OBJECTIVE: To evaluate the role of thalidomide in patients with metastic renal cell carcinoma and the efficacy, toxicity and response rates to thalidomide. METHODS: The phase-II clinical trial study was conducted at the Sindh Institute of Urology and Transplantation (SIUT), Karachi between November 2008, and April 2009, comprising 80 patients with metastic renal cell carcinoma who had either progressed on or were not suitable for immunotherapy/biologic therapy. After institutional approval and informed consent, the patients received thalidomide 400mg daily. Thalidomide was continued until the time of disease progression or documented severe toxicity. Primary endpoints were the safety, response, progression free survival (PFS) and overall survival (OS). SPSS version 16.0 was used for statistical analysis. RESULTS: The median follow-up was 18 months (15-20); median age was 51.11 years (range 23-73). Three were 59 (73.8%) males. The bone (n=83; 47.5%), lungs (n=26; 32.5%) and lymph nodes (n=8; 10%) were frequent sites of distant metastases. Of the patients, 32 (40%) had previous different systemic treatments. Grade 3 and 4 toxicities were; fatigue (n=34; 42.5%), sensory neuropathy (n=8; 10%), deep venous thrombosis (n=7; 8.8%) and gastrointestinal upset (n=6; 7.5%). Response rates were available for 75 patients: partial 48 (60%); stable disease 12 (15%); progression 15 (18.8%); while 5 (6.2%) were not evaluated. Median progression free survival and overall survival rates were 7 months and 19 months respectively. CONCLUSION: Low-dose thalidomide resulted in manageable toxicity, better response rates, progression free survival and overall survival in the study population. Further large randomised trials are warranted.
OBJECTIVE: To evaluate the role of thalidomide in patients with metastic renal cell carcinoma and the efficacy, toxicity and response rates to thalidomide. METHODS: The phase-II clinical trial study was conducted at the Sindh Institute of Urology and Transplantation (SIUT), Karachi between November 2008, and April 2009, comprising 80 patients with metastic renal cell carcinoma who had either progressed on or were not suitable for immunotherapy/biologic therapy. After institutional approval and informed consent, the patients received thalidomide 400mg daily. Thalidomide was continued until the time of disease progression or documented severe toxicity. Primary endpoints were the safety, response, progression free survival (PFS) and overall survival (OS). SPSS version 16.0 was used for statistical analysis. RESULTS: The median follow-up was 18 months (15-20); median age was 51.11 years (range 23-73). Three were 59 (73.8%) males. The bone (n=83; 47.5%), lungs (n=26; 32.5%) and lymph nodes (n=8; 10%) were frequent sites of distant metastases. Of the patients, 32 (40%) had previous different systemic treatments. Grade 3 and 4 toxicities were; fatigue (n=34; 42.5%), sensory neuropathy (n=8; 10%), deep venous thrombosis (n=7; 8.8%) and gastrointestinal upset (n=6; 7.5%). Response rates were available for 75 patients: partial 48 (60%); stable disease 12 (15%); progression 15 (18.8%); while 5 (6.2%) were not evaluated. Median progression free survival and overall survival rates were 7 months and 19 months respectively. CONCLUSION: Low-dose thalidomide resulted in manageable toxicity, better response rates, progression free survival and overall survival in the study population. Further large randomised trials are warranted.