Medline ® Abstract for Reference 78
of 'Toxicity of molecularly targeted antiangiogenic agents: Non-cardiovascular effects'
The safety and efficacy of sunitinib before planned nephrectomy in metastatic clear cell renal cancer.
Powles T, Kayani I, Blank C, Chowdhury S, Horenblas S, Peters J, Shamash J, Sarwar N, Boletti K, Sadev A, O'Brien T, Berney D, Beltran L, Haanen J, Bex A
Ann Oncol. 2011;22(5):1041. Epub 2011 Jan 17.
BACKGROUND: The safety and efficacy of upfront sunitinib, before nephrectomy in metastatic clear cell renal cancer (mCRC), has not been prospectively evaluated.
METHODS: Two prospective single-arm phase II studies investigated either two cycles (study A: n = 19) or three cycles (study B: n = 33) of sunitinib before nephrectomy in mCRC.
RESULTS: Overall, 38 of 52 (73%) of patients obtained clinical benefit (by RECIST) before surgery. The partial response rate of the primary tumour was 6% [median reduction in longest diameter of 12% (range 8%-35%)]. No patients became ineligible due to local progression of disease. A nephrectomy was carried out in 37 (71%) of patients. Necrosis (>50%) was a prominent feature at nephrectomy in 49%. Surgical complications (Clavien-Dindo classification) occurred in 10 (27%) patients, including one death (3%). The median blood loss and surgical time were 725 (90-4200) ml and 189 (70-420) min, respectively. The median progression-free survival was 8 months (95% confidence interval 6-15 months). A comparison of two versus three pre-surgery cycles showed no significant difference in terms of surgical complications or efficacy.
CONCLUSIONS: Nephrectomy after upfront sunitinib can be carried out safely. It obtains control of disease. Randomised studies are required to address if this approach is beneficial.
Department of Medical Oncology, St Bartholomew's Hospital.