Sunitinib appears safe in severe renal impairment

RADAR

The combination of bevacizumab and interleukin (IL)-2 appears to have only modest effects in mRCC, according to the results of a phase II trial (Garcia et al. BJU Int 2011; 107: 562-570; www.ncbi.nlm.nih.gov/pubmed/20840548). A total of 26 treatment-naïve subjects received bevacizumab 10 mg/kg q2weeks and IL-2 125,000 U/kg/day x 5 days for six weeks, followed by a 2-week rest period. Median PFS was 9.6 months. The objective response rate was 15%, and a further 38% showed a reduction in tumour burden < 30%. Grade 3 adverse effects included fatigue, fever/chills and neutropenia.

While no prior studies of combined bevacizumab/IL-2 have been published, a retrospective study of sequential therapy has been performed The study examined the safety and tolerability of IL-2 in 23 consecutive patients previously treated with a VEGF-targeted therapy (sunitinib, sorafenib, bevacizumab) (Cho et al. J Immunother 2009; 32: 181-185; www.ncbi.nlm.nih.gov/pubmed?term=Cho%20DC%2C%20Puzanov%20I%2C%20Regan%20MM). The incidence of severe cardiotoxicity was 40%, and included 1 sudden cardiac death. Only 1 patient in the series received a second cycle of IL-2. No patient achieved a complete or partial response. The authors concluded that careful patient selection is needed when considering sequential treatment with IL-2. Further studies of this sequential approach are warranted.