OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma
PURPOSE: Sunitinib offers improved efficacy for patients with metastatic renal cell carcinoma (mRCC). To provide better disease management in the Middle East, we studied its use in mRCC in real-life practice in this region. MATERIAL AND METHODS: Patients diagnosed with mRCC and started on sunitinib...
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American Society of Clinical Oncology
2019-10-01
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doaj-72f22944eb3a4a5ab951dcde96a8f7f92020-11-25T03:20:55ZengAmerican Society of Clinical OncologyJournal of Global Oncology2378-95062019-10-01511010.1200/JGO.18.002381OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell CarcinomaMarwan Ghosn0Roland Eid1Emad Hamada2Hamdy Abdel Azim3Jamal Zekri4Mubarak Al-Mansour5Mohammed Jaloudi6Fadi Nasr7Hassan Errihani8Adda Bounedjar9Amel Mezlini10Hamouda Boussen11Joseph Kattan12Fadi El Karak13Fadi Farhat14on behalf of the Africa Middle East Cancer IntergroupHotel Dieu de France University Hospital and Saint Joseph University, Beirut, LebanonHotel Dieu de France University Hospital and Saint Joseph University, Beirut, LebanonCairo University, Cairo, EgyptCairo University, Cairo, EgyptKing Faisal Specialist Hospital and Research Centre and Al-Faisal University, Al-Ahsa, Saudi ArabiaKing Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi ArabiaTawam Hospital, Al Ain City, United Arab EmiratesHotel Dieu de France University Hospital and Saint Joseph University, Beirut, LebanonMohammed V University, Rabat, MoroccoCentre Hospitalier Universitaire Blida, Blida, AlgeriaInstitut Salah Azaiez, Tunis, TunisiaAbderrahmen Mami Hospital, Ariana, TunisiaHotel Dieu de France University Hospital and Saint Joseph University, Beirut, LebanonHotel Dieu de France University Hospital and Saint Joseph University, Beirut, LebanonHotel Dieu de France University Hospital and Saint Joseph University, Beirut, LebanonPURPOSE: Sunitinib offers improved efficacy for patients with metastatic renal cell carcinoma (mRCC). To provide better disease management in the Middle East, we studied its use in mRCC in real-life practice in this region. MATERIAL AND METHODS: Patients diagnosed with mRCC and started on sunitinib between 2006 and 2016 from 10 centers in Africa and the Middle East region were studied in this regional, multicenter, observational, retrospective trial to obtain routine clinical practice data on the usage patterns and outcomes of sunitinib in mRCC in real-life practice. RESULTS: A total of 289 patients were enrolled. Median age at diagnosis was 58.7 years. The patient characteristics were as follows: 73.6% of patients were males; 85.8% had clear-cell renal cell carcinoma (RCC); 97.5% had unilateral RCC; 66.3% had metastatic disease at initial diagnosis; 56.3% received previous treatment for RCC, among which 98.7% had undergone surgery; and 15.2% and 31.4% were classified in the favorable and poor-risk groups (expanded Memorial Sloan Kettering Cancer Center criteria), respectively. On treatment initiation, the mean total sunitinib dose was 48.1 mg, and 87.6% of patients were started on a sunitinib dose of 50 mg. The mean duration of sunitinib treatment was 9.6 months. Overall response rate was 20.8%, with a median duration of 8.2 months. Median time to progression was 5.7 months. Median follow-up time was 7.8 months. By months 12 and 24, 34.3% and 11.4% of patients, respectively, were still alive. Seventy-six patients (60.9%) experienced 314 adverse events. Twenty-three patients (8.0%) experienced 28 serious adverse events. Overall, 83 patients (28.7%) discontinued their sunitinib treatment. CONCLUSION: The results are indicative of the general treatment outcomes of patients with mRCC in the Middle East using sunitinib in routine clinical practice. Reported adverse events are similar to those described in the literature but at lower frequencies.http://ascopubs.org/doi/10.1200/JGO.18.00238 |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Marwan Ghosn Roland Eid Emad Hamada Hamdy Abdel Azim Jamal Zekri Mubarak Al-Mansour Mohammed Jaloudi Fadi Nasr Hassan Errihani Adda Bounedjar Amel Mezlini Hamouda Boussen Joseph Kattan Fadi El Karak Fadi Farhat on behalf of the Africa Middle East Cancer Intergroup |
spellingShingle |
Marwan Ghosn Roland Eid Emad Hamada Hamdy Abdel Azim Jamal Zekri Mubarak Al-Mansour Mohammed Jaloudi Fadi Nasr Hassan Errihani Adda Bounedjar Amel Mezlini Hamouda Boussen Joseph Kattan Fadi El Karak Fadi Farhat on behalf of the Africa Middle East Cancer Intergroup OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma Journal of Global Oncology |
author_facet |
Marwan Ghosn Roland Eid Emad Hamada Hamdy Abdel Azim Jamal Zekri Mubarak Al-Mansour Mohammed Jaloudi Fadi Nasr Hassan Errihani Adda Bounedjar Amel Mezlini Hamouda Boussen Joseph Kattan Fadi El Karak Fadi Farhat on behalf of the Africa Middle East Cancer Intergroup |
author_sort |
Marwan Ghosn |
title |
OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma |
title_short |
OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma |
title_full |
OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma |
title_fullStr |
OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma |
title_full_unstemmed |
OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma |
title_sort |
ossmar: an observational study to describe the use of sunitinib in real-life practice for the treatment of metastatic renal cell carcinoma |
publisher |
American Society of Clinical Oncology |
series |
Journal of Global Oncology |
issn |
2378-9506 |
publishDate |
2019-10-01 |
description |
PURPOSE: Sunitinib offers improved efficacy for patients with metastatic renal cell carcinoma (mRCC). To provide better disease management in the Middle East, we studied its use in mRCC in real-life practice in this region. MATERIAL AND METHODS: Patients diagnosed with mRCC and started on sunitinib between 2006 and 2016 from 10 centers in Africa and the Middle East region were studied in this regional, multicenter, observational, retrospective trial to obtain routine clinical practice data on the usage patterns and outcomes of sunitinib in mRCC in real-life practice. RESULTS: A total of 289 patients were enrolled. Median age at diagnosis was 58.7 years. The patient characteristics were as follows: 73.6% of patients were males; 85.8% had clear-cell renal cell carcinoma (RCC); 97.5% had unilateral RCC; 66.3% had metastatic disease at initial diagnosis; 56.3% received previous treatment for RCC, among which 98.7% had undergone surgery; and 15.2% and 31.4% were classified in the favorable and poor-risk groups (expanded Memorial Sloan Kettering Cancer Center criteria), respectively. On treatment initiation, the mean total sunitinib dose was 48.1 mg, and 87.6% of patients were started on a sunitinib dose of 50 mg. The mean duration of sunitinib treatment was 9.6 months. Overall response rate was 20.8%, with a median duration of 8.2 months. Median time to progression was 5.7 months. Median follow-up time was 7.8 months. By months 12 and 24, 34.3% and 11.4% of patients, respectively, were still alive. Seventy-six patients (60.9%) experienced 314 adverse events. Twenty-three patients (8.0%) experienced 28 serious adverse events. Overall, 83 patients (28.7%) discontinued their sunitinib treatment. CONCLUSION: The results are indicative of the general treatment outcomes of patients with mRCC in the Middle East using sunitinib in routine clinical practice. Reported adverse events are similar to those described in the literature but at lower frequencies. |
url |
http://ascopubs.org/doi/10.1200/JGO.18.00238 |
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