title: Response to [90Yttrium-DOTA]-TOC treatment is associated with long-term survival benefit in metastasized medullary thyroid cancer: a phase II clinical trial.
abstract: OBJECTIVE
  We aimed to explore the efficacy of (90)Yttrium-1,4,7,10-tetra-azacyclododecane N,N',N'',N-'''-tetraacetic acid ((90)Y-DOTA)-Tyr(3)-octreotide (TOC) therapy in advanced medullary thyroid cancer.
  
  
  METHODS
  In a phase II trial, we investigated the response, survival, and long-term safety profile of systemic [(90)Y-DOTA]-TOC treatment in metastasized medullary thyroid cancer. Adverse events were assessed according to the criteria of the National Cancer Institute. Survival analyses were done using multiple regression models.
  
  
  RESULTS
  Thirty-one patients were enrolled. A median cumulative activity of 12.6 GBq (range, 1.7-29.6 GBq) of [(90)Y-DOTA]-TOC was administered. Response was found in nine patients (29.0%). Four patients (12.9%) developed hematologic toxicities and seven patients (22.6%) developed renal toxicities. Response to treatment was associated with longer survival from time of diagnosis (hazard ratio, 0.20; 95% confidence interval, 0.05-0.81; P = 0.02) and from time of first [(90)Y-DOTA]-TOC therapy (hazard ratio, 0.16; 95% confidence interval, 0.04-0.63; P = 0.009). The visual grade of scintigraphic tumor uptake was not associated with treatment response or survival.
  
  
  CONCLUSIONS
  Response to [(90)Y-DOTA]-TOC therapy in metastasized medullary thyroid cancer is associated with a long-term survival benefit. Treatment should be considered independently from the result of the pretherapeutic scintigraphy.
authors.affiliation: Institute of Nuclear Medicine, Division of Endocrinology, Diabetology, and Clinical Nutrition, University Hospital Basel, University of Basel, Petersgraben 4, Basel, Switzerland.
authors.forename: Fabienne
authors.initials: F
authors.lastname: Iten
authors.forename: Beat
authors.initials: B
authors.lastname: Müller
authors.forename: Christian
authors.initials: C
authors.lastname: Schindler
authors.forename: Christoph
authors.initials: C
authors.lastname: Rochlitz
authors.forename: Daniel
authors.initials: D
authors.lastname: Oertli
authors.forename: Helmut R
authors.initials: HR
authors.lastname: Mäcke
authors.forename: Jan
authors.initials: J
authors.lastname: Müller-Brand
authors.forename: Martin A
authors.initials: MA
authors.lastname: Walter
mesh_terms: D000328:Adult; D000368:Aged; D018276:Carcinoma, Medullary / Q000401:mortality / Q000532:radiotherapy* / Q000556:secondary; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019275:Radiopharmaceuticals / Q000627:therapeutic use*; D016019:Survival Analysis; D013964:Thyroid Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*
chemical_list: D019275:Radiopharmaceuticals; C496730:90Y-octreotide, DOTA-Tyr(3)-; D015282:Octreotide