Sunday, November 18, 2018

Awesome news regarding how and when to stop immunotherapy in melanoma patients.


A frequent and super important, zillion dollar question for melanoma patients on immunotherapy, with a complete or partial response, is:  How long do I continue treatment?????   Here is a post from earlier this year that examined that very thing:  ASCO 2018 - Outcomes for melanoma peeps after stopping anti-PD-1

For many years, most melanoma patients have been advised to continue immunotherapy (no matter if it is nivo [Opdivo], pembro [Keytruda], or ipi/nivo combo) until "progression".  That, thank goodness, can be for YEARS!!!  And while these meds are a real blessing for so many melanoma patients, they do not come side effect free!!  Toward the end of my nivo trial, which was for 2 1/2 years of treatment - PERIOD!  No matter what we ratties or Dr. Weber preferred because that was what BMS (Bristol-Myers Squibb, the pharmaceutical company that produces nivo) decreed, and certainly in the years after, Dr. Weber consistently mentioned that he felt that "we" had taken the drug longer than was needed.  Here's a post from 2012 when we learned that BMS was sticking to 2 1/2 years only...no matter what....despite hints that they were going to offer it to those who wanted to continue:  BMS anti-PD1 trial - 24months done...6 to go! An update on my cohort

Now, there is this from the Wizard at the end of October (Thanks, Eric!!!!!):
Onclive: Dr. Weber on Discontinuing Immunotherapy in Melanoma

Check out the video for yourself...but, in it...Weber notes:

"In the original trials [for immunotherapy] - often patients were treated until progression - [causing some 15-20% of melanoma patients to stay on in remission] 3, 4, 5, 6, years.  In terms of the toxicity, the convenience, the economics, that's just not practical."  [Then] a number of trials were done [where patients were treated for a finite period, around 2 years where] you were arbitrarily done with PD-1 inhibition, you stopped, you went off, and were followed."

So the question becomes:  'How long should you treat?'  'Could you treat for a year and then stop?'  'Should you treat based on the results of scanning and then stop?'  

I reviewed the available data [largely retrospective from melanoma patients, particularly the Keynote 006 study - a randomized study with 3 arms looking at pembro vs ipi].  When patients achieved a complete response or a partial response and went off treatment, and there were over 100 patients in that category and of course patients who were stable, which was a small minority.  Those patients would stop at 2 years on schedule and then they were followed.  Those patients did extremely well.  The rate of remaining in remission was something like 90%.  So the progression free survival after stopping upon achieving a stability, partial, or complete response, in melanoma was outstanding.

Meaning, you could probably reassure your patients that at year 2 - good to stop, you'll be followed, the likelihood of relapse is low, and even if you do relapse the rate of re-remission would be at least 50%.  Now how long those second remissions would last we don't know.  But the bottom line is you're safe to stop at 2 years."

Is that not awesome????

Interested in the Keynote 006 study?  I got you....here's a TON of reports:  Pembro vs ipi - Keynote 006 study, multiple reports

Thanks, ratties!!  It is amazing to look back on my melanoma journey from 2003, with zero valid treatment options, to my nivo trial in 2010, to today.  We are not where we need to be for far too many.  But, damn!  We've come a long way baby!!!  Lot's to be thankful for right there!!!  My best advice to melanoma peeps????  If you can - take your immunotherapy, get off your immunotherapy, live your life...and don't get any other STUPID cancers!! - much love, c

LATE ADDENDUM:
Because of more questions on this topic by my melanoma peeps...there is also this:

Weber on stopping immunotherapy based on scans

Here Weber speaks further on the topic of stopping immunotherapy based on scan results - saying:

"[...for melanoma patients on immunotherapy at one year] who then had a PET/CT scan or PET/CT scan and biopsy - those who were metabolically or histologically negative and stopped at one year - even if they didn't have a complete response by CT scanning - did very well and had a 90% plus chance of remaining in remission.  So, what that does for me is, in melanoma - I would feel comfortable treating for no less than one year, no more than two years, and at one year, if a patient has had a stable response or has been stable over at least 2 scans - I would be very comfortable telling them to get a PET/CT scan and if there's complete metabolic regression on the PET, no matter what you see anatomically on the CT - I would say you can safely stop.  I might say - Oh, we'll go one more cycle and then stop.  And in those patients, I think they can be safely observed, knowing their likelihood of relapse is really low."

Again, while this whole ta dah is of limited usefulness to melanoma patients who do not gain a complete response, partial response, or lasting stable disease on immunotherapy - for those who do - this is at least a beginning of a road map showing how to proceed.  Hope this helps. - c

3 comments:

  1. We've got a tremendous amount to be thankful for, Les!And there IS more to come! A perfect post as we approach Thanksgiving! Blessings!

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  2. Blessings to you and yours as well. Thankful indeed!!!

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