Marwan Ghosn 1, Roland Eid 1, Emad Hamada 2, Hamdy Abdel Azim 2, Jamal Zekri 3, Mubarak Al-Mansour 4 5, Mohammed Jaloudi 6, Fadi Nasr 1, Hassan Errihani 7, Adda Bounedjar 8, Amel Mezlini 9, Hamouda Boussen 10, Joseph Kattan 1, Fadi El Karak 1, Fadi Farhat 1, Africa Middle East Cancer Intergroup
1Hotel Dieu de France University Hospital and Saint Joseph University, Beirut, Lebanon.
2Cairo University, Cairo, Egypt.
3King Faisal Specialist Hospital and Research Centre and Al-Faisal University, Al-Ahsa, Saudi Arabia.
4King Saud bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia.
5Princess Noorah Oncology Center, Jeddah, Saudi Arabia.
6Tawam Hospital, Al Ain City, United Arab Emirates.
7Mohammed V University, Rabat, Morocco.
8Centre Hospitalier Universitaire Blida, Blida, Algeria.
9Institut Salah Azaiez, Tunis, Tunisia.
10Abderrahmen Mami Hospital, Ariana, Tunisia.
Free PMC article
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.
Conflict of interest statement
Consulting or Advisory Role: Bayer, MSD Oncology, Bristol-Myers Squibb, Pfizer, Novartis, Sanofi, Eli Lilly
Research Funding: Pfizer (Inst), Novartis (Inst), Sanofi (Inst)
Travel, Accommodations, Expenses: Roche, Novartis, Bayer, Merck, MSD Oncology, Eli Lilly, Astellas Pharma, Bristol-Myers Squibb
Hamdy Abdel Azim
Employment: Innate (I)
Honoraria: Amgen, AstraZeneca, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche
Consulting or Advisory Role: AstraZeneca, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche, Hikma
Speakers’ Bureau: Amgen, AstraZeneca, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche
Research Funding: Roche, AstraZeneca, Bayer, Janssen, MSD Novartis, Pfizer
Travel, Accommodations, Expenses: Pfizer
Consulting or Advisory Role: Roche, Novartis, Astellas Pharma
Speakers’ Bureau: Novartis, Pfizer, Eli Lilly, Amgen
Research Funding: Pfizer (Inst), AbbVie (Inst)
Travel, Accommodations, Expenses: Roche, Novartis, Pfizer
No other potential conflicts of interest were reported.