RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:CG Oncology NMIBC data99942Apophis wrote:
CancerSlayer wrote:
Well said Enrique...
This ACT not only has best in class single-agent data, but I'd also say best in class drug efficiency/mechanism of action. And the FDA simply can't ignore the fact that this ACT has demonstrated an "only in class" ability to rid cancer with only one treatment as evidenced by the two Ph 1b patients. This screams loud & clear that this tech carries unprecedented potential. All of this potential wrapped up into 1 to 2 simple outpatient treatments, or a total of no more than 2 to 3 hrs of treatment time. And the benefit of having such an efficient protocol is that you can significantly reduce risk of iatrogenic injury/side effects, problems not uncommonly seen in your more traditional treatments.
In view of the above, I would assign a new metric, "Durable Response Burden", a quality-of-life (QOL) measure that looks beyond response data alone, but also takes into account the number of treatments required to attain a desired result over a set periods of time. That desired result could be a CR, IR or stable disease. Disease-free survival, progression-free disease/survival & other metric data simply discount both treatment & patient burden, which play major roles in a patient's QOL...a metric only a patient can ultimately measure, but certainly deserves more attention. Good luck...
enriquesuave wrote:
On top of our best in class single agent data so far, the fact that this a pretty much a One and Done treatment and see you in 6 months for a maintenance should be used to push the FDA for BTD. Needs of Elderly patients must be taken into account. This option gives them freedom and much less morbidity of having weekly instillations with all of the swelling and pain and possible infections which the procedure involves. IMHO
ScienceFirst wrote:
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There has been innovations in all industries, including oncology. And this wil continue. No plot theories here. Just facts, R&D, innovations and competition.
Public Health budgets are about 50% of all Canadian provinces budgets. So huge incentives to lower them, especially with the growing population of elderly people. Ontario government that sponsored our technology that will spur medical tourism will of course push for such treatment if deemed superior.
Private insurance companies are other parties that will push for it too.
Laparoscopy, arteoscopy, 1-day surgeries, etc ... are all innovative procedures that have been integrated in the health systems. TLT has done the heavy lifting to bring PDT/PDC to bedside and mainstream thanks to a molecule with impressive attributes. It could allow big pharmas to treat way more patients in early stage instead of having too many dying because of lack of efficient treatments.
My question to our medical minded fellow posters on 2nd treatment after the trail is completed would a better option be to monitor the patients on a monthly or quarterly checkup and administer the 2nd treatment when needed. We saw in Phase1 the now famous 2 patients go 2 years Cancer Free and in this Phase2 many needed that second treatment so do you think after the trial is complete stick to current guidelines of 2nd treatment at six months or 2nd treatment as needed?
Hi Apophis....
I just got back from a late night of dancing & appreciate your question. I saw enriquesuave's response & I agree with his comments.
In general, With this type of ACT & considering this more superficial form of cancer, I don't think there would be any significant gains made with regards to giving a 2nd treatment sooner (i.e. giving it at 3 months after the primary treatment vs 6 months). There is also the concern that shorter interval instillations could potentially increase bladder wall side effects.
As for a patient who remains an NR or PR/IR after 6 months, I would also consider giving a 3rd treatment in hopes to not only reach tumor cells previously missed (particularly if there are multiple tumor sites within the bladder wall), but also to potentially boost the immune response. The results of the 3rd treatment would guide treatment thereafter.
If a patient were to remain a PR/IR, I would consider continuing treatments every 3 to 6 months (barring serious side effects/adverse events) until either a CR or NR is achieved. If the 3rd treatment proves to be ineffective (an NR) in a given patient, I would then stop treating, but I would not necessarily question the effectiveness of our ACT. I would have to consider that the drug may not be adequately penetrating this particular bladder lining with its multiple cell layers, hence leading to insufficient tumor uptake of drug. Imo, it is more likely this scenario than due to inadequate light penetration....simply based on the superficial characteristics of NMIBC CIS. I feel that drug penetration limitations is likely playing a major role in the NR/PR rates for any given intravesical drug, especially when you consider the anatomic variation in bladders & the fact that old bladders (& people) can be very stubborn. One would also have to consider the possibility that certain tumor cells may have developed resistance, particularly if the NR result was due to a low/sub-therapeutic drug concentration within the tumor cell(s) (i.e. due to poor drug penetration).
The moral of this long & boring story is that our ACT effectiveness can likely be augmented in a variety of ways....newer generation organometallics that are more robust/efficient ROS producers, use of our ACT in combo or as an adjuvant/add-on, potential modifications to the number & timing of treatments, chemical &/or physical methods of improving drug delivery/penetration into tumor cells, & lastly, improving light/irradiation delivery methods for the deeper solid tumor indications. Sorry for the long-winded answer. Good luck...