Pasireotide Efficacious, Tolerated in Patients with Treatment Refractory NETs

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(ChemotherapyAdvisor) – Pasireotide is effective and generally well tolerated in controlling the symptoms of carcinoid syndrome in patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR therapy, according to an international team of researchers. This conclusion is based on a study entitled “Pasireotide (SOM230) shows efficacy and tolerability in the treatment of patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR: results from a Phase II study,” which was published online in Endocrine-Related Cancer.

Neuroendocrine tumors (NETs), which can arise almost anywhere in the body, present a therapeutic and diagnostic challenge, causing diagnoses and treatment to be delayed by almost 10 years. In recent years, improvement in therapeutic modalities has prolonged survival in patients diagnosed with this rare cancer type.

In the current Phase 2 study, the therapeutic efficacy and safety was sought for pasireotide (SOM230), a somatostatin analogue that binds very tightly to somatostatin receptors. The aim of this study was to determine whether pasireotide could “offer symptom control in patients with neuroendocrine tumors (NET) and carcinoid syndrome no longer responsive to octreotide LAR,” the investigators wrote.

In this open-label, multicenter study, pasireotide was administered to patients at a dose of 150µg, twice a day, subcutaneously (sc). This dose was escalated to a maximum dose of 1200µg until the patient reached a clinical response; efficacy (n = 44 patients) and tolerability (n = 45 patients) were then evaluated.

The investigators found that pasireotide (600–900μg) effectively controlled the symptoms of diarrhea and flushing in 27% of patients. “Evaluation of tumor response in 23 patients showed 13 with stable disease and 10 with progressive disease at study end,” the investigators wrote. In the same dosage range, the drug was generally well tolerated, with the most common drug-related adverse events being nausea (27%), abdominal pain (20%), weight loss (20%) and hyperglycemia (16%).

Based on the findings in this study, the investigators concluded that pasireotide was effective and generally well tolerated in controlling the symptoms of carcinoid syndrome in patients with advanced NET refractory or resistant to octreotide LAR therapy.

Pasireotide is currently being evaluated in Phase 3 clinical trials for the treatment of patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR therapy.

Abstract

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