Docetaxel (Taxotere) for other settings (Recent trial discussion)

Jerry- that's how it was used in that study - with hormone sensitive PC.

I am on ADT vacation my second one as well. Dr. Lam also mentioned that maybe I should go to the chemo + Lupron route when I start to have a PSA rise. I was in the punch trial at City Of Hope 5 years ago which I failed but part of the trial was chemo + Lupron before having the prostate removed. This was over 5 years ago.

Tony,

Do we have the data on the men with less extensive Mets and low PSA. Same trial? What were those results for this category of men?

Thanks,
Jerry

Jerry,
As you can see in the following chart, the median overall survival was 42.3 mos for men taking ADT without Taxotere, and was 52.7 months if they added Taxotere -- a 10 month advantage.

For the men with 4 or more bone mets and/or visceral mets, median overall survival was 32.2 months without Taxotere, and was 49.2 months if they added Taxotere -- a 17 month advantage.

For men with a low volume of mets and no visceral mets, median overall survival is so long that it hasn't yet been reached for either group. However, survival is 42% better so far in the group adding Taxotere, but that difference has not so far reached statistical significance.

Keep in mind that these are overall survival stats rather than PC-specific survival stats and are affected by age and comorbidities. The number of patients who had a significant and major suppression of their PSA was doubled with the combination. Median time to progression — an elevation in PSA level, new symptoms, or worsening scans — was significantly longer with the combination than with ADT alone (20.7 vs 14.7 months), as was median time to clinical progression (32.7 vs 19.8 months).

Impact on overall survival (OS) with chemohormonal therapy versus hormonal therapy for hormone-sensitive newly metastatic prostate cancer (mPrCa): An ECOG-led phase III randomized trial.

I guess I was looking for how many men had lesser disease. I may have missed this. For example, how many had extensive vs. how many were lower psa, lessor involvement...thanks

Allen - was the French study just early chemo...or early chemo + some form of HT...

Thanks Allen...I'll check that out in more detail when I'm not on a mobile device...my eyes aren't what they used to be...or I need a bigger mobile device...

Very confusing for those of us with no visible Mets.

I am currently on HT vacation.

I will see Dr. Lam in 2 1/2 weeks. I GUESS the plan will be:

When PSA rises (above 2.0), get the special C-11 Choline scan at Mayo.

If Mets show up, then we might consider Chemo + ADT.

This is upsetting in that I hope to avoid the miseries of chemo.

This is encouraging since the results might be much greater than with HT alone.

Comments?

Mel

Mel,

Mr. WW would tell you that chemo was the easiest of his treatments, side effect wise.

Yes, it messed with his blood work for a few months, but he wasn't sick. He had one down day...the 2nd day after treatment.

He would get chemo on Friday, drive 600 miles back home on Saturday, crash on Sunday, then was off to work on Monday.

Of course, he lost his hair, but he would take that any day over the hot flashes and other side effects of HT.

Jerry,

The word "median" means half. Researchers use median rather than average survival because they might have to wait another 20 years or more to wait until everyone in the study died to calculate an average. And they may have died of any cause, not just prostate cancer. That's why the prostate cancer-specific survival is longer, as Tony reported from his notes of the meeting. That's also why there is little useful information yet on men with low volume of mets - it will be many years before half of them have died.

No, it gives no insight on when to begin HT. All the men in the study were started on HT or HT+docetaxel after they were diagnosed with mets. The study didn't include any men in whom therapy was delayed. A different study addressed that issue. They looked at non-metastatic, non-SRT men who received HT therapy immediately after a PSA recurrence vs waiting for signs of clinical progression or at least waiting 2 years. They found no difference in overall or PC-specific survival. However, this was not a randomized, controlled trial (RCT). This is congruent with earlier RCTs that showed no statistically significant difference in PC-specific survival with early vs deferred ADT in asymptomatic, M0 men.

Immediate versus deferred initiation of androgen deprivation therapy in prostate cancer patients with PSA-only relapse.

Question #1: So, all of the HIgh Volume-HV (520) have died and not all of the Low Volume-LV (270) have died?

No. As I said, median means half, so only half the high volume have died, and less than half of the low volume.

Question #2: Just so I am clear, when I hear that ..."there was no survival benefit in men with low volume...", is this saying from the data we have so far there is no benefit? Or, is t saying not all of them have died, and therefore we have "not reported" on any of this data.

As I said, "However, survival is 42% better so far in the [low volume] group adding Taxotere, but that difference has not so far reached statistical significance." Median survival has not been reached for low volume men whether they took Taxotere or not.

So, some guys in the chemo arm started fresh with HT and chemo and other guys in this same arm had HT alone for up to 2 years before chemo?

For the guys who had had ADT after radiation or surgery, that had to have ended at least a year ago and there has been no PSA evidence of disease progression, only mets. But they may not have had prior ADT since diagnosis of mets.

So, some guys in the chemo arm started fresh with HT and chemo and other guys in this same arm had HT alone for up to 2 years before chemo?

Yes, they will stratify the results by those who had more than vs less than 12 months of adjuvant ADT when they publish.

Is the important thing that they are hormone sensitive or early hormone sensitive?

They had to have started ADT for mets within the last 120 days, and if they did, their PSA cannot have risen while they were on it. So, this study addresses the early use of chemo and ADT in hormone-sensitive men with mets.

- Allen

Jerry I just sent you an EM. It is Sweeney's presentation slide deck at ASCO 2014. Vogelzang is a co-author and will be presenting it next week for our support group and I will send you the invite to sign up for the online presentation. You can ask whatever you like. I will also be testing the webinar and would like it if you can help me there.