4th treatment on ipi and a question

Hi Val,

Thanks for posting – sorry to hear about your mishap, but at least you wiped out in front of the hospital!  Hope the bumps and bruises don't slow you down much, and hope that you feel better soon.

I know first hand about waiting for scans, and want to offer you some positive feedback on your comments.  If your visible tumors have stopped growing or are shrinking, then the chances are good that your have developed an immune response from Ipi.  As you may know, it is not unusual for recipients to show an inflammatory response to Ipi initially (tumors appear to grow), although it is imposssible to distinguish between inflammation and progression.  In my case, the one visible tumor increase slightly in size until the 3rd treatment, and showed slight reduction after the 4th treatment, which was a hopeful sign for me before doing scans 3 weeks after my 4th infusion. My scans showed no progression with slight decrease in size of numerous very small lung tumors.

The point here is that both your scans in 2 weeks and the ones in 12 weeks are important.  Like one of my Docs said, mel is like a speeding freight train – first you want to slow it down, then stop it, and finally reverse it.  Ipi can actually reverse the disease, but stopping it isn't a bad thing either!  The criteria for not showing progression in my trial is showing no increase in measurable aggregate tumor size of 25%, which allows for some lingering inflammation to be accomodated in determining efficacy. 

Regarding a 3 month interval between rounds, I am now on that schedule myself, with scans every 8 weeks.  I receive Temador every 4 weeks as well.  The 12 week interval is apparently common for the "maintenence" phase, the first 4 cycles being the "induction" phase.  There is not enough data to conclude whether continued maintenence of Ipi improves either the response rate or response durablilty, although clearly that is being researched.  Some of the earliest trials had 4 cycles with no maintenence, while some more recent trials do include maintenence.  I guess the idea behind maintenence is pretty simple – if its working, keep doing it!

There are other points to be made about Ipi, some of which appear below in the "Ipilimumab Success…." post.  One is that it can take time for an immune response to develop, but it is good when it develops sooner.  Some recipients actually show disease progression after 4 rounds, but a significant proportion of them (20-25%) later show a develpoed immune response.  It is important to realize that the immmune response develops at different rates in different patients, and when a response develops it should persist for a fairly long time, even without additional infusions.  Another point is that if a person has developed a response to Ipi and then later shows some progression (new tumors or growth in existing ones), then they should also respond positively to"reinduction", or another 4 courses of Ipi – if it worked once, it will probably also work again.

Hope my comments are helpful and best wishes to you on your upcoming scans.

Best,

Jim

Click on this link for a presentation this week by one of the developers of Ipilimumab, Dr. Jedd Wolchock from Memorial Sloan Kettering in NYC (it runs about 45 minutes):

Hi Val,

Thanks for posting – sorry to hear about your mishap, but at least you wiped out in front of the hospital!  Hope the bumps and bruises don't slow you down much, and hope that you feel better soon.

I know first hand about waiting for scans, and want to offer you some positive feedback on your comments.  If your visible tumors have stopped growing or are shrinking, then the chances are good that your have developed an immune response from Ipi.  As you may know, it is not unusual for recipients to show an inflammatory response to Ipi initially (tumors appear to grow), although it is imposssible to distinguish between inflammation and progression.  In my case, the one visible tumor increase slightly in size until the 3rd treatment, and showed slight reduction after the 4th treatment, which was a hopeful sign for me before doing scans 3 weeks after my 4th infusion. My scans showed no progression with slight decrease in size of numerous very small lung tumors.

The point here is that both your scans in 2 weeks and the ones in 12 weeks are important.  Like one of my Docs said, mel is like a speeding freight train – first you want to slow it down, then stop it, and finally reverse it.  Ipi can actually reverse the disease, but stopping it isn't a bad thing either!  The criteria for not showing progression in my trial is showing no increase in measurable aggregate tumor size of 25%, which allows for some lingering inflammation to be accomodated in determining efficacy. 

Regarding a 3 month interval between rounds, I am now on that schedule myself, with scans every 8 weeks.  I receive Temador every 4 weeks as well.  The 12 week interval is apparently common for the "maintenence" phase, the first 4 cycles being the "induction" phase.  There is not enough data to conclude whether continued maintenence of Ipi improves either the response rate or response durablilty, although clearly that is being researched.  Some of the earliest trials had 4 cycles with no maintenence, while some more recent trials do include maintenence.  I guess the idea behind maintenence is pretty simple – if its working, keep doing it!

There are other points to be made about Ipi, some of which appear below in the "Ipilimumab Success…." post.  One is that it can take time for an immune response to develop, but it is good when it develops sooner.  Some recipients actually show disease progression after 4 rounds, but a significant proportion of them (20-25%) later show a develpoed immune response.  It is important to realize that the immmune response develops at different rates in different patients, and when a response develops it should persist for a fairly long time, even without additional infusions.  Another point is that if a person has developed a response to Ipi and then later shows some progression (new tumors or growth in existing ones), then they should also respond positively to"reinduction", or another 4 courses of Ipi – if it worked once, it will probably also work again.

Hope my comments are helpful and best wishes to you on your upcoming scans.

Best,

Jim

Click on this link for a presentation this week by one of the developers of Ipilimumab, Dr. Jedd Wolchock from Memorial Sloan Kettering in NYC (it runs about 45 minutes):

Val,

Ouch!!  I hope you aren't bruised tomorrow!

Sounds like your having a response! Can't wait to hear good news after your scans!   Did the Doctor say why he thought your platelet counts were down?

Linda

Val,

Ouch!!  I hope you aren't bruised tomorrow!

Sounds like your having a response! Can't wait to hear good news after your scans!   Did the Doctor say why he thought your platelet counts were down?

Linda

Oh Val, you poor thing! Tripping up like that! The construction at the front entrance has been going on for months and months! When do they expect to have it finished? It is a real obstacle for the patients, especially those who have limited mobility! Anyway, I hope you didn't get too bruised up.

I don't think there is necessarily a 3-mo wait after the first 12 weeks. My understanding is that once the resuts of the 12 week scan are in, then they would decide if you'd go right back on it again. That's the re-induction phase, and Dr. M has to recommend it and BMS has to approve it. If you're not responding, or if you have NED, then you go into the Maintenance Phase, which is wait 12 weeks and scan again.

I'll be back in Mtl next Wed night, staying at Opus again (where else?), but we're not leaving until Sat morning — to go to Las Vegas for 4 days, then to Florida for a week, then back to Mtl on Dec 7th, scan on the 8th, and then fly home that night. Are you still doing Bridge on Thursdays? If so, drop up and see me, If not, I'll call. Jim will be with me this time.

Hope to see you next week!

Hugs

Sharyn

Oh Val, you poor thing! Tripping up like that! The construction at the front entrance has been going on for months and months! When do they expect to have it finished? It is a real obstacle for the patients, especially those who have limited mobility! Anyway, I hope you didn't get too bruised up.

I don't think there is necessarily a 3-mo wait after the first 12 weeks. My understanding is that once the resuts of the 12 week scan are in, then they would decide if you'd go right back on it again. That's the re-induction phase, and Dr. M has to recommend it and BMS has to approve it. If you're not responding, or if you have NED, then you go into the Maintenance Phase, which is wait 12 weeks and scan again.

I'll be back in Mtl next Wed night, staying at Opus again (where else?), but we're not leaving until Sat morning — to go to Las Vegas for 4 days, then to Florida for a week, then back to Mtl on Dec 7th, scan on the 8th, and then fly home that night. Are you still doing Bridge on Thursdays? If so, drop up and see me, If not, I'll call. Jim will be with me this time.

Hope to see you next week!

Hugs

Sharyn