晚期转移分化型甲状腺癌患者的生存分析

E. Borodavina, A. Shurinov, V. Krylov, K. Vasilev
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Based on the results of the SELECT study, in an indirect comparison with the data obtained earlier in the DECISION study, lenvatinib was found to be the most effective drug.The study objective is to provide a comparative analysis of response to treatment and overall survival in two groups of patients with progressive metastatic differentiated thyroid cancer. In group 1, treatment was based on continuing radioiodine therapy in combination with suppressive hormone therapy with levothyroxine; in group 2, with the development of radioiodine refractivity, lenvatinib was prescribed.Materials and methods. The study included two groups of patients treated at different times in the A.f. Tsyb medical Radiology Research Center - branch of the National medical Research Center of Radiology, ministry of Health of Russia. group 1 included patients who continued radioiodine therapy, despite disease progression on treatment (historical control group). This group (n = 191) consisted of patients with differentiated thyroid cancer who received radioiodine therapy until January 2015, when the criteria for radioactive iodine refractivity had not yet been established and there was no unified approach to such patients and no possibility of targeted therapy with tyrosine kinase inhibitors. group 2 (n =71) consisted of patients receiving lenvatinib in the 1st line targeted therapy from January 2015 to march 2022, from the time of radiographically confirmed tumor progression according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and establishing the fact of radioactive iodine refractivity.Results. In the historical control group (n = 19) 18 (9.4 %) patients are alive to date. It should be specifically noted that all of them had a miliary dissemination in the lungs. None of the 191 patients had a complete or partial response to treatment. All patients had either disease stabilization (83 (43.45 %) patients), or disease progression (108 (56.54 %) patients). The number of RIT courses varied from 9 to 27, 13 ± 3.4 on average. The total dose for the entire treatment period varied from 21 to 75 GBq, 39.3 ± 10 on average. Overall survival averaged 80 ± 20.3 months (min 54 months, max 162 months). patients with slow disease progression had the longest overall survival. In the lenvatinib group the median duration of therapy in patients who discontinued treatment reached 26.3 months (1-52 months). Tumor response to treatment was evaluated in 71 patients. According to the RECIST 1.1 criteria, the maximum response was regarded as complete in 1 (1.41 %) patient, as partial - in 30 (42.45 %) patients, as stable disease - in 23 (32.39 %) patients, as disease progression - in 13 (18.31 %) cases. The median time to evaluate the first response to treatment was 4 (2-8) months. PFS was 17.3 months (95 % confidence interval 15.1-19.4 months). The median PFS in the subgroup of patients who responded to lenvatinib therapy (with a complete and partial response) was 32.5 months (95 % confidence interval 30.7-37.7). The median overall survival at the time of data analysis was not reached.Conclusion. A comparative analysis showed that the approach to the treatment of patients with progressive radioyod-refracted differentiated thyroid cancer based on continued radioiodine therapy is wrong. It was the only impelled option when tyrosine kinase inhibitors therapy for differentiated thyroid cancer was unavailable. Currently, the majority of patients with progressive radioyodrefracted differentiated thyroid cancer receive lenvatinib in the first line targeted therapy. The role of this therapy in the treatment of patients with radioyodrefracted differentiated thyroid cancer is currently increasing. 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引用次数: 0

摘要

介绍。目前分化型甲状腺癌的治疗包括手术切除甲状腺、放射性碘治疗(RIT)和左甲状腺素激素治疗。如果患者有远处转移,放射性碘治疗变得至关重要,成为一种非竞争性的治疗方法。然而,由于肿瘤细胞不完全表达或丧失了吸收放射性碘(131I)的能力,RIT的作用有限或完全丧失。发生放射性碘折射,尽管持续治疗,病情仍在恶化。酪氨酸激酶抑制剂治疗进展性放射性碘难治性甲状腺癌是目前唯一公认的有效治疗方法。根据SELECT研究的结果,与DECISION研究早期获得的数据进行间接比较,发现lenvatinib是最有效的药物。该研究的目的是对两组进展性转移分化型甲状腺癌患者的治疗反应和总生存期进行比较分析。在第1组,治疗基于持续放射性碘治疗联合左甲状腺素抑制激素治疗;第二组随放射性碘折光性的发展,给予lenvatinib。材料和方法。该研究包括在俄罗斯卫生部国家放射医学研究中心分支机构a.f. Tsyb医学放射学研究中心接受不同时间治疗的两组患者。组1包括继续放射性碘治疗的患者,尽管治疗期间疾病进展(历史对照组)。该组(n = 191)为2015年1月前接受放射性碘治疗的分化型甲状腺癌患者,当时放射性碘的屈光性标准尚未建立,对这类患者没有统一的治疗方法,也没有酪氨酸激酶抑制剂靶向治疗的可能性。组2 (n =71)为2015年1月至2022年3月期间接受lenvatinib一线靶向治疗的患者,从根据实体瘤应答评价标准1.1 (RECIST 1.1)影像学证实肿瘤进展之时开始,建立放射性碘屈光度事实。在历史对照组(n = 19)中,18例(9.4%)患者存活至今。需要特别指出的是,他们都在肺部有军事播散。191例患者中没有一个对治疗有完全或部分反应。所有患者要么病情稳定(83例(43.45%)),要么病情进展(108例(56.54%))。RIT疗程9 ~ 27次,平均13±3.4次。整个治疗期的总剂量为21 ~ 75 GBq,平均为39.3±10。总生存期平均80±20.3个月(最短54个月,最长162个月)。病情进展缓慢的患者总生存期最长。在lenvatinib组中,停止治疗的患者的中位治疗持续时间达到26.3个月(1-52个月)。对71例患者的肿瘤治疗反应进行了评估。根据RECIST 1.1标准,1例(1.41%)患者的最大缓解为完全缓解,30例(42.45%)患者为部分缓解,23例(32.39%)患者为疾病稳定,13例(18.31%)患者为疾病进展。评估首次治疗反应的中位时间为4(2-8)个月。PFS为17.3个月(95%置信区间为15.1-19.4个月)。对lenvatinib治疗有反应(完全缓解和部分缓解)的亚组患者的中位PFS为32.5个月(95%置信区间30.7-37.7)。数据分析时的中位总生存期未达到。一项对比分析表明,基于持续放射性碘治疗的进展性放射折射分化型甲状腺癌的治疗方法是错误的。当酪氨酸激酶抑制剂治疗分化型甲状腺癌不可用时,这是唯一的选择。目前,大多数进展性放射偏光分化型甲状腺癌患者在一线靶向治疗中接受lenvatinib。目前,这种疗法在治疗放射偏光分化型甲状腺癌患者中的作用正在增加。新的靶向药物的合成前景越来越明显,如需要进一步的研究和比较已经在使用的药物。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Survival analysis of patients with advanced metastatic differentiated thyroid cancer
Introduction. Current treatment of differentiated thyroid cancer includes surgical resection of the thyroid gland, radioiodine therapy (RIT) followed by hormone therapy with levothyroxine. If a patient has distant metastases, radioiodine therapy gains vital importance, becoming a non-competitive method of treatment. However, with incomplete expressed or lost ability of tumor cells to absorb radioactive iodine (131I), the effect of RIT occurs to be limited or completely lost. Radioactive iodine refractivity develops, in which the disease progresses despite ongoing therapy. Therapy with tyrosine kinase inhibitors for the progressive radioiodine-refractory thyroid cancer is currently the only recognized effective treatment. Based on the results of the SELECT study, in an indirect comparison with the data obtained earlier in the DECISION study, lenvatinib was found to be the most effective drug.The study objective is to provide a comparative analysis of response to treatment and overall survival in two groups of patients with progressive metastatic differentiated thyroid cancer. In group 1, treatment was based on continuing radioiodine therapy in combination with suppressive hormone therapy with levothyroxine; in group 2, with the development of radioiodine refractivity, lenvatinib was prescribed.Materials and methods. The study included two groups of patients treated at different times in the A.f. Tsyb medical Radiology Research Center - branch of the National medical Research Center of Radiology, ministry of Health of Russia. group 1 included patients who continued radioiodine therapy, despite disease progression on treatment (historical control group). This group (n = 191) consisted of patients with differentiated thyroid cancer who received radioiodine therapy until January 2015, when the criteria for radioactive iodine refractivity had not yet been established and there was no unified approach to such patients and no possibility of targeted therapy with tyrosine kinase inhibitors. group 2 (n =71) consisted of patients receiving lenvatinib in the 1st line targeted therapy from January 2015 to march 2022, from the time of radiographically confirmed tumor progression according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and establishing the fact of radioactive iodine refractivity.Results. In the historical control group (n = 19) 18 (9.4 %) patients are alive to date. It should be specifically noted that all of them had a miliary dissemination in the lungs. None of the 191 patients had a complete or partial response to treatment. All patients had either disease stabilization (83 (43.45 %) patients), or disease progression (108 (56.54 %) patients). The number of RIT courses varied from 9 to 27, 13 ± 3.4 on average. The total dose for the entire treatment period varied from 21 to 75 GBq, 39.3 ± 10 on average. Overall survival averaged 80 ± 20.3 months (min 54 months, max 162 months). patients with slow disease progression had the longest overall survival. In the lenvatinib group the median duration of therapy in patients who discontinued treatment reached 26.3 months (1-52 months). Tumor response to treatment was evaluated in 71 patients. According to the RECIST 1.1 criteria, the maximum response was regarded as complete in 1 (1.41 %) patient, as partial - in 30 (42.45 %) patients, as stable disease - in 23 (32.39 %) patients, as disease progression - in 13 (18.31 %) cases. The median time to evaluate the first response to treatment was 4 (2-8) months. PFS was 17.3 months (95 % confidence interval 15.1-19.4 months). The median PFS in the subgroup of patients who responded to lenvatinib therapy (with a complete and partial response) was 32.5 months (95 % confidence interval 30.7-37.7). The median overall survival at the time of data analysis was not reached.Conclusion. A comparative analysis showed that the approach to the treatment of patients with progressive radioyod-refracted differentiated thyroid cancer based on continued radioiodine therapy is wrong. It was the only impelled option when tyrosine kinase inhibitors therapy for differentiated thyroid cancer was unavailable. Currently, the majority of patients with progressive radioyodrefracted differentiated thyroid cancer receive lenvatinib in the first line targeted therapy. The role of this therapy in the treatment of patients with radioyodrefracted differentiated thyroid cancer is currently increasing. The promising prospects for the synthesis of new targeted drugs are becoming obvious, such as the need for further research and comparison of drugs already in use as well.
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