Recombinant human thyroid-stimulating hormone for post-operative assessment in patients with low- to intermediate-risk differentiated thyroid cancer: results of phase Ⅰ study
10.3760/cma.j.cn321828-20201211-00442
- VernacularTitle:重组人促甲状腺激素用于低中危分化型甲状腺癌患者的术后评估：Ⅰ期临床研究报告
- Author:
Yansong LIN
1
;
Hui YANG
;
Xiaoyi LI
;
Liqing WU
;
Bin ZHANG
;
Yingqiang ZHANG
;
Kai CHEN
;
Zhuanzhuan MU
;
Jianmin JIA
;
Na NIU
;
Di SUN
;
Xin ZHANG
;
Baoxia HE
Author Information
1. 中国医学科学院、北京协和医学院北京协和医院核医学科、核医学分子靶向诊疗北京市重点实验室，北京 100730
- Keywords:
Thyroid neoplasms;
Thyrotropin alfa;
Thyrotropin;
Thyroglobulin;
Radionuclide imaging
- From:
Chinese Journal of Nuclear Medicine and Molecular Imaging
2022;42(2):84-89
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the efficacy by using domestic recombinant human thyroid-stimulating hormone (rhTSH) in patients with differentiated thyroid cancer (DTC) before or after 131I therapy. Methods:From May 2019 to November 2020, a total of 24 patients with DTC (5 males, 19 females, median age 41 years) in Peking Union Medical College Hospital and Affiliated Tumor Hospital of Zhengzhou University were enrolled into the open-label, dose escalation phase Ⅰ study. All patients were divided into 4 domestic rhTSH dose groups: 0.9 mg×1 d (group A), 0.9 mg×2 d (group B), 1.8 mg×1 d (group C), 1.8 mg×2 d (group D) in succession, with 6 patients in each group. Each patient underwent rhTSH phase and thyroid hormone withdrawal (THW) phase. The end point included safety, tolerability, the quality of life (hypothyroidism symptom and sign score (Billewicz score), profile of mood states (POMS)), effectiveness (thyroid-stimulating hormone (TSH) and thyroglobulin (Tg) levels, diagnostic whole-body scan (Dx-WBS)) and pharmacokinetic characteristics (peak time, peak concentration) of rhTSH. Paired t test and Wilcoxon signed rank test were used for statistical analysis. Results:There were no dose-limiting toxicities, serious adverse events, or no grade ≥3 adverse events reported. The quality of life in rhTSH phase was significantly better than those in THW phase, including the lower Billewicz score (-53.00(-53.00, -53.00) vs -39.50(-47.00, -23.00); S=119.50, P<0.001) and the lower POMS score (91.92±12.06 vs 99.67±19.13; t=0.95, P=0.025). Serum TSH level was increased from 0.04(0.02, 0.11) mU/L (baseline) to 150.00(105.20, 173.31) mU/L 24 h after the last rhTSH administration, which was increased along with the elevation of rhTSH doses. In the THW phase, patients′ TSH levels were≥30 mU/L after 23 d (median) of THW, with the median of 73.51(57.22, 106.22) mU/L. Median Tg level of baseline was 0.10(0.10, 0.41) μg/L, which reached a peak of 0.85(0.12, 3.01) μg/L at 48 h after rhTSH administration. The peak Tg level in the THW phase was 0.88(0.15, 8.04) μg/L. The Dx-WBS consistency rate between rhTSH and THW phase was 95.8%(23/24). Conclusion:rhTSH is a safe and effective method to stimulate the serum Tg level and radioiodine uptake in patients undergoing post-operation or post- 131I assessment for DTC, as well as maintain a higher quality of life in comparison to THW phase.
