Phase III Data Show Octreotide Reduced Risk of Disease Progression by 66% in Advanced Neuroendocrine Tumor Patients

Data published in the Journal of Clinical Oncology show that patients with advanced neuroendocrine tumors (NET) of the midgut who were treated with octreotide acetate (Sandostatin LAR Depot) experienced a 66% reduction in risk of disease progression vs placebo. Octreotide is indicated to treat the diarrhea and flushing episodes associated with advanced carcinoid tumors. These data are from the phase IIIb study PROMID (Placebo-controlled, double-blind, prospective Randomized study on the effect of Octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine MIDgut tumors). In the study, patients receiving octreotide LAR more than doubled the time without tumor progression for a median of 14 months, compared with a median of 6 months for those who received placebo.

Key Data
The PROMID study showed antitumor benefit in patients with functioning and nonfunctioning tumors resulting from treatment with octreotide LAR. In an analysis of patients with nonfunctioning tumors, time to tumor progression for patients receiving octreotide LAR was 28.8 months vs 5.9 months for those on placebo (hazard ratio [HR] = 0.25; 95% confidence interval [CI] = 0.10–0.59). For patients with functioning tumors, time to tumor progression for patients receiving octreotide LAR was 14.3 months vs 5.5 months for those on placebo (HR = 0.23; 95% CI = 0.09–0.57).

Earlier this year, the National Comprehensive Cancer Network (NCCN) updated its clinical practice guidelines based on the results of PROMID. The NCCN guidelines now recommend the use of octreotide LAR as a treatment option for all metastatic, unresectable midgut NET patients, regardless of symptoms.