So, Dr. Scholz, you know, we're in 2022 now, but 2021 was a big year for prostate cancer
care. It seems like we're growing leaps and bounds, and new treatments and things that
have come out in the last 10 years, and 2021 continued that, and so, you know,
there are multiple things that got approved in different forms or stages of prostate cancer;
so, I just thought I'd list them out. We can tell the audience about them and let them know about
the latest updates. So, the first one I'd like to cover is Orgovyx. So, this is a hormone therapy;
can you explain how it's different from Lupron and what patients can expect with it?
Yes, so it's a pill which in many ways is comparable to Lupron. Just to remind everybody,
these medicines block the production of testosterone in the testicles and for many
years people thought that was the only source of testosterone and therefore if you took Lupron or
Trelstar or Firmagon or all these different types of shots and block the testosterone
you've pretty much done what you could do. Orgovyx does the same thing-- it blocks testosterone
from the testicles. We now know, of course, that there are second-generation medications
like Zytiga and Xtandi and Nubeqa and Erleada, those block testosterone inside the cancer cell.
So, why then do we need another medication to block testosterone from the testicles? Well, it's
nice for people to have the option of taking a pill instead of a shot. Orgovyx is a pill;
Lupron, Firmagon, those are all injections. That's one advantage. There's another advntage with
Orgovyx in that compared to the injections the recovery of normal testosterone when the treatment
is stopped is much more predictable. When you take Lupron and Firmagon and these other medications,
there is a lingering effect that can last many months after the--in theory--the medicine is
worn off. That, of course, is baked into a lot of the clinical trials. So, if someone gets
18 months of Lupron, in reality, they probably get more like 28 months of low testosterone.
So Orgovyx, you get 18 months of Orgovyx and it'll probably be 20 months of low testosterone. The
testosterone will come back in force very quickly right after the treatment is stopped. In general,
I think that's probably a good thing because we don't want people to be
left with lingering low testosterone levels for a long time after treatment is stopped.
There's also some soft evidence that there may be a lower incidence of cardiac complications. I see
a very low incidence of cardiac complications with Lupron, but we emphasize diet and exercise
and monitor blood sugar levels and all the things that can create cardiac problems when people
have low testosterone. Low testosterone can cause weight gain and high blood pressure and all these
sorts of things, and those need to be managed and they can translate into heart problems,
but in the large randomized trial that got Orgovyx FDA-approved they showed a low incidence of
heart problems with Lupron, but an even lower incidence of heart problems with Orgovyx. So,
there may be an advantage there, particularly if someone's overweight or has pre-existing
heart issues to using Orgovyx. It's a new medicine; it's nice to have another tool
in the tool chest and it doesn't eradicate testosterone more thoroughly--the ultimate
anti-cancer effectiveness is the same as lupron--but there are some other smaller
advantages related to potential side effects that are interesting.
So, the side effect profiles are very similar to
Lupron it's just the effects will end sooner over time?
Correct.
Yeah, it's interesting. So, you know, we were just talking about first-generation hormone therapies
and now we're talking about second, you know, so Nubeqa actually had a different indication in
2021 to be, you know, used in a different way with prostate cancer. Can you explain how that works?
So, these second generation hormone medicines, from my point of view, should be utilized
in anyone where you uh aren't confident that cure rates are optimal with a first-generation
hormone therapy. Where is that? Well, high-risk disease, people with any type of metastasis,
people perhaps--some people--even with very high Gleason scores.
Nubeqa and Erleada, which are two of the newer second-generation medications,
are not approved routinely for patients who have developed early hormone resistance which seems
crazy because that's a place where these types of medicines will be effective. It's nothing
to do with the effectiveness of the medicines; it has everything to do with the way insurance
companies try and limit their responsibility to pay for expensive medicines, and so they--the
pharmaceutical companies--charge a lot of money and the insurance companies push back by saying,
"yeah but you didn't do a study in this particular segment of prostate cancer patients,"
and what you're referring to then is that the people that manufacture Nubeqa
completed at trial in men that were newly diagnosed with hormone-sensitive disease who
already had metastasis and they--just as we would expect--the medicine,
when added to Lupron, improved survival, and so that is the case with all these medicines:
Zytiga and Erleada and Xtandi, that they improve survival in those types of situations. So, what
distinguishes Nubeqa in my mind from the other four second-generation medications is a slightly
better side effect profile. I believe that they're all equally effective against cancer,
but the Nubeqa seems to have less frequency of causing fatigue, which is sometimes seen,
and unlike Zytiga we don't see problems with liver problems or electrolyte problems like with
potassium and whatnot. All of them are effective and if managed by experts they're all very useful.
If people are having trouble with severe fatigue from one of the other second-generation
medications, they might benefit by switching over to Nubeqa as it may be better tolerated.
So, can you summarize, you know, there's a trial that came out with basically showing
the early use of Taxotere was quite helpful. Can you explain that to patients? I know we tend to
think of chemo drugs as a later down the line treatment, so this is kind of exciting news.
Yeah, we've always known that chemotherapy with Taxotere is efficacious. People,
of course, hesitate-- anything called chemotherapy, you could have hair loss,
can make you feel tired, and there are other types of chemotherapy for other types of cancers that
are far worse than what Taxotere entails, so I mean I've given low doses of Taxotere to people
in their 90s and they've tolerated it fine, but it has a terrible name, and it does have more
side effects than some other medications, that's for sure, but it's really indisputable that it has
notable anti-cancer activity and there are certain individuals with prostate cancer
particularly those that have demonstrated metastasis to the bones or the lymph nodes that
we know over the long term are likely to someday become hormone-resistant and hormone-resistant
prostate cancer is very dangerous; it's not like we have an infinite number of treatments for them.
The idea of leveraging treatment at an earlier stage with chemotherapy came up in the treatment
of breast cancer 40 years ago and a guy named [Gianni] Bonadonna brilliantly conceived that if
chemotherapy can shrink large tumors in advanced cancer patients, maybe it can eradicate tiny
tumors in early stage cancer patients, and a number of clinical trials were done that
validated that premise, and so it's really just a matter of picking people that have disease
serious enough to to warrant undergoing this type of treatment and it's not difficult to identify
such individuals. These are the people that have metastasis; they are, unfortunately, likely to
develop hormone resistance someday and it would be better off for them to get their Taxotere early.
So, it all sounds good on paper, but now we have a large randomized clinical trial
where people were treated with maximal hormone treatment--that would be Zytiga plus Lupron--or
treated with Zytiga, Lupron, and Taxotere, and the group that got all three medicines
lived substantially longer than the group that got only two of the medicines and the
people that got the two medicines got Taxotere later when their two medicines stopped working
so it was really a comparison between immediate Taxotere--in this new trial--where they did better
versus delayed Taxotere in people that waited until their hormone treatment stopped working.
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