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

Marwan Ghosn 1Roland Eid 1Emad Hamada 2Hamdy Abdel Azim 2Jamal Zekri 3Mubarak Al-Mansour 4 5Mohammed Jaloudi 6Fadi Nasr 1Hassan Errihani 7Adda Bounedjar 8Amel Mezlini 9Hamouda Boussen 10Joseph Kattan 1Fadi El Karak 1Fadi Farhat 1Africa Middle East Cancer Intergroup

Affiliations

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.

PMID: 31657977

 PMCID: PMC6825247

 DOI: 10.1200/JGO.18.00238

Free PMC article

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.

Conflict of interest statement

Marwan Ghosn

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

Jamal Zekri

Travel, Accommodations, Expenses: Pfizer

Fadi Nasr

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.