To evaluate efficacy and toxicity of 1st line tyrosine kinase inhibitors (TKIs) in metastatic renal cell carcinoma (mRCC) in clinical setting.
This is single institutional review of mRCC patients treated between August 2011 and April 2015. Patients who received at least one month of 1st line TKIs were included for intent-to-treat analysis of toxicity, outcome and prognostic factors.
Eighty-six mRCC patients were treated with median age of 60 years (range: 18-79) and male: female ratio of 71:15. Fifty-seven patients had metastases at presentation. Most common site of metastasis was Lung (n - 63) followed by bone in 27, liver in 11, and brain in 7 patients. The tumor location was - 47 in right kidneys, 36 in left kidneys and 3 patients had bilateral tumors; 56 patients nephrectomised before targeted therapy. Seventy-eight (91%) patients had clear cell histology. Ten patients had low risk disease whereas 49 had intermediate risk and 23 had high risk disease (status not known in 4) according to Memorial Sloan-Kettering Cancer Center risk criteria. Targeted therapy used were sunitinib in 10, pazopanib in 61, sorafenib in 5, and temsirolimus in 5 patients (treatment not received-5). Toxicities of TKIs were grade 1 or 2 in 24 patients and grade 3 or 4 in 23; commonest being hand foot syndrome (n - 23) followed by hypertension (n - 18). Of the evaluable patients (n - 54), response was- complete response in 2, partial response in 14, stable disease in 22, and progressive disease in 16 patients. Sixty-three out of 76 patients treated with TKIs were eligible for survival analysis; 7 (11%) patients defaulted during therapy. At a median follow-up of 14 months (range: 1.8–40.3), median progression free survival (PFS) was 15.4 Â± 2.1 months. Multivariate analysis showed that baseline risk stratification independently prognosticated PFS (p = 0.02) with high risk patients had inferior PFS (HR-3, 95% CI: 1.2–7.6).
This is one of the largest studies of clinical experience of 1st line TKIs in mRCC with intent-to-treat analysis. Within the limitations of a small sample size and short follow up, high risk disease appeared to have inferior outcome.
Clinical trial identification
All authors have declared no conflicts of interest.