Sorafenib with interleukin-2 vs sorafenib alone in metastatic renal cell carcinoma: The ROSORC trial
British Journal of Cancer, 04/04/2011
Exclusive author commentary
Procopio G et al. – The combination of sorafenib and IL–2 did not demonstrate improved efficacy vs sorafenib alone. Improvements in progression–free survival (PFS) appeared greater in patients receiving higher–dose IL–2.
Methods- Open–label, phase II study
- 128 patients with metastatic renal cell carcinoma (mRCC) randomised to receive oral sorafenib, 400 mg twice daily, plus subcutaneous IL–2, 4.5 million international units (MIU) 5 times per week for 6 in every 8 weeks, or sorafenib alone
- After enrolment of first 40 patients, IL–2 dose reduced to improve tolerability
- Median follow–up of 27 months
- Median 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
- Most common AEs were asthenia, hand–foot syndrome, hypertension, and diarrhea
- Grade 3–4 adverse events reported for 38 and 25% of patients receiving combination and single–agent treatment
G.Procopio (04/07/2011) comments:
In the ROSORC trial in the sorafenib alone arm was reported a better activity in comparison with a previous phase 2 trial in untreated patients( mPFS 6.9 months vs 5.7 months).
Considering the eterogeneity of the study population treated in the ROSORC trial ,including also non clear cells histologies and poor risk patients, these results could be considered interesting in 1 line mRCC.
In the subgroups analysis undertaken according to the study design patients with low risk and having clear cells histology had more benefit with the addition of IL-2 to sorafenib.
These data suggest that this combination could be useful in selected patients with a slow progressive disease.
Finally the dose and route of administration of IL-2 coulb be direcly related to the activity of the combination sorafenib+IL-2
