Quick comment on this from me.
I agree completely with all of the posters, and there is no doubt, that this issue, along with an optimal and hopefully very long remission (response) is key, and the most important issue. As suggested by Ellen, however, I do not see this as an issue that can be practically worked into clinical trials. What constitutes QOL (and happiness) is the most subjective topic you could come up with. There are some markers that could be far removed from actual quality (happiness) that could be measured such as side effects, financials, time needed for treatment (in patient or outpatient), however, at the end of the day, people will look at this differently, and they defy a hard "definition". In order to go to the trouble and cost for a clinical trial, you would have to have a very good definition of the "the thing" to be studied. That would be the hardest part, to define "the thing". I do not think that some of the good studies on QOL have been a complete waste, however, they certainly are not relevant across the board to all patients, and none of them that I have read seemed particularly relevant to our specific situation.
There are still issues that are in the realm of the relationship between the patient, and a good experienced caring doctor. Judgements along QOL issues in my view are made in that context. Also, support groups, both associated with hospitals and outside of hospitals, can help individuals work this out. Good luck to all.
Forums
Re: Quality of life
Hello MikeF and MMFeb15:
Another thought for your discussion. If you look in detail at the data of the recent IFM trial for early or delayed transplant, they actually have data on the early mortality in the transplant arm. It is not the headline of the study, but since they are trying to track OS over a long period of time, it is there. The European arm posted results, going back and looking over the numbers, the early mortality was all in the early transplant arm, and about 1.5%.
Adding a little bit of my own data analysis to the results, I think that means that in the major, larger experienced centers in Europe, the risk is about 1%, and about 2% in the more remote rural centers that do it, but have a lesser infrastructure. It will be interesting to see what the results will be when the US data is posted. I don't want to be nationalistic, but I am thinking that it will likely come out that the US will be a little better, at about 1% overall, we will see. If that is correct, the risk in the major US centers would be in the 0.5% to about 1% range. Best Regards and Good Luck
Another thought for your discussion. If you look in detail at the data of the recent IFM trial for early or delayed transplant, they actually have data on the early mortality in the transplant arm. It is not the headline of the study, but since they are trying to track OS over a long period of time, it is there. The European arm posted results, going back and looking over the numbers, the early mortality was all in the early transplant arm, and about 1.5%.
Adding a little bit of my own data analysis to the results, I think that means that in the major, larger experienced centers in Europe, the risk is about 1%, and about 2% in the more remote rural centers that do it, but have a lesser infrastructure. It will be interesting to see what the results will be when the US data is posted. I don't want to be nationalistic, but I am thinking that it will likely come out that the US will be a little better, at about 1% overall, we will see. If that is correct, the risk in the major US centers would be in the 0.5% to about 1% range. Best Regards and Good Luck
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JPC - Name: JPC
Re: Quality of life
Hi JPC,
Actually, health-related quality of life (HRQOL) issues are commonly included as secondary endpoints in trials. Have you ever seen a trial/study with Kyprolis discussing the rates of peripheral neuropathy (PN)? That is done because the rates are lower than the competitor product. They are using it as a secondary endpoint because it is common knowledge that people with PN have a reduced quality of life compared to those who do not.
This is just an example of a quality of life issue being used as a secondary endpoint in a study/trial. Health related quality of life issues relate to side effects that are caused by the disease itself or the therapies used. As an example, if I was to try and quickly assess the HRQOL of a myeloma patient, I would ask questions like:
To use something objective, I would ask if I could see their bloodwork.
Let me show everyone how easy it is to incorporate quality of life into a study along with treatment efficiency and how easy it can be to identify "the thing". One of the studies above comparing HRQOL of long term Gleevec survivors with long term allo transplants includes a statement that is common knowledge and been shown in many studies.
Guess what they are starting to do now in allo transplant studies? They are using graft vs host disease free progression free survival (GRFS). "Real hard" to do. One extra graph and table of data included in a study using data they have already collected.
From:
M Solh et al, "Factors Predicting Gvhd Free, Relapse Free Survival (GRFS) after Allogeneic Hematopoietic Cell Transplantation; A Multivariable Analysis of 531 Allografts from a Single Center," ASH 2015 annual meeting abstract #2028 (link to abstract)
Mark
Actually, health-related quality of life (HRQOL) issues are commonly included as secondary endpoints in trials. Have you ever seen a trial/study with Kyprolis discussing the rates of peripheral neuropathy (PN)? That is done because the rates are lower than the competitor product. They are using it as a secondary endpoint because it is common knowledge that people with PN have a reduced quality of life compared to those who do not.
This is just an example of a quality of life issue being used as a secondary endpoint in a study/trial. Health related quality of life issues relate to side effects that are caused by the disease itself or the therapies used. As an example, if I was to try and quickly assess the HRQOL of a myeloma patient, I would ask questions like:
- Do you have bone pain? (Side effect of the disease)
- Do you experience fatigue? (Disease and therapies)
- How many infections have you had in a set time period and how fast did you recover from them? (Disease and therapies)
- How many days in a certain time period did you spend either in the clinic or in the Hospital?
- Did you work prior to diagnosis and do you work now? (Disease and therapy related)
- Do you have diarrhea and how severe? (Therapy related)
To use something objective, I would ask if I could see their bloodwork.
Let me show everyone how easy it is to incorporate quality of life into a study along with treatment efficiency and how easy it can be to identify "the thing". One of the studies above comparing HRQOL of long term Gleevec survivors with long term allo transplants includes a statement that is common knowledge and been shown in many studies.
Persistent cGVHD reduced the HRQOL of the allo-HSCT group, compared with the non-cGVHD and historic cGVHD group.
Guess what they are starting to do now in allo transplant studies? They are using graft vs host disease free progression free survival (GRFS). "Real hard" to do. One extra graph and table of data included in a study using data they have already collected.
The ideal outcome of allogeneic hematopoietic cell transplantation (allo-HCT) is based on survival that is free of morbidity. The most common causes of treatment failure and morbidity after HCT are relapse, GVHD and non-relapse death. A composite endpoint that measures survival free of clinically significant negative events may be a useful way to determine the success of allo-HCT.
From:
M Solh et al, "Factors Predicting Gvhd Free, Relapse Free Survival (GRFS) after Allogeneic Hematopoietic Cell Transplantation; A Multivariable Analysis of 531 Allografts from a Single Center," ASH 2015 annual meeting abstract #2028 (link to abstract)
Mark
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Mark11
Re: Quality of life
I should have posted this earlier. This is what health related quality of life is.
Source: http://www.cdc.gov/hrqol/concept.htm
The concept of health-related quality of life (HRQOL) and its determinants have evolved since the 1980s to encompass those aspects of overall quality of life that can be clearly shown to affect health – either physical or mental.
On the individual level, this includes physical and mental health perceptions and their correlates –including health risks and conditions, functional status, social support, and socioeconomic status. On the community level, HRQOL includes resources, conditions, policies, and practices that influence a population’s health perceptions and functional status. The construct of HRQOL enables health agencies to legitimately address broader areas of healthy public policy around a common theme in collaboration with a wider circle of health partners, including social service agencies, community planners, and business groups.
HRQOL questions about perceived physical and mental health and function have become an important component of health surveillance and are generally considered valid indicators of service needs and intervention outcomes. SELF-ASSESSED HEALTH STATUS ALSO PROVED TO BE MORE POWERFUL PREDICTOR OF MORTALITY AND MORBITITY THAN MANY OBJECTIVE MEASURES OF HEALTH. HRQOL measures make it possible to demonstrate scientifically the impact of health on quality of life, going well beyond the old paradigm that was limited to what can be seen under a microscope.
Source: http://www.cdc.gov/hrqol/concept.htm
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Mark11
Re: Quality of life
Dear Mike F,
Thanks for your response. Yes I am in the USA. The 2 percent mortality during the transplant process was given by them.
Thank you again.
Thanks for your response. Yes I am in the USA. The 2 percent mortality during the transplant process was given by them.
Thank you again.
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MMFeb16,15 - Who do you know with myeloma?: Self
- When were you/they diagnosed?: February 16, 2015
- Age at diagnosis: 66
Re: Quality of life
For what it's worth, what appears to be one of the most comprehensive surveys of the results of ASCT for myeloma:
http://www.sciencedirect.com/science/article/pii/S1083879113003510
This one looked at ~6000 patients getting ASCTs as "early therapy" for multiple myeloma. It's a detailed look at the process and how well it succeeds, with mortality rates (among a lot of other things) calculated for different cohorts over different time periods (notably prior to 2005 and between 2005 and 2010).
They found that the transplant related mortality rate at 100 days was 2% in the cohorts receiving transplants prior to 2005 and 1% in those receiving them between 2005 and 2010 (the latest range included in the study). They have some ideas as to why there has been an improvement in survival but no solid conclusions. They considered both the 2% and 1% figures to be low, though.
That was the latest article I could find that appeared to be a comprehensive look at the subject, but it's certainly possible something's been published since then.
Not trying to convince you that you should get a transplant, MMFeb16, just wanting to get this stuff as straight as I can for myself.
http://www.sciencedirect.com/science/article/pii/S1083879113003510
This one looked at ~6000 patients getting ASCTs as "early therapy" for multiple myeloma. It's a detailed look at the process and how well it succeeds, with mortality rates (among a lot of other things) calculated for different cohorts over different time periods (notably prior to 2005 and between 2005 and 2010).
They found that the transplant related mortality rate at 100 days was 2% in the cohorts receiving transplants prior to 2005 and 1% in those receiving them between 2005 and 2010 (the latest range included in the study). They have some ideas as to why there has been an improvement in survival but no solid conclusions. They considered both the 2% and 1% figures to be low, though.
That was the latest article I could find that appeared to be a comprehensive look at the subject, but it's certainly possible something's been published since then.
Not trying to convince you that you should get a transplant, MMFeb16, just wanting to get this stuff as straight as I can for myself.
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Mike F - Name: Mike F
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: May 18, 2012
- Age at diagnosis: 53
Re: Quality of life
I hope everyone has been enjoying the holidays.
I did want to get back to this topic since it is an important one and it seems that a lot of people may not understand what health related quality of life is. This is to help patients understand what the above studies I posted are showing.
Take note of the quick questionnaire for a myeloma patient I put together above:
The regular readers know what my treatment history is and current remission status is, but I will answer those questions for 2015 as an example. For those not familiar, I was diagnosed in 2010 and I did four 3-week cycles of Velcade / Doxil / dex and than did a tandem auto transplant - allo transplant in 2011, and I have been myeloma treatment free since.
In earlier posts, there were comments that this is all subjective. If I was to answer these questions for 2011, my answer to question (4) would have been in the area of 70, and I think it was probably higher than that. Just knowing my answer to that question was 70 in 2011 and 7 in 2015, would anyone try and make an argument that my quality of life was better in 2011 than it was in 2015?
I did want to get back to this topic since it is an important one and it seems that a lot of people may not understand what health related quality of life is. This is to help patients understand what the above studies I posted are showing.
Take note of the quick questionnaire for a myeloma patient I put together above:
- Do you have bone pain? (Side effect of the disease)
- Do you experience fatigue? (Disease and therapies)
- How many infections have you had in a set time period and how fast did you recover from them? (Disease and therapies)
- How many days in a certain time period did you spend either in the clinic or in the Hospital?
- Did you work prior to diagnosis and do you work now? (Disease and therapy related)
- Do you have diarrhea and how severe? (Therapy related)
The regular readers know what my treatment history is and current remission status is, but I will answer those questions for 2015 as an example. For those not familiar, I was diagnosed in 2010 and I did four 3-week cycles of Velcade / Doxil / dex and than did a tandem auto transplant - allo transplant in 2011, and I have been myeloma treatment free since.
- No regular bone pain. Only pain is mild lower back pain that require no treatment after activity like shoveling snow or strenuous exercise.
- No fatigue.
- One cold that lasted 24 hours.
- Seven days spent with health care providers. Four trips for treatment/doctor visit, one for a PET scan, one to general practitioner, and one for a bone density test.
- Worked full time prior and currently work full time.
- None.
In earlier posts, there were comments that this is all subjective. If I was to answer these questions for 2011, my answer to question (4) would have been in the area of 70, and I think it was probably higher than that. Just knowing my answer to that question was 70 in 2011 and 7 in 2015, would anyone try and make an argument that my quality of life was better in 2011 than it was in 2015?
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Mark11
Re: Quality of life
As part of the clinical trial I'm in, I've often answered the kind of QOL questions you mentioned, Mark11. While the primary goal of the trial (DFCI 10-106) is to compare targeted therapy+ASCT vs. targeted therapy only protocols for PFS, there must be some interest in QOL because of all the QOL questionnaires I've completed during my almost-three years in the trial.
Initial results for the French part of this trial were published at ASH 2015 (abstract), but the abstract does not mention anything about QOL, unfortunately. That, I think, is an example of one point you're trying to make here - QOL often does not get the attention from researchers that it deserves.
Mike
Initial results for the French part of this trial were published at ASH 2015 (abstract), but the abstract does not mention anything about QOL, unfortunately. That, I think, is an example of one point you're trying to make here - QOL often does not get the attention from researchers that it deserves.
Mike
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mikeb - Name: mikeb
- Who do you know with myeloma?: self
- When were you/they diagnosed?: 2009 (MGUS at that time)
- Age at diagnosis: 55
Re: Quality of life
Hi Mark,
Thank you for starting this very interesting thread.
I would add a few more questions to the “Quality of Life” questionnaire.
I also think it’s very important for those facing a life threatening illness to continue to feed their creative muse(s) during their treatment journey. Again, I would consider my QOL seriously diminished were I unable to continue with my normal creative writing endeavors . (When I read the recent obituary of author, Jackie Collins, I was amazed to learn that she had written 5 novels after her stage IV cancer diagnosis just over 6 years ago! Amazing that she could remain so incredibly productive while dealing with such a grim diagnosis.)
Karen
Thank you for starting this very interesting thread.
I would add a few more questions to the “Quality of Life” questionnaire.
- Are you able – on a fairly regular basis – to continue participating socially in the lives of family, friends etc.?
- Are on you able – on a fairly regular basis – to continue participating in and deriving pleasure from your preferred pre-diagnosis activities such as sports, artistic endeavors, volunteer work etc.?
I also think it’s very important for those facing a life threatening illness to continue to feed their creative muse(s) during their treatment journey. Again, I would consider my QOL seriously diminished were I unable to continue with my normal creative writing endeavors . (When I read the recent obituary of author, Jackie Collins, I was amazed to learn that she had written 5 novels after her stage IV cancer diagnosis just over 6 years ago! Amazing that she could remain so incredibly productive while dealing with such a grim diagnosis.)
Karen
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KarenaD - Name: Karen
- Who do you know with myeloma?: Myself
- When were you/they diagnosed?: November 4, 2015
- Age at diagnosis: 54
Re: Quality of life
Thanks for the post, MikeB. I think you will see more quality of life-related discussion in studies for myeloma, since patients are living longer. I think it is a sign that your therapy is effective long term when you start seeing long-term survivors compared to the general population, as opposed to other blood cancer survivors or comparing patients using different therapies.
I did show a couple of studies comparing long-term CML survivors using Gleevec or allo transplant, but you will also see studies comparing them to the general population. Unfortunately, we are not at the point in myeloma where they will start comparing myeloma patients to the general population, since as the first study I posted shows, myeloma patients compared unfavorably to patients with other cancers.
The other thing I would point out is that you have to look at what factors they are comparing. One comment that was commonly stated in articles / discussions about the ELOQUENT-2 trial (elotuzumab / Revlimid / dex vs. Revlimid / dex) was:
Source: Phoebe Starr, "Elotuzumab, First-in-Class Monoclonal Antibody Immunotherapy, Improves Outcomes in Patients with Multiple Myeloma," American Health & Drug Benefits, August 2015 (full text at PubMed Central)
I do not know what type of questions they asked to come up with that, but I am thinking they did not place any value on a patient's time. The big advantage to using oral meds is that the patient does not have to go to the clinic. I posted a study above that showed how much younger patients valued not having to go to the clinic on a regular basis for therapy. I am sure older patients value that as well.
I did show a couple of studies comparing long-term CML survivors using Gleevec or allo transplant, but you will also see studies comparing them to the general population. Unfortunately, we are not at the point in myeloma where they will start comparing myeloma patients to the general population, since as the first study I posted shows, myeloma patients compared unfavorably to patients with other cancers.
The other thing I would point out is that you have to look at what factors they are comparing. One comment that was commonly stated in articles / discussions about the ELOQUENT-2 trial (elotuzumab / Revlimid / dex vs. Revlimid / dex) was:
We are excited about the progression-free survival [PFS] results attributable to this novel first-in-class monoclonal antibody. Elotuzumab achieved a longer duration of remission and improved overall response rates, without a significant increase in adverse events and no reduction in quality of life,” said lead investigator Sagar Lonial, MD, Chief Medical Officer, Winship Cancer Institute, Emory University School of Medicine, Atlanta.
Source: Phoebe Starr, "Elotuzumab, First-in-Class Monoclonal Antibody Immunotherapy, Improves Outcomes in Patients with Multiple Myeloma," American Health & Drug Benefits, August 2015 (full text at PubMed Central)
I do not know what type of questions they asked to come up with that, but I am thinking they did not place any value on a patient's time. The big advantage to using oral meds is that the patient does not have to go to the clinic. I posted a study above that showed how much younger patients valued not having to go to the clinic on a regular basis for therapy. I am sure older patients value that as well.
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Mark11
41 posts
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