« The main goal of the trial is the proportion of patients who achieve a complete hematologic response, which is indicates that the blood cells are in the normal range (red blood cell volume of less than 45%) for three or more months.
The timeframe of the trial is 24 weeks.Researchers will also look at the cancer-fighting abilities, safety and tolerability for the two dosing regimens of Besremi.
The trial will involve approximately 100 patients with polycythemia vera. They will be randomly assigned to receive either the accelerated dose (starting at 250 mcg then increasing to 350 mcg at week 2, with a goal of getting to 500 mcg at week 4) or the currently approved dosing (50 or 100 mcg), according to a press release published by PharmaEssentia USA."Our goal with this study is to deliver evidence on the potentially enhanced benefits of treating patients with Besremi through this accelerated dosing schedule and to bring additional confidence to clinicians and patients in the utility of the treatment to manage this chronic cancer »
Good to see that there will be data to better support dosing strategies. Based on my experience, I would expect that the more conservative slower and lower dosing strategy will prove to be easier to tolerate and still yield the desired benefits. There would need to be compelling evidence to support the use of a higher dose than is necessary to maintain a complete hematologic response. In addition, my experience has been that the dose needed for a complete hematologic response will also result in a significant reduction in allele burden (38% to 9%).
Note that the emphasis is on my experience. We need treatment decisions to be based on data across large numbers of people with PV. I suspect that the answer will be more nuanced than one approach is better than another. One size will not fit all people with PV. Each individual's PV profile will need to be considered to devise a dosing strategy. We may well find that factors such as allele burden, non-driver mutations, symptom burden, and co-occurring conditions will determine the appropriate dosing strategy. We need more data to support an individualized dosing strategy. Hopefully, the data will emerge through studies like this.
I totally agree with your comments. I believe it is still unknown why some patients respond to lower doses and others like me require the max dose before getting the desired hct response. Dosage will have to be subjective based on the patient profile therefore it seems to always make sense to start low and slowly increase depending on the response. It is the variables within the patent profile that you have mentioned that govern the responsiveness and there is no set dosage for any one patient in my view. Other variables would include the affect of the drug on other lab values. For example I had a dramatic and immediate positive effect to platelets on a lower dose but hct has been much more stubborn. This is just based on my own anecdotal experience and from reviewing others stated experiences with besremi. There is still much that is unknown regarding why some patients respond better or quicker than others. I would lean towards a guess that non driver mutations jak allele burden and how soon after diagnosis one starts interferon all may play a role as you have noted.
Alot of that has already been figured out for the brands of pegylated interferon like Pegasys which have been on the market for 17 years. Interferon specialists like Dr.'s Hasselbalch, Kiladjian and Silver have found early diagnosis and immediate treatment, with interferon while the tumor burden is still small, enables the patient to have the best chance of attaining normalized blood counts and potentially "Minimal Residual Disease": youtu.be/TIlzFKLtj0k
Thanks. I am not sure the medical community fully understands how tumor burden impacts prognosis or disease progression for PV much less how tumor burden affects variations in response to interferon but hopefully some day they will. I do believe in early intervention with inteferons for low risk patients is the way to go which is why I elected same. After five years of phlebotomy only Im now 500 mcgs of besremi and waiting for hema response after 14 months of besremi. Started at 100 mcgs and slowly moved up to max dose 3 mos ago. 40% jak burden before besremi which I am not sure is relevant or not. Still require phlebotomy every 10 weeks but feel much better than before and other blood counts much improved on besremi. My doc says be patient and the hct control should come. She has patients that have instant response on lower doses and some that take well over a year on max dose. I think I am on the right path but ready to dispense with the need for phleb so fingers crossed there.
You're right there is no prospective data on VAF reduction vs progression for IFN. But recent reports for Rux had this as an end point and found a clear benefit. So it seems likely the same will apply to IFN, although such results are not available so far.
I agree with Hunter, in my opinion this accelerated schedule makes no sense. The mfr has been pushing this idea for some time. If the need for cytoreduction is that urgent a phlb is best. I recall a recent video posted here with one expert indicating that even current dosing starts are too high.
Better to take time and watch for any troubles. If I had been on this fast route it's near certain it would have been quick trouble, even 140 was too much. Others on the forum like Hunter also have a max safe dose well below the 1st dose in this study.
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The ECLIPSE PV trial- Besremi
