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

Authors' Affiliations: ¹ Institute of Nuclear Medicine, ² Division of Endocrinology, Diabetology, and Clinical Nutrition, Departments of ³ Oncology and ⁴ Surgery, ⁵ Division of Radiological Chemistry, University Hospital Basel, and ⁶ Institute of Social and Preventive Medicine, University of Basel, Switzerland

Requests for reprints: Martin A. Walter, Institute of Nuclear Medicine, University Hospital, Petersgraben 4, CH-4031 Basel, Switzerland. Phone: 41-61-265-5684; Fax: 41-61-265-4897; E-mail: m.a.walter{at}gmx.net.

Purpose: We aimed to explore the efficacy of ⁹⁰Yttrium–1,4,7,10-tetra-azacyclododecane N,N',N'',N-'''-tetraacetic acid (⁹⁰Y-DOTA)–Tyr³-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 [⁹⁰Y-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 [⁹⁰Y-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 [⁹⁰Y-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 [⁹⁰Y-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.