Journal
BRITISH JOURNAL OF CANCER
Volume 104, Issue 8, Pages 1256-1261Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/bjc.2011.103
Keywords
sorafenib; interleukin-2; targeted therapies; renal cell carcinoma; immunotherapy
Categories
Funding
- Bayer HealthCare
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BACKGROUND: Preclinical investigations support combining sorafenib with IL-2 in the treatment of metastatic renal cell carcinoma (mRCC). METHODS: In this open-label, phase II study, 128 patients with mRCC were randomised to receive oral sorafenib, 400 mg twice daily, plus subcutaneous IL-2, 4.5 million international units (MIU) five times per week for 6 in every 8 weeks, or sorafenib alone. After enrolment of the first 40 patients, IL-2 dose was reduced to improve the tolerability. RESULTS: After a median follow-up of 27 months, median progression-free survival (PFS) was 33 weeks with sorafenib plus IL-2, and 30 weeks with sorafenib alone (P = 0.109). For patients receiving the initial higher dose of IL-2, median PFS was 43 weeks vs 31 weeks for those receiving the lower dose. The most common adverse events were asthenia, hand-foot syndrome, hypertension, and diarrhoea. Grade 3-4 adverse events were reported for 38 and 25% of patients receiving combination and single-agent treatment, respectively. CONCLUSION: The combination of sorafenib and IL-2 did not demonstrate improved efficacy vs sorafenib alone. Improvements in PFS appeared greater in patients receiving higher-dose IL-2. British Journal of Cancer (2011) 104, 1256-1261. doi:10.1038/bjc.2011.103 www.bjcancer.com Published online 29 March 2011 (C) 2011 Cancer Research UK
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