Practice Update | Onology

17 / 32

or not?” and I always said, “You know, probably not a lot, but I don’t
know.” And now we know.
Dr Haffizulla: Among high-risk patients who’ve received CAPOX
as opposed to FOLFOX, there appears to be less of a difference
between 3 and 6 months of therapy. Do you see this as a reason
to consider the CAPOX over the FOLFOX upfront?
Dr Grothey: This is one of the surprise findings that we had because
we allowed investigators and patients to choose between CAPOX
and FOLFOX, which CAPOX is oral capecitabine, oxaliplatin, and
FOLFOX is IV 5-FU leucovorin. Not every study allowed it. The
US study only allowed FOLFOX; there was no CAPOX. But there
is some preference in the countries like Japan, like the UK, and
even in Italy that they are leaning more toward CAPOX because
it’s cheaper for society because you don’t need a port, pump,
and nursing time, etc. For society, it’s cheaper to use CAPOX
than FOLFOX.
The surprising data were that 3 months of CAPOX tracked very
favorably compared to 6 months. I mean even in higher-risk group
of patients, the ones we identified before, 3 months of CAPOX
seemed to be enough. The hazard-ratio estimate was 1.02. That
is really as close to one as you can probably get in this subgroup
analysis. For FOLFOX, it seemed to be that higher-risk patients
needed longer duration of therapy, as you mentioned, but we
still don’t completely understand why that is. And we don’t have
a randomization, meaning a direct comparison between CAPOX
and FOLFOX, so you can’t say one is better. But having said that,
if patients or physicians prefer to use CAPOX, 3 months is enough.
Will that influence our clinical practice? I could see, yes. It could
be that physicians might have to at least offer CAPOX to patients,
and then patients can decide. And I can see a lot of patients will
not want to have a port placed; will not want to have surgery to
put it in and take it out, and might be willing to get 4 infusions of
oxaliplatin through peripheral access, and take pills at home. And
then after 12 weeks be done with the adjuvant chemotherapy. It
could be quite attractive, so we’ll see how this evolves over time.
Dr Haffizulla: We talked about the idea of collaboration before,
and I know that one of the reasons it was designed and imple-
mented was because the number of patients needed to answer
the important questions about adjuvant therapy to ratio was more
than one group could really accrue or maintain. What are some
other unanswered questions that could come from such large-
scale collaborations like IDEA?
Dr Grothey: First of all, we will really mine that data for the benefit
of our patients. Can we identify patients beyond the stage groups
that we just talked about who might need more or can get away
with less treatment? The CAPOX versus FOLFOX question will also
try to be analyzed with propensity analysis and sensitivity analy-
sis. That’s something we are already planning to do. Then some
of these studies, actually mostly of the studies have biomarkers.
That’s another important point we have concurrently randomized
patients in a worldwide effort to now really compare, for instance,
outcome of patients with certain molecular features in Japan ver-
sus the UK versus Italy, etc.
We can look at lifestyle factors because these factors might be
different in different countries. Genetics, pharmacogenetic and
genetic predispositions might be different, so that is partly one of
the future strengths that we can mine the data. We could do a lot
of, what we call, exploratory analysis, which always sounds a little
bit like after the fact, but it’s important to look at the whole data
pool of 12,800 patients to get the best out of that. That’s for the
benefit of patients in future research.
Watch the full interview on
Extent of lymph
node dissection in
prostatectomy: an update
Interview with Thomas J Guzzo MD, MPH
Dr Farzanna Haffizulla speaks with
Dr Guzzo, Assistant Professor of Urology
and Surgery at the University of
Pennsylvania’s Perelman Center for
Advanced Medicine, on limited vs
extended lymphadenectomy in prostate
cancer.
Dr Haffizulla: I wanted to talk about the group from Sao Paulo
conducting the phase 3 trial comparing limited and extended
lymphadenectomy in prostate cancer. Can you tell us how the
results of this particular study can affect clinical practice?
Dr Guzzo: Sure. There is a lot of question as to what the extent of
lymph node dissection should be in a variety of cancers. In urology,
we debate all the time what the extent of a lymph node dissection
should be in both bladder cancer and prostate cancer, and there’s
a lot of retrospective data that says the more lymph nodes that you
take out the potentially better the patient’s going to do, not only
from knowing their stage standpoint but potentially from an onco-
logic standpoint as well.
This group actually did a prospective study, a phase 3 randomized
trial including patients with intermediate and high-risk prostate can-
cer, and they randomized them to a standard limited pelvic lymph
node dissection that you would expect that most prostate cancer
patients would get versus an extended pelvic lymph node dis-
section. And what they found was that the groups were very well
matched, as youwould expect in a randomized trial, and the patients
were no different pathologically. So what they found was there was
no difference in the groups preoperatively with regard to clinical or
pathologic features. But, as you would expect, they found 6 times
the amount of metastatic disease in the extended pelvic lymph node
patients because obviously, they were taking more lymph nodes
out, but importantly, the oncologic outcomes weren’t the same.
This is very early data and you would expect potentially with
further follow-up that may change, but the oncologic outcomes
were the same. I still think this is an important study because in
prostate cancer we have many new therapies for patients with
advanced disease and I think knowing which patients have meta-
static disease early on may direct adjuvant and salvage therapies
after radical prostatectomies, so still a very important study.
Dr Haffizulla: What is your current clinical practice in determining
who should get a limited versus an extended lymphadenectomy?
DrGuzzo: I use nomograms likemost physicians do, and patients with
intermediate to high-risk disease, particularly high-risk disease, I will
do an extended pelvic lymph node dissection for prostate cancer.
Again, I think it gives us very important staging information. The
jury’s still out as to whether it changes oncologic outcomes, but I
do think patients want to know where they stand from a disease
standpoint. I do think it can help us make decisions postoperatively
with regard to adjuvant therapies.
Watch the full interview on
ASCO 2017 17
VOL. 1 • NO. 2 • 2017