Response to [90Yttrium-DOTA]-TOC treatment is associated with long-term survival benefit in metastasized medullary thyroid cancer: a phase II clinical trial.
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.
Iten
Fabienne
F
Institute of Nuclear Medicine, Division of Endocrinology, Diabetology, and Clinical Nutrition, University Hospital Basel, University of Basel, Petersgraben 4, Basel, Switzerland.
Müller
Beat
B
Schindler
Christian
C
Rochlitz
Christoph
C
Oertli
Daniel
D
Mäcke
Helmut R
HR
Müller-Brand
Jan
J
Walter
Martin A
MA
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*
D019275:Radiopharmaceuticals; C496730:90Y-octreotide, DOTA-Tyr(3)-; D015282:Octreotide