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See Latest ArticlesOverall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma
Journal of Clinical Oncology, 08/04/09
Motzer RJ et al. – Phase III trial demonstrates a longer overall survival with sunitinib as compared to IFN-α, plus improvement in response and progression-free survival in the first-line treatment of patients with metastatic renal cell carcinoma (RCC).
Methods- A randomized phase III trial to report final survival analyses and updated results in the treatment of pts with metastatic RCC with sunitinib vs interferon-α
- 750 treatment-naïve pts were randomly assigned to:
- Sunitinib 50 mg orally once daily on a 4 wks on, 2 wks off dosing schedule, or
- IFN-α 9 MU subcutaneously thrice weekly
- OS was compared by two-sided log-rank and Wilcoxon tests
- PFS, response, and safety end points were assessed with updated f/u
- Median OS was greater in the sunitinib group vs IFN-α group (26.4 v 21.8 mo) per the primary analysis of unstratified log-rank test
- By stratified log-rank test, the HR was 0.818
- Within the IFN-α group, 33% of pts received sunitinib, and 32% received other VEGF-signaling inhibitors after discontinuation from the trial
- Median PFS was 11 mo for sunitinib vs 5 mo for IFN-α
- Objective response rate was 47% for sunitinib vs 12% for IFN-α
- Most commonly reported sunitinib-related grade 3 AEs included hypertension (12%), fatigue (11%), diarrhea (9%), and hand-foot syndrome (9%).
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