NE-AUA 2006 Annual Meeting, September 28 - 30, 2006, The Westin Hotel & Rhode Island Convention Center Providence, Rhode Island
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Sunitinib Malate (SU11248) Shows Efficacy in Two Consecutively Conducted Phase II Studies of Patients with Metastatic Renal Cell Carcinoma (RCC)
M. Dror Michaelson, MD, PhD1, BI Rini, MD2, DJ George, MD3, BG Redman, MD4, GR Hudes, MD5, G Wilding, MD6, RM Bukowski, MD2, ST Kim, PhD7, I Chen, PhD7, RJ Motzer, MD8.
1Massachusetts General Hospital, Boston, MA, USA, 2Cleveland Clinic Foundation, Cleveland, OH, USA, 3Duke University, Durham, NC, USA, 4University of Michigan, Ann Arbor, MI, USA, 5Fox Chase Cancer Center, Philadelphia, PA, USA, 6University of Wisconsin, Madison, WI, USA, 7Pfizer, Inc, La Jolla, CA, USA, 8Memorial Sloan-Kettering Cancer Center, New York, NY,

Background: Sunitinib malate (SU11248, SUTENT) is an oral, multitargeted tyrosine kinase inhibitor of VEGFR, PDGFR, and other related receptors. The efficacy and safety of sunitinib have been evaluated in two phase II trials in pts with metastatic RCC refractory to cytokine therapy.
Methods: For both trials, eligibility criteria included measurable disease, failure of one prior cytokine therapy, ECOG PS of 0 or 1 and adequate organ function. Pts received 6-week cycles of oral sunitinib 50 mg/day for 4 weeks followed by 2 weeks off drug. Best response was assessed using RECIST.
Results: Best responses and progression-free survival for evaluable pts are summarized below.


n (%)

n (%)

n (%)

≥3 months
n (%)

SD <3 months or not evaluable
n (%)

Median PFS Months (95% CI)

Trial 1 (N=63)

25 (40)

0 (0)

25 (40)

17 (27)

21 (33)


Trial 2 (N=105)*

46 (44)

1 (1)

45 (43)

23 (22)

36 (34)


Pooled analysis (N=168)

71 (42)

1 (1)

70 (42)

40 (24)

57 (34)


*Study ongoing
One pt omitted from efficacy analysis due to change in diagnosis
Median overall survival was 16.4 months in Trial 1 and has not been reached for Trial 2. Most treatment-related adverse events were mild to moderate in severity.
Conclusions: Sunitinib has demonstrated substantial single-agent antitumor activity in pts with cytokine-refractory metastatic RCC in two phase II trials. Based on these data, FDA approval was recently granted for the treatment of advanced RCC. Sunitinib has manageable adverse events, with responding pts receiving treatment for >2 years. A phase 3 study exploring sunitinib as first-line therapy is underway.

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