› Forums › General Melanoma Community › what type and dosage adjuvant therapy for stage IIIb melanoma should we choose? IPI? PD1?
- This topic has 42 replies, 6 voices, and was last updated 7 years, 5 months ago by
ed williams.
- Post
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- October 30, 2016 at 4:14 pm
folks my husband has been diagnosed with stage IIIb melanoma with ulceration and 50 cells of micro mets found in his sentinel node biopsy. we are trying to make some decisions on next steps. one is CLND or no CLND which i posted seperately.
Another decision is what kind of adjuvant therapy. one doctor (known in the field ) is reommending 3mg/kg IPI (not standard for stage III). he is recommending the lower dose due to toxicity of 10mg IPI. another doctor is saying he would go with standard 10 mg IPI for stage III.
To decide, i suppose it would help to know the history behind what led to the standard dosage of 10mg/kg for stage III vs 3mg/kg for stage IV? was it something random like at the time of IPI trial for stage III, the 3 mg dosage was not yet proven for stage IV? or is it that they believe you need a stronger dose to get rid of the mico mets vs tumor mets?
we also will try to get into IPI vs PD1 trial and see if get PD1. Are there different dosages of PD1 in different trials?
what else? should we ask for CTL4 and PD1 response staining before deciding?
what about PDL1 testing? can we get anti-PDL1 treatment anywhere?
thank you so much for your guidance.
- Replies
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- October 30, 2016 at 5:57 pm
From what I understand, Ipi was first approved at 3mg/kg as a treatment for stage IV. In clinical trials to see if it would be viable adjuvant treatment for stage III, they tested it at its highest dose of 10mg/kg. SInce the trials were done using the 10mg/kg, that's the only dose the FDA approved for stage III adjuvant treatment.
Since the side effects at the higher dose can be pretty rough, most doctors will prescribe it at the 3mg/kg (if your insurance company will allow it).
I'm sure that others will chime in with more info for you but, in the meantime, I hope this helps.
Good luck,
Ann
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- October 30, 2016 at 5:57 pm
From what I understand, Ipi was first approved at 3mg/kg as a treatment for stage IV. In clinical trials to see if it would be viable adjuvant treatment for stage III, they tested it at its highest dose of 10mg/kg. SInce the trials were done using the 10mg/kg, that's the only dose the FDA approved for stage III adjuvant treatment.
Since the side effects at the higher dose can be pretty rough, most doctors will prescribe it at the 3mg/kg (if your insurance company will allow it).
I'm sure that others will chime in with more info for you but, in the meantime, I hope this helps.
Good luck,
Ann
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- October 30, 2016 at 5:57 pm
From what I understand, Ipi was first approved at 3mg/kg as a treatment for stage IV. In clinical trials to see if it would be viable adjuvant treatment for stage III, they tested it at its highest dose of 10mg/kg. SInce the trials were done using the 10mg/kg, that's the only dose the FDA approved for stage III adjuvant treatment.
Since the side effects at the higher dose can be pretty rough, most doctors will prescribe it at the 3mg/kg (if your insurance company will allow it).
I'm sure that others will chime in with more info for you but, in the meantime, I hope this helps.
Good luck,
Ann
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- October 30, 2016 at 8:07 pm
I was diagnosed Stage IIIa and I found a doctor to prescribe ipi at 3mg … I had 4 infusions with only a little intestinal disturbance and a rash on my legs. I will go through the maintenance phase of 1 ipi 3mg infusion every three months for a year. You can look over my profile for more details.
Good luck!
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- October 30, 2016 at 10:57 pm
July 2013 I began participation in a stage three clinical trial that is comparing the adjuvant treatment of resected [metastatic] melanoma comparing the use of 10mg/Kg ipilimumab, interferon, and 3mg/Kg ipilimumab I am in the 3 mg group. After 2 infusions, I developed a toxic reaction (severe colitis) that started at level 2 and progressed to level 4 toxicity. All treatment was stopped (and was never resumed). I was hospitalized for twenty-four days in the intermediate intensive care unit. I received the most excellent care. My overactive immune system had to be "shut down"..I received two infusions of infleximab and my colon was "saved." I did not need any surgery. I had reactions to the high doses of prednisone that were effectively dealt with. Everything seems to have been resolved.
I am beginning my fourth year n the trial and report every six months. I am NEAD, No Evidence of Active Disease. I have been NEAD since the radical surgery, June 2013, of my left pituitary and sub mandibular [salivary] glands and all the lymph [5] glands on the left side of my neck. I am very grateful be in the trial and have received the two infusions of 3mg ipi. No matter what pain, discomfort, fear, anger I experienced, I would think of my father who died of metastatic malignant melanoma almost twenty-eight years ago. He is why I entered the trial.
Good luck!
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- October 30, 2016 at 10:57 pm
July 2013 I began participation in a stage three clinical trial that is comparing the adjuvant treatment of resected [metastatic] melanoma comparing the use of 10mg/Kg ipilimumab, interferon, and 3mg/Kg ipilimumab I am in the 3 mg group. After 2 infusions, I developed a toxic reaction (severe colitis) that started at level 2 and progressed to level 4 toxicity. All treatment was stopped (and was never resumed). I was hospitalized for twenty-four days in the intermediate intensive care unit. I received the most excellent care. My overactive immune system had to be "shut down"..I received two infusions of infleximab and my colon was "saved." I did not need any surgery. I had reactions to the high doses of prednisone that were effectively dealt with. Everything seems to have been resolved.
I am beginning my fourth year n the trial and report every six months. I am NEAD, No Evidence of Active Disease. I have been NEAD since the radical surgery, June 2013, of my left pituitary and sub mandibular [salivary] glands and all the lymph [5] glands on the left side of my neck. I am very grateful be in the trial and have received the two infusions of 3mg ipi. No matter what pain, discomfort, fear, anger I experienced, I would think of my father who died of metastatic malignant melanoma almost twenty-eight years ago. He is why I entered the trial.
Good luck!
-
- October 30, 2016 at 10:57 pm
July 2013 I began participation in a stage three clinical trial that is comparing the adjuvant treatment of resected [metastatic] melanoma comparing the use of 10mg/Kg ipilimumab, interferon, and 3mg/Kg ipilimumab I am in the 3 mg group. After 2 infusions, I developed a toxic reaction (severe colitis) that started at level 2 and progressed to level 4 toxicity. All treatment was stopped (and was never resumed). I was hospitalized for twenty-four days in the intermediate intensive care unit. I received the most excellent care. My overactive immune system had to be "shut down"..I received two infusions of infleximab and my colon was "saved." I did not need any surgery. I had reactions to the high doses of prednisone that were effectively dealt with. Everything seems to have been resolved.
I am beginning my fourth year n the trial and report every six months. I am NEAD, No Evidence of Active Disease. I have been NEAD since the radical surgery, June 2013, of my left pituitary and sub mandibular [salivary] glands and all the lymph [5] glands on the left side of my neck. I am very grateful be in the trial and have received the two infusions of 3mg ipi. No matter what pain, discomfort, fear, anger I experienced, I would think of my father who died of metastatic malignant melanoma almost twenty-eight years ago. He is why I entered the trial.
Good luck!
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- November 7, 2016 at 4:06 pm
Thank you Laulamb. happy to hear things are proressing well for you. 3mg IPI is where my husband is also leaning towards. his staging was juat chaged back to IIIa from the original IIIb "due to clerical error" they said !
he is deciding against CLND surgery.
keep us posted please and thanks again
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- November 7, 2016 at 4:06 pm
Thank you Laulamb. happy to hear things are proressing well for you. 3mg IPI is where my husband is also leaning towards. his staging was juat chaged back to IIIa from the original IIIb "due to clerical error" they said !
he is deciding against CLND surgery.
keep us posted please and thanks again
-
- November 7, 2016 at 4:06 pm
Thank you Laulamb. happy to hear things are proressing well for you. 3mg IPI is where my husband is also leaning towards. his staging was juat chaged back to IIIa from the original IIIb "due to clerical error" they said !
he is deciding against CLND surgery.
keep us posted please and thanks again
-
- October 30, 2016 at 8:07 pm
I was diagnosed Stage IIIa and I found a doctor to prescribe ipi at 3mg … I had 4 infusions with only a little intestinal disturbance and a rash on my legs. I will go through the maintenance phase of 1 ipi 3mg infusion every three months for a year. You can look over my profile for more details.
Good luck!
-
- October 30, 2016 at 8:07 pm
I was diagnosed Stage IIIa and I found a doctor to prescribe ipi at 3mg … I had 4 infusions with only a little intestinal disturbance and a rash on my legs. I will go through the maintenance phase of 1 ipi 3mg infusion every three months for a year. You can look over my profile for more details.
Good luck!
-
- November 7, 2016 at 4:07 pm
thank you Ann. we are going to try to get IPI 3mg and see how it goes.
thank you again
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- November 7, 2016 at 4:07 pm
thank you Ann. we are going to try to get IPI 3mg and see how it goes.
thank you again
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- November 7, 2016 at 4:07 pm
thank you Ann. we are going to try to get IPI 3mg and see how it goes.
thank you again
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- October 30, 2016 at 10:25 pm
Hi there Anon, if you take a look at the link that I will give you of Dr.Jason Luke talking about stage 3 decision making, around the 23min mark he gets into explaining the history of why Ipi is at 10mg/kg based on the EORTC 18071 study if I remember correctly. Then at around the 45 min mark he gets into Pd-1 drugs like Nivo and Pembr and the trials that are going on at present. Best Wishe!!!Ed https://www.youtube.com/watch?v=eofW8d4J6sI
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- October 30, 2016 at 10:31 pm
This article goes along with the Ipi information in the above post. http://www.nejm.org/doi/full/10.1056/NEJMoa1611299#t=article
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- October 30, 2016 at 10:31 pm
This article goes along with the Ipi information in the above post. http://www.nejm.org/doi/full/10.1056/NEJMoa1611299#t=article
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- October 30, 2016 at 10:31 pm
This article goes along with the Ipi information in the above post. http://www.nejm.org/doi/full/10.1056/NEJMoa1611299#t=article
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- November 7, 2016 at 4:03 pm
Hello Ed. thank you so much for the very valuble info. I wateched the presentation. our staging was changed to IIIb from IIIa. i am not sure how usual this is but the pathologist had said he made a "clerical error". my husband is now really struggling with the CLND surgery decision as it is even less justifiable. he is leaning towards IPI 3mg. for IIIa, i haven't found any other trials for less toxic agents.
thanks you again
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- November 8, 2016 at 10:22 pm
Hi Anon, I don't know if you will qualify for a Pd-1 trial but I would try to get into the Pd-1 vs Ipi trial if it is still taking new patients. I think it is called 238 trial and Dr. Weber in New York city is part of the team. Best Wishes!!!Ed
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- November 8, 2016 at 10:22 pm
Hi Anon, I don't know if you will qualify for a Pd-1 trial but I would try to get into the Pd-1 vs Ipi trial if it is still taking new patients. I think it is called 238 trial and Dr. Weber in New York city is part of the team. Best Wishes!!!Ed
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- November 8, 2016 at 10:22 pm
Hi Anon, I don't know if you will qualify for a Pd-1 trial but I would try to get into the Pd-1 vs Ipi trial if it is still taking new patients. I think it is called 238 trial and Dr. Weber in New York city is part of the team. Best Wishes!!!Ed
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- November 7, 2016 at 4:03 pm
Hello Ed. thank you so much for the very valuble info. I wateched the presentation. our staging was changed to IIIb from IIIa. i am not sure how usual this is but the pathologist had said he made a "clerical error". my husband is now really struggling with the CLND surgery decision as it is even less justifiable. he is leaning towards IPI 3mg. for IIIa, i haven't found any other trials for less toxic agents.
thanks you again
-
- November 7, 2016 at 4:03 pm
Hello Ed. thank you so much for the very valuble info. I wateched the presentation. our staging was changed to IIIb from IIIa. i am not sure how usual this is but the pathologist had said he made a "clerical error". my husband is now really struggling with the CLND surgery decision as it is even less justifiable. he is leaning towards IPI 3mg. for IIIa, i haven't found any other trials for less toxic agents.
thanks you again
-
- October 30, 2016 at 10:25 pm
Hi there Anon, if you take a look at the link that I will give you of Dr.Jason Luke talking about stage 3 decision making, around the 23min mark he gets into explaining the history of why Ipi is at 10mg/kg based on the EORTC 18071 study if I remember correctly. Then at around the 45 min mark he gets into Pd-1 drugs like Nivo and Pembr and the trials that are going on at present. Best Wishe!!!Ed https://www.youtube.com/watch?v=eofW8d4J6sI
-
- October 30, 2016 at 10:25 pm
Hi there Anon, if you take a look at the link that I will give you of Dr.Jason Luke talking about stage 3 decision making, around the 23min mark he gets into explaining the history of why Ipi is at 10mg/kg based on the EORTC 18071 study if I remember correctly. Then at around the 45 min mark he gets into Pd-1 drugs like Nivo and Pembr and the trials that are going on at present. Best Wishe!!!Ed https://www.youtube.com/watch?v=eofW8d4J6sI
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- October 31, 2016 at 5:02 pm
Hi again,
The thing you are faced with is no walk in the park because underlying the adjuvant therapy is CLND! And with such a low burden node tumour… And everything associated with it… One thing I forgot to mention in the other post is when i asked my onco surgeon about "rare isolated cells" he said it is rare and he really thought I would have had like a real infested lymph node if not two or three. Well, it seems he only found 1 out of 3 with such low burden. And he also said that there was maybe a 10% chance to find additional positivity in my remaining groin lymph nodes…
You are faced with the very same dilemma I'm afraid…
What did the 2 oncos said about the tumour burden? Anything besides : its positive! Was there any analysis of this particular situation?
Also, was the parhologist able to say if there was a cluster of cells or not? Frankly, this is the very worry I wrestle with at the moment and I am completely lost myself. My girlfriend while being supportive everywhere in my life, is totally against anything medical so, if you are willing to exchange your chain of thought, I would be very grateful to you both.
As for adjuvant, If I were convince and wanted to do something, I could maybe consider the low dose of ipi. But knowing that, at the moment, the nivo+ipi combo in naive treatment patients has a response rate of 60-70% (that is for stage 4 patients only), I am on the fence also on this one. Here in Canada, I am only offered interferon or the two clinical trials (that require CLND!) I think you are offered as well with pembro-interferon or vaccine-placebo (I may have mixed up the combinations)
Again lets keep in touch more closely through email
-
- October 31, 2016 at 5:02 pm
Hi again,
The thing you are faced with is no walk in the park because underlying the adjuvant therapy is CLND! And with such a low burden node tumour… And everything associated with it… One thing I forgot to mention in the other post is when i asked my onco surgeon about "rare isolated cells" he said it is rare and he really thought I would have had like a real infested lymph node if not two or three. Well, it seems he only found 1 out of 3 with such low burden. And he also said that there was maybe a 10% chance to find additional positivity in my remaining groin lymph nodes…
You are faced with the very same dilemma I'm afraid…
What did the 2 oncos said about the tumour burden? Anything besides : its positive! Was there any analysis of this particular situation?
Also, was the parhologist able to say if there was a cluster of cells or not? Frankly, this is the very worry I wrestle with at the moment and I am completely lost myself. My girlfriend while being supportive everywhere in my life, is totally against anything medical so, if you are willing to exchange your chain of thought, I would be very grateful to you both.
As for adjuvant, If I were convince and wanted to do something, I could maybe consider the low dose of ipi. But knowing that, at the moment, the nivo+ipi combo in naive treatment patients has a response rate of 60-70% (that is for stage 4 patients only), I am on the fence also on this one. Here in Canada, I am only offered interferon or the two clinical trials (that require CLND!) I think you are offered as well with pembro-interferon or vaccine-placebo (I may have mixed up the combinations)
Again lets keep in touch more closely through email
-
- October 31, 2016 at 11:34 pm
Hi there Sole, I thought you might like to read this new information from Bristol Myer Squibb!!!http://www.newswire.ca/news-releases/first-ever-combination-of-two-immuno-oncology-agents-for-metastatic-melanoma-approved-by-health-canada-599349481.html
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- November 1, 2016 at 4:33 am
Hi Ed,
My «current» oncologist told me about it last week as this was happening.
Here is a bit I dont understand
Relative to OPDIVO® monotherapy, an increase in progression-free survival for the combination of OPDIVO® with YERVOY® is established only in patients with low tumour PD-L1 expression (based on the predefined expression level of < 5 per cent).1
I was researching on Vit C tonight. There something there definetely.
Check this out: http://www.tedhowardnz.wordpress.com/cancer-treatment
I will post it separately.
-
- November 1, 2016 at 4:33 am
Hi Ed,
My «current» oncologist told me about it last week as this was happening.
Here is a bit I dont understand
Relative to OPDIVO® monotherapy, an increase in progression-free survival for the combination of OPDIVO® with YERVOY® is established only in patients with low tumour PD-L1 expression (based on the predefined expression level of < 5 per cent).1
I was researching on Vit C tonight. There something there definetely.
Check this out: http://www.tedhowardnz.wordpress.com/cancer-treatment
I will post it separately.
-
- November 1, 2016 at 4:33 am
Hi Ed,
My «current» oncologist told me about it last week as this was happening.
Here is a bit I dont understand
Relative to OPDIVO® monotherapy, an increase in progression-free survival for the combination of OPDIVO® with YERVOY® is established only in patients with low tumour PD-L1 expression (based on the predefined expression level of < 5 per cent).1
I was researching on Vit C tonight. There something there definetely.
Check this out: http://www.tedhowardnz.wordpress.com/cancer-treatment
I will post it separately.
-
- October 31, 2016 at 11:34 pm
Hi there Sole, I thought you might like to read this new information from Bristol Myer Squibb!!!http://www.newswire.ca/news-releases/first-ever-combination-of-two-immuno-oncology-agents-for-metastatic-melanoma-approved-by-health-canada-599349481.html
-
- October 31, 2016 at 11:34 pm
Hi there Sole, I thought you might like to read this new information from Bristol Myer Squibb!!!http://www.newswire.ca/news-releases/first-ever-combination-of-two-immuno-oncology-agents-for-metastatic-melanoma-approved-by-health-canada-599349481.html
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- November 7, 2016 at 3:58 pm
hi Sole, thank you for your quick response. i haven't been back on the site as we were thrown for a loop. our pathology reading was "updated" and our staging was changed to IIIa. So now my husband is really questioning the value of CLND. with IIIa, not all CLNDs will qaulify us for the trial as it needs a minimum number of positive nodes which we may not get even after CLND.
my husband is leaning towards IPI and as everyone says that is not a walk in the park either.
We have repeatedly asked for staining to identify response rates but have been told those are inconclusive and will not have an impact on the type of therapy chosen.
Thank you for offering email conatct. I am new to the site so I will look at your profile to see if there is an email listed for you that my husband and i can respond to.
what have you decided.,
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- November 7, 2016 at 3:58 pm
hi Sole, thank you for your quick response. i haven't been back on the site as we were thrown for a loop. our pathology reading was "updated" and our staging was changed to IIIa. So now my husband is really questioning the value of CLND. with IIIa, not all CLNDs will qaulify us for the trial as it needs a minimum number of positive nodes which we may not get even after CLND.
my husband is leaning towards IPI and as everyone says that is not a walk in the park either.
We have repeatedly asked for staining to identify response rates but have been told those are inconclusive and will not have an impact on the type of therapy chosen.
Thank you for offering email conatct. I am new to the site so I will look at your profile to see if there is an email listed for you that my husband and i can respond to.
what have you decided.,
-
- November 7, 2016 at 3:58 pm
hi Sole, thank you for your quick response. i haven't been back on the site as we were thrown for a loop. our pathology reading was "updated" and our staging was changed to IIIa. So now my husband is really questioning the value of CLND. with IIIa, not all CLNDs will qaulify us for the trial as it needs a minimum number of positive nodes which we may not get even after CLND.
my husband is leaning towards IPI and as everyone says that is not a walk in the park either.
We have repeatedly asked for staining to identify response rates but have been told those are inconclusive and will not have an impact on the type of therapy chosen.
Thank you for offering email conatct. I am new to the site so I will look at your profile to see if there is an email listed for you that my husband and i can respond to.
what have you decided.,
-
- October 31, 2016 at 5:02 pm
Hi again,
The thing you are faced with is no walk in the park because underlying the adjuvant therapy is CLND! And with such a low burden node tumour… And everything associated with it… One thing I forgot to mention in the other post is when i asked my onco surgeon about "rare isolated cells" he said it is rare and he really thought I would have had like a real infested lymph node if not two or three. Well, it seems he only found 1 out of 3 with such low burden. And he also said that there was maybe a 10% chance to find additional positivity in my remaining groin lymph nodes…
You are faced with the very same dilemma I'm afraid…
What did the 2 oncos said about the tumour burden? Anything besides : its positive! Was there any analysis of this particular situation?
Also, was the parhologist able to say if there was a cluster of cells or not? Frankly, this is the very worry I wrestle with at the moment and I am completely lost myself. My girlfriend while being supportive everywhere in my life, is totally against anything medical so, if you are willing to exchange your chain of thought, I would be very grateful to you both.
As for adjuvant, If I were convince and wanted to do something, I could maybe consider the low dose of ipi. But knowing that, at the moment, the nivo+ipi combo in naive treatment patients has a response rate of 60-70% (that is for stage 4 patients only), I am on the fence also on this one. Here in Canada, I am only offered interferon or the two clinical trials (that require CLND!) I think you are offered as well with pembro-interferon or vaccine-placebo (I may have mixed up the combinations)
Again lets keep in touch more closely through email
-
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