Efficacy of Neoadjuvant Targeted Therapy in Treatment of Patients with Localised Clear-Cell Renal Cell Carcinoma.

IF 1.8 Q3 UROLOGY & NEPHROLOGY Advances in Urology Pub Date : 2021-04-30 eCollection Date: 2021-01-01 DOI:10.1155/2021/6674637
O A Voylenko, O E Stakhovsky, I V Vitruk, O A Kononenko, M V Pikul, S L Semko, E O Stakhovsky
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引用次数: 1

Abstract

Aim: This study aimed to evaluate the efficacy of neoadjuvant targeted therapy (TT) in patients with localised clear-cell renal cell carcinoma (RCC).

Materials and methods: A special randomised trial was planned and conducted by the Research Department of Plastic and Reconstructive Oncology in the National Cancer Institute of Ukraine for testing the clinical efficacy of neoadjuvant TT in the treatment of clear-cell localised RCC, and the primary endpoint was tumour response evaluation after TT. The secondary endpoints included evaluation of dependence between the use of neoadjuvant TT and the probability of partial nephrectomy and the correlation between tumour size, stage, remaining functioning parenchyma volume, and response to systemic therapy.

Results: Overall, 118 patients met the inclusion criteria and were randomly assigned to receive combined treatment or surgery alone. The percentage of tumour regression ranged from 0% to 60%, and the median was (95% confidence interval) 20.5 ± 14.3 (16.8-24.3%). Most of the patients had a slightly positive response to TT (3%-29% decrease in tumour size); n = 44 (76.9%) cases. Partial response by the Response Evaluation Criteria in Solid Tumours, version 1.1, was observed in 14 (24.1%) patients and reached a maximum of 60% regression. Tumour reduction in the neoadjuvant TT group allowed kidney preservation in 53 (91.4%) patients. In the control group, the number of organ-sparing procedures was significantly lower (n = 20, 33.3%). The statistical difference was relevant (x 2 = 42.1; p < 0.001).

Conclusion: The positive results of neoadjuvant TT obtained in our study indicate the clinical validity of combined treatment in patients with localised RCC.

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新辅助靶向治疗局部透明细胞肾细胞癌的疗效观察。
目的:本研究旨在评价新辅助靶向治疗(TT)在局部透明细胞肾细胞癌(RCC)患者中的疗效。材料与方法:乌克兰国家癌症研究所整形与重建肿瘤学研究部计划并开展了一项特殊的随机试验,以检测新辅助TT治疗透明细胞局限性RCC的临床疗效,主要终点为TT后肿瘤反应评价。次要终点包括评估新辅助TT的使用与部分肾切除术的可能性之间的依赖性,以及肿瘤大小、分期、剩余功能实质体积和对全身治疗反应之间的相关性。结果:总体而言,118例患者符合纳入标准,随机分配接受联合治疗或单独手术。肿瘤消退的百分比范围为0% ~ 60%,中位数为(95%可信区间)20.5±14.3(16.8 ~ 24.3%)。大多数患者对TT有轻微的阳性反应(肿瘤大小减少3%-29%);N = 44例(76.9%)。根据实体肿瘤反应评价标准(1.1版),在14例(24.1%)患者中观察到部分缓解,最大退行率达到60%。新辅助TT组肿瘤减少,使53例(91.4%)患者的肾脏得以保存。在对照组中,保留器官的手术次数明显较低(n = 20, 33.3%)。统计学差异具有相关性(x2 = 42.1;P < 0.001)。结论:本研究获得的新辅助TT阳性结果表明联合治疗局部肾细胞癌的临床有效性。
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来源期刊
Advances in Urology
Advances in Urology UROLOGY & NEPHROLOGY-
CiteScore
2.90
自引率
0.00%
发文量
17
审稿时长
15 weeks
期刊介绍: Advances in Urology is a peer-reviewed, open access journal that publishes state-of-the-art reviews and original research papers of wide interest in all fields of urology. The journal strives to provide publication of important manuscripts to the widest possible audience worldwide, without the constraints of expensive, hard-to-access, traditional bound journals. Advances in Urology is designed to improve publication access of both well-established urologic scientists and less well-established writers, by allowing interested scientists worldwide to participate fully.
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