title: 177 Lu-Dota-octreotate radionuclide therapy of advanced gastrointestinal neuroendocrine tumors: results from a phase II study.
abstract: OBJECTIVE
  We evaluated the activity and safety profile of (177)Lu-Dotatate peptide receptor radionuclide therapy (Lu-PRRT) in patients with advanced, well-differentiated (G1-G2) gastrointestinal neuroendocrine tumors (GI-NETs).
  
  
  METHODS
  Forty-three patients with radiological tumor progression at baseline and a positive Octreoscan® completed the treatment with Lu-PRRT, resulting in the cumulative activity of 18.5 or 27.8 GBq in five cycles. Total activity was scheduled on the basis of kidney function or bone marrow reserve.
  
  
  RESULTS
  Twenty-five (58 %) patients were treated with a "standard" Lu-PRRT full dosage (FD) of 25.7 GBq (range 22.2-27.8), while the remaining 18 patients (42 %) who, at enrolment, showed a higher probability of developing kidney or bone marrow toxicity received a reduced dosage (RD) of 18.4 GBq (range 14.4-20.4). According to SWOG criteria, the overall response was complete response (CR) in (7 %) cases and stable disease (SD) in 33 (77 %), with a disease control rate (DCR) of 84 %. Median response duration was 25 months (range 7-50). Median progression-free survival (PFS) was 36 months (95 % CI 24-nr), and median overall survival (OS) has not yet been reached. Remarkably, none of the patients, including those at a higher risk of toxicity, showed side-effects after either dosage of Lu-PRRT.
  
  
  CONCLUSIONS
  Lu-PRRT was shown to be an effective therapeutic option in our patients with advanced progressive GI-NETs, showing an 84 % DCR (95 % CI 73-95) that lasted for 25 months and a PFS of 36 months. Both activities of 27.8 GBq and 18.5 GBq proved safe and effective in all patients, including those with a higher probability of developing kidney or bone marrow toxicity.
authors.affiliation: Nuclear Medicine and Radiometabolic Units, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, via P. Maroncelli 40, 47014, Meldola, FC, Italy, giovanni.paganelli@irst.emr.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Paganelli
authors.forename: Maddalena
authors.initials: M
authors.lastname: Sansovini
authors.forename: Alice
authors.initials: A
authors.lastname: Ambrosetti
authors.forename: Stefano
authors.initials: S
authors.lastname: Severi
authors.forename: Manuela
authors.initials: M
authors.lastname: Monti
authors.forename: Emanuela
authors.initials: E
authors.lastname: Scarpi
authors.forename: Caterina
authors.initials: C
authors.lastname: Donati
authors.forename: Annarita
authors.initials: A
authors.lastname: Ianniello
authors.forename: Federica
authors.initials: F
authors.lastname: Matteucci
authors.forename: Dino
authors.initials: D
authors.lastname: Amadori
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018358:Neuroendocrine Tumors / Q000532:radiotherapy*; D015282:Octreotide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009942:Organometallic Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D019275:Radiopharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D009942:Organometallic Compounds; D019275:Radiopharmaceuticals; C447941:lutetium Lu 177 dotatate; D015282:Octreotide