Real-word evidence in anti-VEGF naive patients treated with pazopanib for metastatic renal cell carcinoma (mRCC), the APOLON Study

ESMO Real World Data and Digital Oncology Pub Date : 2025-06-03 DOI:10.1016/j.esmorw.2025.100155

P. Barthelemy , A. Thiery-Vuillemin , T. Lebret , P. Bigot , U. Stein , L.M. Dourthe , R. Longo , P. Gimel , B. Auberger , J. De La Cruz , D. Malak , Z. Samia , N. Texier , L. Albiges

{"title":"Real-word evidence in anti-VEGF naive patients treated with pazopanib for metastatic renal cell carcinoma (mRCC), the APOLON Study","authors":"P. Barthelemy , A. Thiery-Vuillemin , T. Lebret , P. Bigot , U. Stein , L.M. Dourthe , R. Longo , P. Gimel , B. Auberger , J. De La Cruz , D. Malak , Z. Samia , N. Texier , L. Albiges","doi":"10.1016/j.esmorw.2025.100155","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Immune checkpoint inhibitor-based combinations have become the standard of care for treatment-naive metastatic renal cell carcinoma <strong>(</strong>mRCC). Tyrosine kinase inhibitor (TKI) monotherapy, however, may remain an option particularly for patients with a favourable International Metastatic Database Consortium (IMDC) risk.</div></div><div><h3>Material and methods</h3><div>APOLON is a non-interventional, multicentric prospective study with mRCC patients receiving frontline pazopanib treatment, designed to assess progression-free survival (PFS), overall survival (OS), objective response rate, tolerability, and subsequent post-pazopanib therapy sequences.</div></div><div><h3>Result</h3><div>The 217 patients were 71.0% male, with a median age of 69.6 years, an Eastern Cooperative Oncology Group performance status ≥2 in 17.6%, and mRCC with a favourable (27.1%), intermediate (52.1%) or poor (20.8%) IMDC score. Metastases were mainly located in lung (64.1%), bone (28.6%), mediastinal (18%)/abdominal (17.1%) lymph nodes. Median PFS was 10.6 months [95% confidence interval (CI) 9-12.5 months], similarly in patients aged <65 years with PFS 11.3 months (95% CI 6.8-16.1 months) and aged ≥65 years with PFS 10.1 months (95% CI 9.0-12.4 months). The median PFS was 17.1 months (95% CI 9.9-23.2 months), 12.5 months (95% CI 9.0-15.4 months) and 6.2 months (95% CI 3.5-9.5 months) in patients with a favourable, intermediate, and poor IMDC score, respectively. The median OS was 29.1 months (95% CI 24.3-41.3 months). Objective response rate was 48.3% with a complete response in 6 (3.5%) and a partial response in 77 patients (44.8%). Grade 3/4 adverse events were reported in 45.8% of patients. No safety signals were newly identified.</div></div><div><h3>Conclusion</h3><div>The APOLON study confirmed pazopanib effectiveness and safety in patients with mRCC in a real-world setting. The efficacy remained significant in patients aged ≥65 years and was highly associated with the risk score.</div></div>","PeriodicalId":100491,"journal":{"name":"ESMO Real World Data and Digital Oncology","volume":"9 ","pages":"Article 100155"},"PeriodicalIF":0.0000,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"ESMO Real World Data and Digital Oncology","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S294982012500044X","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Immune checkpoint inhibitor-based combinations have become the standard of care for treatment-naive metastatic renal cell carcinoma (mRCC). Tyrosine kinase inhibitor (TKI) monotherapy, however, may remain an option particularly for patients with a favourable International Metastatic Database Consortium (IMDC) risk.

Material and methods

APOLON is a non-interventional, multicentric prospective study with mRCC patients receiving frontline pazopanib treatment, designed to assess progression-free survival (PFS), overall survival (OS), objective response rate, tolerability, and subsequent post-pazopanib therapy sequences.

Result

The 217 patients were 71.0% male, with a median age of 69.6 years, an Eastern Cooperative Oncology Group performance status ≥2 in 17.6%, and mRCC with a favourable (27.1%), intermediate (52.1%) or poor (20.8%) IMDC score. Metastases were mainly located in lung (64.1%), bone (28.6%), mediastinal (18%)/abdominal (17.1%) lymph nodes. Median PFS was 10.6 months [95% confidence interval (CI) 9-12.5 months], similarly in patients aged <65 years with PFS 11.3 months (95% CI 6.8-16.1 months) and aged ≥65 years with PFS 10.1 months (95% CI 9.0-12.4 months). The median PFS was 17.1 months (95% CI 9.9-23.2 months), 12.5 months (95% CI 9.0-15.4 months) and 6.2 months (95% CI 3.5-9.5 months) in patients with a favourable, intermediate, and poor IMDC score, respectively. The median OS was 29.1 months (95% CI 24.3-41.3 months). Objective response rate was 48.3% with a complete response in 6 (3.5%) and a partial response in 77 patients (44.8%). Grade 3/4 adverse events were reported in 45.8% of patients. No safety signals were newly identified.

Conclusion

The APOLON study confirmed pazopanib effectiveness and safety in patients with mRCC in a real-world setting. The efficacy remained significant in patients aged ≥65 years and was highly associated with the risk score.

查看原文本刊更多论文

APOLON研究：抗vegf初始患者接受pazopanib治疗转移性肾细胞癌（mRCC）的真实证据

背景：基于免疫检查点抑制剂的联合治疗已经成为治疗初发转移性肾细胞癌（mRCC）的标准治疗方案。然而，酪氨酸激酶抑制剂（TKI）单药治疗可能仍然是一种选择，特别是对于具有良好国际转移数据库联盟（IMDC）风险的患者。sapolon是一项非介入性、多中心前瞻性研究，研究对象为接受帕唑帕尼一线治疗的mRCC患者，旨在评估无进展生存期（PFS）、总生存期（OS）、客观缓解率、耐受性和随后的帕唑帕尼治疗后序列。结果217例患者中男性占71.0%，中位年龄69.6岁，东部肿瘤合作组表现状态≥2的患者占17.6%，mRCC IMDC评分为良好（27.1%）、中等（52.1%）或较差（20.8%）。转移灶主要位于肺（64.1%）、骨（28.6%）、纵隔(18%)/腹腔（17.1%）淋巴结。中位PFS为10.6个月[95%可信区间（CI） 9-12.5个月]，65岁患者PFS为11.3个月（95% CI 6.8-16.1个月），65岁以上患者PFS为10.1个月（95% CI 9.0-12.4个月）。IMDC评分良好、中等和较差的患者的中位PFS分别为17.1个月（95% CI 9.9-23.2个月）、12.5个月（95% CI 9.0-15.4个月）和6.2个月（95% CI 3.5-9.5个月）。中位OS为29.1个月（95% CI 24.3-41.3个月）。客观缓解率为48.3%，其中完全缓解6例（3.5%），部分缓解77例（44.8%）。45.8%的患者报告了3/4级不良事件。没有新发现的安全信号。APOLON研究证实了帕唑帕尼在mRCC患者中的有效性和安全性。在年龄≥65岁的患者中，疗效仍然显著，且与风险评分高度相关。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

ESMO Real World Data and Digital Oncology

自引率

0.00%

发文量