{"title":"Efficacy and Treatment Outcomes of First-line Pazopanib Therapy in Advanced Renal Cell Carcinoma in Greece.","authors":"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","doi":"10.21873/anticanres.17624","DOIUrl":null,"url":null,"abstract":"<p><strong>Background/aim: </strong>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.</p><p><strong>Patients and methods: </strong>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.</p><p><strong>Results: </strong>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; <i>p</i>=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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":8072,"journal":{"name":"Anticancer research","volume":"45 6","pages":"2527-2534"},"PeriodicalIF":1.6000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Anticancer research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.21873/anticanres.17624","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}
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.
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.