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

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