Among patients with advanced neuroendocrine tumors of the midgut, treatment with Sandostatin® LAR Depot (octreotide acetate for injectable suspension) appears to significantly delay cancer progression. The results of this Phase III clinical trial were published in the Journal of Clinical Oncology.
Neuroendocrine tumors form from cells that release hormones in response to a signal from the nervous system. These tumors include carcinoid tumors, islet cell tumors, medullary thyroid carcinomas, pheochromocytomas, and Merkel cell carcinomas. Although they can occur in many different parts of the body, neuroendocrine tumors often develop in the digestive system.
Sandostatin LAR is a drug used to treat diarrhea and flushing associated with advanced carcinoid tumors and watery diarrhea associated with VIP (vasoactive intestinal polypeptide)–secreting tumors.
To evaluate whether Sandostatin LAR has anticancer effects in patients with metastatic neuroendocrine tumors of the midgut, researchers conducted a Phase IIIb study known as PROMID (Placebo-controlled, double-blind, prospective Randomized study on the effect of Ocreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine MIDgut tumors).
The study, which was conducted in Germany, enrolled 85 patients who were treated with either Sandostatin LAR or placebo. All of the study participants had locally inoperable or metastatic neuroendocrine tumors with the primary tumor in the midgut.
The study included patients with functioning and nonfunctioning neuroendocrine tumors. Functioning tumors produce symptoms that are related to the oversecretion of hormones.
- Patients treated with Sandostatin LAR remained free of cancer progression longer than patients treated with placebo. Median time to cancer progression was 14.3 months among patients treated with Sandostatin LAR compared with six months among patients in the placebo group.
- The benefit of Sandostatin LAR was similar in patients with functioning and non-functioning tumors.
- The greatest benefit of Sandostatin LAR was observed in patients with little or no tumor in the liver, and patients whose primary tumors had been surgically removed.
- After six months of treatment, stable disease was observed in 66.7% of patients treated with Sandostatin LAR and 37.2% of patients in the placebo group.
- Five of the 42 patients treated with Sandostatin LAR discontinued treatment due to side effects. None of the patients in the placebo group discontinued treatment as a result of side effects.
The results of this study suggest that Sandostatin LAR may delay progression of metastatic neuroendocrine tumors of the midgut.
Reference: Rinke A, Muller H-H, Schade-Brittinger C et al. Placebo-controlled, doubled-blind, prospective, randomized study on the effect of ocreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: A report from the PROMID study group. Journal of Clinical Oncology. 2009;27:4656-4663.
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