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

G. Procopio, E. Verzoni, S. Bracarda, S. Ricci, C. Sacco, L. Ridolfi, C. Porta, R. Miceli, N. Zilembo, E. Bajetta

Research output: Contribution to journalArticle


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.

Original languageEnglish
Pages (from-to)1256-1261
Number of pages6
JournalBritish Journal of Cancer
Issue number8
Publication statusPublished - Apr 12 2011



  • immunotherapy
  • interleukin-2
  • renal cell carcinoma
  • sorafenib
  • targeted therapies

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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