title: 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.affiliation: 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.
authors.forename: Ebrahim S
authors.initials: ES
authors.lastname: Delpassand
authors.forename: Amin
authors.initials: A
authors.lastname: Samarghandi
authors.forename: Sara
authors.initials: S
authors.lastname: Zamanian
authors.forename: Edward M
authors.initials: EM
authors.lastname: Wolin
authors.forename: Mohammadali
authors.initials: M
authors.lastname: Hamiditabar
authors.forename: Gregory D
authors.initials: GD
authors.lastname: Espenan
authors.forename: Jack L
authors.initials: JL
authors.lastname: Erion
authors.forename: Thomas M
authors.initials: TM
authors.lastname: O'Dorisio
authors.forename: Larry K
authors.initials: LK
authors.lastname: Kvols
authors.forename: Jaime
authors.initials: J
authors.lastname: Simon
authors.forename: Robert
authors.initials: R
authors.lastname: Wolfangel
authors.forename: Arthur
authors.initials: A
authors.lastname: Camp
authors.forename: Eric P
authors.initials: EP
authors.lastname: Krenning
authors.forename: Alireza
authors.initials: A
authors.lastname: Mojtahedi
mesh_terms: D000328:Adult; D000368:Aged; D004067:Digestive System Neoplasms / Q000378:metabolism / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D018450:Disease Progression; D019583:Dose Fractionation, Radiation; D005260:Female; D019788:Fluorodeoxyglucose F18; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D064847:Multimodal Imaging; D060787:Neoplasm Grading; D018358:Neuroendocrine Tumors / Q000378:metabolism / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary; D015282:Octreotide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009942:Organometallic Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D049268:Positron-Emission Tomography; D011237:Predictive Value of Tests; D011788:Quality of Life; D019275:Radiopharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D017481:Receptors, Somatostatin / Q000378:metabolism*; D013781:Texas; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D009942:Organometallic Compounds; D019275:Radiopharmaceuticals; D017481:Receptors, Somatostatin; D019788:Fluorodeoxyglucose F18; C447941:lutetium Lu 177 dotatate; D015282:Octreotide