Peptide receptor radionuclide therapy with 177Lu-DOTATATE for patients with somatostatin receptor-expressing neuroendocrine tumors: the first US phase 2 experience.

Abstract

OBJECTIVE:

Peptide receptor radionuclide therapy with radiolabeled somatostatin analogs is a novel method of treatment in patients with metastatic neuroendocrine tumors (NETs). For the first time in the United States, we present preliminary results of the treatment with Lutetium (177)(Lu) DOTATATE in patients with progressive NETs.

METHODS:

Thirty-seven patients with grade 1 and grade 2 disseminated and progressive gastroenteropancreatic NET were enrolled in a nonrandomized, phase 2 clinical trial. Repeated cycles of 200 mCi (7.4 GBq; ±10%) were administered up to the cumulative dose of 800 mCi (29.6 GBq; ±10%).

RESULTS:

Among 32 evaluable patients, partial response and minimal response to treatment were seen in 28% and 3%, respectively, and stable disease was seen in 41% of patients. A total of 28% had progressive disease. A response to treatment was significantly associated with lower burden of disease in the liver. No significant acute or delayed hematologic or kidney toxicity was observed. An impressive improvement of performance status and quality of life were seen after Lu-DOTATATE therapy.

CONCLUSIONS:

Treatment with multiple cycles of (177)Lu-DOTATATE peptide receptor radionuclide therapy is well tolerated. This treatment results in control of the disease in most patients, whereas systemic toxicities are limited and reversible. Quality of life is also improved.

• Authors: Ebrahim S Delpassand, Amin Samarghandi, Sara Zamanian, Edward M Wolin, Mohammadali Hamiditabar, Gregory D Espenan, Jack L Erion, Thomas M O'Dorisio, Larry K Kvols, Jaime Simon, Robert Wolfangel, Arthur Camp, Eric P Krenning, Alireza Mojtahedi
• Journal: Pancreas (Pancreas) Vol. 43 Issue 4 Pg. 518-25 (May 2014) ISSN: 1536-4828 [Electronic] United States
• PMID: 24632546 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Organometallic Compounds
• Radiopharmaceuticals
• Receptors, Somatostatin
• Fluorodeoxyglucose F18
• lutetium Lu 177 dotatate
• Octreotide

Topics

• Adult
• Aged
• Digestive System Neoplasms (metabolism, mortality, pathology, radiotherapy)
• Disease Progression
• Dose Fractionation, Radiation
• Female
• Fluorodeoxyglucose F18
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Multimodal Imaging
• Neoplasm Grading
• Neuroendocrine Tumors (metabolism, mortality, radiotherapy, secondary)
• Octreotide (adverse effects, analogs & derivatives, therapeutic use)
• Organometallic Compounds (adverse effects, therapeutic use)
• Positron-Emission Tomography
• Predictive Value of Tests
• Quality of Life
• Radiopharmaceuticals (adverse effects, therapeutic use)
• Receptors, Somatostatin (metabolism)
• Texas
• Time Factors
• Tomography, X-Ray Computed
• Treatment Outcome