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Letter to the Editor

Re: Brian I. Rini, Tanya B. Dorff, Paul Elson, et al. Active

Surveillance in Metastatic Renal-cell Carcinoma:

A Prospective, Phase 2 Trial. Lancet Oncol Lancet


Active Surveillance in Metastatic Renal Cell Carcinoma:

Option or Exception?

The study by Rini and colleagues


is the first prospective

observational study of asymptomatic patients with meta-

static renal cell carcinoma (mRCC) who undergo an initial

period of surveillance before starting systemic therapy.

Virtually all the patients (


= 47/48) underwent previous

nephrectomy showing optimal performance status (Kar-

nofsky 90–100 in


= 45/48) and favourable/intermediate



= 47/48) International Metastatic Database Consortium

risk score

[1] .

The authors concluded that in this specific

scenario, some mRCC patients might safely undergo

observation before starting targeted therapy.

The study is of outstanding importance, since it confirms

the clinical feeling that a very select cohort of asymptomatic

patients with favourable disease do not show clinical or

radiologic progression in the first months after surgery,

even in the absence of subsequent systemic therapy.

Moreover, these findings are of overwhelming importance

considering the potential toxicity and costs related to

targeted therapy. However, the authors’ postulation that ‘‘in

a subset of patients with mRCC surveillance does not clearly

compromise the benefit of systemic therapy when initiated’’

is still premature.

First, this is not a comparative trial between active

surveillance and immediate systemic therapy. Therefore, it

cannot be determined whether active surveillance is

equally or less effective than an immediate multimodal

approach (surgery + systemic therapy).

Second, the inclusion criteria are too heterogeneous:

although the majority of patients underwent prior nephrec-

tomy, the report has not considered the effect of surgical

debulking and its extent on the natural history of the

disease. Indeed, patients who were included had mainly

lung or lymph node metastases, with most having only one

metastatic organ and a low tumour burden at baselin

e [1] .

In daily clinical practice, these favourable characteristics

frequently allow consideration of the indication, besides

nephrectomy, for upfront surgical metastasectomy or

retroperitoneal lymph node dissection or bone radiation

as well. Although its effect on cancer control is debatable,

this multimodal approach might at least mitigate the extent

of progression and postpone the initiation of systemic



. Although their level of evidence is limited,

previous published data have indeed shown a benefit of

metastasectomy for mRCC patients who have been selected

for favourable characteristics and low metastatic tumour


[2–5] .

Therefore, it is possible that patients who

might be candidates for surveillance before starting

systemic therapy might be those who receive the greatest

extent of debulking on initial management.

In conclusion, this study does represent an important

milestone in the setting of mRCC management. However,

the dilemma still persists as to whether cancer control is

compromised among patients who undergo an initial period

of observation in comparison to immediate systemic

therapy, and how critical the extent of initial debulking is.

Conflicts of interest:

The authors have nothing to disclose.


[1] Rini BI, Dorff TB, Elson P, Rodriguez CS, Shepard D. Active surveil-

lance in metastatic renal-cell carcinoma: a prospective, phase

2 trial. Lancet Oncol 2016;17:1317–24. S1470-2045(16)30196-6


[2] Capitanio U. FRCS PFM. Renal cancer. Lancet 2016;387:894–906.


[3] Dabestani S, Marconi L, Hofmann F, Stewart F. Local treatments for

metastases of renal cell carcinoma: a systematic review. Lancet

2014;15:e549–61. 70235-9


[4] Zaid HB, Parker WP, Safdar NS, et al. Outcomes following complete

surgical metastasectomy for patients with metastatic renal cell

carcinoma: a systematic review and meta-analysis. J Urol 2017;



[5] Capitanio U, Abdollah F, Matloob R, et al. Effect of number and

location of distant metastases on renal cell carcinoma mortality in

candidates for cytoreductive nephrectomy: implications for multi-

modal therapy. Int J Urol 2013;20:572–9. 1111/iju.12004 . E U R O P E A N U R O L O G Y 7 1 ( 2 0 1 7 ) e 1 3 9 – e 1 4 0

ava ilable at

journal homepage:



2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.