舒尼替尼诱导的甲状腺功能减退是否是转移性肾细胞癌患者更好反应的预测性临床标志物？

Is sunitinib-induced hypothyroidism a predictive clinical marker for better response in metastatic renal cell carcinoma patients?

作者信息

Bozkurt Oktay, Karaca Halit, Hacıbekiroglu Ilhan, Kaplan Muhammed Ali, Duzkopru Yakup, Uysal Mukremin, Berk Veli, Inanc Mevlude, Duran Ayse Ocak, Ozaslan Ersin, Ucar Mahmut, Ozkan Metin

机构信息

a Department of Medical Oncology , Erciyes University Faculty of Medicine , Kayseri , Turkey.

b Department of Medical Oncology , Trakya University Faculty of Medicine , Edirne , Turkey.

出版信息

J Chemother. 2016 Jun;28(3):230-4. doi: 10.1179/1973947815Y.0000000039. Epub 2016 May 30.

DOI:10.1179/1973947815Y.0000000039

PMID:25948423

Abstract

BACKGROUND

The main goal of this study was to examine whether the occurrence of hypothyroidism during sunitinib therapy in patients with metastatic renal cell carcinoma (mRCC) is associated with a better outcome.

METHODS

The study enrolled 81 patients with pathologically proven mRCC who were treated with sunitinib between March 2008 and June 2013.Thyroid function evaluation comprised (free-thyroxine) FT4 and thyroid-stimulating hormone (TSH) before treatment and at day 1 of each 6-week cycle. Survival analysis was performed using the Kaplan-Meier method, and the differences among the groups were determined using the log-rank test.

RESULTS

Hypothyroidism occurred in 30 (37%) of 81 patients within a median 3 months (range 1-18) of treatment initiation. There was a statistically significant correlation between the occurrence of hypothyroidism during treatment and the rate of objective remission (ORR) (hypothyroid patients vs euthyroid patients: 46.7 vs 13.7%, respectively; P = 0.001). Median progression-free survival (PFS) was 10 (95% CI 6.13-13.8) months in the euthyroid patients, and 17 (95% CI 9.33-24.6) months in the hypothyroid patients (P = 0.001). The median overall survival (OS) was 39 (95% CI 25.4-52.5) months in the hypothyroid patients and 20 (95% CI 14.7-25.2) months in the euthyroid patients (P = 0.019).

CONCLUSIONS

The occurrence of hypothyroidism during treatment in patients was significantly associated with longer PFS, OS and better ORR in the current study.

摘要

背景

本研究的主要目的是探讨转移性肾细胞癌（mRCC）患者在接受舒尼替尼治疗期间发生甲状腺功能减退是否与更好的预后相关。

方法

本研究纳入了81例经病理证实的mRCC患者，这些患者于2008年3月至2013年6月期间接受舒尼替尼治疗。甲状腺功能评估包括治疗前以及每6周周期第1天的游离甲状腺素（FT4）和促甲状腺激素（TSH）。采用Kaplan-Meier方法进行生存分析，并使用对数秩检验确定组间差异。

结果

81例患者中有30例（37%）在开始治疗的中位3个月（范围1 - 18个月）内发生甲状腺功能减退。治疗期间甲状腺功能减退的发生与客观缓解率（ORR）之间存在统计学显著相关性（甲状腺功能减退患者与甲状腺功能正常患者的ORR分别为46.7%和13.7%；P = 0.001）。甲状腺功能正常患者的中位无进展生存期（PFS）为10个月（95%置信区间6.13 - 13.8），甲状腺功能减退患者为17个月（95%置信区间9.33 - 24.6）（P = 0.001）。甲状腺功能减退患者的中位总生存期（OS）为39个月（95%置信区间25.4 - 52.5），甲状腺功能正常患者为20个月（95%置信区间14.7 - 25.2）（P = 0.019）。