Overall survival for sorafenib plus interleukin-2 compared with sorafenib alone in metastatic renal cell carcinoma (mRCC): Final results of 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 journalArticlepeer-review

Abstract

Background: The ROSORC trial, a randomised, phase II trial comparing sorafenib plus interleukin (IL-2) versus sorafenib alone as first-line treatment of metastatic renal cell carcinoma (mRCC) failed to demonstrate differences in progression-free survival (PFS). Updated overall survival (OS) results are reported. Patients and methods: In this study, 128 patients were randomised to receive sorafenib 400 mg twice daily plus subcutaneous IL-2 4.5 million international units (MIU) five times per week for 6 weeks every 8 weeks (arm A) or sorafenib alone (arm B). OS was estimated with the Kaplan-Meier method and compared with the two-sided log-rank test. Results: After a median follow-up of 58 months (interquartile range: 28-63 months), the median OS was 38 and 33 months in arms A and B, respectively (P = 0.667). The 5-year OS was 26.3% [95% confidence interval (CI) 15.9-43.5) and 23.1% (95% CI 13.2-40.5) for the combination- and single-agent arm, respectively. Most of the patients who were refractory to first-line treatment were subsequently treated with different targeted agents; they had a median survival greater than expected. Conclusions: This outcome suggests a synergistic effect of the subsequent therapies following sorafenib failure.

Original languageEnglish
Article numbermdt375
Pages (from-to)2967-2971
Number of pages5
JournalAnnals of Oncology
Volume24
Issue number12
DOIs
Publication statusPublished - Dec 2013

Keywords

  • First-line treatment
  • Interleukin-2
  • Renal cell carcinoma
  • Sorafenib
  • Targeted therapies

ASJC Scopus subject areas

  • Oncology
  • Hematology

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