› Forums › General Melanoma Community › Yervoy, clinical trial and stats
- This topic has 24 replies, 8 voices, and was last updated 14 years, 5 months ago by
Lisa13.
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- July 31, 2011 at 2:11 pm
I've been thinking about all these "stat numbers" for ipi and all other drugs in clinical trials. These results are from a large group of people from different ages, health status, sex, etc. My question is, have any of these studies been broken down (mainly in Stage 4 patients) in terms of M1a, b, c, LCD levels, health etc? I think any of the results would be very different if they were broken down in these groups since some people with Stage 4 are healthier and have controlled disease over others. Take for example, the TIL program at NCI.
I've been thinking about all these "stat numbers" for ipi and all other drugs in clinical trials. These results are from a large group of people from different ages, health status, sex, etc. My question is, have any of these studies been broken down (mainly in Stage 4 patients) in terms of M1a, b, c, LCD levels, health etc? I think any of the results would be very different if they were broken down in these groups since some people with Stage 4 are healthier and have controlled disease over others. Take for example, the TIL program at NCI. My oncologist mentioned that even though the results are good from this trial, Rosenberg is very selective in who is accepted in the program and it's mainly people who are healthy, so these people would generally do better under these circumstances, or so you would think.
Going into an ipi trial myself, I look at all the numbers from previous trials and wonder what everyone's predicament was at the time. With IL-2 – they claim that 6% have a complete, durable response – were these people younger, healthier, less disease, etc?? As I'm fighting this beast, I dwell too much on the numbers and look for the odds that something will work and it drives me crazy! I'm going to try very hard to go into this ipi trial and just hope for the best and not dwell too much on the numbers.
Lisa – Stage 4
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- July 31, 2011 at 4:57 pm
I think you can drive yourself crazy trying to make sense of the statistics. You are right – the statistics are skewed by how many, how healthy, age, gender, where (brain or not).
Perhaps more importantly – is to understand that if standard, approved treatment X doesn't work, what is next and what did treatment X exclude you from in terms of potential clinical trial participation. Also it is super important to know your mutation types (BRAF wild or postive, HLA-2).
I think the fact that your are moving forward quickly is right on – the faster something doesn't work, move on. Because if it gets to the brain your options dwindle fast. So just focus on the treatment at hand once you've made the decision.
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- July 31, 2011 at 4:57 pm
I think you can drive yourself crazy trying to make sense of the statistics. You are right – the statistics are skewed by how many, how healthy, age, gender, where (brain or not).
Perhaps more importantly – is to understand that if standard, approved treatment X doesn't work, what is next and what did treatment X exclude you from in terms of potential clinical trial participation. Also it is super important to know your mutation types (BRAF wild or postive, HLA-2).
I think the fact that your are moving forward quickly is right on – the faster something doesn't work, move on. Because if it gets to the brain your options dwindle fast. So just focus on the treatment at hand once you've made the decision.
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- July 31, 2011 at 9:14 pm
Here's the rub. People complain about having difficulty getting into clinical trials. But if the trials are to mean anything, you HAVE to have people in the trials with no outlying characteristics. No disease or other cancers or other problems that might skew the results. Everyone in a trial has to meet a certain level of "healthy" to participate – otherwise they look for "compassionate use". But that doesn't mean everyone is as healthy as others in the trial. Statistics are historical, and meaningless if you try to apply it to a single individual. Statistics are to give you a general look and feel for how a treatment may work. But they give you no indication on how YOU will do in a particular circumstance. Statistics are great when narrowing down options, but don't look any further than that for answers!
Best wishes,
Janner
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- July 31, 2011 at 9:14 pm
Here's the rub. People complain about having difficulty getting into clinical trials. But if the trials are to mean anything, you HAVE to have people in the trials with no outlying characteristics. No disease or other cancers or other problems that might skew the results. Everyone in a trial has to meet a certain level of "healthy" to participate – otherwise they look for "compassionate use". But that doesn't mean everyone is as healthy as others in the trial. Statistics are historical, and meaningless if you try to apply it to a single individual. Statistics are to give you a general look and feel for how a treatment may work. But they give you no indication on how YOU will do in a particular circumstance. Statistics are great when narrowing down options, but don't look any further than that for answers!
Best wishes,
Janner
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- July 31, 2011 at 10:51 pm
Hi Lisa
Try to avoid concentrating on statistics. Everybody responds differently. Some respond to ipi completely like Donna in VT, others like myself were partial responders. The ipi trial by the way was 'compassionate'.
I disagree with your doctor's comment about Dr. Rosenberg accepting only healthy patients….I had to pass several tests to ensure that I did not have brain mets, a stress test to ensure that my heart could take the drugs, and colonoscopy to ensure that these potent drugs wouldn't perhaps cause more problems. Any clinical trial would want to ensure the safety of their patients before proceeding. But as far as being healthy…well, they removed two tumor masses from my left groin plus this week's ct scan showed a significant increase in growth of sub-qs within a span of 3 weeks (no controlled disease going on there). I will be able to tolerate the drugs, the question is if they will work and that's from where the statistics are reported. Val
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- July 31, 2011 at 10:51 pm
Hi Lisa
Try to avoid concentrating on statistics. Everybody responds differently. Some respond to ipi completely like Donna in VT, others like myself were partial responders. The ipi trial by the way was 'compassionate'.
I disagree with your doctor's comment about Dr. Rosenberg accepting only healthy patients….I had to pass several tests to ensure that I did not have brain mets, a stress test to ensure that my heart could take the drugs, and colonoscopy to ensure that these potent drugs wouldn't perhaps cause more problems. Any clinical trial would want to ensure the safety of their patients before proceeding. But as far as being healthy…well, they removed two tumor masses from my left groin plus this week's ct scan showed a significant increase in growth of sub-qs within a span of 3 weeks (no controlled disease going on there). I will be able to tolerate the drugs, the question is if they will work and that's from where the statistics are reported. Val
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- July 31, 2011 at 11:12 pm
Hi Val,
Sorry to hear your ct scan revealed an increase in growth in your sub-q's, but no brain mets! Lucky for you, you're starting a new trial which holds alot of promise. My oncologist said Dr. Rosenberg is a fantastic Dr. and scientist, so obviously you're in very good hands.
I'm not sure the exact conversation with my onc. re: your trial. I had just found out the dacarbazine hadn't worked for me, so my head wasn't entirely focused 🙂 He certainly wasn't indicating it wasn't successful, just wondered if the stats were a bit flawed in terms of the healthy participants. He may have been speaking about earlier stages in the study, not present figures. I personally feel it's going to be the next best thing in terms of treatment and hope this is your magic bullet.
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- July 31, 2011 at 11:12 pm
Hi Val,
Sorry to hear your ct scan revealed an increase in growth in your sub-q's, but no brain mets! Lucky for you, you're starting a new trial which holds alot of promise. My oncologist said Dr. Rosenberg is a fantastic Dr. and scientist, so obviously you're in very good hands.
I'm not sure the exact conversation with my onc. re: your trial. I had just found out the dacarbazine hadn't worked for me, so my head wasn't entirely focused 🙂 He certainly wasn't indicating it wasn't successful, just wondered if the stats were a bit flawed in terms of the healthy participants. He may have been speaking about earlier stages in the study, not present figures. I personally feel it's going to be the next best thing in terms of treatment and hope this is your magic bullet.
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- July 31, 2011 at 11:44 pm
The arm I am in..TIL with TBI..did have to be stopped although they had exceptional stats..some were found to have some burning to their organs due to radiation. After 5 years, there have been no repercussions as in diabetes, kidney failure etc. so it has been approved to go forward of the 112, 1/2 will be with TBI. Since there were only 25 patients the first time..there might be a difference in success..eg. flipping a coin 25 times might give you a different ratio of heads and tails flipped 1000 times…so our group will either confirm or differ (I'm hoping slightly if so) with the first group. At least that is how it was explained to me. But TIL on the whole has showed pretty good results over the years, just doesn't have the numbers re. participants as say yervoy.
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- July 31, 2011 at 11:44 pm
The arm I am in..TIL with TBI..did have to be stopped although they had exceptional stats..some were found to have some burning to their organs due to radiation. After 5 years, there have been no repercussions as in diabetes, kidney failure etc. so it has been approved to go forward of the 112, 1/2 will be with TBI. Since there were only 25 patients the first time..there might be a difference in success..eg. flipping a coin 25 times might give you a different ratio of heads and tails flipped 1000 times…so our group will either confirm or differ (I'm hoping slightly if so) with the first group. At least that is how it was explained to me. But TIL on the whole has showed pretty good results over the years, just doesn't have the numbers re. participants as say yervoy.
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- August 1, 2011 at 12:47 am
I understand the need for restrictive clinical trials. Many of my posts here have noted that while many treatments work on a few, we need to know much more about why the treatments work on those that it does. Without this knowledge too much time and energy is wasted on things that will not help, but may actually wear one down sooner. The Human Gneome Project has also helped get a better start on the necessary knowledge.
I also acknowledge extreme irritation with the timing that changed new participants in the Ipi trials from fairly wide open to require Brain mets in late 2008/early 2009. (When the IL-2 quit workiing for me and I didn't have brain mets).
One particular irritation I have is with the promises that were made to Amy Busby that she could re-enter the BRAF trial if she met certain criteria after the great reduction in all her mets, except for the extension to the spinal column and Brain. She met the criteria of two months clear in those areas and the pharmacuticals they backed out on their word to her. She felt that the Pharmacuticals were afraid she would die on their "watch" is why they refused her chance to re-enter the trial as they had promised her Oncologist.
The definition of HEALTHY does vary. Yes, one thing they want is people that are healthy enough to survive the possible side effects of the drugs. (IE, not die as a direct result of their drug.) Sometimes it also appears that they don't want to take a chaance on some that are possibly going to die during their trial. Some of those might could have been helped, but trial ressults would not have looked as good.
Trial numbers are really not too explict and trustworthy to apply to any one persons particular case without knowing many details.
I too have heard may complaints that while NIH is on the cuttig edge of cancer development, They alsotend to be somewhat self centred on what they are workiing on.
While we are making progres toward improving survivability, there is still much more distaance to be traveled, especially for those of us that are in the smaller groups of particular melanomas.
One of the problems with IL-2 has always ben that many Onc's do not know how to handle the side effects and so wait until one has stried everything else and is not in shape to try the IL-2 or else are too far gone.
As you may know, my personal feeling is that if one does not have a tknown DNA mutation with a targeted drug avilable, then a possible sequence of IPI and IL-2 started as early as posible when one one is healthy enough for it.
Still too many unknows.
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- August 1, 2011 at 12:47 am
I understand the need for restrictive clinical trials. Many of my posts here have noted that while many treatments work on a few, we need to know much more about why the treatments work on those that it does. Without this knowledge too much time and energy is wasted on things that will not help, but may actually wear one down sooner. The Human Gneome Project has also helped get a better start on the necessary knowledge.
I also acknowledge extreme irritation with the timing that changed new participants in the Ipi trials from fairly wide open to require Brain mets in late 2008/early 2009. (When the IL-2 quit workiing for me and I didn't have brain mets).
One particular irritation I have is with the promises that were made to Amy Busby that she could re-enter the BRAF trial if she met certain criteria after the great reduction in all her mets, except for the extension to the spinal column and Brain. She met the criteria of two months clear in those areas and the pharmacuticals they backed out on their word to her. She felt that the Pharmacuticals were afraid she would die on their "watch" is why they refused her chance to re-enter the trial as they had promised her Oncologist.
The definition of HEALTHY does vary. Yes, one thing they want is people that are healthy enough to survive the possible side effects of the drugs. (IE, not die as a direct result of their drug.) Sometimes it also appears that they don't want to take a chaance on some that are possibly going to die during their trial. Some of those might could have been helped, but trial ressults would not have looked as good.
Trial numbers are really not too explict and trustworthy to apply to any one persons particular case without knowing many details.
I too have heard may complaints that while NIH is on the cuttig edge of cancer development, They alsotend to be somewhat self centred on what they are workiing on.
While we are making progres toward improving survivability, there is still much more distaance to be traveled, especially for those of us that are in the smaller groups of particular melanomas.
One of the problems with IL-2 has always ben that many Onc's do not know how to handle the side effects and so wait until one has stried everything else and is not in shape to try the IL-2 or else are too far gone.
As you may know, my personal feeling is that if one does not have a tknown DNA mutation with a targeted drug avilable, then a possible sequence of IPI and IL-2 started as early as posible when one one is healthy enough for it.
Still too many unknows.
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- August 1, 2011 at 1:49 am
I know how you feel about the "statistics" Lisa. When Dave was trying to determine which drug to try first with his stage iv disease, everybody was leaning towards IPI. But I knew (from watching the board) that IL-2 was only available if you were healthy enough. Given that Dave has what the onc called "bulky" disease only in his chest, we knew that if he was going to give IL-2 a try now was the time to do it, before the disease progressed. That being said, the oncologist also noted that IL-2 has the best response with sub-q's and distant lymph node disease, then lung, liver, and bone (in that order). That's not to say that it will or will not work for Dave, only what the "statistics" showed. And we know how much mel likes to follow statistics, right?
Choosing a treatment almost seems more difficult when you are educated about the options. It is quite honestly a "crap shoot". But whatever you do, don't second guess it. If you don't respond to treatment, try another. Like others have said, stable is better than progression.
Best wishes to you,
Maria
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- August 1, 2011 at 1:49 am
I know how you feel about the "statistics" Lisa. When Dave was trying to determine which drug to try first with his stage iv disease, everybody was leaning towards IPI. But I knew (from watching the board) that IL-2 was only available if you were healthy enough. Given that Dave has what the onc called "bulky" disease only in his chest, we knew that if he was going to give IL-2 a try now was the time to do it, before the disease progressed. That being said, the oncologist also noted that IL-2 has the best response with sub-q's and distant lymph node disease, then lung, liver, and bone (in that order). That's not to say that it will or will not work for Dave, only what the "statistics" showed. And we know how much mel likes to follow statistics, right?
Choosing a treatment almost seems more difficult when you are educated about the options. It is quite honestly a "crap shoot". But whatever you do, don't second guess it. If you don't respond to treatment, try another. Like others have said, stable is better than progression.
Best wishes to you,
Maria
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- August 1, 2011 at 12:30 pm
I think ipi is the best route to take at this stage for me. Since my melanoma is growing slowly and ipi needs time to work, this seems to be the time to use it. If ipi doesn't work and my melanoma continues to grow slow, then IL-2 would be my next option – although my oncologist has suggested clinical trials as well.
I agree with Michael, there is still work to be done to determine why some respond to treatment and others don't. With the new drugs that have been approved this year, there is HOPE that they are on their way to figuring it out soon.
Lisa
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- August 1, 2011 at 12:30 pm
I think ipi is the best route to take at this stage for me. Since my melanoma is growing slowly and ipi needs time to work, this seems to be the time to use it. If ipi doesn't work and my melanoma continues to grow slow, then IL-2 would be my next option – although my oncologist has suggested clinical trials as well.
I agree with Michael, there is still work to be done to determine why some respond to treatment and others don't. With the new drugs that have been approved this year, there is HOPE that they are on their way to figuring it out soon.
Lisa
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- August 1, 2011 at 1:04 pm
I sit and read about all these chemicals people are using, one right after the other. And I don't know how you do it. I was kicked on my butt by biochemo and am almost afraid to try anything else. Yet you all have such courage to continue fighting.
Since I am Stage 3b and currently ned, I don't really have to worry about it right now. But I think that rather than doing thrugh all that pain, I might just do what I always swore I would NOT do………………..go gently into that good night.
Nicki, Stage 3b
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- August 1, 2011 at 1:04 pm
I sit and read about all these chemicals people are using, one right after the other. And I don't know how you do it. I was kicked on my butt by biochemo and am almost afraid to try anything else. Yet you all have such courage to continue fighting.
Since I am Stage 3b and currently ned, I don't really have to worry about it right now. But I think that rather than doing thrugh all that pain, I might just do what I always swore I would NOT do………………..go gently into that good night.
Nicki, Stage 3b
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- August 1, 2011 at 7:54 pm
Hi Nicki,
In my situation, I've been married 2.5 years and have a 21 month old daughter, so I don't care what kind of poison goes into my body, as long as it keeps me going. I think when you're stage 4, there is a survival mechanism that kicks in that becomes greater than fear.
I did 2 rounds of dacarbazine and didn't have any symptoms. I presume ipi might be rougher, but I have no choice but to suck it up. I hope you never have to worry about anything and stay cozy in your Stage 3b place 🙂
Lisa
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- August 1, 2011 at 7:54 pm
Hi Nicki,
In my situation, I've been married 2.5 years and have a 21 month old daughter, so I don't care what kind of poison goes into my body, as long as it keeps me going. I think when you're stage 4, there is a survival mechanism that kicks in that becomes greater than fear.
I did 2 rounds of dacarbazine and didn't have any symptoms. I presume ipi might be rougher, but I have no choice but to suck it up. I hope you never have to worry about anything and stay cozy in your Stage 3b place 🙂
Lisa
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