OSSMAR: An Observational Study to Describe the Use of Sunitinib in Real-Life Practice for the Treatment of Metastatic Renal Cell Carcinoma

Author:

Ghosn Marwan1,Eid Roland1,Hamada Emad2,Abdel Azim Hamdy2,Zekri Jamal3,Al-Mansour Mubarak45,Jaloudi Mohammed6,Nasr Fadi1,Errihani Hassan7,Bounedjar Adda8,Mezlini Amel9,Boussen Hamouda10,Kattan Joseph1,El Karak Fadi1,Farhat Fadi1,

Affiliation:

1. Hotel Dieu de France University Hospital and Saint Joseph University, Beirut, Lebanon

2. Cairo University, Cairo, Egypt

3. King Faisal Specialist Hospital and Research Centre and Al-Faisal University, Al-Ahsa, Saudi Arabia

4. King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia

5. Princess Noorah Oncology Center, Jeddah, Saudi Arabia

6. Tawam Hospital, Al Ain City, United Arab Emirates

7. Mohammed V University, Rabat, Morocco

8. Centre Hospitalier Universitaire Blida, Blida, Algeria

9. Institut Salah Azaiez, Tunis, Tunisia

10. Abderrahmen Mami Hospital, Ariana, Tunisia

Abstract

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Oncology,Cancer Research

Reference13 articles.

1. Renal cell carcinoma

2. Campbell MT, Jonasch E, Wood CG, et al: Renal cell carcinoma, in Kantarjian HM, Wolff RA (eds): The MD Anderson Manual of Medical Oncology (ed 3). New York, NY, McGraw-Hill Medical, 2016

3. Cancer statistics, 2017

4. Surgical Management of Renal Cell Carcinoma

5. A Comprehensive Overview of Targeted Therapy in Metastatic Renal Cell Carcinoma

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