The combination of antiangiogenic therapy and cytotoxic chemotherapy is active and well tolerated in patients with sarcomatoid and poor-risk renal cell carcinoma (RCC), a recent study published online this week in the journal Cancer has shown.
This single-arm, phase 2 trial evaluated the activity of sunitinib and gemcitabine combination in 39 patients with sarcomatoid RCC and 33 patients with poor-risk RCC.
The primary endpoint was objective response rate (ORR), and secondary endpoints were time to progression (TTP), overall survival (OS), safety, and biomarker correlatives.
Results showed that patients with sarcomatoid RCC and poor-risk RCC had an ORR of 26% and 24%, respectively. Both disease progression and overall survival were slightly higher in patients with poor-risk RCC (TTP=5.5 months; OS=15 months) compared with sarcomatoid RCC (TTP=5 months; OS=10 months).
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Moreover, patients with greater sarcomatoid histology (>10%) had a higher ORR with stable disease than lower sarcomatoid histology (≤10%) (P=0.04). The common grade ≥3 adverse events reported were neutropenia (n = 20), anemia (n = 10), and fatigue (n = 7).
The study demonstrates that sunitinib and gemcitabine combination shows activity in both sarcomatoid and poor-risk RCC. Additional studies are currently under investigation to see if combination therapy is better than either therapy alone.