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Sorafenib with interleukin-2 vs sorafenib alone in metastatic renal cell carcinoma: the ROSORC trial.

Author(s): Procopio G, Verzoni E, Bracarda S, Ricci S, Sacco C, Ridolfi L, Porta C, Miceli R, Zilembo N, Bajetta E

Affiliation(s): Department of Medical Oncology, Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori, Via G. Venezian, Milan 1-20133, Italy. giuseppe.procopio@istitutotumori.mi.it

Publication date & source: 2011-04-12, Br J Cancer., 104(8):1256-61. Epub 2011 Mar 29.

Publication type: Clinical Trial, Phase II; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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.

Page last updated: 2011-12-09

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