Background: phase III RCT included 723 patients with metastatic RCC who progressed on first-line therapy (sunitinib, bevacizumab plus interferon-alfa, temsirolimus, or other)

Arm A: axitinib 5mg BID
Arm B: Sorafenib 400mg BID

Primary end point: PFS

mPFS: 6.7mo vs 4.7mo; A vs B respectively with HR 0.665, 95%CI 0.544-0.812, one-sided P<.0001

STUDY UPDATE: Motzer RJ, Lancet Onc, 2013, PMID:23598172

mOS: 21.1mo vs 19.2mo, HR 0.96, 95%CI 0.80-1.17, one-sided P=.3744
mPFS: 8.3mo vs 5.7mo, HR 0.65, 95%CI 0.55-0.77, one-sided P<.0001

Main adverse events. Treatment discontinuation 4% vs 8%. Most common AE in group A: diarrhea, fatigue and HTN; in group B: diarrhea, hand and foot syndrome and hair loss.

Conclusions: axitinib improves PFS in second line settings without improving OS.

Summarized by Veli Bakalov, MD

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