Response to Sorafenib at a Low Dose in Patients with Radioiodine-Refractory Pulmonary Metastases from Papillary Thyroid Carcinoma
Response to Sorafenib at a Low Dose in Patients with Radioiodine-Refractory Pulmonary Metastases from Papillary Thyroid Carcinoma
复制标题
甲状腺乳头状癌放射性碘难治性肺转移患者对低剂量索拉非尼的反应
DOI：
10.1089/thy.2010.0199
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发表时间：
2011-02-01
期刊：
影响因子：
6.6
通讯作者：
Zhu, Ruisen
中科院分区：
文献类型：
--
作者：
Chen, Libo;Shen, Yan;Zhu, Ruisen
背景：索拉非尼已显示出治疗晚期或转移性甲状腺癌的前景。然而，最佳剂量尚未确定，中国人群的数据不可用。我们进行了一项研究，以评估索拉非尼在低剂量的200毫克，每天两次的患者进行性放射性碘难治性肺转移乳头状甲状腺癌（PTC）的反应和方法：符合条件的患者接受索拉非尼200毫克口服，每天两次。使用实体瘤疗效评价标准评估疗效，并定期评估不良事件。终点包括反应率和无进展生存率。结果：9例放射性碘难治性PTC患者参加了这项研究，治疗至少13周。客观部分缓解率为33%。病情稳定率为44%。平均无进展生存期为42周（95%置信区间，29.5 - 53.9）。2例患者出现疾病进展，其中1例在治疗开始后4个月死亡。治疗开始后，血清甲状腺球蛋白水平发生了显著而迅速的变化，12周内平均下降60%，与放射学结果一致。虽然毒性类型与其他索拉非尼试验一致，但其严重程度相对较轻。没有患者停止索拉非尼或减少其剂量，因为治疗相关的不良事件。结论：索拉非尼在200 mg，每日两次的剂量有潜在的治疗效果，并在中国PTC和放射性碘难治性肺转移瘤患者的耐受性良好。需要对更大的患者队列进行进一步研究。
Background: Sorafenib has shown promise in the treatment of patients with advanced or metastatic thyroid carcinoma. However, the optimal dose has not been established and data on Chinese population are not available. We conducted a study to assess the responses to sorafenib at a low dose of 200 mg twice daily in patients with progressive radioiodine-refractory pulmonary metastases from papillary thyroid carcinoma (PTC).Patients and Methods: Eligible patients received sorafenib 200 mg orally twice daily. Responses were assessed using Response Evaluation Criteria in Solid Tumors and adverse events were assessed periodically. The end points included response rate and progression-free survival.Results: Nine patients with radioiodine-refractory PTC were enrolled in the study and treated for a minimum of 13 weeks. The objective partial response rate was 33%. The stable disease rate was 44%. The mean progression-free survival was 42 weeks (95% confidence interval, 29.5 to 53.9). Two patients showed disease progression, and one of them died at 4 months after beginning of treatment. There was a marked and rapid change in the serum thyroglobulin level after start of treatment, with a mean decrease of 60% within 12 weeks, consistent with radiographic findings. Although the types of toxicities were consistent with other sorafenib trials, their severity was relatively mild. None of the patients discontinued sorafenib or reduced their dose because of treatment-related adverse events.Conclusion: Sorafenib at a dose of 200 mg twice daily has a potential therapeutic effect and is well tolerated in Chinese patients with PTC and radioiodine-refractory pulmonary metastases. Further study is warranted with a larger cohort of patients.