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Pancreas. 2014 May;43(4):518-25. doi: 10.1097/MPA.0000000000000113.

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

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From the *Excel Diagnostics and Nuclear Oncology Center, Houston, TX; †RadioMedix, Inc, Houston, TX; ‡Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, Los Angeles, CA; §Physics Services Inc, Metairie, LA; ∥BioSynthema Inc, St Louis, MO; ¶Department of Internal Medicine, Holden Comprehensive Cancer Center, University of Iowa Health Care, Iowa City, IA; #Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center, Tampa, FL; **IsoTherapeutics Group, Angleton, TX; ††Certus International, Inc, St Louis, MO; ‡‡Iso-Tex Diagnostics, Inc, Friendswood, TX; and §§Department of Nuclear Medicine, Erasmus Medical Center, Rotterdam, the Netherlands.



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.


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%).


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.


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.

[Indexed for MEDLINE]

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