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Donafenib in Progressive Locally Advanced or Metastatic Radioactive Iodine-Refractory Differentiated Thyroid Cancer: Results of a Randomized, Multicenter Phase II Trial.
Lin, YS, Yang, H, Ding, Y, Cheng, YZ, Shi, F, Tan, J, Deng, ZY, Chen, ZD, Wang, RF, Ji, QH, et al
Thyroid : official journal of the American Thyroid Association. 2021;(4):607-615
Abstract
Background: An unmet need for more effective and affordable kinase inhibitors remains in patients with progressive radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC) in China, where only sorafenib is approved for this indication. This study evaluated the 24-week objective response rate (ORR) to donafenib-a new, domestic multikinase inhibitor-in the treatment of locally advanced or metastatic RAIR-DTC in patients with measurable lesions. Two dose regimens (300 mg twice daily vs. 200 mg twice daily) were used to determine its optimal dosage and safety for further phase III studies. Methods: This study was a randomized, open-label, multicenter phase II trial. Thirty-five adult RAIR-DTC patients with at least one measurable targeted lesion according to RECIST 1.1 were enrolled from 12 centers in China and randomized to receive either 200 mg (17 patients) or 300 mg (18 patients) of donafenib orally twice daily for 24 weeks. The primary endpoint was ORR, and the secondary endpoints included progression-free survival (PFS) among others. Additionally, biochemical (serum thyroglobulin) and structural (total tumor diameter [TTD]) responses were assessed, change (ΔTTD) rates were calculated, and safety was evaluated. Results: The ORRs for the 200- and 300-mg arms were 12.5% and 13.33% (p = 1.000), respectively. The 300-mg arm had a nonsignificant, longer median PFS than the 200-mg arm (14.98 months vs. 9.44 months) (p = 0.351). There was a trend toward more tumor shrinkage in the 300-mg arm compared with the 200-mg arm (average ΔTTD rate -0.52 ± 0.71 vs. -0.04 ± 1.55 mm/month, p = 0.103). Most treatment-related adverse events (AEs) in both arms were grades 1-2. The most common grade 3 treatment-related AEs in both arms were palmar-plantar erythrodysesthesia and hypertension; the sum occurrence rates of these two AEs in the 200-mg and 300-mg arms were 11.43% and 22.86%, respectively. Conclusions: Donafenib was generally well tolerated. Both donafenib regimens demonstrated similar efficacy in terms of the ORR in locally advanced or metastatic RAIR-DTC. The results warrant further studies on donafenib as a new, feasible treatment option for RAIR-DTC patients. Clinical Trials.gov IDs: NCT02870569; CTR20160220.
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Blood prognostic predictors of treatment response for patients with papillary thyroid cancer.
Liu, X, Huang, Z, He, X, Zheng, X, Jia, Q, Tan, J, Fan, Y, Lou, C, Meng, Z
Bioscience reports. 2020;(10)
Abstract
BACKGROUND Papillary thyroid cancer (PTC) is a very common malignant disease with high morbidity. We needed some pretreatment indicators to help us predict prognosis and guide treatment. We conducted a study about some pretreatment prognostic indicators. METHODS This clinical study recruited 705 postoperative PTC patients (211 males, 494 females). Clinical data before radioactive iodine (RAI) treatment were collected. Patients' response to therapy were classified into two categories: 'Good Prognosis Group' (GPG) and 'Poor Prognosis Group' (PPG), according to '2015 American Thyroid Association Guidelines'. Differences of indicators between different prognosis groups were compared. Odds ratios (ORs) were calculated by univariate/multiple binary logistic regression models. Difference of body mass index (BMI) changes before and after RAI treatment between different prognosis groups was also compared. RESULTS A total of 546 (77.45%) belonged to GPG, and 159 (22.55%) belonged to PPG. Platelet (PLT), neutrophil (NEUT), PLT subgroups, and combination of red blood cell distribution width (RDW) and BMI (COR-BMI) were different between two prognosis groups. The significance of the difference between the two groups of BMI disappeared after the Bonferroni correction. PLT and PLT subgroups had detrimental effects on the risk of PPG; T stage had a positive effect on the risk of PPG. PLT subgroup showed a detrimental effect on the risk of PPG when we included additional covariates. CONCLUSIONS We found that lower pretreatment PLT levels may indicate a poor prognosis for PTC. The relationship between platelet-derived growth factor (PDGF) and radiation sensitivity may be the key to this association.
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Different Radioiodine Dose for Remnant Thyroid Ablation in Patients With Differentiated Thyroid Cancer: A Meta-analysis.
Song, X, Meng, Z, Jia, Q, Zhang, L, Xu, K, Tan, J, Zhang, G, Zheng, W, Li, X, Zhang, J
Clinical nuclear medicine. 2015;(10):774-9
Abstract
OBJECTIVE Remnant thyroid ablation is crucial in the management of patients with differentiated thyroid cancer. However, the optimal dose of radioactive I for ablation is still controversial. This study aimed to compare the success rate of different activities of I for postoperative remnant ablation in randomized controlled trials (RCTs) and to determine the optimal dose. PATIENTS AND METHODS Sources were retrieved from the Cochrane Library, Medline, Embase, Scopus, and Google Scholar until March 2014. All RCTs that assessed the efficacy of different doses of I for ablation were selected. After data extraction, statistics were performed by Review Manager 5.2 software. RESULTS Seventeen RCTs were considered eligible, involving 3737 patients. The overall methodological quality of the studies was good. The rate of successful remnant ablation of low versus moderate I activities (risk ratio [RR], 0.89; 95% confidence interval [CI], 0.80-1.00; P = 0.06) and moderate versus high I activities (RR, 0.94; 95% CI, 0.89-1.00; P = 0.05) showed no significant differences. However, high I activities had 11% higher successful ablation rate than low activities with an RR of 0.89 (95% CI, 0.81-0.97; P = 0.008), which was significant. CONCLUSIONS We summarized all available randomized evidence to demonstrate that high dose of I was significantly better than low dose to achieve successful remnant thyroid ablation.
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Clinical investigations on the spinal osteoblastic metastasis treated by combination of percutaneous vertebroplasty and (125)I seeds implantation versus radiotherapy.
Yang, Z, Tan, J, Zhao, R, Wang, J, Sun, H, Wang, X, Xu, L, Jiang, H, Zhang, J
Cancer biotherapy & radiopharmaceuticals. 2013;(1):58-64
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Abstract
To investigate the clinical efficacy of combining digital subtraction angiography-guided percutaneous vertebroplasty (PVP) and (125)I seeds implantation for the treatment of spinal osteoplastic metastasis. A combination of PVP and (125)I implantation was conducted for 50 patients with spinal osteoplastic metastasis, while the other 50 patients who received regular radiation therapy were used as a comparison. Visual analogue pain scale (VAS) and score of life quality (EORTCQLQ-30) were determined for all the patients. Surgery was successful in 89 spinal segments of vertebral body in 50 patients. Each segment of vertebral body was injected with 1-5 mL (2.8 mL for thoracic and 3.1 mL for lumbar vertebral body on average) of bone cement. Postoperative X-ray and CT examination showed that all the patients in the PVP group achieved spinal stability. During the follow-up examination from 6 months to 5 years, 49 patients (98.0%) had significantly relieved back pain, and only 1 case (2.0%) had no obvious improvement. Postoperative VAS score and Karnofsky performance score (KPS) were significantly different from the preoperative scores (p<0.05); and compared to the regular treatment group, PVP combined (125)I seeds showed much better clinical efficacy (p<0.05). PVP is a minimally invasive treatment with easy operation and less complications. PVP can effectively relieve the pain, stabilize the spine, improve the life quality, and reduce the occurrence of paraplegia in patients with spinal osteoplastic metastasis. Utilization of (125)I seeds with PVP can enhance the clinical efficacy.