Hoff, P.M., Saragiotto, D.F., Barrios, C.H., del Giglio, A., Coutinho, A.K., Andrade, A.C., . . . van Eyll, B. (2014). Randomized phase III trial exploring the use of long-acting release octreotide in the prevention of chemotherapy-induced diarrhea in patients with colorectal cancer: The LARCID trial. Journal of Clinical Oncology, 32(10), 1006–1011.
To evaluate the efficacy and safety of long-acting release (LAR) octreotide for the prevention of chemotherapy-induced diarrhea (CID)
This prospective, randomized clinical trial compared the administration of octreotide LAR 30 mg IM every four weeks beginning with first-cycle to the administration of a physician’s choice of medication in a group of patients with colorectal cancer starting adjuvant or first-line treatment. Patients received combination chemotherapy with fluorouracil, capecitabine, and/or irinotecan. Treatment with octreotide LAR was continued for six months or until chemotherapy discontinued or until the patient developed unacceptable toxicity related to the study drug (whichever occurred first). The choice for the treatment for diarrhea for both arms was at the physicians' discretion, but the control group could not receive octreotide LAR. Patients were stratified according to the use of irinotecan.
Randomized, multi-centered, open-labeled, phase III trial
139 patients were randomly assigned. Most received a fluorouracil (treatment 98.5%, control 98.6%) or oxaliplatin (treatment 76.5%, control 63.4%) containing regimen. The rate of diarrhea was 76.1% in the treatment group (n = 68) and 78.9% in the control group (n = 71). Treatment with octreotide LAR did not prevent or reduce the severity of chemotherapy-induced diarrhea.
There was no benefit in using octreotide LAR prophylactic in patients with colorectal cancer starting adjuvant or first-line treatment with combination chemotherapy containing fluorouracil, capecitabine, and/or irinotecan.
There was no benefit in using octreotide LAR prophylactic in patients with colorectal cancer starting adjuvant or first-line treatment with combination chemotherapy containing fluorouracil, capecitabine, and/or irinotecan. This has also been evaluated in other studies that have looked at octreotide LAR using escalation doses of 30 or 40 mg, and the results were similar. Per the authors of this study, the short-acting octreotide remains the formulation of choice in the treatment of CID.