PROMID – A first-line study in patients with advanced midgut neuroendocrine tumors (NET)
The ability of Sandostatin® LAR® to provide tumor control was studied in the PROMID trial—a Phase III, randomized, double-blind, placebo-controlled trial of newly diagnosed, treatment-naïve patients with advanced midgut gastrointestinal NET. Patients with both functioning and nonfunctioning NET were involved in the trial, reflecting the typical newly diagnosed patient population. Median time since diagnosis was 4.3 months, and all patients were treatment-naïve. The primary endpoint was time to tumor progression (TTP), calculated from the date of random assignment until the date of first progressive disease or tumor-related death.1
30 mg of Sandostatin® LAR® provided first-line tumor control1
PROMID demonstrated the antiproliferative effect of 30 mg of Sandostatin® LAR® every 4 weeks in treatment-naïve patients with either functional or nonfunctional advanced midgut NET. 30 mg of Sandostatin® LAR® more than doubled TTP in both functional and nonfunctional advanced midgut NET.1
- TTP: 14.3 months with 30 mg of Sandostatin® LAR® vs 6.0 months with placebo (P=0.000072)1
- 30 mg of Sandostatin® LAR® reduced the risk of disease progression by 66% (HR=0.34; 95% CI: 0.20-0.59)1
PROMID: Per-protocol subgroup analyses of TTP1
Initiate 30 mg of Sandostatin® LAR® every 4 weeks for tumor control in patients with advanced midgut NET.2
30 mg of Sandostatin® LAR®: Reduced the risk of progression vs placebo1
Results of the Phase III, randomized, double-blind, placebo-controlled PROMID trial in treatment-naïve patients with locally inoperable or metastatic well-differentiated NET of the midgut or unknown origin. 42 patients were treated with Sandostatin® LAR® and 43 patients received placebo. The primary endpoint was TTP, calculated from the date of random assignment until the date of first progressive disease.1
The recommended dose of Sandostatin® LAR® for tumor control in advanced midgut NET is 30 mg administered every 4 weeks. Treatment with Sandostatin® LAR® for tumor control should be continued in the absence of tumor progression.2
30 mg of Sandostatin® LAR® is proven to reduce disease progression.1
References:
1. Rinke A, Muller H-H, Schade-Brittinger C, et al. 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: a report from the PROMID Study Group. J Clin Oncol. 2009;27:4656-4663. 2. Sandostatin® LAR® Summary of Product Characteristics. Novartis Pharma AG. 2018.