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Keytruda Off Label

KeepCalmAnd's picture
KeepCalmAnd
Posts: 8
Joined: Nov 2014

I just started a monotherapy of Keytruda (Off Label) 1 week ago this past Thursday.  I saw on another post that Nano happened to start Keytruda on the same day (although it appears not to a monotherapy).  Does anyone else have any experience with Keytruda?  

NanoSecond's picture
NanoSecond
Posts: 653
Joined: Oct 2012

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's picture
todd121
Posts: 1422
Joined: Dec 2012

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

NanoSecond's picture
NanoSecond
Posts: 653
Joined: Oct 2012

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.

vinnyc
Posts: 19
Joined: Jun 2011

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.

NanoSecond's picture
NanoSecond
Posts: 653
Joined: Oct 2012

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
Posts: 19
Joined: Jun 2011

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

 

 

NanoSecond's picture
NanoSecond
Posts: 653
Joined: Oct 2012

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.

 

vinnyc
Posts: 19
Joined: Jun 2011

Got it. Thanks

vinnyc
Posts: 19
Joined: Jun 2011

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's picture
NanoSecond
Posts: 653
Joined: Oct 2012

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.

vinnyc
Posts: 19
Joined: Jun 2011

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.

NanoSecond's picture
NanoSecond
Posts: 653
Joined: Oct 2012

There is correlation with PDL1 expression in many cases but it is not always.  That is why oncologists are reluctant to use this as a biomarker.

I have chromophobe - a rare cancer to begin with.  Rarer still is whenever chromophobe metastases.  Therefore there will never be a Phase III trial for metastatic chromophobe patients.  My insurance company agreed with this and waived that provision.

Srashedb
Posts: 482
Joined: Dec 2013

Vinny, who do you see at UCSF? My husband is being treated there.

Sarah

vinnyc
Posts: 19
Joined: Jun 2011

Started Dr. Minor CPMC, now Dr.Fong.

Srashedb
Posts: 482
Joined: Dec 2013

is Dr. Fong at UCSF or PMC?

 

vinnyc
Posts: 19
Joined: Jun 2011

 ucsfmedctr 

dr sneed for radiation 

 

KeepCalmAnd's picture
KeepCalmAnd
Posts: 8
Joined: Nov 2014

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

NanoSecond's picture
NanoSecond
Posts: 653
Joined: Oct 2012

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

sledhead
Posts: 11
Joined: Dec 2014

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

vinnyc
Posts: 19
Joined: Jun 2011

read the dec 3 reply conversation, it's there

angec's picture
angec
Posts: 923
Joined: Mar 2012

Hi Neil.. Very interesting that the doc took you off and started you on the Pd-1.  I am very hopeful that you will do well with that.  Do you still have many mets now that the Affinitor has helped you?  I thought you already was on the Yervo trial? I can be mistaken and right now my brain cannot think of even the correct spelling of that. The one they say they can add to double the pd-1 if needed.  Interesting that you had fevers again. I don't recall anyone having fevers with it.  Do you? Did Fox?  But I am very glad you are on it.  Looking forward to your updates.  Also, a very nice donation you gave for JoeyWings.  I hope and pray that the vision is realized, soon!  Hugs!

NanoSecond's picture
NanoSecond
Posts: 653
Joined: Oct 2012

Hi Angec.  I am not in a clinical trial but I am following the exact protocol of one.  That is, I take both Keytruda and Avastin.  In fact yesterday I got my second infusion of Keytruda.

Because it can take up to 3 months before Keytruda does it thing (of the responders: 1/3 respond after 6 weeks; 1/3 respond after 10 weeks; 1/3 respond after 12 weeks) my oncologist did not want to wait until my health started to decline.  Remember, I have been off of Afinitor for over 3 weeks now so I am in a bit of limbo.  At first I started to have fevers and night sweats (typical of tumor cytokine storms) but that ended after the first few days.  The major issue for me right now is extreme fatigue after Keytruda infusions. I also have some fluid at the base of my right lung - likely due to irritation from some enlarged lymph nodes in that area.

It is my sense that Keytruda (or Avastin) is doing something good or else I would be in really bad shape. Still, my lymph and liver mets are very slowly progressing.  This is in contrast to when I was in a clinical trial for an anti-PDL1 back in April/May.  At that time my mets were exploding and extremely aggressive and by the end of June I was just weeks away from liver failure.

Regardless, my next CT-scan will be in 3 weeks (just before my 3rd infusion) and that will tell the tale.

One of my prized possessions is a personal note/picture from Joey.  He wrote to thank me for providing him with a quick delivery of some Cabo while they were waiting on the pharmacy to fill his prescription.  It is horrible when we lose anyone - but far worse when it is a youngster like Joey or Cody.  Some days it really takes it out of you.

vinnyc
Posts: 19
Joined: Jun 2011

 

hey nanosecond

I did not realize you were in a clinical trial for PD-1. It's not clear if you're out of the trial because of progression or liver problems.I'm trying to learn about the PD-1 drug sequencing. I know you had success with Afinitor on the three-month CT scan. I know there were issues with some of your labs. The decision was made to go back on PD-1. I can speculate on the reasons why that would happen. What is the exact reasoning on going back on the PD-1 drug? It also would seem that it would make it difficult to determine which drug is actually working. Vinny

NanoSecond's picture
NanoSecond
Posts: 653
Joined: Oct 2012

Hi Vinny. I have not "gone back" on a previous "anti-PD1" drug.  I am now taking a completely different version drug made by a different company.

I entered a clinical trial for an anti-PDL1 drug manufactured by EMD Serono.  The trial was supervised by the NIH in Bethesda.  That was back in April.  This drug proved to be a total bust - not just for me but for virtually everyone in the trial.  In fact I believe this drug will not be brought to market - it's finished.  During the trial my liver and lymph node mets "exploded" and became extremely aggressive.  So much so that no one had ever seen such a response before.  In fact the head of the trial was troubled by the thought that the drug had actually accelerated my progression.  In any case, I left that trial in early June and switched to Cabo.  But it failed within 2 weeks.  After that I switched to Afinitor.

My oncologist felt that my experience on this flawed anti-PDL1 drug was in no way indicative of how I might respond to a "legitimate" anti-PD1 or anti-PDL1 antigen.  That is why I am now trying Keytruda.  And my response, so far, has been favorable in that my liver and lymph node mets are not "exploding".  They may still be slowly progressing - that will be determined in 3 weeks at my next CT-scan.  Even so, that would not be cause for concern (yet) since it could take up to 3 months before Keytruda does its thing (if it works).

Bohjo
Posts: 1
Joined: Apr 2016

Can you give me some info how to look for off label treatments 

 

icemantoo's picture
icemantoo
Posts: 3198
Joined: Jan 2010

Unfortunately NanoSecond (Neil Feldman) is no longer with us. If he was he would have answered your question as he had for so many in the past. He is missed.

 

 

 

Icemantoo

Mr Ape
Posts: 1
Joined: Apr 2018

Hello my wife is undergoing her first Chemo treatment today for her stage 2 breast cancer .  The Tumor is very close to the Chest wall so they want to shrink it down before removing it .  we where hoping for keytruda but not chosen for the drug by computer . So just Chemo Taxol to start .

I read about Keyturda off-label ? what is that ? nurse told me it may be for compassionate use ? but to ask Doctor

anyone know what Keytruda Off-Label means ?

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