Efficacy and Treatment Outcomes of First-line Pazopanib Therapy in Advanced Renal Cell Carcinoma in Greece.

IF 1.6 4区医学 Q4 ONCOLOGY

Anticancer research Pub Date : 2025-06-01 DOI:10.21873/anticanres.17624

Evangelos Bournakis, Ioannis Xanthakis, Michail Vaslamatzis, Parisis Makrantonakis, Charisios Karanikiotis, Ilias Athanasiadis, Alexandros Ardavanis, Pavlos Papakotoulas, Epaminondas Samantas, Christos Papandreou, Maria Michailidou, Panagiotis Katsaounis, Christos Christodoulou

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引用次数: 0

Abstract

Background/aim: Pazopanib is a tyrosine kinase inhibitor (TKI) approved as first-line treatment for renal cell carcinoma (RCC). Although pazopanib efficacy and safety have been established in phase III studies, real-world data are limited. The aim of this study was to evaluate pazopanib efficacy, duration of responses and safety, as first-line treatment in patients with advanced/metastatic RCC with favorable-intermediate prognosis.

Patients and methods: This single-arm prospective Greek observational study evaluated 59 patients treated with first-line pazopanib as indicated, and who were followed-up every 3 months for 2 years, or until disease progression. The primary objective was to evaluate the efficacy of first-line pazopanib treatment in patients with favorable-intermediate prognosis metastatic RCC at 9 months from treatment onset.

Results: The primary composite efficacy point (complete response, partial response, or stable disease at 9 months) was reached by 30.5% [95% confidence interval (CI)=19.2-43.9%] of patients, with 27.1% (95% CI=16.4-40.3%) of patients demonstrating stable disease. Best overall response was complete response in 5.1% (3/59 patients), partial response in 22% (13/59 patients), and stable disease in 35.6% (21/59 patients). Median progression-free survival was 17.7 (95% CI=9.15-26.25) months and declined with the International Metastatic Renal Cell Carcinoma Database Consortium progressive risk (24.5 and 6.97 months for favorable- and intermediate-risk, respectively; p=0.012). The cumulative overall survival rate was 95% after 9 (95% CI=89.8-100.0%) months and 24 (95% CI=89.8-100.0%) months. Median overall survival was not reached. Overall, 234 adverse events were reported in 55 patients, of which the most common were malignant neoplasm progression, diarrhea, and hypertension.

Conclusion: These data demonstrate that pazopanib is well-tolerated and effective as first-line treatment in patients with favorable-intermediate risk metastatic RCC in real-life conditions in Greece.

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希腊晚期肾细胞癌一线帕唑帕尼治疗的疗效和治疗结果。

背景/目的：Pazopanib是一种酪氨酸激酶抑制剂（TKI），被批准作为肾细胞癌（RCC）的一线治疗药物。尽管pazopanib的有效性和安全性已在III期研究中得到证实，但实际数据有限。本研究的目的是评估pazopanib作为晚期/转移性RCC患者一线治疗的疗效、反应持续时间和安全性，这些患者预后良好。患者和方法：这项单臂前瞻性希腊观察性研究评估了59例接受一线帕唑帕尼治疗的患者，每3个月随访2年，或直到疾病进展。研究的主要目的是评估帕唑帕尼一线治疗在治疗开始9个月后预后良好的中度转移性肾癌患者中的疗效。结果：30.5%[95%置信区间(CI)=19.2 ~ 43.9%]的患者达到主要综合疗效点（完全缓解、部分缓解或9个月时病情稳定），27.1% （95% CI=16.4 ~ 40.3%）的患者病情稳定。最佳总体缓解为5.1%（3/59例）完全缓解，22%（13/59例）部分缓解，35.6%（21/59例）病情稳定。中位无进展生存期为17.7个月（95% CI=9.15-26.25），随着国际转移性肾细胞癌数据库联盟的进展风险（有利和中危分别为24.5个月和6.97个月）而下降；p = 0.012)。9个月（95% CI=89.8-100.0%）和24个月（95% CI=89.8-100.0%）后的累积总生存率为95%。中位总生存期未达到。总体而言，55例患者报告了234例不良事件，其中最常见的是恶性肿瘤进展、腹泻和高血压。结论：这些数据表明，在希腊的现实生活条件下，帕唑帕尼作为一线治疗中危转移性RCC患者具有良好的耐受性和有效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Anticancer research 医学-肿瘤学

CiteScore

3.70

自引率

10.00%

发文量

566

审稿时长

2 months

期刊介绍： ANTICANCER RESEARCH is an independent international peer-reviewed journal devoted to the rapid publication of high quality original articles and reviews on all aspects of experimental and clinical oncology. Prompt evaluation of all submitted articles in confidence and rapid publication within 1-2 months of acceptance are guaranteed. ANTICANCER RESEARCH was established in 1981 and is published monthly (bimonthly until the end of 2008). Each annual volume contains twelve issues and index. Each issue may be divided into three parts (A: Reviews, B: Experimental studies, and C: Clinical and Epidemiological studies). Special issues, presenting the proceedings of meetings or groups of papers on topics of significant progress, will also be included in each volume. There is no limitation to the number of pages per issue.