Schultz/Lam & Zytiga for HS men in 2012

If I understand correctly from an old thread on HW that I found, Schultz/Lam at Prostate Oncology Specialists have been prescribing Zytiga for hormone-sensitive men since 2012

www.healingwell.com/community/default.aspx?f=35&m=2586482

It appears Michael_T and MsWorryWart both had Zytiga added to hormones before castrate resistance.

It appears that Schultz/Lam were a step ahead of the Stampede trial published 2 months ago.

I wonder if these members could share their experience.

ie: how long did they take Zytiga + ADT (until it stopped working or for a specified time)
How did PSA respond?
In retrospect, did adding Zytiga seem to be a beneficial step in your treatment?

Thanks!

I wouldn't say they were "ahead" of STAMPEDE-- it was a very different clinical trial for a very different setting. STAMPEDE and LATITUDE only showed a survival benefit for men with metastases. In fact, there was no survival benefit in the subgroup of men who had no metastases in STAMPEDE. It's similar to docetaxel or Provenge in that regard - it only seems to have a benefit after the cancer has progressed to a certain point. There's no way for any patient to be able to tell on his own - that's why we need RCTs.

The HR wasn't significantly different from 1 - so there is no evidence of benefit from it. I know it's tempting to look at men in completely different situations to try to generalize - if it works for those men in that stage, maybe it can work for him even though his situation is different - but, unfortunately, with cancer, that's usually not the case. And if there weren't considerable cost and toxicity involved, why not? But because cost and toxicity are high, randomized clinical trials are necessary to prove a benefit for each setting.

Thanks for your contribution Compiler. How long have you been with Dr. Lam and what was your status when you first started? Have you seen Dr. Lam since the Zytiga study came our and if so, have you discussed adding Zytiga to your HT? Just curious because I have a friend who is doing iHT and thinking about it.

Tall Allen,

It is the comparison between progression free survival for ADT vs ADT+AA that is most compelling. Cost and toxicity are subjective, depending on a man's personal situation.

A drug that optimizes the opportunity to see your youngest child graduate from high school means a lot.

Certainly a hot topic and one that I am struggling with right now as well. I think what we (or at least me) are struggling with is "Who exactly is adjunct Zytiga appropriate for based upon the newest Stampede/Lattitude findings?"

Having just finished ART when the newest news regarding this came out, I asked my RO about his thoughts on Zytiga for my situation. He didn't really have much to say regarding it and instead referred me to an MO who specializes in PCa at the Clinic for guidance. I met with the MO a couple of days ago. The bottom line is that the MO told me that in his opinion, adjunct Zytiga is not appropriate for my case. He pretty much said that since my PSA is undetectable, I should finish out my ADT and see if further action is needed in the future. I must admit though I am still not clear on why it wouldn't be appropriate for me. What you said, Tall Allen, sounds allot like what he said but I still don't exactly get it. What I am not fully understanding is if adjunct Zytiga could significantly delay possible relapse and the need to start treatment again, wouldn't that be the optimal situation? Even if it doesn't effect overall survival, wouldn't it be better to reduce the amount of time a man is required to be on ADT? That is, living treatment free vs. living with the SEs of ADT?

Who exactly is adjunct Zytiga appropriate for based upon the newest Stampede/Lattitude findings?

Actually TA, it is progression-free survival that matters to us.

I do understand population data and my husband has a very bleak prognosis, thanks to the GP not screening, a bad surgeon and low dose aRT. He doesn't want to extend his life in a state of continual suffering. He wants a few more good years until the youngest goes off to university.

Tall Allen,

Thank you for helping me with this. That is exactly my point, I am confused/not fully understanding this. I think it would help me if someone could simply finish the following sentence for me -

"The information that came out this summer indicates that adjuvant Zytiga benefits men who ..."

I am Gleason 9 and had positive nodes. I've had surgery and whole pelvis radiation. I started Lupron immediately upon diagnosis which will continue for a minimum of six more months for a total of 18 months. My PSA has been undetectable since surgery. The current plan is to end ADT (Lupron) in six months and see what happens. The ultimate question I am trying to answer of course is whether there is any evidence that adding Zytiga to my ADT for the next six months would be in any way beneficial to me.

Here is what Dr. Nicholas James, lead author of the STAMPEDE trial wrote about Abiraterone/Zytiga for non-metastatic patients:

The STAMPEDE study included more than just men with frankly metastatic disease, in that it also included almost 1000 men with non-metastatic prostate cancer, including some men who had a rising PSA after definitive therapy to the prostate. It appears from the data that there was a survival benefit to using abiraterone plus androgen deprivation therapy in the non-metastatic population; however, the overall number of deaths in this subgroup of patients was rather small, so it is not so clear that this study has changed the standard of care for these non-metastatic patients. With more time we may be able to see more events which may give more statistical confidence in the outcomes. I think figuring out whether to offer abiraterone to men with non-metastatic prostate cancer will be a major point of discussion in the years to come, and eagerly await the follow up data and subset analyses from STAMPEDE to help answer this question.

/www.healio.com/hematology-oncology/prostate-cancer/news/online/%7B25924563-f00c-48d5-91ac-7d4baecd966c%7D/guest-commentary-stampede-trial-provides-exciting-results-questions-in-prostate-cancer-treatment

schoolpsych-
"The information that came out this summer indicates that adjuvant Zytiga benefits men who ..." are newly diagnosed with metastases.

Annie-
My information comes from the overall survival HR chart where they break out the subgroups. The 95% confidence interval for M0 passes through 1, which means there is no statistically significant overall survival benefit. James, in his quote, is saying the same thing, but he is expressing his hope that it will reach statistical significance with longer follow up. He is saying that there are so far very few deaths in the M0 placebo group, and with more deaths over time the statistics will solidify. That may or may not happen, but a more likely scenario is what happened on the CHAARTED trial with men who had low volume mets-- with longer follow-up, it made less of a difference if they got docetaxel, not more. What we're learning from these RCTs is that we have to hit the cancer with the right medicine at the time when it is most prone to destruction by that medicine. Too early, and we may only be adding selective pressure towards more virulent strains. Too late, and there is no survival benefit.

The section on abiraterone toxicity was eye-opening for me. There was the same degree of serious and life-threatening side effects as there were with docetaxel. This is not a medicine to take without substantial proof of efficacy.