874 - A multi-center, Middle-East, phase II study of the RAF-kinase inhibitor sorafenib in patients with advanced renal cell carcinoma

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Renal Cell Cancer
Biological Therapy
Presenter Hussein M. Khaled
Authors H.M. Khaled1, H. Abdel Azim2, E. Barsoum1, G. Chahine3, A. Shamseddine4, G. Abdel Metaal5, A. Omar6, A.R. Jazeih7, A. Badran8
  • 1Medical Oncology, Cairo University, 11796 - Cairo/EG
  • 2Clinical Oncology, Cairo University, 11796 - Cairo/EG
  • 3Hematology-oncology Department, Hotel Dieu de France Hospital, LB-1107 2020 - Beirut/LB
  • 4Dept Of Internal Medicine, American University of Beirut Medical Center, LB-1107 2020 - Beirut/LB
  • 5Medical Oncology, Maadi Military Hospital, 11796 - Cairo/EG
  • 6Clinical Oncology, Alexandria University, 43553 - Alexandia/EG
  • 7Oncology Department, National Guard Hospital, Riyadh/SA
  • 8Oncology Department, national cancer institute, 11796 - Cairo/EG



Treatment of advanced renal cell carcinoma (RCC) has evolved rapidly over the last two decades. This multicenter study was designed with a primary objective to evaluate the efficacy & safety of Sorafenib as first line treatment in patients with advanced or metastatic RCC in the Middle East region who are unsuitable for another approved first line therapy.


Seventy-five eligible patients from 8 centers in Middle East region were included in the study. They were 48 males and 27 females with a median age of 52 years (range: 19–78 years). Fifty patients had clear cell carcinoma, 17 patients had papillary carcinoma, and 8 patients had other pathologic subtypes. At enrollment in the study, 55 out of the 75 patients had undergone previous nephrectomy. Sixty-seven patients presented with metastatic disease while 8 patients had regional residual lesions or local recurrence.

Patients were treated with 400 mg oral Sorafenib twice a day on a continuous basis as a single agent. Treatment was discontinued upon disease progression, prohibitive toxicity, surgical complications, lost to follow up, or refusal to continue therapy. Seven patients died, and 5 patients are still on treatment (1 CR and 4 SD). The median duration of treatment was 21 weeks (range 1–137 weeks).

Treatment results

Sorafenib was tolerated by most of the patients. Grade III and IV hand and foot syndrome occurred in 17 patients, diarrhea in 3 patients, and elevated liver functions in 2 patients, while grade III and IV fatigue, vomiting, hypertension, anemia, hematemesis, and bleeding per rectum in one patient each.

Out of the 75 patients included in the study, 60 patients were evaluable for response. One patient achieved CR for 91 weeks, and 6 patients had PR (median duration of response of 23 weeks) with an overall response rate of 12%. Disease stabilization occurred in 37 patients. Thus disease control was achieved in 44/60 patientrs (73%). At a median follow-up period of 129 weeks, 6 patients are still alive. In intent to treat analysis, the median progression free survival was 22 weeks while the median overall survival was 48 weeks.


The use Sorafenib as first line therapy in patients with advanced RCC is tolerable and effective.


All authors have declared no conflicts of interest.