On the Definition of Failure–a Rant

Please can I join your rant ? Was on a stage 3 keytruda trial… developed a medical problem 1 week after infusion 2. Knee  blew up- massive swelling, CRP over 150 ( Which continued for months ). Have had numerous knee surgeries and had aspiration in theatre- which was negative for infection. Carried progressively worsening problems for months- Keytruda suspended after infusion 7 , infection in old surgical scar finally diagnosed and treated .. but now timed out of trial- as in hospital on Iv antibiotics for most of September. Possibility is that old infection ( 2 years ago following surgical plate removal ) in biofilm came out of dormancy with immunotherapy- my theory anyway.

Still don't know if investigator has put down problems to probable or possible IRAE, but if I am now infection free.. and this is a realworld type scenario- like you- would like to have been given the chance to continue.

In your case  reversing majorityof tumours by 15% sounds like a great result and the one new could be a further mutation of your melanoma.Really hope they are testing for that. I don't think you should be left feeling cast out in shame .. but can see how it might feel that way. 

It must be a nightmare designing ethical trials where real world issues intrude- whilst we are "lab Rats" – amd willingly so, the definition of treatment success and failure is not black and white and as you say there may be small contributions that build to making big picture answers.

Hope the next big thing is shortly on your horizon and that you are a complete responder.

All the best

Please can I join your rant ? Was on a stage 3 keytruda trial… developed a medical problem 1 week after infusion 2. Knee  blew up- massive swelling, CRP over 150 ( Which continued for months ). Have had numerous knee surgeries and had aspiration in theatre- which was negative for infection. Carried progressively worsening problems for months- Keytruda suspended after infusion 7 , infection in old surgical scar finally diagnosed and treated .. but now timed out of trial- as in hospital on Iv antibiotics for most of September. Possibility is that old infection ( 2 years ago following surgical plate removal ) in biofilm came out of dormancy with immunotherapy- my theory anyway.

Still don't know if investigator has put down problems to probable or possible IRAE, but if I am now infection free.. and this is a realworld type scenario- like you- would like to have been given the chance to continue.

In your case  reversing majorityof tumours by 15% sounds like a great result and the one new could be a further mutation of your melanoma.Really hope they are testing for that. I don't think you should be left feeling cast out in shame .. but can see how it might feel that way. 

It must be a nightmare designing ethical trials where real world issues intrude- whilst we are "lab Rats" – amd willingly so, the definition of treatment success and failure is not black and white and as you say there may be small contributions that build to making big picture answers.

Hope the next big thing is shortly on your horizon and that you are a complete responder.

All the best

Please can I join your rant ? Was on a stage 3 keytruda trial… developed a medical problem 1 week after infusion 2. Knee  blew up- massive swelling, CRP over 150 ( Which continued for months ). Have had numerous knee surgeries and had aspiration in theatre- which was negative for infection. Carried progressively worsening problems for months- Keytruda suspended after infusion 7 , infection in old surgical scar finally diagnosed and treated .. but now timed out of trial- as in hospital on Iv antibiotics for most of September. Possibility is that old infection ( 2 years ago following surgical plate removal ) in biofilm came out of dormancy with immunotherapy- my theory anyway.

Still don't know if investigator has put down problems to probable or possible IRAE, but if I am now infection free.. and this is a realworld type scenario- like you- would like to have been given the chance to continue.

In your case  reversing majorityof tumours by 15% sounds like a great result and the one new could be a further mutation of your melanoma.Really hope they are testing for that. I don't think you should be left feeling cast out in shame .. but can see how it might feel that way. 

It must be a nightmare designing ethical trials where real world issues intrude- whilst we are "lab Rats" – amd willingly so, the definition of treatment success and failure is not black and white and as you say there may be small contributions that build to making big picture answers.

Hope the next big thing is shortly on your horizon and that you are a complete responder.

All the best

So sorry for your progression.  Sorry for all you've worked so hard to achieve.  And…I am glad you had the break you did.  You are right.  The success you achieved with your treatment is just as important as the current sittuation you find your body has put you in.  There is ever so much to learn from both sides of your "results".  In a sort of op-ed about clinical trials I posted in Jan of this year, I wrote:

"…The rattie needs to know anything that is learned about them.  It may impact later treatment options or choices they make.  The data needs to be readily available for other researchers, too – even if they work for diferent organizations.  A different set of eyes may find patterns and trends not apparent to the initial investigators, thereby elevating what is 'known' to a new level.  Even failed or negative study results need to be available.  People died for it.  Think of the data you have learned in your own life experiences.  I know I certailnly learned as much from my failures as I did from my successes!!"

Just one of my many rants on the topic. If you are interested in the rest, here's a link:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/01/the-problem-with-clinical-trials.html

I am sorry that you were made feel as you reported here.  Yes, "successes" are important.  But, on average, the best treatments for melanoma acquire responses in about 40% of patients (maybe a little more depending).  So that leaves a whopping 60% of us out in the cold.  Those folks matter.  AND they hold the key to what we need to learn about melanoma!!!!

Hopefully, the tide is turning.  Both in treatments available and in how we deal with clinical trials and treatment results.  I also posted this:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/09/new-rules-to-push-for-published-trial.html

Thanks for your post.  Thanks for yelling.  Sadly, with all that melanoma patients have to deal with…this is one more thing that we have to try to work to fix.  Hang in there.  I wish you an effective treatment plan very soon.  Seek peace my friend, celeste

So sorry for your progression.  Sorry for all you've worked so hard to achieve.  And…I am glad you had the break you did.  You are right.  The success you achieved with your treatment is just as important as the current sittuation you find your body has put you in.  There is ever so much to learn from both sides of your "results".  In a sort of op-ed about clinical trials I posted in Jan of this year, I wrote:

"…The rattie needs to know anything that is learned about them.  It may impact later treatment options or choices they make.  The data needs to be readily available for other researchers, too – even if they work for diferent organizations.  A different set of eyes may find patterns and trends not apparent to the initial investigators, thereby elevating what is 'known' to a new level.  Even failed or negative study results need to be available.  People died for it.  Think of the data you have learned in your own life experiences.  I know I certailnly learned as much from my failures as I did from my successes!!"

Just one of my many rants on the topic. If you are interested in the rest, here's a link:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/01/the-problem-with-clinical-trials.html

I am sorry that you were made feel as you reported here.  Yes, "successes" are important.  But, on average, the best treatments for melanoma acquire responses in about 40% of patients (maybe a little more depending).  So that leaves a whopping 60% of us out in the cold.  Those folks matter.  AND they hold the key to what we need to learn about melanoma!!!!

Hopefully, the tide is turning.  Both in treatments available and in how we deal with clinical trials and treatment results.  I also posted this:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/09/new-rules-to-push-for-published-trial.html

Thanks for your post.  Thanks for yelling.  Sadly, with all that melanoma patients have to deal with…this is one more thing that we have to try to work to fix.  Hang in there.  I wish you an effective treatment plan very soon.  Seek peace my friend, celeste

So sorry for your progression.  Sorry for all you've worked so hard to achieve.  And…I am glad you had the break you did.  You are right.  The success you achieved with your treatment is just as important as the current sittuation you find your body has put you in.  There is ever so much to learn from both sides of your "results".  In a sort of op-ed about clinical trials I posted in Jan of this year, I wrote:

"…The rattie needs to know anything that is learned about them.  It may impact later treatment options or choices they make.  The data needs to be readily available for other researchers, too – even if they work for diferent organizations.  A different set of eyes may find patterns and trends not apparent to the initial investigators, thereby elevating what is 'known' to a new level.  Even failed or negative study results need to be available.  People died for it.  Think of the data you have learned in your own life experiences.  I know I certailnly learned as much from my failures as I did from my successes!!"

Just one of my many rants on the topic. If you are interested in the rest, here's a link:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/01/the-problem-with-clinical-trials.html

I am sorry that you were made feel as you reported here.  Yes, "successes" are important.  But, on average, the best treatments for melanoma acquire responses in about 40% of patients (maybe a little more depending).  So that leaves a whopping 60% of us out in the cold.  Those folks matter.  AND they hold the key to what we need to learn about melanoma!!!!

Hopefully, the tide is turning.  Both in treatments available and in how we deal with clinical trials and treatment results.  I also posted this:  http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2016/09/new-rules-to-push-for-published-trial.html

Thanks for your post.  Thanks for yelling.  Sadly, with all that melanoma patients have to deal with…this is one more thing that we have to try to work to fix.  Hang in there.  I wish you an effective treatment plan very soon.  Seek peace my friend, celeste

Rant away G Sama!  Congrats are your SUCCESSFUL TIL trial. Hope you find another successful treatment in short order. 

Rant away G Sama!  Congrats are your SUCCESSFUL TIL trial. Hope you find another successful treatment in short order. 

Rant away G Sama!  Congrats are your SUCCESSFUL TIL trial. Hope you find another successful treatment in short order. 

Rant away G-Samsa, you have earned the right to. One of your last lines holds a great deal of truth: "there is no failure in science, only an opportunity to learn and that somewhere in here each lowly patient makes a contribution to getting at the big answers and just how that small contribution might fit in"

Doctors do speak with one another at conferences, over lunches, or the occasional phone call or email to ask "Have you ever seen something like……?". When enough of what may seem like the smallest contribuitions come up again and again, they learn and move forward with new theories. Anyone who has been in a trial, or even those experiencing "unusual" side effects from known medications, is an opportunity for them to learn. I believe it was Celeste who mentioned something to the effect of the 60% who things do not work for (aka "the failures) are those who we have the most to learn from. Although it is a harsh strike when progression occurs and the next treatment choice must be found/made…….. know that YOU have made a difference. No matter how small the contribution to the learning may seem or have been, it is important. You've now lived for a higher purpose… the gift of knowledge to others, which can lead to more future success, not only for you, but for those who will follow in your unfortunate footsteps. 

Thank you for sharing. 

Rant away G-Samsa, you have earned the right to. One of your last lines holds a great deal of truth: "there is no failure in science, only an opportunity to learn and that somewhere in here each lowly patient makes a contribution to getting at the big answers and just how that small contribution might fit in"

Doctors do speak with one another at conferences, over lunches, or the occasional phone call or email to ask "Have you ever seen something like……?". When enough of what may seem like the smallest contribuitions come up again and again, they learn and move forward with new theories. Anyone who has been in a trial, or even those experiencing "unusual" side effects from known medications, is an opportunity for them to learn. I believe it was Celeste who mentioned something to the effect of the 60% who things do not work for (aka "the failures) are those who we have the most to learn from. Although it is a harsh strike when progression occurs and the next treatment choice must be found/made…….. know that YOU have made a difference. No matter how small the contribution to the learning may seem or have been, it is important. You've now lived for a higher purpose… the gift of knowledge to others, which can lead to more future success, not only for you, but for those who will follow in your unfortunate footsteps. 

Thank you for sharing. 

Rant away G-Samsa, you have earned the right to. One of your last lines holds a great deal of truth: "there is no failure in science, only an opportunity to learn and that somewhere in here each lowly patient makes a contribution to getting at the big answers and just how that small contribution might fit in"

Doctors do speak with one another at conferences, over lunches, or the occasional phone call or email to ask "Have you ever seen something like……?". When enough of what may seem like the smallest contribuitions come up again and again, they learn and move forward with new theories. Anyone who has been in a trial, or even those experiencing "unusual" side effects from known medications, is an opportunity for them to learn. I believe it was Celeste who mentioned something to the effect of the 60% who things do not work for (aka "the failures) are those who we have the most to learn from. Although it is a harsh strike when progression occurs and the next treatment choice must be found/made…….. know that YOU have made a difference. No matter how small the contribution to the learning may seem or have been, it is important. You've now lived for a higher purpose… the gift of knowledge to others, which can lead to more future success, not only for you, but for those who will follow in your unfortunate footsteps. 

Thank you for sharing.