Response to [90Yttrium-DOTA]-TOC Treatment is Associated with Long-term Survival Benefit in Metastasized Medullary Thyroid Cancer: A Phase II Clinical Trial

• Published in: Clinical cancer research Vol. 13; no. 22; pp. 6696 - 6702
• Main Authors: ITEN, Fabienne, MÜLLER, Beat, SCHINDLER, Christian, ROCHLITZ, Christoph, OERTLI, Daniel, MÄCKE, Helmut R, MÄLLER-BRAND, Jan, WALTER, Martin A
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA American Association for Cancer Research 15-11-2007
• Subjects: Adult; Aged; Antineoplastic agents; Biological and medical sciences; Carcinoma, Medullary - mortality; Carcinoma, Medullary - radiotherapy; Carcinoma, Medullary - secondary; Clinical Protocols; DOTA; Female; Humans; Male; Medical sciences; medullary thyroid cancer; Middle Aged; Octreotide - adverse effects; Octreotide - analogs & derivatives; Octreotide - therapeutic use; Pharmacology. Drug treatments; Radiopharmaceuticals - therapeutic use; somatostatin; survival; Survival Analysis; Thyroid Neoplasms - mortality; Thyroid Neoplasms - pathology; Thyroid Neoplasms - radiotherapy; TOC; Endocrinopathy; Human; Thyroid cancer; Treatment; Thyroid diseases; Phase II trial; Advanced stage; Malignant tumor; Long term; Survival; Cancer
• ISSN: 1078-0432; 1557-3265
• DOI: 10.1158/1078-0432.CCR-07-0935

Purpose: 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.
Experimental Design: 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.