title: Outcome and toxicity of salvage therapy with 177Lu-octreotate in patients with metastatic gastroenteropancreatic neuroendocrine tumours.
abstract: OBJECTIVE
  We assessed the outcome and toxicity of salvage therapy (repeat treatment) with (177)Lu-octreotate and high cumulative activities in patients with metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NET).
  
  
  METHODS
  We retrospectively analysed a consecutive cohort of 33 patients with metastatic GEP-NET who underwent salvage peptide receptor radionuclide therapy (PRRT) in our institution. All patients had progressive NET prior to salvage treatment and had shown an initial response to PRRT. The mean cumulative activity was 44.3 GBq (30.0-83.7 GBq). Radiographic response was assessed using CT and/or MRI according to modified SWOG criteria. Toxicity was evaluated using laboratory data, including complete blood counts and renal function tests using CTCAE 3.0. Survival analysis was performed with the Kaplan-Meier curve method and a significance level at p < 0.05.
  
  
  RESULTS
  Radiographic responses consisted of complete response in 1 patient (3.0%), partial response in 6 patients (18.2%), minor response in 1 patient (3.0%), stable disease in 14 patients (42.4%), and progressive disease in 11 patients (33.3%). Median progression-free survival (PFS) from the start of salvage therapy was 13 months (95% CI 9-18) and patients with a history of a durable PFS after initial PRRT tended to have long-lasting PFS after salvage treatment (p = 0.04). None of the patients developed severe nephrotoxicity (grade 3/4) or a myelodysplastic syndrome during follow-up. Relevant albeit reversible haematotoxicity (grade 3/4) occurred in 7 patients (21.2%). The cumulative administered activity was not associated with an increased incidence of haematotoxicity.
  
  
  CONCLUSIONS
  PRRT with (177)Lu-octreotate in the re-treatment setting is safe and effective in patients with metastatic GEP-NET.
authors.affiliation: Department of Nuclear Medicine, University Hospital Bonn, Sigmund-Freud-Str. 25, 53105, Bonn, Germany.
authors.forename: Amir
authors.initials: A
authors.lastname: Sabet
authors.forename: Torjan
authors.initials: T
authors.lastname: Haslerud
authors.forename: Ulrich-Frank
authors.initials: UF
authors.lastname: Pape
authors.forename: Amin
authors.initials: A
authors.lastname: Sabet
authors.forename: Hojjat
authors.initials: H
authors.lastname: Ahmadzadehfar
authors.forename: Frank
authors.initials: F
authors.lastname: Grünwald
authors.forename: Stefan
authors.initials: S
authors.lastname: Guhlke
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Biersack
authors.forename: Samer
authors.initials: S
authors.lastname: Ezziddin
mesh_terms: D000328:Adult; D000368:Aged; D004067:Digestive System Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D064847:Multimodal Imaging; D009362:Neoplasm Metastasis / Q000532:radiotherapy; D018358:Neuroendocrine Tumors / Q000473:pathology / Q000532:radiotherapy*; D015282:Octreotide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D049268:Positron-Emission Tomography; D019275:Radiopharmaceuticals / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D016879:Salvage Therapy; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: C554548:177Lu-octreotate; D019275:Radiopharmaceuticals; D015282:Octreotide
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