[(90)Yttrium-DOTA]-TOC response is associated with survival benefit in iodine-refractory thyroid cancer: long-term results of a phase 2 clinical trial.

Abstract

BACKGROUND:

The authors 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) in advanced iodine-refractory thyroid cancer.

METHODS:

In a phase 2 trial, the authors investigated biochemical response (assessed by serum thyroglobulin levels), survival, and the long-term safety profile of systemic [(90)Y-DOTA]-TOC treatment in metastasized iodine-refractory thyroid cancer. Adverse events were assessed according to the National Cancer Institute criteria. Survival analyses were performed by using multiple regression models.

RESULTS:

A total of 24 patients were enrolled. A median cumulative activity of 13.0 GBq (range, 1.7-30.3 GBq) was administered. Response was found in 7 (29.2%) patients. Eight (33.3%) patients developed hematologic toxicity grade 1-3, and 4 (16.7%) patients developed renal toxicity grade 1-4. The median survival was 33.4 months (range, 3.6-126.8 months) from time of diagnosis and 16.8 months (range, 1.8-99.1 months) from time of first [(90)Y-DOTA]-TOC treatment. Response to treatment was associated with longer survival from time of diagnosis (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.03-0.92; P = .04) and from time of first [(90)Y-DOTA]-TOC therapy (HR, 0.20; 95% CI, 0.04-0.94; P = .04). The visual grade of scintigraphic tumor uptake was not associated with treatment response (odds ratio [OR], 0.98; 95% CI, 0.26-3.14; P = 1.00).

CONCLUSIONS:

Response to [(90)Y-DOTA]-TOC in metastasized iodine-refractory thyroid cancer was associated with longer survival. Upcoming trials should aim to increase the number of treatment cycles.

• Authors: Fabienne Iten, Beat Muller, Christian Schindler, Helmut Rasch, Christoph Rochlitz, Daniel Oertli, Helmut R Maecke, Jan Muller-Brand, Martin A Walter
• Journal: Cancer (Cancer) Vol. 115 Issue 10 Pg. 2052-62 (May 15 2009) ISSN: 0008-543X [Print] United States
• PMID: 19280592 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Heterocyclic Compounds
• Iodine Radioisotopes
• Organometallic Compounds
• yttrium(III)-1,4,7,10-tetraazacyclotetradecane-N,N',N'',N'''-tetraacetic acid
• Thyroglobulin
• Iodine

Topics

• Adult
• Aged
• Aged, 80 and over
• Drug Resistance, Neoplasm
• Female
• Heterocyclic Compounds (adverse effects, therapeutic use)
• Humans
• Iodine (therapeutic use)
• Iodine Radioisotopes (therapeutic use)
• Male
• Middle Aged
• Organometallic Compounds (adverse effects, therapeutic use)
• Thyroglobulin (blood)
• Thyroid Neoplasms (drug therapy, mortality)