symptoms related to colon cancer were randomized to receive 150 micrograms of octreotide subcutaneously three times daily or, initially, no treatment. After 91 patients were entered in the double-blind study, saline placebo injections were used for patients in the control arm.


RESULTS
The randomization culminated in balanced assignment of patients with respect to disease site(s), presence or absence of measurable or evaluable disease, and interval from diagnosis of metastasis to protocol entry. Steatorrhea and diarrhea, usually mildly severe, resulted more often from treatment than from the placebo. The major end points were time to progression and survival. Curves for both parameters overlapped in the blind and open trial segments.


CONCLUSIONS
Octreotide at a dose of 150 micrograms given three times daily is not effective therapy for patients with advanced asymptomatic colon carcinoma.
Goldberg
R M
RM
Mayo Clinic, Rochester, MN 55905, USA.
Moertel
C G
CG
Wieand
H S
HS
Krook
J E
JE
Schutt
A J
AJ
Veeder
M H
MH
Mailliard
J A
JA
Dalton
R J
RJ
D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D002277:Carcinoma / Q000188:drug therapy*; D003110:Colonic Neoplasms / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis
D018931:Antineoplastic Agents, Hormonal; D015282:Octreotide