A multicenter, randomized trial of long-acting octreotide for the optimum prevention of chemotherapy-induced diarrhea: Results of the STOP trial

Stephen H. Rosenoff, Nashat Y. Gabrail, Richard Conklin, John A. Hohneker, William J. Berg, Ghulam Warsi, Jennifer Maloney, John J. Benedetto, Elizabeth A. Miles, Wei Zhu, Lowell Anthony

Research output: Contribution to journalArticlepeer-review

24 Scopus citations

Abstract

Diarrhea is a well-recognized side effect of chemotherapy and can result in chemotherapy delay and/or dose reduction, potentially reducing the therapeutic benefit of treatment. Octreotide has been shown to be effective in controlling chemotherapy-induced diarrhea (CID). In this open-label, randomized, multicenter study, designed to asses the effects of two dose levels of octreotide long-acting release (LAR), patients with active or prior CID and scheduled for chemotherapy were randomized to receive up to six doses of either 30 or 40 mg of octreotide LAR. The primary endpoint was the proportion of patients experiencing severe diarrhea during the trial. Secondary endpoints included the proportion of patients requiring IV fluids due to diarrhea, unscheduled visits to healthcare professionals due to diarrhea, and changes in primary therapy, as well as treatment satisfaction and quality of life. In total, 147 patients were randomized and received at least 1 dose; 124 patients were efficacy-evaluable. Baseline characters were balanced in the 30-mg and 40-mg groups with the exception of gender. Fewer patients in the 40-mg group compared with those in the 30-mg group experienced severe diarrhea (61.7% vs 48.4%; P = 0.14), required IV fluid (31.7% vs 18.8%; P = 0.10), and had diarrhea-related unscheduled healthcare visits (41.7% vs. 28.1%; P = 0.11); however, these differences were not statistically significant. No significant differences were observed between the treatment groups in either measured quality of life or treatment satisfaction. Adverse events were balanced between the two groups. No specific recommendations can be made from this trial regarding the use of 30 mg versus 40 mg of octreotide LAR for CID.

Original languageEnglish
Pages (from-to)289-294
Number of pages6
JournalJournal of Supportive Oncology
Volume4
Issue number6
StatePublished - Jun 2006

ASJC Scopus subject areas

  • Oncology
  • Pharmacology (medical)

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