Clinical trial for adjuvant immunotherapy?

Portal Forums Cancer Basics Clinical Trials and Drug Development Clinical trial for adjuvant immunotherapy?

This topic contains 6 replies, has 2 voices, and was last updated by  onthemark 1 year, 7 months ago.

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April 19, 2016 at 11:51 am  #1273682    

onthemark

I have an opportunity to participate in a double blind placebo controlled clinical trial of an anti-PD L1 antibody MEDI4736 as an adjuvant treatment following complete resection (with or without adjuvant chemo) of early stage lung cancer. I am leaning against this for the following reasons but am wondering if these concerns are valid. Certainly I discuss this all with my oncologist soon but maybe this also helps other people decide what to do in their case.

Reasons not to do adjuvant immunotherapy trial

1. No evidence it cures lung cancer but rather controls it for awhile in best cases.
2. Side effects
3. Rebound of cancer growth once trial is over and medication is stopped
4. Acquired resistance to future PD and/or PD L1 immunotherapies if not others
5.Potential exclusion in future clinical trials as a result of having taken this medicine potentially.
6. Only 2/3 chance to actually get the medication

Reasons to do immunotherapy trial

1. Small chance this could put off my disease for long enough until a robust cure is found.
2. Better follow up and surveillance than I can expect to receive otherwise in Canada.

I am wondering if these are reasonable concerns and if I have missed anything.

April 20, 2016 at 8:13 am  #1273693    
catdander forum moderator
catdander forum moderator

Hi otm,

It sounds as though you’ve put a good bit of thought into your options. I have a couple of thoughts about what you’ve written.

While there isn’t evidence the treatment would be curative the trial is being conducted to build evidence one way or the other.

There’s no reason to believe there would be any kind of rebound effect. The “rebound effect” that is talked about in cancer care happens in a small percentage of people when the tki drug tarceva is stopped and the cancer grows rapidly just after. It’s not a problem seen anywhere else in lung cancer care.

You stated that you’d get better care in Canada being on a trial. The truth of the matter is you get better care anywhere including U.S., Congo or Canada. It’s the nature of the research.

The following links are to a series on clinical trials with audio and slides. There is bound to be some info in it that sparks thoughts you’ve not had.

http://cancergrace.org/cancer-101/2013/01/06/clin-trials-ramalingam-pt-1/

http://cancergrace.org/cancer-101/2013/01/18/how-are-clin-trials-developed/

http://cancergrace.org/cancer-101/2013/01/27/ramalingam-clin-trials-pt-3/

Please do keep us posted on your journey. I hope it’s all good news and few bumps in the road.
Janine

April 20, 2016 at 10:29 am  #1273698    

onthemark

Hi Janine,

Thank you very much for your thoughtful reply. I am looking forward to watching those videos and I agree with what you wrote about getting better medical care elsewhere as well. There are some differences between private medical care in the US and what the standard is in some places in Canada. For instance my surgeon did not order a brain scan before surgery. I am not eligible for any genetic tests because I don’t have advanced disease, and my surgeon said my first ct scan for follow up would be after one year (!!!) because there was no reason to do it earlier. Having said that I think he is highly skilled in the operating room. Participating in the clinical trial will offer me ct scans every 3 months and detailed medical exam every month.

I have read that PD, PD L1 expression can change once the immune system/cancer microenviroment is exposed to anti PD or anti PD L1 antibodies like MEDI4736, so my concern is that taking one immunotherapy now could close off a number of medications aimed at this binding pair in the future due to evolution to less expression in the cells in my body.

My oncologist said he thought this was unlikely and in any case with cancer it is best the use the best medication available when it is still early stage and potentially curable and not worry about how this might impact me in the future.

He did agree that taking this medication now, or at least possibly getting it in a double blind placebo controlled trial, could close off participating in some clinical trials in the future.

Thank you for clearing up my rebound concern.

I wanted to add a third reason to do it which is
3. contribution to medical research

April 20, 2016 at 3:12 pm  #1273706    
catdander forum moderator
catdander forum moderator

Oh my yes, the contribution to research is so valuable to everyone and on behalf of everyone I think I can say a big THANK YOU to everyone who participates.

I wonder if there are any similar trials near you that are testing a targeting a genetic mutation. You would get genetic testing for at least the genes being studied, you would have access to the tissue so you’d not likely need another sample, at least for a little while for other tests. A mostly up to date listing is kept on clinicaltrials.gov

April 21, 2016 at 9:24 am  #1273714    

onthemark

Hi Janine,

It’s great that the US government provides information about clinical trials around the world. I searched for all open clinical trials in my province in Canada for lung cancer and this is the only one that I am eligible for because I don’t have advanced disease. I am unfortunately not up to the task of getting in an airplane and flying to a remote location, staying overnight etc for regular treatments, which is what would be necessary to go out of province…

I could pay to have samples of my tumour sent off to a lab for genetic analysis. The reason I haven’t done so is that none of the targetted therapies would be available to me now in Canada as adjuvant treatment and also if I were to develop a recurrence, then a new sample would need to be tested because the mutation characteristics could be quite different then.

My understanding also is that all the targetted therapies in the end inevitable incur resistance whereas durable responses with no apparent resistance have been observed in some cases with immunotherapy. My main concern is that any resistance that is developed could be transferable, not just for one drug but for any drug aimed at a specific interaction like e.g. PD1- PD L1 binding. i am not sure if this is a valid concern though.

April 21, 2016 at 11:18 pm  #1273726    
catdander forum moderator
catdander forum moderator

Unfortunately no one can answer that question about valid concern.

Targeted therapies aren’t available for anyone without advanced disease. Being in Canada or not. Like immunotherapy, genetic mutation targeted treatments have only been proven beneficial in advanced disease. Assuming they would add benefit as adjuvant treatment is dangerous outside a trial setting.

All the best
Janine

April 22, 2016 at 7:16 am  #1273730    

onthemark

Hi Janine,

That’s also my understanding about targetted therapy in an adjuvant setting. Incidentally my comments about ‘in Canada’ are not meant to imply anything about what is available elsewhere — just about what’s available in Canada…

I still haven’t been able to nail down the likelihood of cross resistance developing as a result of taking one antagonist PD-L1 antibody… what’s the likelihood of developing resistance to other agents operating on the same binding pair: PD; PD-L1. I mean is this even a theoretical possibility?

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