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Frequently Asked Questions About Neuroendocrine Tumors (NET)

  1. What are NET?
  2. What are the goals of treatment for NET?
  3. What types of treatment options are available for patients with NET?
  4. When is it appropriate to treat NET with Sandostatin® LAR®?
  5. What are the side effects of Sandostatin® LAR® therapy?
  6. How is the updated Sandostatin® LAR® solution* different from the previous formulation?
  7. What are the advantages of the specially designed vial adapter with the updated formulation*?
  8. Can the vial be shaken with the updated formulation*?
  9. Has the dosing changed with the updated formulation*?
  10. Is the efficacy of the updated formulation* different from the original?

1. What are NET?

NET arise from cells throughout the nervous and endocrine systems (eg, cells of the pancreas, parathyroid, adrenal, and pituitary glands) and the calcitonin-producing cells of the thyroid glands.1

Significant disease progression may occur during the period of delayed diagnosis.2 Many are not diagnosed until the hormonal secretions of the metastases start to cause debilitating symptoms that may be associated with worse outcomes.3

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2. What are the goals of treatment for NET?

Tumor control is the recommended treatment goal for NET. Sandostatin® is indicated for tumor control in patients with advanced NET of the midgut or unknown primary tumor location.

  • Routinely monitor for progression4
    • Perform CT or MRI scan every 3 to 6 months for NET4
  • Treat with antiproliferative therapy5
    • "As most patients with NET are diagnosed once metastases have occurred, [patients] require chronic postoperative medical management with the aim of […] suppressing tumor growth and spread"5

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3. What types of treatment options are available for patients with NET?

  • Surgery6
  • Hepatic embolization4
  • Symptom control with somatostatin analogs, such as Sandostatin® LAR®7
  • Antiproliferative therapy with somatostatin analogs7
  • Chemotherapy8
  • Radiation8
  • Interferon therapy8

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4. When is it appropriate to treat NET with Sandostatin® LAR®?

NET are frequently misdiagnosed for years and patients may have to wait 5 to 7 years from the onset of symptoms to receive a correct diagnosis.3 Significant disease progression may occur during the period of delayed diagnosis. Upon diagnosis, disease management and treatment with Sandostatin® LAR® should begin.2

Disease progression9:

Neuroendocrine tumors are frequently misdiagnosed for years

Adapted from Vinik & Moattari.9

In one placebo-controlled trial of patients with advanced midgut NET (n=85)10:

  • 51% of untreated patients progressed at 6 months
  • 79% of untreated patients progressed at 12 months

In PROMID, a Phase III, randomized, double-blind, placebo-controlled trial of a broad range of treatment-naïve patients with advanced midgut gastrointestinal NET, 30 mg of Sandostatin® LAR® more than doubled time to progression in both functional and nonfunctional disease (14.3 months vs 6.0 months with placebo [P=0.000072]).10

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5. What are the side effects of Sandostatin® LAR® therapy?

Adverse reactions: Very common (≥1/10) adverse drug reactions are diarrhea, abdominal pain, nausea, constipation, flatulence, headache, cholelithiasis, hyperglycemia, and injection site reaction. Common (≥1/100, <1/10) adverse drug reactions are dyspepsia, vomiting, abdominal bloating, steatorrhea, loose stools, discoloration of feces, dizziness, hypothyroidism, thyroid dysfunction (eg, decreased thyroid stimulating hormone [TSH], decreased total T4, and decreased free T4), cholecystitis, biliary sludge, hyperbilirubinemia, hypoglycemia, impaired glucose tolerance, anorexia, asthenia, elevated transaminase levels, pruritus, rash, alopecia, dyspnea, and bradycardia.7

Click here to see additional safety information.

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6. How is the updated Sandostatin® LAR® solution* different from the original presentation?

With the updated solution, there is a 20% reduction in injection volume (2.0 mL vs 2.5 mL/2.0 cc vs 2.5 cc). Also, the flexible warming period (at least 30 to 60 minutes; up to 24 hours) allows for the solution to be brought to room temperature well in advance of administration. If unused within the 24-hour period, it can be re-refrigerated.

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7. What are the advantages of the specially designed vial adapter with the updated formulation*?

The vial adapter simplifies preparation. It connects the vial and syringe and enables the suspension to be mixed with the syringe attached to the vial for easy, fast mixing. Additionally, the vial adapter features an audible click to confirm secure attachment to the vial.

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8. Can the vial be shaken with the updated formulation*?

Yes! The vial must now be shaken for approximately 30 seconds for easy mixing. (Original formulation had to be carefully swirled, not shaken.)

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9. Has the dosing changed with the updated formulation*?

No, the dosing of Sandostatin® LAR® has not changed. Patients receive the same dose of the updated solution that they previously received.

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10. Is the efficacy of the updated formulation* different from the original?

The updated solution of Sandostatin® LAR® has the established efficacy on which you have always relied. It is the same molecule, with the same clinical history as the previous formulation.

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*Not available in all countries. Please consult your local Summary of Product Characteristics.
A head-to-head study vs the previous diluent has not been performed.
Positive results from a Novartis bioequivalence study suggest the efficacy findings are interchangeable between the original and updated Sandostatin® LAR® diluent formulations.

References:
1. Vinik AI, Woltering EA, O’Dorisio TM, Go VLW, Mamikunian G. Neuroendocrine Tumors: A Comprehensive Guide to Diagnosis and Management. 5th ed. Inglewood, CA: Inter Science Institute; 2012. 2. Toth-Fejel S, Pommier RF. Relationships among delay of diagnosis, extent of disease, and survival in patients with abdominal carcinoid tumors. Am J Surg. 2004;187:575-579. 3. Modlin IM, Oberg K, Chung DC, et al. Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol. 2008;9:61-72. 4. Howell DL, O'Dorisio MS. Management of neuroendocrine tumors in children, adolescents, and young adults. J Pediatr Hematol Oncol. 2012;34:S64-S68. 5. Oberg KE. The management of neuroendocrine tumours: current and future medical therapy options. Clin Oncol. 2012;24:282-293. 6. Oberg K, Jelic S; on behalf of the ESMO Guidelines Working Group. Neuroendocrine gastroenteropancreatic tumors: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol. 2008;19(suppl 2):ii104-ii105. 7. Sandostatin® LAR® Summary of Product Characteristics. Novartis Pharma AG. 2016. 8. Plockinger U, Rindi G, Arnold R, et al. Guidelines for the diagnosis and treatment of neuroendocrine gastrointestinal tumours: a consensus statement on behalf of the European Neuroendocrine Tumour Society (ENETS). Neuroendocrinology. 2004;80:394-424. 9. Vinik A, Moattari AR. Use of somatostatin analog in management of carcinoid syndrome. Dig Dis Sci. 1989;34(suppl 3):14S-27S. 10. 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.