Progression free survival in patients with metastatic and recurrent renal cancer treated with sorafenib—Single center experience

Abstract

16141 Background: Treatment of metastatic renal cell carcinoma (RCC) with sorafenib was previously shown to prolong progression free survival (PFS) with a median of 5.5 months. One of the advantages of using sorafenib is a relatively tolerable side effect profile. We examined our own experience with sorafenib as first line treatment of metastatic RCC in a heterogonous patient population, including patients with brain and bone metastases. Methods: We analyzed PFS defined as increased in size of target lesion or appearance of new metastases. Twenty one patients with metastatic RCC were treated with oral sorafenib (400mg bid administered in 4- week cycles for the first 24 weeks and in 8- week cycles thereafter). Follow up consisted of four-weekly appointments with blood work and physical exams, quarterly or/as needed CT and bone scans, and ranged from 23–85 weeks (median 54 weeks). Soft tissue metastases were defined as within the lungs or liver (n=12). Two patients had brain metastases, five had bone metastases and two had local recurrence in the nephrectomy bed. Nine patients presented initially with metastatic tumor and 7 underwent cytoreductive nephrectomy. Eleven patients underwent therapeutic nephrectomy for localized disease. Results: The median PFS was 8.4 months (range 1.2–59 months). Four patients (19%) were progression free at last follow-up (median 12.75 months). Median PFS for patients with soft tissue metastases vs. patients with brain or bone metastases was 8.7 vs 6.1 months respectively, with no statistically significant difference. Median PFS for patients with solitary vs. multiple metastases was 12.25 vs. 8.75 months respectively. Durable PFS greater than 1 year was observed in 24% of patients. Stage, grade, age or gender did not predict PFS. During a follow-up period of up to 85 weeks, 7 (33%) death were recorded. All patients had some degree of side effects, most commonly gastro intestinal (81%), skin reaction (76%), fatigue (76%), and cardiovascular (57%). However, none of them had to stop therapy. Four patients who progressed were switched to sunitinib. Conclusions: Treatment of patients who have heterogonous and diverse metastatic RCC with sorafenib can achieve a median PFS of 8.4 months with frequent but tolerable side effects. No significant financial relationships to disclose.