Keytruda Off Label

While it is true that I still take Avastin along with Keytruda (which I started on a little less than 2 weeks ago).  However, the Avastin is to prevent fluid build-up - it is not clear, what, if any, synergism there might be with Keytruda - although I am aware there is a clinical trial that combines them in the same manner I am.

If I do not respond to Keytruda alone then my oncologist plans to add Ipilumumab (Yervoy - an anti-CTLA4) to the mix.  This will almost double the chances that I will show a response - but it likewise will more than double the risk of a severe auto-immune response (not good).

todd121 said:

Good Luck!

Neil,

Best of luck to you on this drug. I'm pulling for you. Glad that you've been pretty stable on Afinitor.

Did you experience any side effects on Afinitor? How did you feel? How long have you been taking it now?

Todd

Many thanks Todd. I had been more than stable on Afinitor.  I was considered an "exceptional responder" because after 8 weeks all of my tumors has shrunk - some by as much as 50%.  Only 3% of patients get that kind of response.

The only side effect I had on Afinitor was annoying Acne - mostly on my scalp and chest.  I felt great on the drug and have regretted having to stop it.  I started it on June 28th and stopped taking it on November 9th - 4 days before I got my first infusion of Keytruda.

KeepCalmAnd said:

Side Effects

Nano - how have your side effects been on Keytruda?  Anything noticeable? 

So far only high fatigue for about 5 days following the infusion.  Some low grade fevers that came and went as well.

vinnyc said:

Affinitor

My massive neck lymph node started to shrink after a week on Affinitor. 3 month scan all lesions shrunk. It wasn't clear why you had to stop affinitor after just over 4 months.

Even though my CT-scan on October 30th looked good on paper - with no progression and no new mets - my oncologist was concerned about 4 blood test results.  Three of them concerned my liver enzymes.  They were slowly rising.  The fourth parameter, my LDH (Lactate Dehydrogenase) level was also increasing.  This was a bad sign because my LDH has perfectly tracked the progression and regression of my mets.  The bottom line is that my oncologist felt that these results meant that Afinitor was failing or about to fail.  He did not want to wait to find out which because Keytruda can take up to 3 months before it "works".  So we immediately took steps to get it, figuring we would have to fight with my insurance company to get coverage.  However, there was no fight.  They approved coverage in less than one week.

I have now been off of Afinitor for over 3 weeks.  My next Keytruda infusion will be this Thursday.  Of course we will also be looking closely at those 4 blood tests.  Last week, 2 of the 3 liver enzymes had reversed and were heading back to normal.  Of more significance, my LDH level had also reversed and was heading back down again.  I am hoping this trend will be shown to be continuing on Thursday.  We'll see.

vinnyc said:

Off label

Hi NanoSecond   I may be in a similar situation, but I'll ride affinitor for as long as I can, as long as my scans are ok. I'm in San Francisco @ UCSF.

My Dr. thinks a dramatic response can equal a long response. I guess you could go back to Affinitor in the future, if needed.

Liver enzymes could be from Affinitor and dying cancer cells could raise LDH.

I was dying and had a few weeks left, I started Affinitor and after a week I could feel my massive neck masses starting to shrink,

3 month scan showed multiple liver, lung, abdominal and the mediastinal masses squeezing my heart all shrunk.

My next scan will be in January 2015. We are almost synced.

Ofcourse I have to think about the next option.

I'm so worried about using retirement money my wife will need later, just to buy PD-1 for me , with no guarantee.

You have renal cell and your insurance approved. You're so lucky. I have Healthnet/Senority Plus, a Medicare plan.

What is your health plan? Are there any special pre-authorization codes or techniques?

I know my doctor is already treating renal cell patients out-of-pocket with PD-1. I guess the patients did not even attempt to get it

authorized or it was denied.  Good luck, I hope you have good results with your PD1 infusion. Vinny

 

 

Hi Vinny.  Yes, you are correct, the elevated liver enzymes could have been due to Afinitor and the LDH could have been due to reasons other than Afinitor failing.  The point was we did not want to wait to find out if that was the case.  And yes, I can still go back to Afinitor at a later date as it did not "officially" fail me.

Like you I was only weeks away from death when I started on Afinitor. And it worked almost immediately for me as well.  However, my LDH soon started to drop as well.  That is why when it starting going back up (while still on Afinitor) my oncologist got very concerned.

My insurance is CareFirst/BlueCross/BlueShield in Maryland.  There are no special pre-authorization or techniques that I am aware of. They have been terrific.  They also never disputed covering the cost of Cabozantinib off-label.

I was fully prepared to pay for Keytruda personally if necessary.  And then fight for as long as necessary to get coverage.  But that turned out to be not necessary in my case.

Hang in there.  Nivolumab is now due to be FDA approved no later than March 2015.

NanoSecond said:

Off-label

Hi Vinny.  Yes, you are correct, the elevated liver enzymes could have been due to Afinitor and the LDH could have been due to reasons other than Afinitor failing.  The point was we did not want to wait to find out if that was the case.  And yes, I can still go back to Afinitor at a later date as it did not "officially" fail me.

Like you I was only weeks away from death when I started on Afinitor. And it worked almost immediately for me as well.  However, my LDH soon started to drop as well.  That is why when it starting going back up (while still on Afinitor) my oncologist got very concerned.

My insurance is CareFirst/BlueCross/BlueShield in Maryland.  There are no special pre-authorization or techniques that I am aware of. They have been terrific.  They also never disputed covering the cost of Cabozantinib off-label.

I was fully prepared to pay for Keytruda personally if necessary.  And then fight for as long as necessary to get coverage.  But that turned out to be not necessary in my case.

Hang in there.  Nivolumab is now due to be FDA approved no later than March 2015.

 

Forgot to ask, did your Dr. check your PDL1 expression? 

Also a quick check online shows March 2015 date for Nivolumab FDA review for 

melanoma, I did not see anything specific for Renal Cell Carcinoma. Where is the

online link?

Thanks Vinny

NanoSecond said:

Side effects

So far only high fatigue for about 5 days following the infusion.  Some low grade fevers that came and went as well.

How can one apply/obtain Keytruda off label for RCC? 

sledhead said:

off-label process

How can one apply/obtain Keytruda off label for RCC? 

read the dec 3 reply conversation, it's there

NanoSecond said:

Questions

1.  No, my doctor did not check for PDL1 expression.  It would be rather pointless.  You see some patients who do not express PDL1 have had significant responses while other patients with PDL1 expression have had none.  In other words, it is not a reliable marker.

2. Nivolumab, like Keytruda, will first attempt to get approval for Melanoma, not renal cancer.  You will still have to apply to get Nivolumab off-label for mRCC.  Eventually they may or may not try to do the same for renal cancers.

3.  There is no online link.  I got this information from several different doctors up at Johns Hopkins.  They conducted many of the initial clinical trials of Nivolumab.

There is a statistical correlation in the trials, I just thought the insurance would want 

to see that before authorizing,  since this not a trial and your getting it before FDA

approval for Renal Cell. But this is not the case.

Srashedb said:

UCSF?

is Dr. Fong at UCSF or PMC?

 

 ucsfmedctr 

dr sneed for radiation