› Forums › General Melanoma Community › Yervoy 3mg side effects
- This topic has 45 replies, 9 voices, and was last updated 9 years, 2 months ago by jogo.
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- November 18, 2015 at 1:02 am
I could be wrong but the last I read stage 3 ipi is 10mg per kg of body weight.
For my stage 4 ipi at 3mg per kg the side affects were super mild. After 2nd dose very mild rash, mild stomach churning, mild fever. Maybe a few other mild things. I did all 4 doses but it didn't work.
But side affects vary per person. Some people have had a severe reaction.
Artie
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- November 18, 2015 at 12:07 pm
I believe when I had the ipi/nivo combo in May and June of this year ipi was 10mg per kilo. This is for mucosal m. in the sinus. I could only do two infusions before my side effects (thyroiditis, a. immune hepatitis & and other issues) put me in hospital, stopped the infusions and took me off the trial. Impossible to know for sure which drug caused most side effects, but the ipi is always more suspect, I believe. However, clearly one of the two or the combo kept the tumor from growing for a montth or a little more, but it began again while I was off so long recovering from the s. effects. Now on Pembro since Sept (10 mg p. kilo, a drug very similar to Nivolumab) and very mild s. effects so far. Too eary for scans, though. Clearly one of the struggles of the researchers is learning why some patients react so mildly to ipi while others (like me) have severe reactions – part of the reason we all participate in these trials!
Chris
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- November 18, 2015 at 12:07 pm
I believe when I had the ipi/nivo combo in May and June of this year ipi was 10mg per kilo. This is for mucosal m. in the sinus. I could only do two infusions before my side effects (thyroiditis, a. immune hepatitis & and other issues) put me in hospital, stopped the infusions and took me off the trial. Impossible to know for sure which drug caused most side effects, but the ipi is always more suspect, I believe. However, clearly one of the two or the combo kept the tumor from growing for a montth or a little more, but it began again while I was off so long recovering from the s. effects. Now on Pembro since Sept (10 mg p. kilo, a drug very similar to Nivolumab) and very mild s. effects so far. Too eary for scans, though. Clearly one of the struggles of the researchers is learning why some patients react so mildly to ipi while others (like me) have severe reactions – part of the reason we all participate in these trials!
Chris
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- November 18, 2015 at 12:07 pm
I believe when I had the ipi/nivo combo in May and June of this year ipi was 10mg per kilo. This is for mucosal m. in the sinus. I could only do two infusions before my side effects (thyroiditis, a. immune hepatitis & and other issues) put me in hospital, stopped the infusions and took me off the trial. Impossible to know for sure which drug caused most side effects, but the ipi is always more suspect, I believe. However, clearly one of the two or the combo kept the tumor from growing for a montth or a little more, but it began again while I was off so long recovering from the s. effects. Now on Pembro since Sept (10 mg p. kilo, a drug very similar to Nivolumab) and very mild s. effects so far. Too eary for scans, though. Clearly one of the struggles of the researchers is learning why some patients react so mildly to ipi while others (like me) have severe reactions – part of the reason we all participate in these trials!
Chris
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- November 18, 2015 at 1:02 am
I could be wrong but the last I read stage 3 ipi is 10mg per kg of body weight.
For my stage 4 ipi at 3mg per kg the side affects were super mild. After 2nd dose very mild rash, mild stomach churning, mild fever. Maybe a few other mild things. I did all 4 doses but it didn't work.
But side affects vary per person. Some people have had a severe reaction.
Artie
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- November 18, 2015 at 1:02 am
I could be wrong but the last I read stage 3 ipi is 10mg per kg of body weight.
For my stage 4 ipi at 3mg per kg the side affects were super mild. After 2nd dose very mild rash, mild stomach churning, mild fever. Maybe a few other mild things. I did all 4 doses but it didn't work.
But side affects vary per person. Some people have had a severe reaction.
Artie
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- November 18, 2015 at 1:10 am
I posted a response to the TAKKAT thread below yours. You will get a fuller picture if you begin with the post I linked there. However, this link: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/ipi-vs-nivo-trial-as-adjuvant-for-stage.html
….probably has the crux of the info you are looking for. The jist of which is this: From 2008 – 2011 NED Stage III patients were treated: 475 were given ipi at 10mg/kg and 476 were given placebo. Median recurrence free survival was 26.1 months for the patients given ipi, 17.1 months for the patients given placebo. A total of 5 patients died due to grade 3/4 side effects.
IMPORTANT POINTS TO REMEMBER!!!!! This dosage was 10mg/kg. NOT what is being offered currently. These wonderful ratties taught us that 10mg/kg did not improve response more than a 3mg/kg dose but DID cause much greater side effects. Additionally, we (and docs and researchers) have learned a TON about what side effects may occur with ipi, how to recognize them rapidly, and how to treat them effectively. Folks do not suffer nearly as much from ipi side effects now as they did in the beginning. Thanks again to some amazing ratties for this knowledge. Here is just one example of that sort of progress: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/03/melanoma-patients-teach-us-more-about.html
I wish you luck in whatever treatment path you choose. Celeste
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- November 18, 2015 at 3:44 am
Are you sure you made the correct statement? FDA approval for adjuvant IPI dosage is 10mg/kg, not 3mg/kg. It is NOT being offered at the 3mg/kg dosage for stage III. If you read back to Tim's recent post about new therapies, it explains this and a method of obtaining the drug for free given the pricing structure that would be required for 10mg/kg dosage..
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- November 18, 2015 at 3:44 am
Are you sure you made the correct statement? FDA approval for adjuvant IPI dosage is 10mg/kg, not 3mg/kg. It is NOT being offered at the 3mg/kg dosage for stage III. If you read back to Tim's recent post about new therapies, it explains this and a method of obtaining the drug for free given the pricing structure that would be required for 10mg/kg dosage..
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- November 18, 2015 at 11:32 am
Actually, you are correct as far as the most recent FDA approval regarding ipi as adjuvant is concerned. Additionally, Artie already made the point that 3mg/kg has been the routine dose used else-wise. As both doses are FDA approved, doctors are allowed discretion in what they utilize, though what payors will cover certainly affects use as well. Were it me, I would be asking to try the 3mg/kg dose….but whether that could happen for an NED patient is unclear. Additionally….I was responding the poster's question which was specifically regarding the 3mg/kg dose. Celeste
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- November 18, 2015 at 11:32 am
Actually, you are correct as far as the most recent FDA approval regarding ipi as adjuvant is concerned. Additionally, Artie already made the point that 3mg/kg has been the routine dose used else-wise. As both doses are FDA approved, doctors are allowed discretion in what they utilize, though what payors will cover certainly affects use as well. Were it me, I would be asking to try the 3mg/kg dose….but whether that could happen for an NED patient is unclear. Additionally….I was responding the poster's question which was specifically regarding the 3mg/kg dose. Celeste
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- November 18, 2015 at 10:01 pm
I asked my Melanomo onocologist this exact question last week…and he indicated that he could dose 3mg/kg…and in fact had just did it that day.
Michel
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- November 18, 2015 at 10:01 pm
I asked my Melanomo onocologist this exact question last week…and he indicated that he could dose 3mg/kg…and in fact had just did it that day.
Michel
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- November 18, 2015 at 10:01 pm
I asked my Melanomo onocologist this exact question last week…and he indicated that he could dose 3mg/kg…and in fact had just did it that day.
Michel
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- November 18, 2015 at 11:32 am
Actually, you are correct as far as the most recent FDA approval regarding ipi as adjuvant is concerned. Additionally, Artie already made the point that 3mg/kg has been the routine dose used else-wise. As both doses are FDA approved, doctors are allowed discretion in what they utilize, though what payors will cover certainly affects use as well. Were it me, I would be asking to try the 3mg/kg dose….but whether that could happen for an NED patient is unclear. Additionally….I was responding the poster's question which was specifically regarding the 3mg/kg dose. Celeste
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- November 18, 2015 at 3:44 am
Are you sure you made the correct statement? FDA approval for adjuvant IPI dosage is 10mg/kg, not 3mg/kg. It is NOT being offered at the 3mg/kg dosage for stage III. If you read back to Tim's recent post about new therapies, it explains this and a method of obtaining the drug for free given the pricing structure that would be required for 10mg/kg dosage..
-
- November 18, 2015 at 1:10 am
I posted a response to the TAKKAT thread below yours. You will get a fuller picture if you begin with the post I linked there. However, this link: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/ipi-vs-nivo-trial-as-adjuvant-for-stage.html
….probably has the crux of the info you are looking for. The jist of which is this: From 2008 – 2011 NED Stage III patients were treated: 475 were given ipi at 10mg/kg and 476 were given placebo. Median recurrence free survival was 26.1 months for the patients given ipi, 17.1 months for the patients given placebo. A total of 5 patients died due to grade 3/4 side effects.
IMPORTANT POINTS TO REMEMBER!!!!! This dosage was 10mg/kg. NOT what is being offered currently. These wonderful ratties taught us that 10mg/kg did not improve response more than a 3mg/kg dose but DID cause much greater side effects. Additionally, we (and docs and researchers) have learned a TON about what side effects may occur with ipi, how to recognize them rapidly, and how to treat them effectively. Folks do not suffer nearly as much from ipi side effects now as they did in the beginning. Thanks again to some amazing ratties for this knowledge. Here is just one example of that sort of progress: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/03/melanoma-patients-teach-us-more-about.html
I wish you luck in whatever treatment path you choose. Celeste
-
- November 18, 2015 at 1:10 am
I posted a response to the TAKKAT thread below yours. You will get a fuller picture if you begin with the post I linked there. However, this link: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/04/ipi-vs-nivo-trial-as-adjuvant-for-stage.html
….probably has the crux of the info you are looking for. The jist of which is this: From 2008 – 2011 NED Stage III patients were treated: 475 were given ipi at 10mg/kg and 476 were given placebo. Median recurrence free survival was 26.1 months for the patients given ipi, 17.1 months for the patients given placebo. A total of 5 patients died due to grade 3/4 side effects.
IMPORTANT POINTS TO REMEMBER!!!!! This dosage was 10mg/kg. NOT what is being offered currently. These wonderful ratties taught us that 10mg/kg did not improve response more than a 3mg/kg dose but DID cause much greater side effects. Additionally, we (and docs and researchers) have learned a TON about what side effects may occur with ipi, how to recognize them rapidly, and how to treat them effectively. Folks do not suffer nearly as much from ipi side effects now as they did in the beginning. Thanks again to some amazing ratties for this knowledge. Here is just one example of that sort of progress: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2014/03/melanoma-patients-teach-us-more-about.html
I wish you luck in whatever treatment path you choose. Celeste
-
- November 18, 2015 at 1:40 pm
HI
My husband is a participant in the Ipi vs Interferon Adjuvant trial. In this trial there are two Ipi doses (3mg/kg and 10mg/kg)–ECOG 1609. My husband (Stage IIIC-T4bN2cM0) is in the 3mg/kg arm. He began the trial in the early Summer of 2013. He had to stop infusions after 4 doses due to Grade 3/4 side effects. This trial includes 4 maintenance doses every 3 months following the initial 4 induction infusions (every 3 weeks). My husband had lots of side effects which were Grade 1 or 2 (itching, rashes, ocular, minor diarrhea etc). He developed hypophysitis following his 4th infusion. It's a long and complicated story but he is now steroid dependent but stable. He worked throughout the treatments (except when he was hospitalized for an adrenal crisis)
Something to note from the trial Celeste posted: 52% of patients in that trial had to stop the infusions due to side effects. Celeste has great info on her blog.
Our trial doctor and coordinator are saying they are seeing higher rates of side effects in the adjuvant population. No patient at my husband's site has been able to finish all the doses (trial criteria is very strict on when the infusions must be stopped). There have been 8 deaths in the ECOG 1609 trial (all in the 10 mg/kg arm). The 10mg arm was suspended for a period of time due to these deaths but it was re-opened following review of the data (the assumption being the data was positive enough to re-open) There have been a higher incidence (according to the routine updates my husband must sign) of endocrinopathies -and other side effects in both the 3mg/kg and 10mg/kg arms of the trial.
I'm not trying to discourage you in the least. My husband is so very thankful he had the opportunity to participate in this trial—though glad he was in the 3mg/kg arm given his side effects. Just know that in the adjuvant setting the ratties that have gone before have shown a higher incidence of all side effects (especially endocrinopathies) vs in the metastatic setting.
My husband remains NED 29 months after his first infusion of Ipi
Best,
Kate
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- November 18, 2015 at 2:40 pm
Thank you Kate! I definately value your information as well. I am hoping to hear stories of all good and bad. It such a touch decistion to make. I am 32 with two small girls so on one hand I want to do everything I can to make sure this disease doesn't come back but at the same time – is it worth the side effects to take certain drugs knowing it might possibly not come back.
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- November 18, 2015 at 2:40 pm
Thank you Kate! I definately value your information as well. I am hoping to hear stories of all good and bad. It such a touch decistion to make. I am 32 with two small girls so on one hand I want to do everything I can to make sure this disease doesn't come back but at the same time – is it worth the side effects to take certain drugs knowing it might possibly not come back.
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- November 18, 2015 at 3:34 pm
My husband was a Stage IIIb at his initial diagnosis in Jan 2008 and after several surgeries advanced to Stage IV with a unresectable tumor pressing on the spine at C1-2 area, liver mets, lung mets and 4 or 5 sub q's in Oct. 2010. He began the IPI 10mg/kg in Mar. 2011. He had the original 4 doses every 3 weeks for 12 weeks and then went into the maintenance phase of once every 12 weeks. He was also given GMCSF daily self injections 14 days on 7 days off for the full time. We literally watched the sub q's disappear as we took pictures every 3 weeks just before his IPI infusions.
He had some side effects but mostly minor and easy to handle. He remained on the IPI and GMCSF until Dec. 2013 when he went off and is just followed by his onc. He has been 3 years NED. If you would like to read more about him you can read his profile.
Judy (loving wife to Gene Stage IV and now NED for over 3 years.)
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- November 18, 2015 at 3:34 pm
My husband was a Stage IIIb at his initial diagnosis in Jan 2008 and after several surgeries advanced to Stage IV with a unresectable tumor pressing on the spine at C1-2 area, liver mets, lung mets and 4 or 5 sub q's in Oct. 2010. He began the IPI 10mg/kg in Mar. 2011. He had the original 4 doses every 3 weeks for 12 weeks and then went into the maintenance phase of once every 12 weeks. He was also given GMCSF daily self injections 14 days on 7 days off for the full time. We literally watched the sub q's disappear as we took pictures every 3 weeks just before his IPI infusions.
He had some side effects but mostly minor and easy to handle. He remained on the IPI and GMCSF until Dec. 2013 when he went off and is just followed by his onc. He has been 3 years NED. If you would like to read more about him you can read his profile.
Judy (loving wife to Gene Stage IV and now NED for over 3 years.)
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- November 18, 2015 at 3:34 pm
My husband was a Stage IIIb at his initial diagnosis in Jan 2008 and after several surgeries advanced to Stage IV with a unresectable tumor pressing on the spine at C1-2 area, liver mets, lung mets and 4 or 5 sub q's in Oct. 2010. He began the IPI 10mg/kg in Mar. 2011. He had the original 4 doses every 3 weeks for 12 weeks and then went into the maintenance phase of once every 12 weeks. He was also given GMCSF daily self injections 14 days on 7 days off for the full time. We literally watched the sub q's disappear as we took pictures every 3 weeks just before his IPI infusions.
He had some side effects but mostly minor and easy to handle. He remained on the IPI and GMCSF until Dec. 2013 when he went off and is just followed by his onc. He has been 3 years NED. If you would like to read more about him you can read his profile.
Judy (loving wife to Gene Stage IV and now NED for over 3 years.)
-
- November 18, 2015 at 2:40 pm
Thank you Kate! I definately value your information as well. I am hoping to hear stories of all good and bad. It such a touch decistion to make. I am 32 with two small girls so on one hand I want to do everything I can to make sure this disease doesn't come back but at the same time – is it worth the side effects to take certain drugs knowing it might possibly not come back.
-
- November 21, 2015 at 5:55 am
I am in the same clinical trial, ECOG 1609. I was also randomized into arm C, 3 mg ipi/Kg. My infusions were stopped after the second infusion due to 3/4 adverse events: severe colitis which involved administrating 9 units of blood, adrenal insufficinecy due to the high doses of steriods that were administered, and orthostatic hypotention that had me totally confined to my bed for two weeks. I was hospitalized for 24 days in the intermediate critical care unit of the hospital. I had two infusions of infleximab to deal with the colitis. I was on fludrocortosone and prednisone for several months after my discharge from the hospital. My endocronologist was very diligent about getting me off the steriods and the corticiods. It took almost a year to do that. My synthroid was increased from 0.050 mg [before the trial] to 0.075 mg.
As part of trial ECOG 1609, I now go for blood work and CT Scans and see the oncologist every 6 months; Once a year, I see the endocronologist, gastroenterologist, oncodermatologist, and the [ENT] head and neck surgeon who performed a total left parotidectomy and radical dissection of the lymph glands on the left side of my neck. I see my [regular] dermatologist every forth;and eighth month (the oncodermatologist every 12th month).
I am very glad that I am participant in the Ipi vs Interferon Adjuvant trial and that I was randomized into arm C 3 mg ipi/ kg. I have been NED 28 months since my last infusion.
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- November 21, 2015 at 5:55 am
I am in the same clinical trial, ECOG 1609. I was also randomized into arm C, 3 mg ipi/Kg. My infusions were stopped after the second infusion due to 3/4 adverse events: severe colitis which involved administrating 9 units of blood, adrenal insufficinecy due to the high doses of steriods that were administered, and orthostatic hypotention that had me totally confined to my bed for two weeks. I was hospitalized for 24 days in the intermediate critical care unit of the hospital. I had two infusions of infleximab to deal with the colitis. I was on fludrocortosone and prednisone for several months after my discharge from the hospital. My endocronologist was very diligent about getting me off the steriods and the corticiods. It took almost a year to do that. My synthroid was increased from 0.050 mg [before the trial] to 0.075 mg.
As part of trial ECOG 1609, I now go for blood work and CT Scans and see the oncologist every 6 months; Once a year, I see the endocronologist, gastroenterologist, oncodermatologist, and the [ENT] head and neck surgeon who performed a total left parotidectomy and radical dissection of the lymph glands on the left side of my neck. I see my [regular] dermatologist every forth;and eighth month (the oncodermatologist every 12th month).
I am very glad that I am participant in the Ipi vs Interferon Adjuvant trial and that I was randomized into arm C 3 mg ipi/ kg. I have been NED 28 months since my last infusion.
-
- November 21, 2015 at 5:55 am
I am in the same clinical trial, ECOG 1609. I was also randomized into arm C, 3 mg ipi/Kg. My infusions were stopped after the second infusion due to 3/4 adverse events: severe colitis which involved administrating 9 units of blood, adrenal insufficinecy due to the high doses of steriods that were administered, and orthostatic hypotention that had me totally confined to my bed for two weeks. I was hospitalized for 24 days in the intermediate critical care unit of the hospital. I had two infusions of infleximab to deal with the colitis. I was on fludrocortosone and prednisone for several months after my discharge from the hospital. My endocronologist was very diligent about getting me off the steriods and the corticiods. It took almost a year to do that. My synthroid was increased from 0.050 mg [before the trial] to 0.075 mg.
As part of trial ECOG 1609, I now go for blood work and CT Scans and see the oncologist every 6 months; Once a year, I see the endocronologist, gastroenterologist, oncodermatologist, and the [ENT] head and neck surgeon who performed a total left parotidectomy and radical dissection of the lymph glands on the left side of my neck. I see my [regular] dermatologist every forth;and eighth month (the oncodermatologist every 12th month).
I am very glad that I am participant in the Ipi vs Interferon Adjuvant trial and that I was randomized into arm C 3 mg ipi/ kg. I have been NED 28 months since my last infusion.
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- November 21, 2015 at 5:56 am
I am in the same clinical trial, ECOG 1609. I was also randomized into arm C, 3 mg ipi/Kg. My infusions were stopped after the second infusion due to 3/4 adverse events: severe colitis which involved administrating 9 units of blood, adrenal insufficinecy due to the high doses of steriods that were administered, and orthostatic hypotention that had me totally confined to my bed for two weeks. I was hospitalized for 24 days in the intermediate critical care unit of the hospital. I had two infusions of infleximab to deal with the colitis. I was on fludrocortosone and prednisone for several months after my discharge from the hospital. My endocronologist was very diligent about getting me off the steriods and the corticiods. It took almost a year to do that. My synthroid was increased from 0.050 mg [before the trial] to 0.075 mg.
As part of trial ECOG 1609, I now go for blood work and CT Scans and see the oncologist every 6 months; Once a year, I see the endocronologist, gastroenterologist, oncodermatologist, and the [ENT] head and neck surgeon who performed a total left parotidectomy and radical dissection of the lymph glands on the left side of my neck. I see my [regular] dermatologist every forth;and eighth month (the oncodermatologist every 12th month).
I am very glad that I am participant in the Ipi vs Interferon Adjuvant trial and that I was randomized into arm C 3 mg ipi/ kg. I have been NED 28 months since my last infusion.
-
- November 21, 2015 at 5:56 am
I am in the same clinical trial, ECOG 1609. I was also randomized into arm C, 3 mg ipi/Kg. My infusions were stopped after the second infusion due to 3/4 adverse events: severe colitis which involved administrating 9 units of blood, adrenal insufficinecy due to the high doses of steriods that were administered, and orthostatic hypotention that had me totally confined to my bed for two weeks. I was hospitalized for 24 days in the intermediate critical care unit of the hospital. I had two infusions of infleximab to deal with the colitis. I was on fludrocortosone and prednisone for several months after my discharge from the hospital. My endocronologist was very diligent about getting me off the steriods and the corticiods. It took almost a year to do that. My synthroid was increased from 0.050 mg [before the trial] to 0.075 mg.
As part of trial ECOG 1609, I now go for blood work and CT Scans and see the oncologist every 6 months; Once a year, I see the endocronologist, gastroenterologist, oncodermatologist, and the [ENT] head and neck surgeon who performed a total left parotidectomy and radical dissection of the lymph glands on the left side of my neck. I see my [regular] dermatologist every forth;and eighth month (the oncodermatologist every 12th month).
I am very glad that I am participant in the Ipi vs Interferon Adjuvant trial and that I was randomized into arm C 3 mg ipi/ kg. I have been NED 28 months since my last infusion.
-
- November 21, 2015 at 5:56 am
I am in the same clinical trial, ECOG 1609. I was also randomized into arm C, 3 mg ipi/Kg. My infusions were stopped after the second infusion due to 3/4 adverse events: severe colitis which involved administrating 9 units of blood, adrenal insufficinecy due to the high doses of steriods that were administered, and orthostatic hypotention that had me totally confined to my bed for two weeks. I was hospitalized for 24 days in the intermediate critical care unit of the hospital. I had two infusions of infleximab to deal with the colitis. I was on fludrocortosone and prednisone for several months after my discharge from the hospital. My endocronologist was very diligent about getting me off the steriods and the corticiods. It took almost a year to do that. My synthroid was increased from 0.050 mg [before the trial] to 0.075 mg.
As part of trial ECOG 1609, I now go for blood work and CT Scans and see the oncologist every 6 months; Once a year, I see the endocronologist, gastroenterologist, oncodermatologist, and the [ENT] head and neck surgeon who performed a total left parotidectomy and radical dissection of the lymph glands on the left side of my neck. I see my [regular] dermatologist every forth;and eighth month (the oncodermatologist every 12th month).
I am very glad that I am participant in the Ipi vs Interferon Adjuvant trial and that I was randomized into arm C 3 mg ipi/ kg. I have been NED 28 months since my last infusion.
-
- November 18, 2015 at 1:40 pm
HI
My husband is a participant in the Ipi vs Interferon Adjuvant trial. In this trial there are two Ipi doses (3mg/kg and 10mg/kg)–ECOG 1609. My husband (Stage IIIC-T4bN2cM0) is in the 3mg/kg arm. He began the trial in the early Summer of 2013. He had to stop infusions after 4 doses due to Grade 3/4 side effects. This trial includes 4 maintenance doses every 3 months following the initial 4 induction infusions (every 3 weeks). My husband had lots of side effects which were Grade 1 or 2 (itching, rashes, ocular, minor diarrhea etc). He developed hypophysitis following his 4th infusion. It's a long and complicated story but he is now steroid dependent but stable. He worked throughout the treatments (except when he was hospitalized for an adrenal crisis)
Something to note from the trial Celeste posted: 52% of patients in that trial had to stop the infusions due to side effects. Celeste has great info on her blog.
Our trial doctor and coordinator are saying they are seeing higher rates of side effects in the adjuvant population. No patient at my husband's site has been able to finish all the doses (trial criteria is very strict on when the infusions must be stopped). There have been 8 deaths in the ECOG 1609 trial (all in the 10 mg/kg arm). The 10mg arm was suspended for a period of time due to these deaths but it was re-opened following review of the data (the assumption being the data was positive enough to re-open) There have been a higher incidence (according to the routine updates my husband must sign) of endocrinopathies -and other side effects in both the 3mg/kg and 10mg/kg arms of the trial.
I'm not trying to discourage you in the least. My husband is so very thankful he had the opportunity to participate in this trial—though glad he was in the 3mg/kg arm given his side effects. Just know that in the adjuvant setting the ratties that have gone before have shown a higher incidence of all side effects (especially endocrinopathies) vs in the metastatic setting.
My husband remains NED 29 months after his first infusion of Ipi
Best,
Kate
-
- November 18, 2015 at 1:40 pm
HI
My husband is a participant in the Ipi vs Interferon Adjuvant trial. In this trial there are two Ipi doses (3mg/kg and 10mg/kg)–ECOG 1609. My husband (Stage IIIC-T4bN2cM0) is in the 3mg/kg arm. He began the trial in the early Summer of 2013. He had to stop infusions after 4 doses due to Grade 3/4 side effects. This trial includes 4 maintenance doses every 3 months following the initial 4 induction infusions (every 3 weeks). My husband had lots of side effects which were Grade 1 or 2 (itching, rashes, ocular, minor diarrhea etc). He developed hypophysitis following his 4th infusion. It's a long and complicated story but he is now steroid dependent but stable. He worked throughout the treatments (except when he was hospitalized for an adrenal crisis)
Something to note from the trial Celeste posted: 52% of patients in that trial had to stop the infusions due to side effects. Celeste has great info on her blog.
Our trial doctor and coordinator are saying they are seeing higher rates of side effects in the adjuvant population. No patient at my husband's site has been able to finish all the doses (trial criteria is very strict on when the infusions must be stopped). There have been 8 deaths in the ECOG 1609 trial (all in the 10 mg/kg arm). The 10mg arm was suspended for a period of time due to these deaths but it was re-opened following review of the data (the assumption being the data was positive enough to re-open) There have been a higher incidence (according to the routine updates my husband must sign) of endocrinopathies -and other side effects in both the 3mg/kg and 10mg/kg arms of the trial.
I'm not trying to discourage you in the least. My husband is so very thankful he had the opportunity to participate in this trial—though glad he was in the 3mg/kg arm given his side effects. Just know that in the adjuvant setting the ratties that have gone before have shown a higher incidence of all side effects (especially endocrinopathies) vs in the metastatic setting.
My husband remains NED 29 months after his first infusion of Ipi
Best,
Kate
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