Sunitinib As First-Line Treatment For Metastatic Renal Cell Carcinoma (mRCC)

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 13 Apr 2008 - 0:00 PDT

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UroToday.com - Updated results and analysis of prognostic factors from a phase III randomized trial.

Sunitinib malate has demonstrated statistically superior progression-free survival (PFS) and objective response rate (ORR) compared with IFN-alfa (IFN-α) in an international, randomized phase III trial of first-line therapy in patients (pts) with metastatic renal cell carcinoma (mRCC). Updated efficacy and safety results from this trial, and analysis of prognostic factors for PFS, are now available and presented from an international group of investigators.

Treatment-naive pts with mRCC received oral sunitinib 50 mg/day for 4 weeks, followed by 2 weeks off treatment (4/2 schedule) or subcutaneous IFN-α 9 MU three times per week. The primary endpoint was PFS.

750 pts were randomized: 375 pts to sunitinib and 375 to IFN-α. At the time of analysis, the median duration of treatment for sunitinib and IFN-α was 11.1 mo vs. 4.1 mo, respectively. 59 pts (16%) on sunitinib had discontinued due to AEs vs. 86 pts (23%) on IFN-α. ORR, as assessed by independent central review, was 39% (95% CI: 34-44) for sunitinib vs. 8% (95% CI: 6-12) for IFN-α (P<0.000001). Median PFS was 11.0 mo for sunitinib vs. 5.1 mo for IFN-α. Sunitinib was favored across all MSKCC risk factor groups; pts with 0 risk factors had a median PFS of 14.9 mo for sunitinib vs. 8.4 mo for IFN-α; pts with 1 2 risk factors had a median PFS of 10.7 mo vs. 3.8 mo, respectively; and pts with ≥3 risk factors had a median PFS of 3.9 mo vs. 1.2 mo, respectively. Baseline features predictive of longer investigator-assessed PFS in sunitinib-treated pts were time interval from diagnosis to treatment (≥1 year vs. <1 year; P<0.001); ECOG performance status (0 vs. 1; P=0.007); and corrected calcium (≤10mg/dL vs. >10 mg/dL; P=0.0084). The most common treatment-related AEs for the sunitinib group were diarrhea, fatigue and nausea and, for IFN-α, fatigue, nausea and pyrexia. The investigators conclude that Sunitinib is significantly superior to IFN-α in the first-line treatment of mRCC and is a new reference standard in this setting. The benefits of sunitinib extend across all subgroups of mRCC pts, and previously defined MSKCC risk factors predict longer PFS with sunitinib.

Presented by: S. Oudard, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

Reported by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

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