Kidney Cancer Journal 109
Woldu et al (Poster #52) used the NCDB to study the effect
of delay of receiving targeted therapy on outcomes of
2716 patients with metastatic clear cell RCC. They noted
that a delay in receiving targeted therapy (divided in subgroups
of less than 2 month, 2-3 months, 3-6 months,
and over 6 months) was not associated with worse outcomes
in this patient population, keeping in mind that
selection bias was an important factor in this delay.
Xia et al (Poster #145) used the NCDB to study shortterm
outcomes after cytoreductive nephrectomy in relation
to hospital volume. Hospitals with 8 or more cases
per year were considered high-volume for the purpose of
this study. Patients treated at high-volume hospitals experienced
to an IRC analysis, this phase is likely to reveal a tendency
in the earlier stages of the trial to be somewhat
sanguine about outcomes. For example, among RCC patients
who have shown, let’s say, a 25% reduction in
tumor size, investigators may characterize this finding
as a “partial response.” However, such responses scrutinized
in the IRC analysis may be recategorized because
the review suggests otherwise. This is particularly true
when evaluations of whether end points have been
reached are considered in a relatively subjective context.
The advantage of having an independent review
board review all the radiological data was important.
With regard to this IRC data, the reviewers are not
aware of which patients are assigned to a drug. And
they are not aware of what the investigators had said
about these patients. The board simply measures the
tumors and whether there was progression or reduction.
The bottom line is that a major question mark regarding
the validity of results previously presented through
the CABOSUN trial has essentially been lifted. The
robust data translate to an improvement in outcomes
for patients in first line therapy who are intermediate
to poor risk compared to treatment with sunitinib.
Results presented at ESMO with respect to CABOSUN
were important for other reasons as well, particularly
as we look for evidence on progression-free
survival (PFS) and overall survival OS) to guide clinical
decision making. CABOSUN did not produce definitive
data on OS because the trial was not large enough for
that measure. Nevertheless, CABOSUN did show an
overall survival benefit trend. But with all the combinations
emerging and undergoing study (such as a new
trial investigating ipi-nivo combined with cabozantinib)
we need to question the wisdom of spending years on
assessing this end point with monotherapy, whether it
achieves improved OS. Practically speaking, it may be
superfluous and not a good investment for a pharmaceutical
company’s research program to undertake this
study. Why? Because it is likely that a combination of
agents, including the drug for which OS has not been
unequivocally determined, will produce data showing
superior OS.
As we evaluate the expanded spectrum of therapy
and the overarching excitement for immune-oncologic
approaches, the subtext of the debate is also a cautionary
tale. As impressive as the OS findings are with IO
therapy, not all patients are candidates for IO. The
cautionary tale reflects the fact that in many patients
IO therapy may not be the appropriate first choice—
particularly in those with bone metastases, autoimmune
disease and the elderly whose ability to undergo
infusions may be limited.
With this issue, we conclude our 15th year of
publishing the Kidney Cancer Journal. Who would have
known that when this publication was launched in
2003 that we would be talking about “future shock”
and an overwhelming volume of information in
frontline therapy? At that time there was only one drug
approved for RCC Perhaps the new year will bring
much in the way of a new paradigm, as much perhaps
as what the situation was more than 10 years ago when
the current standard of anti-VEGF therapy was about
to be approved. On behalf of the journal, its Medical
Advisory Board and Editorial Advisory Board, we wish
you the best for the new year.
Robert A. Figlin, MD
Editor-in-Chief
EDITOR’S MEMO
(continued from page 90)
lower rates of 30-day and 90-day mortality, prolonged
length of stay, and 30-day readmission. In addition,
these outcomes were noted to improve more with
higher numbers of surgeries performed within these centers.
Lenis et al (Poster #147) used the NCDB to study trends
and effects of overall survival of surgery in patients with
metastatic RCC and IVC tumor thrombus. The authors
noted that patients with T3b and T3c potentiallywere less
likely to undergo surgery than those with T3a disease. In
this cohort, cytoreductive nephrectomy was associated
with improved survival in patients with T3a and T3b, but
not T3c disease. KCJ