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Ann Oncol. 2011 May;22(5):1041-7. doi: 10.1093/annonc/mdq564. Epub 2011 Jan 17.

The safety and efficacy of sunitinib before planned nephrectomy in metastatic clear cell renal cancer.

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  • 1Department of Medical Oncology, St Bartholomew's Hospital.

Abstract

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.

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PMID:
21242586
[PubMed - indexed for MEDLINE]
PMCID:
PMC3082157
Free PMC Article
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