Early Randomized Clinical Trial suggests survival benefit to oligometastatic treatment using SBRT

[Tall_Allen]

Medpage reports results from a Phase 2 randomized clinical trial that will be presented at next week's ASTRO meeting. It suggests, for the first time, that there MAY be a survival benefit to oligometastatic treatment using SBRT for various cancers.

People, most of whom had 1-3 detected metastases, survived 29 months without the SBRT but 41 months with it. At 5 years, 46% who got SBRT were alive vs 24% in the control arm. This was across 99 people with breast (18), colon(18), lung(18), prostate (16) and assorted other cancers with solid tumors. It did not meet 95% confidence that the result could have occurred by chance (p=0.09), but they are going ahead with an expanded (Phase 3) trial anyway. Hopefully, there will be a LOT more prostate cancer patients.

There were no differences in quality of life.

Here's the Medpage article:

medpagetoday.com/meetingcov...

Here are the Phase 2 specs:

clinicaltrials.gov/ct2/show...

[snoraste]

That's great news. A bit lacking in PCa details, but hopefully in phase III we'll hear more about PCa and >3 mets. It does give credence to Dr. Kwon's approach, wouldn't you agree?

[Tall_Allen in reply to snoraste]

There were only 16 men with prostate cancer - presumably only 8 of them received SBRT treatment, and we do not yet know if survival improved for those 8. There were 3 deaths in the SBRT arm. Many ROs routinely treat oligometastases, and as I've said frequently - why not, if it is safe to do so? Especially since it will be many years before we have more definitive results.

[cesanon in reply to snoraste]

Snoraste, what is Dr Kwon's approach?

[snoraste in reply to cesanon]

I meant treating Oligo cases with local therapy (RP+RT) in addition to systemic. He has some youtube videos talking about it

[Hawk56 in reply to cesanon]

I went to see Dr. Kwon in Jan 17 after surgery and SRT had failed and my PSADT and PSAV were less than three months. The C11 Choline scan showed four pelvic lymph nodes with PCa. Given my clinical statistics there was likely micro metastatic disease. His approach is rather than linear and sequential treatment, each destined to fail. combine therapies and bring them forward in treatment to overwhelm the PCa early. I went with a treatment plan that included six cycles of taxotere. 24 months of ADT and 25 more radiation treatments. With the C11 Choline scan imagining my radiologist was able to devise a better treatment plan, boosts to the four lymph nodes, wider margins around them...PSA dropped from 4.88 to .8 after the first treatment, undetectable by the 2nd. My last Lupron was in May of this year(we agreed to stop at 18 months given my response to treatment). PSA is undetectable, we are doing every 90 day PSA and testosterone tests along with a urology consult.

Our objective was the elusive cure, if not, a long progression free survival period and an increase in overall survival. Did we achieve those, too early to tell...I like my chances though because the standard of care was not working for me. We have a plan to monitor my PSA, if it comes back (when!?) image and then treat based on the clinical data and treatment options at the time.

More and more. combined versus mono therapies are becoming mainstream practice.

The C11 Choline scan is showing its age, newer ones are approved and in clinical trails. Here is a link, you can find other articles.

urotoday.com/journal/everyd...

Peace, Kevin.

[George71 in reply to Hawk56]

Hawk56,

when were you first diagnosed and when did you do SRT that failed (prior to going to Dr. Kwon

Thanks

George

[Hawk56 in reply to George71]

George

Diagnosed in Jan 14, robotic surgery in Mar 14, GS 8, T2CNoMx, ECE, margins, seminal vesicles negative, 10% prostate involvement. I knew with GS 8 and Mx I was at risk for BCR.

Sure enough, Sep 15 PSA .2, Jan 16 PSA .3 Started SRT in Mar 14, 90 days after the 39 IMRT treatments, PSA was .7. 30 days after that, 1.0. We knew then SRT had failed. To quote my radiologist "Kevin, I don't like what your PSA is doing...!"

When I went to Mayo in early Jan 17, PSA was 3.8, when I started treatment late January, PSA was 4.8. To quote my urologist "Kevin, I don't like what your PSA is doing...!"

[George71 in reply to Hawk56]

I am similar --Diagnosed Jan 2016 Gleason 8 PSA 8.1

had surgery April 2016 --Post surgery PSA 0.033

found cancer in 4 of 10 lymph nodes ---- 4 months later PSA 0.2 --- Dec. 2016 PSA 0.4 -- March 2017 PSA 0.6 started Avadart once daily Feb. 2018 PSA dropped to 0.4 currently PSA 0.5 --HAd F18 scan and PSMA scan 2 months ago -- no mets visible. thinking about radiation, clinical trial or Dr. Bob

watch the attached video and tell me what you think.

youtube.com/watch?v=Y2PBLau...(Not working as expected?)

[Tall_Allen in reply to George71]

This was from a 2009 study on which he has published no f/u. Be very careful with Dr Bob - many think he is a charlatan.

[Hawk56 in reply to George71]

I have watched it before. In theory, I understand what he says. The reality for me is I'm not ready to go unconventional though I have been willing to be an erly adapter of emerging clinical practice derived from extensive studies. To an extent, my medical team and I have agreed on intermittent ADT for the time being. That to has it pros and cons and I don't exactly fit the profile for IADT.

I do believe that given my response to treatment we are ok to come off the ADT, monitor and then act if, ok when it comes back. In the interim I may have gained some small benefit to my QOL, fatigue has already lessened, not so for the hot flashes...! I do believe that if my medical path is to become resistant to Lupron, doing ADT may extend that.

We know of course that buying time brings new treatment options!

Peace, Kevin

[Hawk56 in reply to Hawk56]

Mean started SRT in March 16...

[Kimmilemo in reply to Hawk56]

What would the standard of care look like vs what you had?

[Hawk56 in reply to Kimmilemo]

I went for a 2nd opinion at Kansas University Medical Center. Dr. Thrasher, Chief of Urology listened to me as I talked about the CHAARTER and STAMPEDE studies and said those did not apply to me. He said my clinical data did not fit those studies and he would treat me only with ADT, no imaging and no combined therapies. He told me that ADT was the NCCN standard of care guidelines for a patient who had surgery, BCR, failed SRT and had rising PSA...

I more or less said thanx but I disagreed and basically fired him. Good decision.

[StayingOptimistic in reply to Hawk56]

Haw56,

I am exactly in the same situation as you were and very confused as what to do next. My MO at MSK told me to start ADT after failed surgery, radiation, BCR and rising psa ( current at .44). Please tell me what was your next form of action/treatments?

Thank you

[Hawk56 in reply to StayingOptimistic]

So, as my PSA began its rapid ascent I went to Mayo for the C11 Choline scan and consult with Dr. Kwon.

The scan showed PCa in four pelvic lymph nodes, no visceral tissues or bones (PSA was 3.8).

Because of my clinical data, GS8, BCR after only 18 months, PSADT and PSAV <3 months we agreed aggressive treatment was necessary. We ruled out surgery because of micro-mestastic disease and settled on a regimen of six cycles of chemotherapy, 24 months of ADT and 25 more radiation treatments.

The affects of the combined ADT (Lupron) and taxotere were immediate, PSA dropped from 4.8 to .8 after the initial treatment and then <.1 after that, testosterone dropped to <3. Both stayed there throughout the treatment. My radiologist was able to build a treatment plan that included boosts to those four locations with wider margins.

More and more combination therapy along with bringing treatments forward in the disease is the norm.

There are other studies which use ADT and Zytiga versus taxotere and Lupron like I did which is a possibility. The outcomes may be similar, difference is length of treatment, cost and side affects of taxotere vs Zytiga.

There are other options to radiation too as well as the newer Aximum scan and of course the PMSA PET CT scans in clinical trials.

I believe the key is to image, locate, decide on a combined therapy, be aggressive.

Last Lupron was May, we stopped at 18 versus 24 months because I responded so well. Labs in August were negative for T and PSA, Oct PSA was negative, T was 135, next labs are February.

My goals were a 3rd attempt at an elusive cure, if not a long progression free survival period and increased overall survival. Too early to tell obviously.

Kevin

[StayingOptimistic in reply to Hawk56]

Thank you very much, Kevin. Very inspiring. Best of luck

[kmack57]

Allen, if your initial treatment was radiation, in my case Proton, does that preclude you from getting SBRT ?

[Tall_Allen in reply to kmack57]

No. This is for DISTANT oligometastases that would be outside of the treatment field of your primary radiation.

[GoBucks]

Are there any trials trying this with 5 or more mets?

[Tall_Allen in reply to GoBucks]

"A follow-up phase III study, SABR-COMET-3, will test the approach in patients with up to three metastatic lesions, and the phase III SABR-COMET-10 will test this approach with lower SBRT doses in patients with up to 10 lesions."

[cesanon in reply to GoBucks]

Gobucks, Dattoli Clinic in Sarasota treated 5 Mets with radiation back in 2011. If anyone is willing to do more than 5 Mets today it would be them. I would see what they are willing to do.

[Grumpyswife]

This has been my contrarian belief all along as you may recall. However, finding a RO willing to treat lung lesions with stereotactic radiation has proven difficult and tiring. We started out being told it was unethical to last year that it is just too difficult and risky to the surrounding tissue.

This study was from Canada and I am wondering if US residents are allowed in.

[Tall_Allen in reply to Grumpyswife]

You can't have external beam radiation where it is unsafe. Let me stress to you that the results so far are equivocal. We'll find out next week what it did, if anything, for the 8 men with prostate cancer.

[Noel91]

Thank for sharing. Did the trial patients combined Radiation with ADT and Zytiga or were their treatment just radiation?

Thank you

[Tall_Allen in reply to Noel91]

I don't know. There were only 16 prostate cancer patients. My best guess would be that with only 2 years median f/u, I doubt that ANY of the deaths occurred among men with prostate cancer; and if so, if their deaths were at all related to their prostate cancer. If this is the case, there is NO evidence that oligometastatic treatment has any survival benefit for prostate cancer. I probably should not have posted this yet, but I know there is a lot of interest in the subject and I thought I could short-circuit any media hype about it. I know some doctors attending the ASTRO conference who promised that they would let me know if any more details are provided.