A PHASE-III EVALUATION OF A SOMATOSTATIN ANALOG (OCTREOTIDE) IN THE TREATMENT OF PATIENTS WITH ASYMPTOMATIC ADVANCED COLON-CARCINOMA

Background. The purpose of this study was to determine by randomized, controlled, double-blind evaluation whether therapy with the somatosta tin analogue, octreotide, would delay tumor progression and improve su rvival of patients with metastatic colorectal carcinomas who were ambu latory with no significant symptoms. Methods. Two hundred sixty patien ts with an Eastern Cooperative Oncology Group performance status of 0 or 1 and without symptoms related to colon cancer were randomized to r eceive 150 mu g of octreotide subcutaneously three times daily or, ini tially, no treatment. After 91 patients were entered in the double-bli nd study, saline placebo injections were used for patients in the cont rol arm. Results. The randomization culminated in balanced assignment of patients with respect to disease site(s), presence or absence of me asurable or evaluable disease, and interval from diagnosis of metastas is to protocol entry. Steatorrhea and diarrhea, usually mildly severe, resulted more often from treatment than from the placebo. The major e nd points were time to progression and survival. Curves for both param eters overlapped in the blind and open trial segments. Conclusion. Oct reotide at a dose of 150 mu g given three times daily is not effective therapy for patients with advanced asymptomatic colon carcinoma.