Feb 18, 2021
In today’s episode, Dr. Stephen Boorjian, professor of urology at the Mayo Clinic, in Minnesota, and chair of the GU Cancers Symposium, discusses key advances across GU malignancies.
Transcript
ASCO Daily News: Welcome to the ASCO Daily News Podcast. I'm Geraldine Carroll, a reporter for the ASCO Daily News. My guest today is Dr. Stephen Boorjian, professor of urology at the Mayo Clinic in Minnesota and chair of the 2021 Genitourinary Cancer Symposium. Dr. Boorjian joins me to discuss new developments in the GU field featured at the meeting. Dr. Boorjian serves as a consultant for Ferring, FerGene, and ArTara. Full disclosures relating to all episodes of the podcast are available on our transcripts at ASCO.org/podcasts. Dr. Boorjian, it's great to have you on the podcast today.
Dr. Stephen Boorjian: Thank you very much. It's a
privilege to be here and I'm happy to participate.
ASCO Daily News: There was a lot of
interest in the CheckMate 274 trial. What can you tell us about
this study and its likely impact on the future management of
patients with muscle invasive urothelial carcinoma after radical
surgery?
Dr. Stephen Boorjian: Absolutely. Thanks,
Geraldine. So this trial was presented in Abstract 391. This was the first
results released from this phase III randomized, double blind,
multicenter clinical trial. The trial tested adjuvant therapy with
the immune checkpoint agent nivolumab versus placebo in patients
with muscle invasive urothelial carcinoma following radical
surgery. This was a trial that enrolled over 700 patients. Patients
were randomly assigned in a one to one fashion for 1 year of
treatment. The primary endpoints of the trial were disease-free
survival in all patients, as well as in patients with tumor
expression of PD-L1 ≥ to 1%.
Very importantly, the primary endpoint of disease-free survival was
met in both of those study cohorts, specifically in the
intention-to-treat population. The median disease-free survival in
the patients treated with nivolumab was 21 months versus 10.9
months in the placebo arm. And that result was highly statistically
significant. Likewise, in the cohort of patients with PD-L1
expression ≥ 1%, the median disease-free survival was actually not
reached in the nivolumab arm versus 10.8 months in the placebo arm.
And again, highly statistically significant.
Grade 3-4 treatment-related adverse events in the study occurred in
17.9% and 7.2% in nivolumab and placebo arms, respectively. I
selected this trial for highlighting because I believe this has the
potential to significantly impact future management of these
patients' [disease]. The role of adjuvant therapy after radical
surgery in urothelial carcinoma has remained very poorly defined.
These results, I should say, really represent an opportunity, I
think, for our patients to now receive an adjuvant therapy with
demonstrated subsequent efficacy in the median disease-free
survival, as we saw.
ASCO Daily News: It's great to hear about
such promising data on the role of adjuvant therapy for this
patient population. Moving on to the SEMS trial, Abstract 375. This study reported
promising results for a young patient population with early
metastatic seminoma. You were a co-investigator on this trial. What
can you tell us about it?
Dr. Stephen Boorjian: So Abstract 375 reports the
results from a Phase II multi-institutional surgical trial in early
metastatic seminoma. What was particularly exciting to me about
this trial is it gave the opportunity to incrementally impact a
long-held management paradigm and to change it. So the management
for patients with early stage metastatic seminoma has historically
been with radiotherapy or chemotherapy, and each of these carry
with them the potential for long-term adverse side effects in what
is otherwise a very young and healthy patient population.
So this trial tested the use of retroperitoneal lymph node
dissection, so surgical resection, in patients with early
metastatic seminoma. It accrued at 12 sites in the United States
and Canada. Patients had isolated retroperitoneal lymphadenopathy
between one and three centimeters and testicular seminoma. The
primary endpoint of the trial was 2-year recurrence-free survival.
Fifty five patients were enrolled in the trial and with a median
follow-up of 24 months, the overall recurrence rate was 18% for a
2-year recurrence-free survival of 87% and overall survival of 100%
There were only two Clavien [Dindo] grade 3 complications in the
perioperative period and no long-term complications associated with
it.
So I think this trial has the potential to establish
retroperitoneal lymph node dissection as a therapeutic option in
first-line therapy for early metastatic seminoma. It's effective.
It's safe in both the short and the long term. And I was really
privileged to be part of a surgical trial, which can be often quite
difficult to conduct. And I want to congratulate Dr. Daneshmand,
the trial's principal investigator.
ASCO Daily News: Absolutely. Focusing on
kidney cancer for a moment, can you tell us about the CLEAR
study--that's Abstract 269--and the opportunity it
represents to offer another potential first-line therapy to
patients with advanced renal cell carcinoma?
Dr. Stephen Boorjian: Sure. So Abstract 269
reported the phase III trial, which was a three-armed prospective
randomized trial for patients with advanced renal cell carcinoma.
These patients were randomly assigned in the study to receive
either the combination of lenvatinib and pembrolizumab, or
lenvatinib and everolimus, or sunitinib. The primary endpoint of
the study was progression-free survival. And the study was targeted
at patients with no prior systemic therapy. So this was a
first-line therapy trial.
The trial enrolled over 1,000 patients, and with a median follow-up
of 27 months, the trial demonstrated that progression-free survival
was significantly improved among patients who received the
combination of lenvatinib and pembrolizumab at 24 months versus
sunitinib at 9 months. Likewise, the complete response rate in the
cohort of patients treated with the combination of lenvatinib and
pembrolizumab was 16% compared to 4% with patients treated with
sunitinib. And the median duration of response was quite durable at
26 months among the lenvatinib-pembrolizumab arm.
So the trial was exciting to me as an opportunity to bring forth
another potential first-line therapeutic management strategy for
patients with advanced renal cell carcinoma. I think as we continue
to evolve in this field, treatment selection will depend on
biomarkers as they continue to be explored and developed,
differences in side effects, [and] patient tolerability profiles.
So I think having one more option in the armamentarium can only
help to benefit our patients going forward.
ASCO Daily News: Indeed. There were
multiple studies about the impact of health disparities. Abstract 14 is really interesting
because it provides a real-world snapshot of the genomic landscape
of advanced prostate cancer in a hospital that serves racial and
ethnic minority communities. The study highlights the importance of
next generation sequencing in guiding therapies for these patients.
So improving access to this care is crucially important. What are
your thoughts on this study?
Dr. Stephen Boorjian: Abstract 14, I thought,
highlights a very important and very timely topic and that is to
evaluate the genomic landscape of advanced prostate cancer in
racial minority populations. It used a real-world safety net
hospital experience and demonstrated higher frequencies of androgen
receptor as well as other homologous recombination repair gene
mutations in African-American cohort compared to patients with
prostate cancer of other races and ethnicities.
As the study utilized next generation sequencing, I thought the
approach was quite elegant. And I think, ultimately, this
demonstrates the potential importance of that type of next
generation sequencing strategy to guide therapy as we move more and
more towards targeted therapies in patients with advanced prostate
cancer. And I think it emphasizes the need to decrease barriers to
access to such types of investigative modalities such as next
generation sequencing for racial minorities. So I liked the fact
that that abstract sort of specifically brought forth a couple of
different themes around a very important and timely topic.
ASCO Daily News: Absolutely. Staying in
the prostate cancer space, a University of California Health System
registry study looked at androgen deprivation and the risk of
COVID-19 infection in men with prostate cancer. This is a very
timely topic. Can you tell us about it, Abstract 37?
Dr. Stephen Boorjian: Yeah, Abstract 37, I thought
again, addressed a very timely topic in 2020 and 2021, which was
the association of men receiving androgen deprivation therapy with
COVID-19 infection. So we are getting lots of questions about the
potential interaction of cancer diagnosis and cancer therapies and
COVID-19 diagnosis, and this study, which was conducted using a
retrospective registry of adult men with prostate cancer in the
University of California Health System, evaluated the correlation
between COVID-19 diagnosis and androgen deprivation therapy
use.
Androgen deprivation therapy is a baseline therapy for men with
advanced prostate cancer used quite frequently. And therefore,
understanding the potential interaction that androgen deprivation
therapy might have with COVID diagnosis is important for patient
counseling and treatment going forward. And in fact, what the study
found was no association between the use of androgen deprivation
therapy and the risk of testing positive for COVID-19 in their
patient cohort population.
And I think that can be looked at in one of two ways. Androgen
deprivation therapy is not protective, based on these data, against
COVID-19 infection, as it might have been speculated to be because
of intracellular expression modification. But at the same time,
there wasn't a negative association, and there was no increased
risk of COVID-19 diagnosis noted among men receiving androgen
deprivation therapy. So I think this sort of can help us going
forward, as we understand more and more about the potential
interactions of our cancer therapies with COVID-19 diagnosis.
ASCO Daily News: Dr. Boorjian, Thanks so
much for taking the time to share these really interesting
highlights from the GU Cancer Symposium with us.
Dr. Stephen Boorjian: Thanks very much for having
me. It is my pleasure.
ASCO Daily News: And thanks to our
listeners for joining us today. If you enjoyed this episode, please
take a moment to rate and review us wherever you get your
podcasts.
Disclosures: Dr. Stephen Boorjian
Consulting or Advisory Role: Ferring, Sanofi, ArTara, FerGene
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