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Clinical Trial
. 2011 May;22(5):1041-1047.
doi: 10.1093/annonc/mdq564. Epub 2011 Jan 17.

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

T Powles  1 , I Kayani  2 , C Blank  3 , S Chowdhury  4 , S Horenblas  3 , J Peters  5 , J Shamash  1 , N Sarwar  1 , K Boletti  6 , A Sadev  1 , T O'Brien  4 , D Berney  1 , L Beltran  5 , J Haanen  3 , A Bex  7
Affiliations
Clinical Trial

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

T Powles et al. Ann Oncol. 2011 May.

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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Figures

Figure 1.
Figure 1.
Progression-free survival curves. Some patients were not included: (A) rapid PD/death (n = 2). Patients changed to sorafenib (n = 1). (B) Bone metastasis only (n = 3) rapid PD/death (n = 3). Patients changed to sorafenib (n = 1).
Figure 2.
Figure 2.
Percentage change of the tumours with sunitinib (A) primary tumour (measures the longest diameter of the primary tumour) (B) metastatic site [measures only the combined metastatic sites (RECIST v1.1)]
See this image and copyright information in PMC

Comment in

References

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