1.What is the definition of progression-free survival?
a.Starting date? When first diagnosed? When first treated? When?
b.Until M-spike hits what number?
c.In other words how is it measured?
2.Same question about overall survival. (I know the end point is death, but what is the starting point?
3.Same question about response rate and PFS2
thanks,
Coach Hoke
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Re: Survival and response rate definitions?
Hi Coach Hoke,
The most widely accepted definitions of response and survival in multiple myeloma are the International Myeloma Working Group's definitions, which can be found in this article:
Rajkumar et al, "Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1", Blood, 2011
http://bloodjournal.hematologylibrary.org/content/bloodjournal/117/18/4691.full.pdf (PDF)
The key definitions are in Table 1. The article does not explicitly state it, but it's fairly clear that "disease progression" occurs when a patient experiences "progressive disease" (PD).
To your specific questions,
Progression-free survival is usually measured in connection with a specific treatment, so, in that case, it is measured from the time the treatment is started until disease progression (or death).
PFS2, which is not mentioned in this article because it is a relatively new concept that is not -- as far as we know -- standardized, is the time from when a treatment regimen is started until when a patient progresses (or dies) after the next treatment regimen the patient receives.
For example, a patient starts Velcade maintenance. Eventually, she progresses and is switched to treatment with Pomalyst and dexamethasone for six cycles. She then stays in remission for 2 years but then her disease starts to progress.
In this case, PFS2 would be measured from the time she started her Velcade maintenance regimen until when she experienced disease progression 2 years after her Pomalyst-dex regimen ended.
In the case of overall survival, the starting point depends more on what you're trying to measure. If you're trying to measure the overall survival of a specific treatment regimen, then you typically would use the time when the treatment started.
However, if you're talking, say, about the typical overall survival of all myeloma patients, then that's something that usually uses the time of diagnosis.
Generally with overall survival, it's important to look at the fine print to see how the authors have defined the starting point.
The final issue is: What is disease progression? As you'll see in Table 1 in the article, there's a complicated definition. The most common way of thinking of it is that it's a 25 percent increase in the serum M-spike, but the increase has to be at least 0.5 g/dL.
However, as you can see, there are other cases addressed in Table 1 as well.
Hope this is helpful. Sorry it went on for a while!
The most widely accepted definitions of response and survival in multiple myeloma are the International Myeloma Working Group's definitions, which can be found in this article:
Rajkumar et al, "Consensus recommendations for the uniform reporting of clinical trials: report of the International Myeloma Workshop Consensus Panel 1", Blood, 2011
http://bloodjournal.hematologylibrary.org/content/bloodjournal/117/18/4691.full.pdf (PDF)
The key definitions are in Table 1. The article does not explicitly state it, but it's fairly clear that "disease progression" occurs when a patient experiences "progressive disease" (PD).
To your specific questions,
Progression-free survival is usually measured in connection with a specific treatment, so, in that case, it is measured from the time the treatment is started until disease progression (or death).
PFS2, which is not mentioned in this article because it is a relatively new concept that is not -- as far as we know -- standardized, is the time from when a treatment regimen is started until when a patient progresses (or dies) after the next treatment regimen the patient receives.
For example, a patient starts Velcade maintenance. Eventually, she progresses and is switched to treatment with Pomalyst and dexamethasone for six cycles. She then stays in remission for 2 years but then her disease starts to progress.
In this case, PFS2 would be measured from the time she started her Velcade maintenance regimen until when she experienced disease progression 2 years after her Pomalyst-dex regimen ended.
In the case of overall survival, the starting point depends more on what you're trying to measure. If you're trying to measure the overall survival of a specific treatment regimen, then you typically would use the time when the treatment started.
However, if you're talking, say, about the typical overall survival of all myeloma patients, then that's something that usually uses the time of diagnosis.
Generally with overall survival, it's important to look at the fine print to see how the authors have defined the starting point.
The final issue is: What is disease progression? As you'll see in Table 1 in the article, there's a complicated definition. The most common way of thinking of it is that it's a 25 percent increase in the serum M-spike, but the increase has to be at least 0.5 g/dL.
However, as you can see, there are other cases addressed in Table 1 as well.
Hope this is helpful. Sorry it went on for a while!
Re: Survival and response rate definitions?
Hi,
I can't get my head around what progression-free survival versus overall survival means when trying to analyze clinical trials for efficacy of Revlimid as maintenance therapy. Does it mean you live for a certain amount of years or so then drop dead?
This is the meaning I found on Internet:
"The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Also called PFS."
That's all I have found and no more. I feel like a imbecile since this means nothing to me and makes no sense. Please enlighten me. Any thoughts out there in Myeloma Land?
I can't get my head around what progression-free survival versus overall survival means when trying to analyze clinical trials for efficacy of Revlimid as maintenance therapy. Does it mean you live for a certain amount of years or so then drop dead?
This is the meaning I found on Internet:
"The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Also called PFS."
That's all I have found and no more. I feel like a imbecile since this means nothing to me and makes no sense. Please enlighten me. Any thoughts out there in Myeloma Land?
-
Pmckeon - Name: PEM
- When were you/they diagnosed?: 2013
- Age at diagnosis: 59
Re: Survival and response rate definitions?
Hi,
if I may be permitted to add a thought to this discussion, purely as a patient.
This is connected with the 'overall survival' term. To date, my two treatment regimens since my diagnosis five years ago have both been classed as clinical trials. The first trial was started in January 2012 and was the Revlimid, Velcade, and dexamethasone regimen, which was for 7 months and was followed by 12 months maintenance on low-dose Revlimid alone. I had disease progression starting October 2015 and a new clinical trial regimen was started 9 months later in June 2016.
In my estimation, this clinical trial could not produce an 'overall survival' figure based upon death because despite the continuously mounting M-spike, the trial conditions must have ended upon my receiving the second treatment regimen in June 2016. Based on the above figures, I would think my 'overall survival' figure from start of treatment would be 45 months (26 months if we exclude the period during which I was receiving treatment, i.e., 7 months treatment + 12 months maintenance. The 26 months would therefore be the 'progression free' period from ending all treatment in August 2013 until disease progression in October 2015.
My current trial is Pomalyst (pomalidomide, Imnovid), cyclophosphamide, and dexamethasone, which is producing good results since starting in June 2016 and has reduced the M-spike back to where it was in December 2015.
I too have given some thought to the 'overall survival' criteria because I cannot see any hospital simply leaving the patient to die in order to enter a date in the dossier when there are other treatment options which are readily available.
Kind Regards,
Victor L
if I may be permitted to add a thought to this discussion, purely as a patient.
This is connected with the 'overall survival' term. To date, my two treatment regimens since my diagnosis five years ago have both been classed as clinical trials. The first trial was started in January 2012 and was the Revlimid, Velcade, and dexamethasone regimen, which was for 7 months and was followed by 12 months maintenance on low-dose Revlimid alone. I had disease progression starting October 2015 and a new clinical trial regimen was started 9 months later in June 2016.
In my estimation, this clinical trial could not produce an 'overall survival' figure based upon death because despite the continuously mounting M-spike, the trial conditions must have ended upon my receiving the second treatment regimen in June 2016. Based on the above figures, I would think my 'overall survival' figure from start of treatment would be 45 months (26 months if we exclude the period during which I was receiving treatment, i.e., 7 months treatment + 12 months maintenance. The 26 months would therefore be the 'progression free' period from ending all treatment in August 2013 until disease progression in October 2015.
My current trial is Pomalyst (pomalidomide, Imnovid), cyclophosphamide, and dexamethasone, which is producing good results since starting in June 2016 and has reduced the M-spike back to where it was in December 2015.
I too have given some thought to the 'overall survival' criteria because I cannot see any hospital simply leaving the patient to die in order to enter a date in the dossier when there are other treatment options which are readily available.
Kind Regards,
Victor L
-
Victor L - Name: Victor L
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: 2012
- Age at diagnosis: 58
Re: Survival and response rate definitions?
Hi everyone,
Overall survival (OS) = time from starting point (diagnosis, start of treatment, etc) to time of patient's death, whenever it occurs, and regardless of the cause of death.
So overall survival from time of diagnosis is the time from diagnosis until the patient's death from any cause.
Likewise, overall survival for a treatment being tested in a clinical trial is typically the time from when a patient starts the treatment until when they die, regardless if they are still on the treatment, or have gone on to other treatments, and regardless of the cause of death.
Progression-free survival (PFS) = time from starting point (usually the start of a treatment being tested) until whichever of the following come first
(a) The patient's disease progresses (loosely speaking, the time the patient relapses), OR
(b) The patients's death.
Hope this helps clarify things a bit.
Overall survival (OS) = time from starting point (diagnosis, start of treatment, etc) to time of patient's death, whenever it occurs, and regardless of the cause of death.
So overall survival from time of diagnosis is the time from diagnosis until the patient's death from any cause.
Likewise, overall survival for a treatment being tested in a clinical trial is typically the time from when a patient starts the treatment until when they die, regardless if they are still on the treatment, or have gone on to other treatments, and regardless of the cause of death.
Progression-free survival (PFS) = time from starting point (usually the start of a treatment being tested) until whichever of the following come first
(a) The patient's disease progresses (loosely speaking, the time the patient relapses), OR
(b) The patients's death.
Hope this helps clarify things a bit.
Re: Survival and response rate definitions?
Hi TerryH,
Many thanks for the clarification, I am sure you can understand why people are slightly confused. In a more rigid scientific setting, Patient A would receive the treatment and Patient B would receive a placebo. They would then be observed and the required survival periods noted. In reality, this would seldom be possible because all other treatment options must be tried, and so perhaps we must be a little more careful about how much credence we lend to statistics, and further it may give more emphasis to the credibility of large clinical trials as opposed to very small trials.
Thank you again and Best Wishes !
Victor L
Many thanks for the clarification, I am sure you can understand why people are slightly confused. In a more rigid scientific setting, Patient A would receive the treatment and Patient B would receive a placebo. They would then be observed and the required survival periods noted. In reality, this would seldom be possible because all other treatment options must be tried, and so perhaps we must be a little more careful about how much credence we lend to statistics, and further it may give more emphasis to the credibility of large clinical trials as opposed to very small trials.
Thank you again and Best Wishes !
Victor L
-
Victor L - Name: Victor L
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: 2012
- Age at diagnosis: 58
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