EURURO Vol. 71 No. 5

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in the sunitinib arm did not have improved overall survival
[1]; however, these data are crucial as sunitinib is frequently
used as first line treatment after progression. According to
Ravaud et al [1], overall survival data as secondary endpoints
were not yet mature. However, the hazard ratio for overall
survival was close to 1, and no trend in favour of any armwas
seen after a relatively long follow-up interval of 5+ yr. Given
the fact that the majority of patients recurred within the 1st
2 yr and that the median overall survival time of patients
with metastatic disease is about 2 yr, the author feels that
the follow-up interval should be sufficient to demonstrate a
trend. Thus, the author thinks that it is unlikely that an
overall survival benefit will be demonstrated in this cohort.
Adverse events under sunitinib were prevalent and fre-
quently led to a dose reduction. In clinical practice, the
management of patients with Grade 3 or 4 adverse events
may be more difficult in the adjuvant than in the palliative
setting.
ASSURE (NCT00326898) compared adjuvant sunitinib or
sorafenib to placebo in 1943 patients with high-risk RCC. In
contrast to S-TRAC, the ASSURE trial was completely
negative, with no significant differences among the three
groups (hazard ratio: 1.02, p = 0.8 and hazard ratio: 0.97,
p = 0.7). The selection of high-risk patients was slightly
different in both trials, but these differences cannot explain
the conflicting results. Comparably, a significant proportion
of patients experienced Grade 3 or 4 adverse events. In
ASSURE, there were five deaths related to treatment or
occurring within 30 d of the end of treatment [2].
How should we proceed with high-risk RCC in clinical
practice? The author agrees with the recent statement
by the European Association of Urology Guidelines Group
that, at present, sunitinib should not be recommended to
high-risk patients after complete tumour removal [3]. Dif-
ferences in disease-free survival may be minor or not
present at all, and an overall survival benefit has not been
demonstrated. Meta-analyses were attempted [4], but will
not replace further trials. Finally, the risk of toxicities is not
balanced by possible minor improvements in outcomes.
Conflicts of interest: The author has nothing to disclose.
References
[1]
[2]
[3]
[4] Gyawali B, Ando Y. Adjuvant sunitinib for high-risk resected renal
cell carcinoma: a meta-analysis of ASSURE and S-TRAC trials. Ann
Oncol. In press.
Tobias Klatte*
Department of Urology, Medical University of Vienna, Vienna, Austria
*Department of Urology, Medical University of Vienna, Wa¨hringer Gu¨ rtel
18-20, A-1090 Vienna, Austria.
E-mail address:
# 2017 European Association of Urology.
Published by Elsevier B.V. All rights reserved.
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