News & Views: Our NET community
This part winter, the University of Iowa published an article which was a congratulary piece about the husband and wife team of Drs. Tom and Sue O'Dorisio who received a prestigious research grant on behalf of the University. The National Cancer Institute's (NCI) Specialized Programs of Research Excellence (SPORE) grant was awarded to the UI (University of Iowa) Holden Comprehensive Cancer Center in 2015. This is the first SPORE grant focusing on neuroendocrine tumors.Dr. Sue O’Dorisio is the principal investigator. It is the first SPORE grant focusing on neuroendocrine tumors.
The O'Dorisios' focus on providing U.S. patients with access to promising new treatments through clinical trials and they have drawn patients to the UI from across the country. Today, the Iowa Neuroendocrine Tumor Clinic that Tom O’Dorisio helped create, and still runs, is one of the largest in our country. The clinic has more than 1,100 patient visits per year.
FDA approves Lanreotide (cont'd from home page)
The approval was based on demonstration of improved progression-free survival (PFS) in a multi-center, international, randomized (1:1), double-blind, placebo-controlled study (Trial 2- 55-52030-726) that enrolled 204 patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic, non-functioning GEP-NETs. Fifty-five percent of patients (113/204) had neuroendocrine tumors arising outside the pancreas. Patients were randomized to receive either lanreotide 120 mg or placebo subcutaneously every 28 days.
The primary efficacy endpoint was PFS as determined by independent radiology review. The trial demonstrated a significant prolongation of PFS for the lanreotide arm [HR 0.47 (95% CI: 0.30, 0.73); p < 0.001; log-rank test]. The median PFS in the lanreotide arm had not been reached at the time of the final analysis and will exceed 22 months. The median PFS in the placebo arm was 16.6 months.
Safety data were evaluated in 101 patients who received at least one dose of lanreotide. The most commonly (greater than or equal to 10%) reported adverse reactions in lanreotide-treated patients were abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. The most common serious adverse reaction of lanreotide observed in this trial was vomiting (4%).
The recommended dose and schedule for lanreotide for GEP-NET is lanreotide 120 mg administered by deep subcutaneous injection every 28 days. Treatment should continue until disease progression or unacceptable toxicity.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088). Released 12/16/2014 by the FDA.
Somatuline Depot is marketed by Basking Ridge, New Jersey-based Ipsen Biopharmaceuticals, Inc.