Difference in the Performance Envelopes of 1 Month, 3 Month and 6 Month Lupron Shots
I recollect being told by someone here that there is a difference in the Performance Envelopes of 1 Month, 3 Month and 6 Month Lupron Shots.
That shorter shots provide more stable serum levels.
My recollection of my original source, was someone on this forum said he had an informal discussion with an employee of the manufacturer of Lupron. That employee said that the short term shots were better able to maintain stable serum levels. And that the comparison was not even that close.
Are you still here to provide more detail?
There must exist serum level performance envelope data comparing the serum level performance before AND after the end date of 1 month, 3 month, and 6 month shots.
Certainly the manufacturer and the FDA have this data.
Pretty much all prostate cancer patients end up taking Lupron (or equivalent shots).
So I think this is an important subject to most of us.
Has anyone ever seen or heard of hard data on this subject that is publicly available?
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cesces
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I looked into the difference between monthly and 3/6-month shots, and there is data that shows the serum level of Lupron is much higher initially and at 4 weeks with the longer term shots. So if you are looking for lower SE's monthly shots may be better., eg the monthly shot has less than half the serum level at 4 hours and 4 weeks as shown below, but there aren't any RCT's that would support one dose is superior ovr another.
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Absorption
LUPRON DEPOT 7.5 mg for 1-Month Administration
Following a single injection of LUPRON DEPOT 7.5 mg for 1-month administration to patients, mean plasma measured concentrations were 20 ng/mL at 4 hours and 0.36 ng/mL at 4 weeks. However, intact leuprolide and an inactive major metabolite could not be distinguished by the assay which was employed in the study.
LUPRON DEPOT 22.5 mg for 3-Month Administration
Following a single injection of LUPRON DEPOT 22.5 mg for 3-month administration in patients, mean peak plasma concentrations were 48.9 ng/mL at 4 hours and then declined to 0.67 ng/mL at 12 weeks. Leuprolide appeared to be released at a constant rate following the onset of steady-state concentrations during the third week after dosing, providing steady plasma concentrations through the 12-week dosing interval. However, intact leuprolide and an inactive major metabolite could not be distinguished by the assay which was employed in the study. The initial burst, followed by a decline to a steady-state concentration, was similar to the release pattern seen with the monthly formulation.
LUPRON DEPOT 30 mg for 4-Month Administration
Following a single injection of LUPRON DEPOT 30 mg for 4-month administration in sixteen orchiectomized prostate cancer patients, mean plasma concentrations were 59.3 ng/mL at 4 hours and then declined to 0.30 ng/mL at 16 weeks. Mean plasma concentrations from weeks 3.5 to 16 was 0.44 ± 0.20 ng/mL (range: 0.20-1.06). Leuprolide appeared to be released at a constant rate following the onset of steady-state concentrations during the fourth week after dosing, providing steady plasma concentrations throughout the 16-week dosing interval. However, intact leuprolide and an inactive major metabolite could not be distinguished by the assay which was employed in the study. The initial burst, followed by a decline to a steady-state concentration, was similar to the release pattern seen with the other depot formulations.
LUPRON DEPOT 45 mg for 6-Month Administration
Following a single injection of LUPRON DEPOT 45 mg for 6-month administration in 26 prostate cancer patients, mean peak plasma concentration of 6.7 ng/mL was observed at 2 hours and then declined to 0.07 ng/mL at 24 weeks. Leuprolide appeared to be released continuously following the onset of steady-state concentrations during the third week after dosing providing steady plasma concentrations through the 24-week dosing interval. The initial burst, followed by a decline to a steady-state concentration, was similar to the release pattern seen with the other depot formulations. In this study, mean plasma concentration-time profiles were similar after the first and second dose
Thanks for the good information on suppression of T. Are there any references to average recovery times of T with the different doses?
cesces, I have no idea about your “recollection”; however I know what my Research Professor Medical Oncologist told me. There is no difference; each work equally as well. I chose quarterly injections because timing corresponded with my quarterly blood draws and meet with the MO, One month injections were inconvenient and six month injections were too long. For me, it was simple, have a blood draw, see my MO, and receive an injection are on quarterly schedule. No mess; no fuss; no delay, do what works the best for you.
I think whatever your conclusion about the published data, the decision also needs to integrate with how frequently you want to have your PSA monitored. I have always felt the sooner I found a change and acted the better off I would be particularly when you consider it can take several months to change the course of your therapy with insurance and appointment delays.
I have been on Lupron depot since July 8th, about two months. So far, it has reduced my nightly urination frequency from 4x to 3x. I am on the 6-mons shot therapy. My urinary stream has improved tremendously and I do not have strain to empty my bladder. Daytime urination frequency and the urgency to urinate have also decreased greatly. However, the frequency of hot flashes has increased. My desire for sexual intimacy is almost nonexistent, which started earlier before Lupron inception.
In the next three days, my oncologist will be doing blood tests to determine my testosterone and PSA levels. I will also be starting a course of Zytiga with prednisone. As per my oncologist, I will be on both Lupron and Zytiga for 2 years, God willing. Depending on the results, I am considering an 8-course radiotherapy early next year.
At the moment, I am following the info in HealthUnlocked, which has providing me with a tremendous emotional support. I am also following the current medical literature on treatment options for PC, which I discus with my oncologist. Tall_Allen, has been a treasure trove of new info on some of the nagging aspect of PC therapy. Thanks T_A.
Thanks to everyone who contributes to this board, you all have been great help in my acceptance of what is without much fuss.
Glad you found the forum. I agree with you in the value here and the comrade. The forum and men and women here helped me get over some of my initial emotions regarding diagnosis and have helped me to understand treatments to a further degree.
Your improved peeing is a good sign that your cancer is reacting well to hormone treatment.
Interesting always as we contemplate these paths we travel! Some of my thoughts on this thread...
Intersting too how todays Oncology still doesn't treat patients as an individual... Ill get back to that in a moment.
I remember, (but don't have access to links), of a study reflecting the efficacy of Lupron Injections vs Time. That there was a wave (form) used to show the graph of T response. How the smaller interval of time had a better efficacy at maintaining T response as the curve was quicker, leaving less time for a drop off (so to say) between injections. Think of a small series of bumps, more more abundant, over the same time period with larger but less frequent applications over the same time as a comparative. The curve, or amount of drug present naturally having a larger swing with the larger interval. Notwithstanding OS of course, that seems to be another discussion about arriving at the end game regardless of path chosen.
The reason I was looking at this was because I was very interested as an individual Patient Sensitivity to these drugs we might get. And how/who determines the 7.5 mg for 1-month, 22.5 mg for 3-month, 30 mg for 4-month, and 45 mg for 6-month... and which might benefit"me" the most.
Again, largley because we get this neat little risk stratification anand puy into a box, matching a patient cohort from a study, but completely dismissing the patient as an individual. Who says 7.5mg might not work for some patients over 3 months...? Maybe someome else needs 22.5mg per month! And if we could use the absolute "minimum" a patient might require for response, we my then also extend their sensitivity to the drug or therapy!? But this isnt done...
When studies are began with only a particular end point in mind, and results support that pre-concepted conclusion, great! But that doesnt mean its the only path... And we all KNOW the heterogeneous nature of this disease dictates we all have our OWN cancer that is ours alone. No two exactly alike? And if we aren't treating a patient as an individual, maybe testing their particular cell type for sensitivity to the drugs theyre about to receive, then what are we doing?
Studies are great, but they dont provide all the answers, especially when the study is required to show OS effect and thats not what we are looking for. Anyways, I'll dig in my notes and see if I can find the link...
"That there was a wave (form) used to show the graph of T response. How the smaller interval of time had a better efficacy at maintaining T response as the curve was quicker, leaving less time for a drop off (so to say) between injections. Think of a small series of bumps, more more abundant, over the same time period with larger but less frequent applications over the same time as a comparative. The curve, or amount of drug present naturally having a larger swing with the larger interval. "
Cooolone, would you please say that in different words. I think you are saying something very important. But its sort of hard to dicypher out.
In the end, what matters is its effect upon the "cancer", as T eventually is not controlled, or more to say, the T doesn't effect the PCa. Maintaining "Castrate" levels of T, is not as reliable as once thought. And is an almost 80yr old paradigm used to treat PCa. And the lumping of all patient together is not conducive to achieving the best reault for all. Does it work? Yes, of course, no doubt. Is there a better way? Maybe...
So based upon the SOC use of ADT, let's use Lupron... What are the minimum levels used that had response? What was the blood serum levels of Lupron and the associated response. I know castrate levels are maintained, but are we drowning in ADT which then teaches our PCa to behave differently (resist the environment). When using a bare minimum may have a different result. Some patients better, some worse. How do we know? Raising the drug serum levels to a plateau whereas a definite respomse occurs does not mean it is appropriate for every patient. Absorbsion is noy a constant, everyone has different metabolism too. Additionally, those who receive the greater doses, ie, 6 month, have higher incidence of side effects. Why? And it's ok, is still distributed that way, maybe bexause insurance cost(s), but certainly not for the best effect.
You assume it is not important, and maybe to the large majority it isnt... That doesn't dismiss the fact that its Pharmacokinetics aren't completely understood. You couldn't tell me its absorbsion rate, or how much passes through the system, how it is metabolized... And this alone could account for the disparity of aide effects between patients.
Yes, the simple answer is it works, it creates a low T environment. But that "Low" T environment is comimg into question more and more. So I do believe its important to establish a minimum for each patient as an individual for maximum effect. It is recorded in these studies how 30 day injection patients suffer less side effects, but in a lower serum level of Lupron and has the same effect on T levels (castrate). So, why then do we drown patients in larger doses for an extended time interval? Can you explain this effect? Or just blindly accept that they didn't test this, or examine it, even though it was evident in studies?
"It is recorded in these studies how 30 day injection patients suffer less side effects, but in a lower serum level of Lupron and has the same effect on T levels (castrate). "
That by itself is reason to favor the 1 month injections.
"Returning to the discussion of the thread, it is not important for the drug to be maintained at constant serum levels, albeit that would be ideal. Rather it is important that T < 20 is maintained for the duration of treatment."
That may be true. And it is plausible.
But I don't believe there is any hard evidence (publicly available) that supports that. And I don't see any incentives for big pharma to spend the money to finance such studies.
The results of this study indicate that the new 3-month leuprolide acetate 22.5-mg depot formulation is effective in achieving and maintaining testosterone concentration below castration levels in patients with prostate cancer and is well tolerated."
But the study does not say this, or even imply it:
"it is not important for the drug to be maintained at constant serum levels".
Then I will stand corrected on my recollection of phase 1 . I thought they were for safety, side effects and range of potential doses to then be tested in phase 2.
But the logic stands on "There needs to be data that says that its either important or not important. Otherwise it is unknown and unanswered."
You seem like an intelligent person, but you seem to keep altering my primary premise and knocking it down, over and over.
Nope. On stability of serum levels. And lack of data thereof... or perhaps lack of curiosity thereof.
Don't forget this issue was allegedly raised by an alleged employee of the pharma company saying "the short term shots are better"
So the data might exist (you and I just don't have it). If it did, it would not be difficult to see why a manufacturer would have an economic incentive to minimize the significance of this.
"There must exist serum level performance envelope data comparing the serum level performance before AND after the end date of 1 month, 3 month, and 6 month shots.
Certainly the manufacturer and the FDA have this data."
If it exists, as you suspect, you should be able to locate it online.
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