[73] Outcomes of patients with advanced clear-cell renal cell carcinoma treated by sunitinib as first-line therapy: A prospective observational study in real-world practice of the Academic Hospital of Oran, Algeria

Objective: To investigate the effectiveness of sunitinib as first-line therapy in real-world practice in terms of progression-free survival (PFS), objective response rate (ORR), and overall survival (OS), and to evaluate the safety profile for advanced or metastatic clear-cell renal cell carcinoma (...

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Autores principales:	Nadia Ameziane, Louafi Djellali, Mohamed Yamouni, Ali Bazzi, Mostafa Djamal Yousfi, Abderrahmane Attar, Abdelkader Bousahba
Formato:	article
Lenguaje:	EN
Publicado:	Taylor & Francis Group 2018
Materias:	Diseases of the genitourinary system. Urology RC870-923
Acceso en línea:	https://doaj.org/article/5ecc5685575f4e83ab3b6de9d0f97b37
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spelling	oai:doaj.org-article:5ecc5685575f4e83ab3b6de9d0f97b372021-12-02T12:07:16Z[73] Outcomes of patients with advanced clear-cell renal cell carcinoma treated by sunitinib as first-line therapy: A prospective observational study in real-world practice of the Academic Hospital of Oran, Algeria2090-598X10.1016/j.aju.2018.10.026https://doaj.org/article/5ecc5685575f4e83ab3b6de9d0f97b372018-11-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2090598X18301207https://doaj.org/toc/2090-598XObjective: To investigate the effectiveness of sunitinib as first-line therapy in real-world practice in terms of progression-free survival (PFS), objective response rate (ORR), and overall survival (OS), and to evaluate the safety profile for advanced or metastatic clear-cell renal cell carcinoma (ccRCC).There is lack of published Algerian prospective data in advanced RCC. Methods: An observational prospective study was conducted at the Medical Oncology Department of the Academic Hospital of Oran between January 2012 and May 2015. Patients enrolled were aged >18 years, with untreated ccRCC with a Karnofsky performance status (KPS) >70%. Sunitinib was administered with schedule of 50 mg/day, 4-weeks on/2-weeks off. Dose adjustment and changing schedule to 2-weeks on/1-week off, were possible in cases of persistent severe toxicity. Results: In all, 43 patients with advanced or metastatic ccRCC were enrolled in the study. The sex ratio was 1.8, with a mean (SD) age of 58.4 (3.5) years. The KPS was 100%, 80–90% and 60–70% in 11%, 77% and 12% of the patients, respectively. In all, 339 cycles were administered, with a mean (SD; range) of 11.6 (2.8; 1–42) cycles. The median PFS by intention-to-treat (ITT) was 10.5 months (95% confidence interval [CI] 6.1–14.9) with a PFS rate at 12 months of 34.8%. The ORR in ITT was 45% (95% CI 30–60). The median OS was 21.3 months (95% CI 11.5–31.07) with an OS rate at 2-years of 30.2%. The main grade 3–4 toxicities were represented by asthenia (56%), anorexia (32%), hand-foot syndrome (33%), stomatitis (28%), diarrhoea (23%), hypertension (21%), and thrombocytopaenia (14%). Conclusions: The effectiveness results of sunitinib in our present study are similar to those in the literature, with a manageable and acceptable toxicity profile.Nadia AmezianeLouafi DjellaliMohamed YamouniAli BazziMostafa Djamal YousfiAbderrahmane AttarAbdelkader BousahbaTaylor & Francis GrouparticleDiseases of the genitourinary system. UrologyRC870-923ENArab Journal of Urology, Vol 16, Iss , Pp S34-S35 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	Diseases of the genitourinary system. Urology RC870-923
spellingShingle	Diseases of the genitourinary system. Urology RC870-923 Nadia Ameziane Louafi Djellali Mohamed Yamouni Ali Bazzi Mostafa Djamal Yousfi Abderrahmane Attar Abdelkader Bousahba [73] Outcomes of patients with advanced clear-cell renal cell carcinoma treated by sunitinib as first-line therapy: A prospective observational study in real-world practice of the Academic Hospital of Oran, Algeria
description	Objective: To investigate the effectiveness of sunitinib as first-line therapy in real-world practice in terms of progression-free survival (PFS), objective response rate (ORR), and overall survival (OS), and to evaluate the safety profile for advanced or metastatic clear-cell renal cell carcinoma (ccRCC).There is lack of published Algerian prospective data in advanced RCC. Methods: An observational prospective study was conducted at the Medical Oncology Department of the Academic Hospital of Oran between January 2012 and May 2015. Patients enrolled were aged >18 years, with untreated ccRCC with a Karnofsky performance status (KPS) >70%. Sunitinib was administered with schedule of 50 mg/day, 4-weeks on/2-weeks off. Dose adjustment and changing schedule to 2-weeks on/1-week off, were possible in cases of persistent severe toxicity. Results: In all, 43 patients with advanced or metastatic ccRCC were enrolled in the study. The sex ratio was 1.8, with a mean (SD) age of 58.4 (3.5) years. The KPS was 100%, 80–90% and 60–70% in 11%, 77% and 12% of the patients, respectively. In all, 339 cycles were administered, with a mean (SD; range) of 11.6 (2.8; 1–42) cycles. The median PFS by intention-to-treat (ITT) was 10.5 months (95% confidence interval [CI] 6.1–14.9) with a PFS rate at 12 months of 34.8%. The ORR in ITT was 45% (95% CI 30–60). The median OS was 21.3 months (95% CI 11.5–31.07) with an OS rate at 2-years of 30.2%. The main grade 3–4 toxicities were represented by asthenia (56%), anorexia (32%), hand-foot syndrome (33%), stomatitis (28%), diarrhoea (23%), hypertension (21%), and thrombocytopaenia (14%). Conclusions: The effectiveness results of sunitinib in our present study are similar to those in the literature, with a manageable and acceptable toxicity profile.
format	article
author	Nadia Ameziane Louafi Djellali Mohamed Yamouni Ali Bazzi Mostafa Djamal Yousfi Abderrahmane Attar Abdelkader Bousahba
author_facet	Nadia Ameziane Louafi Djellali Mohamed Yamouni Ali Bazzi Mostafa Djamal Yousfi Abderrahmane Attar Abdelkader Bousahba
author_sort	Nadia Ameziane
title	[73] Outcomes of patients with advanced clear-cell renal cell carcinoma treated by sunitinib as first-line therapy: A prospective observational study in real-world practice of the Academic Hospital of Oran, Algeria
title_short	[73] Outcomes of patients with advanced clear-cell renal cell carcinoma treated by sunitinib as first-line therapy: A prospective observational study in real-world practice of the Academic Hospital of Oran, Algeria
title_full	[73] Outcomes of patients with advanced clear-cell renal cell carcinoma treated by sunitinib as first-line therapy: A prospective observational study in real-world practice of the Academic Hospital of Oran, Algeria
title_fullStr	[73] Outcomes of patients with advanced clear-cell renal cell carcinoma treated by sunitinib as first-line therapy: A prospective observational study in real-world practice of the Academic Hospital of Oran, Algeria
title_full_unstemmed	[73] Outcomes of patients with advanced clear-cell renal cell carcinoma treated by sunitinib as first-line therapy: A prospective observational study in real-world practice of the Academic Hospital of Oran, Algeria
title_sort	[73] outcomes of patients with advanced clear-cell renal cell carcinoma treated by sunitinib as first-line therapy: a prospective observational study in real-world practice of the academic hospital of oran, algeria
publisher	Taylor & Francis Group
publishDate	2018
url	https://doaj.org/article/5ecc5685575f4e83ab3b6de9d0f97b37
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[73] Outcomes of patients with advanced clear-cell renal cell carcinoma treated by sunitinib as first-line therapy: A prospective observational study in real-world practice of the Academic Hospital of Oran, Algeria

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