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Upfront, randomized, phase II trial of sorafenib versus sorafenib and low-dose interferon alfa in patients with advanced renal cell carcinoma
Cancer, 11/03/09

Jonasch E et al. – The objective of this study was to independently evaluate the objective response rate of sorafenib and sorafenib plus low-dose interferon-alfa 2b (IFN) as frontline therapy in patients with metastatic renal cell carcinoma (mRCC). The addition of low-dose IFN to sorafenib resulted in efficacy outcomes that were comparable to those achieved with sorafenib monotherapy. The current results indicated that pAKT levels may predict for clinical outcome.

Methods

Untreated patients with clear cell mRCC randomized to receive sorafenib 400 mg orally twice daily or sorafenib 400 mg orally twice daily plus subcutaneous IFN 0.5 million U (MU) twice daily
Primary endpoints included ORR and safety
Secondary endpoints included PFS and OS
Exploratory endpoints included predictive value of tumor tissue biomarkers

Results

80 patients enrolled
Median follow-up was 19.7 months (range, 0-34.2 months)
ORR 30% (95% confidence interval [CI], 16.6%-46.5%) in sorafenib arm and 25% (95% CI, 12.7%-41.2%) in combination arm
Median PFS 7.39 months in sorafenib-alone arm (95% CI, 5.52-9.20 months) and 7.56 months in sorafenib plus IFN arm (95% CI, 5.19-11.07 months)
Median OS 27.04 months in combination arm (95% CI, from 22.31 to not attained) and not reached in sorafenib arm
Toxicities comparable in both arms
In multivariate model, increased phosphorylated protein kinase B (pAKT) levels associated with poorer PFS

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