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

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.

• Authors: G Procopio, E Verzoni, S Bracarda, S Ricci, C Sacco, L Ridolfi, C Porta, R Miceli, N Zilembo, E Bajetta
• Journal: British journal of cancer (Br J Cancer) Vol. 104 Issue 8 Pg. 1256-61 (Apr 12 2011) ISSN: 1532-1827 [Electronic] England
• PMID: 21448165 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Benzenesulfonates
• Interleukin-2
• Phenylurea Compounds
• Pyridines
• Niacinamide
• Sorafenib

Topics

• Aged
• Algorithms
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Benzenesulfonates (administration & dosage, adverse effects)
• Carcinoma, Renal Cell (drug therapy, pathology)
• Disease-Free Survival
• Female
• Humans
• Interleukin-2 (administration & dosage, adverse effects)
• Kidney Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Metastasis
• Niacinamide (analogs & derivatives)
• Phenylurea Compounds
• Pyridines (administration & dosage, adverse effects)
• Sorafenib
• Treatment Outcome