RE:RE:RE:RE:RE:RE:Tertiary objectives. At first glance I couldn`t understand why the optimised treatment had apparently elicited no response whatsoever in one of the patients. TBH with my faith in the tech it came as a real shock.
Of course this is the patient who sadly died.
Since there was no cancer in his/her urine at 30 days` I believe that had he/she lived we might still be on track for 100% CRs with the 6 most recent optimised treatments and this is very much more in line with pre-Quarterly hopes.
Thanks to all whose most interesting recent posts have provided clarification here.
tdon1229 wrote: enriquesuave wrote: What I wrote earlier seems to make sense. Patients 13 and on got an Optimized Treatment. There are 3 more patients pending for 90 days data (ie. patients 16, 17,18). Hence of 13,14 and 15 , 2 are CR and unfortunately 1 died unrelated to treatment. They do indicate in Quarterly that the patient who died had negative Urine cytology at 30 days ( hence no sign of cancer)and would very likely have been CR as well IMO. We are waiting for 16,17,18 who also got optimized treatment. This is all my own interpretation. Do your DD.
enriquesuave wrote: It seems possible that either 13 or 14 or 15 was the patient who died as this patient showed negative urine cytology eliminating sign of cancer at 30 days, but unfortunately did not live long enough to get to 3 months exam. Just guessing here, as we only now learned of this outcome.
If this was the case it would have been 3 on 3. Just a guess.
enriquesuave wrote: I wonder when will the partial responders be ruled out as either CR or not. So far even at 6 months they are showing a negative cystoscope ( no visible cancer) but a positive urine cytology. They have to use a uretoscope to examen for possible UTUC. This is a very good sign that they are still showing no cancer with cystoscope after 6 months. Numbers can go up dramatically if they are also deemed CR. IMO. The numbers are showing the minimum possible CR rates which can only go up if those pending or partial responders become CR. Add to that the second treatment which can possibly increase CR rates at 9 months and beyond.
Enrique,
i wouldn't be too quick to dismiss the death as unrelated. True, I think it's plain to see it's not from exposure to either the TLD-1433 or to the light source or the activation. However, filling the bladder and holding it for an hour during instillation, with successive prerinses and post rinses, results in back pressure on the kidneys. That can lead to some degree of kidney filtration damage, or even to failure in the case of kidneys already weakened by age or disease. Anyone who has suffered an incidence of urine retention knows how quickly that situation becomes uncomfortable, even painful.
If I were doing the trial, I'd be all over the procedure looking for ways to minimize or eliminate the potential for this challenging condition, and making sure the bladder isn't overfilled during the treatment. That could result in tighter screening for eligibility for the treatment. But then I'm an engineer by training, not a doctor or urologist or a clinical trials expert.