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PCa [2], there are two major limitations in testing these
therapies in the adjuvant setting, when micrometastases, if
present, are more sensitive to therapies and may be eradicat-
ed, resulting in a decrease in PCa lethality: (1) a long follow-up
time is needed to reach an irrefutable OS endpoint; and (2)
selection of patients for adjuvant trials. In localized PCa,
reaching an OS endpoint can require 10–15 yr, which is a
prohibitive timeframe for pharmaceutical companies. This
fact has translated into only limited improvements in the
treatment of early aggressive PCa in the last decade. The
identification of MFS as a surrogate endpoint can now be
forwarded to regulatory agencies and drug companies to
hasten clinical trials and regulatory approval for new therapies
for early PCa. The study also provides unique insight into the
natural history of PCa. Two out of three patients who experi-
enced an MFS event had high-risk disease. However, several
trials in this population failed to show a survival benefit for
adjuvant treatment, possibly because of the overall low event
rate and the heterogeneity of this population, with varying
risk for death from PCa [3–5]. Here, the authors found that a
constant rate of relapses and late relapses had less impact on
OS than relapses before 7 yr. This is the first of a number of
steps to inform on the use of intermediate endpoints for future
clinical trial design. This information could facilitate quicker
evaluation of new therapies and accelerate improvements if
the treatments improve patient care.
Conflicts of interest: The author has nothing to disclose.
References
[1]
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[2]
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[3]
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[4]
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[5]
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Martin Spahn *
Department of Urology, Inselspital, University of Bern, Bern, Switzerland
*Department of Urology, Inselspital, University of Bern,
Anna Seiler-Haus, Bern 3010, Switzerland.
E-mail address:
© 2017 European Association of Urology.
Published by Elsevier B.V. All rights reserved.
Re: Robot-assisted Salvage Lymph Node Dissection for
Clinically Recurrent Prostate Cancer
Montorsi F, Gandaglia G, Fossati N, et al
Eur Urol 2017;72:432–8
Experts’ summary:
The authors retrospectively evaluated outcomes for
16 patients with nodal recurrence after radical prostatectomy
(RP) treated with robot-assisted salvage lymph node dissec-
tion (SLND) and adjuvant androgen deprivation therapy (ADT)
in 50% of the cases. Overall, 33.3% patients experienced
a biochemical response (BR). Ureteral and vascular injuries
occurred in one and three patients, respectively. Postoperative
complications were mild (31.2% Clavien 1–2).
Experts’ comments:
Up to 40% of men undergoing RP for localized prostate cancer
(PCa) experience clinical recurrence, and regional nodes
are usually involved. Patients affected by nodal metastases
showed better prognosis only compared to those with visceral
or skeletal lesions. Considered as the standard of care for
years, early ADT did not provide a clear overall survival benefit
[1], so it can be postponed in asymptomatic patients.
Prostate-specific membrane antigen (PSMA) positron
emission tomography (PET)/computed tomography (CT)
allows accurate early detection of PCa lesions, opening the
way to the novel concept of metastases-targeting treat-
ments (MTTs) [2].
SLND can maximize disease control and delay ADT. BR
rates range from 33.3% to 59.3% among series [3,4]. Few
long-term studies are available and the results (9–40% 5-yr
progression-free survival [PFS]; 75–89.1% 5-yr cancer-
specific survival) should be carefully interpreted, consider-
ing that adjuvant ADT was often (60 –83%) offered [5]. When
ADT is omitted, PFS is as short as 19–24 mo [5].
Few experienced surgeons reported SLND-related com-
plications; most of them were Clavien grade 1–2 (15.3%
lymphorrhoea, 14.5% fever, 11.2% ileus), and Clavien grade
3b complications were rare [3]. Minimally invasive
approaches recently provided lower complication rates [4].
Radiotherapy targeted to nodal metastases is an alterna-
tive to SLND. Oncological outcomes are comparable to those
from surgical series and remarkable toxicity is reported [5].
Since one rationale for use of MTTs would be to defer the
administration of systemic treatments, their usefulness
should be reassessed considering that adjuvant ADT was
often offered.
Although no perioperative mortality and relatively low
morbidity were reported, the incidence of lymphocele and
lymphedema is still significant, and some vascular/ureteral
injuries have been reported. SLND remains a demanding
procedure even in experienced hands.
Since RP is being reserved for patients harboring high-
risk PCa, managing oligometastatic disease is the challenge
of the next few years. MMTs are promising weapons and
new evidence is needed to define the best indications for
each approach. Results from trial NCT01558427 are awaited.
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