[90Yttrium-DOTA]-TOC Response Is Associated With Survival Benefit in Iodine-Refractory Thyroid Cancer Long-term Results of a Phase 2 Clinical Trial
[90Yttrium-DOTA]-TOC Response Is Associated With Survival Benefit in Iodine-Refractory Thyroid Cancer Long-term Results of a Phase 2 Clinical Trial
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DOI：
10.1002/cncr.24272
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发表时间：
2009-05-15
期刊：
影响因子：
6.2
通讯作者：
Walter, Martin A.
中科院分区：
文献类型：
--
作者：
Iten, Fabienne;Muller, Beat;Walter, Martin A.
背景：作者旨在探讨 (90)Yttrium-1,4,7,10-四氮杂环十二烷 N,N',N '',N'''-四乙酸 [Y-90-DOTA]-Tyr(3)-奥曲肽 (TOC) 在晚期碘难治性甲状腺癌中的疗效。方法：在一项 2 期试验中，作者研究了转移性碘难治性甲状腺癌全身 [Y-90-DOTA]-TOC 治疗的生化反应（通过血清甲状腺球蛋白水平评估）、生存率和长期安全性。根据国家癌症研究所的标准评估不良事件。使用多元回归模型进行生存分析。结果：共有 24 名患者入组。施用的中位累积活动为 13.0 GBq（范围为 1.7-30.3 GBq）。 7 名 (29.2%) 患者出现缓解。 8 名（33.3%）患者出现 1-3 级血液毒性，4 名（16.7%）患者出现 1-4 级肾毒性。从诊断时起中位生存期为 33.4 个月（范围为 3.6-126.8 个月），从首次 [Y-90-DOTA]-TOC 治疗时起中位生存期为 16.8 个月（范围为 1.8-99.1 个月）。对治疗的反应与从诊断时起（风险比 [HR]，0.17；95% 置信区间 [CI]，0.03-0.92；P = .04）和从首次 [Y-90-DOTA]-TOC 治疗时起（HR，0.20；95% CI，0.04-0.94；P = .04）的较长生存期相关。闪烁扫描肿瘤摄取的视觉分级与治疗反应无关（比值比 [OR]，0.98；95% CI，0.26-3.14；P = 1.00）。结论：转移性碘难治性甲状腺癌对 [90Y-DOTA]-TOC 的反应与较长的生存期相关。即将进行的试验应旨在增加治疗周期的数量。癌症 2009；115：2052-62。 (C) 2009 年美国癌症协会。
BACKGROUND: The authors aimed to explore the efficacy of (90)Yttrium-1,4,7,10-tetra-azacyclododecane N,N',N '',N'''-tetraacetic acid [Y-90-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 [Y-90-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 [Y-90-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 [Y-90-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 [90Y-DOTA]-TOC in metastasized iodine-refractory thyroid cancer was associated with longer survival. Upcoming trials should aim to increase the number of treatment cycles. Cancer 2009;115:2052-62. (C) 2009 American Cancer Society.