The Turkish experience with sunitinib in metastatic renal cell cancer

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Nazim Serdar Turhal

Scientific Tracks Abstracts: Pharmaceut Reg Affairs

Abstract :

Renal cell cancer (RCC) is number 8th in incidence of male cancersin Turkey. Although sunitinib malate has been approved for 7 years in USA, this agent has become available in Turkey for three years. Initially we could prescribe it only after failure of response to first line interferon treatment. As part of this effort, 21 doctors of 18 institutions in 10 cities, representing over 90% of the centers caring for cancer patients in Turkey collaborated in this observational study to closely monitor the efficacy, side effects and tolerability of sunitinib. Four hundred and seven patients analyzed, 99 of them received sunitinib as first line and the rest received it for second line of treatment for metastatic RCC. Over 70% of them were male. The ECOG performance score was 0&1in close to 90% of the patients. The majority (73%) had clear cell variant and had prior nephrectomy (87%). The most common metastatic sites were lung (61%), bone (31%), liver (21%), and brain (8%) respectively. The overall response rate was 28% in first line and 20% in second line of treatment. The median progression free survival is 9 months at both settings. The median overall survival is 27 and 23 months respectively and the difference is not statistically significant. Although other side effects are comparable, the hypothyroidism is seen in 5% of the patients and slightly higher than expected. Besides Febrile neutropenia (13 vs. 1%), there were no statistically significant difference of the side effects in first or second line setting.

Biography :

Nazim Serdar Turhal was graduated from University of Istanbul, Cerrahpasa Medical School, had his training in Internal Medicine in a Yale University Affiliated Program and in Medical Oncology at Mount Sinai School of Medicine Hospital in New York. Since then he is working at Marmara University in Istanbul. He has about 70 peer reviewed international publications and about 350 citations to them. He is a member of ASCO, ESMO, EORTC, BUON, TOD. He is the national representative of Turkey in Balkan Union of Oncology. He is board certified in Medical Oncology until 2017 by American Board of Internal Medicine.