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Clinical Trial
. 2011 Apr 12;104(8):1256-61.
doi: 10.1038/bjc.2011.103. Epub 2011 Mar 29.

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

G Procopio  1 , E Verzoni, S Bracarda, S Ricci, C Sacco, L Ridolfi, C Porta, R Miceli, N Zilembo, E Bajetta
Affiliations
Clinical Trial

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

G Procopio et al. Br J Cancer. .

Abstract

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.

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Figures

Figure 1
Figure 1
Flow of patients through the study.
Figure 2
Figure 2
Progression-free survival curves in patients treated with the combination of sorafenib plus IL-2 (S+IL2) or sorafenib alone (S).
Figure 3
Figure 3
Waterfall plot showing the best variation from baseline in the sum of target lesion diameters. The investigator-assessed response is differentiated by colour (partial response, white; stable disease, grey; disease progression, black).
Figure 4
Figure 4
Progression-free survival curve in the low-risk subgroup of patients treated with the combination of sorafenib plus IL-2 (S+IL2) or sorafenib alone (S).
Figure 5
Figure 5
Progression-free survival curves in patients treated with the combination of sorafenib plus higher dose of IL-2 (S+higher dose IL2), sorafenib plus lower dose of IL-2 (S+lower dose IL2), or sorafenib alone (S).
See this image and copyright information in PMC

References

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