Survival prognosis analysis of Donafenib adjuvant therapy for radioactive iodine-refractory differentiated thyroid cancer
10.3760/cma.j.cn321828-20241113-00393
- VernacularTitle:多纳非尼辅助治疗碘难治性分化型甲状腺癌的生存预后分析
- Author:
Xianmin DING
1
;
Xin ZHANG
;
Xing MA
;
Si ZHOU
;
Deyu LI
;
Wenliang LI
;
Yansong LIN
;
Hui YANG
Author Information
1. 郑州大学附属肿瘤医院、河南省肿瘤医院核医学科，郑州 450008
- Publication Type:Journal Article
- Keywords:
Thyroid neoplasms;
Tyrosine kinase inhibitors;
Pyridines;
Treatment outcome;
Donafenib
- From:
Chinese Journal of Nuclear Medicine and Molecular Imaging
2025;45(12):738-743
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To report the follow-up status of patients participating phase Ⅲ clinical trial (ZGDD3) of Donafenib tosilate (abbreviated as Donafenib) in the treatment of progressive radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC), and to explore its efficacy, safety and prognostic factors.Methods:This study was a randomized controlled trial, and the clinicopathological data and follow-up results of 29 patients (16 males, 13 females, age 40-68 years) who participated in the clinical trial ZGDD3 between August 2018 and March 2021 were analyzed. Patients were divided into Donafenib group and placebo group using the central dynamic randomization method with the ratio of 2∶1. Adverse reactions (AE) during the trial were observed. Independent-sample t test, Mann-Whitney U test and Fisher exact test were used to analyze the differences of baseline characteristics between the two groups. Progression-free survival (PFS) and overall survival (OS) were followed up. Kaplan-Meier method was used to draw the survival curve (log-rank test) and Cox regression analysis was used to analyze the prognostic factors. Results:There were 22 patients in Donafenib group and 7 patients in placebo group. There were no significant differences of baseline characteristics between the two groups ( t values: -0.68, Z values: from -1.47 to -0.56, all P>0.05). The follow-up was 32.07(21.07, 49.85) months. During the trial, drug-related AEs occurred in all patients in Donafenib group, mostly was grade Ⅰ-Ⅱ, no grade Ⅳ or Ⅴ AEs were found. The median PFS was significantly longer in Donafenib group than that in placebo group (13.23 vs 4.03 months; χ2=9.68, P=0.002), and the median OS was 55.00 and 24.30 months respectively ( χ2=2.07, P=0.150). Metastasis to less common sites was the independent risk factor for OS (hazard ratio ( HR)=6.789, 95% CI: 1.272-36.246, P=0.025). Conclusions:Donafenib shows good clinical application in the treatment of RAIR-DTC, demonstrating good safety and efficacy. Metastasis to less common sites is closely related to OS.
