Theralase Technologies Inc. V.TLT

RE:RE:RE:RE:RE:RE:RE:RE:Let me try again.....

[CancerSlayer]

enriquesuave wrote:

Eoganacht wrote: Good post DJDawg. Thanks for sharing.

DJDawg wrote:
I work in a medical area that deals with cancer among other things. Whenever a patient is in remission from cancer it means that, as far as we can tell, it is gone. But the limit is whatever technology we have. An MRI scan may show breast cancer all gone. However if there are tiny clusters of cancer cells somewhere there, sometimes in a quiet phase of growth, then, the cancer may come back. Sometimes the immune system takes care of the small leftover stuff. Other times it slowly grows till it becomes evident again.

Bladder cancer may be gone when they look at the wall of the bladder. The cancer cells may not be enough to slough off into the urine consistently for a cytology. That patient will be a CR. But if enough time passes the cancer cells, if still present, can grow again to the point of being frankly obvious. So you can argue that all patients that convert to NR where never CR or IR in first place. The drug worked well enough to get rid of 99% of the cancer but enough survived to grow again. For a window, nothing was there and everyone hopes that that means they are CR.

That is why Ruvidar might need to have some future protocol whereby you do it more than 2 times.

That is why I never trust protocols that use drug instillations over and over again for years because the patient is definitely benefitting but don't call it a cure from day 0. More like whack a mole with the drug being needed over and over again to know down the residual cells growing. Call it a treatment protocol.

Phase 1b patients, 2 of 3, got one treatment and the cancer has not returned despite many years. That is a cure as cancer like that would have declared again by now. If there had been even a few cells that escaped the Ruvidar it would have come back by now. But nothing.

So, in summary, all CR or IR that convert to NR were probably never a perfect CR in the first place. By my reading, if a cancer does come back it should be evident by day 360. That is why all day 360 CR's have all stayed CR for good. That is when you say cured in the fullest sense of what that mena to the patient. It is gone and we don't worry that it will come back.  I would go as far as to consider all perfect sequences of CR that go from 90 to 360 as full cures and you might as well count that in the 450 day column (if you were allowed to do so).

There is also the possibility that a patient is CR, but is counted as IR as cancer cells  coming from the UTUC are detected in Urine.  Eventually reseeding of cancer cells on bladder lining can cause a new Tumor lesion.  I wonder if they map out bladder and see if the same lesions are still there ofr new ones?  An IR patient who becomes NR, may have been CR in actual fact but becomes NR eventually due to reseeding from UTUC to bladder over time and end up with a new lesion.  IMO. That's why they should ideally early rule out UTUC.  IMHO 

 

Per FDA's 2018 guidance letter:

"Bladder mapping and random biopsies in patients with CIS should be performed before trial entry (Gudjonsson et al. 2012)."