Rosenoff, S.H., Gabrail, N.Y., Conklin, R., Hohneker, J.A., Berg, W.J., Ghulam, W., … Anthony, L. (2006). A multicenter, randomized trial of long-acting octreotide for the optimum prevention of chemotherapy-induced diarrhea: Results of the STOP trial. Journal of Supportive Oncology, 4(6), 289–294.

To compare the efficacy of two dose levels of octreotide long-acting release (LAR) in preventing chemotherapy-induced diarrhea (CID) in patients with active or prior CID

A sample of 124 evaluable patients were assigned randomly to either the 30-mg or 40-mg octreotide dose group. The first dose of ocreotide was given intramuscularly 7–14 days prior to day 1 of the patient's next chemotherapy cycle. The second dose coincided with the chemotherapy cycle. Subsequent cycles were given every 28 days up to a total of 6 doses on a schedule independent of the chemotherapy cycles. Prior to initiation of octreotide LAR, patients were given a 100-mcg test dose of octreotide subcutaneously to determine potential intolerance.

• The two treatment groups were similar in current chemotherapy regimens, severity of most recent diarrhea episode, body weight, primary tumor type, and proportion of patients with colostomy prior to study entry.
• More than half (57%) of patients were receiving regimens with 5-fluorouracil (5-FU) with or without irinotecan, leucovoran, or oxaliplatin; 25% were receiving irinotecan regimens with or without 5-FU, leucovoran, or oxaliplatin.
• Primary tumor types were colorectal (75%), breast (7%), lung (6%), hematologic (1%), other (10%).

This was an open label, randomized, multicenter study with a parallel-group design.

• Patient diaries were collected on a monthly basis to obtain data for diarrhea assessment, concomitant medications, adverse events, and use of healthcare resources.
• Health-related quality of life (QOL) was assessed at baseline and at the end of each study visit using a modified Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT_D) scale.
• Investigators collected data from the Treatment Satisfaction Questionnare for Medication for Chemotherapy Induced Diarrhea (TSQM-CID), a version of the previously validated TSQM, at baseline for loperamide and diphenoxylate and at the end of study visit for octreotide LAR.
• The primary study endpoint was the proportion of patients experiencing severe diarrhea (National Cancer Institute [NCI] grade 3 or 4).
• Secondary study endpoints were the proportion of patients requiring IV fluids, unscheduled provider visits, and changes in primary therapy because of diarrhea as well as treatment satisfaction and QOL.

• The proportion of patients who experienced severe diarrhea (grade 3 or 4) during the study was 61.7% in the 30-mg group and 48.4% in the 40-mg group (p = 0.14).
• Fewer patients in the 40-mg group experienced severe diarrhea, required IV fluid (p = 0.11), or had unscheduled diarrhea-related healthcare visits (p = 0.11).
• The percentage of patients in the 30-mg group who had changes in their primary therapy as a result of diarrhea was 61.7%, and the percentage in the 40-mg group was 64.1% (p = 0.78).

• No comparison was made between daily and three times per day octreotide and octreotide LAR.
• The 30-mg group contained a significantly greater proportion of females because sensitivity analysis showed no need to adjust for gender.

No specific recommendations regarding the superiority of 30 mg or 40 mg octreotide in the management of CID can be made based on this study.