Experience of Sorafenib as First-Line Treatment in Metastatic Renal Cell Carcinoma in a Tertiary Care Centre.

Metastatic renal cell carcinoma is chemoresistant and radioresistant disease with poor survival historically, but outcome has improved in past decade after introduction of tyrosine kinase inhibitors like sunitinib and sorafenib. Sorafenib has not been tested in Indian patients with metastatic RCC till now. This is a single arm, prospective, observational study done in unselected population of 60 patients with metastatic RCC treated with sorafenib as first- line therapy to assess efficacy and safety. Twenty three out of 60 patients (38.33%) continued sorafenib by the end of the study. Overall response rates (ORR), stable disease (SD) and disease control rates (DCR) were 35%, 43.33% and 78.33%, respectively. Median progression- free survival (PFS) and overall survival (OS) were 6 and 8 months, respectively and associated with histopathology, Memorial Sloan Kettering Cancer Centre (MSKCC) risk groups, Heng risk groups and performance status. Best tolerated dose was 400 mg per day which was half of standard dose. Fatigue, diarrhea, rashes and hand foot syndrome were common side effects while hypertension was rare. Sorafenib, as first-line therapy, is an effective and safe treatment in Indian patients with metastatic RCC with poor tolerance to dose more than 400 mg per day. Side effects are mostly manageable.