Immunotherapy (Nivolumab + Ipilimumab) trial vs Chemo - factors to consider? - 1274630

Fri, 07/08/2016 - 14:03

blueberry21

Posts:7

My mother was diagnosed with stage IV NSCLC adenocarcinoma in June 2016. 62yo, otherwise healthy, never smoked. Testing for mutations was negative. She is likely eligible to participate in a phase II study of Nivolumab + Ipilimumab as first-line therapy in stage IV NSCLC. https://clinicaltrials.gov/ct2/show/NCT02659059?term=nivolumab+%2B+ipilimumab+%2B+NSCLC&rank=5

She has also been given the option of chemo - Carboplatin + Pemetrexed (Alimta).

My question is, what should we consider when deciding whether to enroll her in the trial? This world is so new to us. I have reviewed some interim results I found from phase I of the Nivolumab + Ipilimumab NSCLC trial, but I don't know what my takeaway thoughts should be.

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Reply # - July 8, 2016, 07:59 PM

Hi blueberry,

JimC

Posts: 2753

Hi blueberry,

These are two reasonable options. I think one of the most important considerations hinges on the question of how symptomatic your mother is. If symptoms are significant, that may push the decision in favor of an established chemo regimen such as Carbo/Alimta, which tends to be well-tolerated and proves effective for a significant percentage of patients. Immunotherapy, on the other hand, can be extremely effective for a smaller percentage of patients, and often the effect of the treatment takes longer to manifest itself.

Another consideration in the question of chemo vs. a trial is whether choosing chemo first will disqualify a patient from the trial later. Although the trial you mention does not list previous treatment as an exclusion factor, it is listed as a first-line therapy trial. One shouldn't over-emphasize the importance of this factor, though, since there are many trials of immunotherapy agents and even if this particular combination might not be available, something similar should be.

JimC
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Reply # - July 8, 2016, 09:10 PM

Hi blueberry.

scohn

Posts: 237

Hi blueberry.

I am so sorry to hear about your mother's diagnosis. My wife (60 yo, never smoker) was also diagnosed with Stage IV NSCLC last year. We are currently in a clinical trial (of another type of drug) but in the process of thinking about clinical trials we ended up coming up with a lot of questions, so here are another couple of thoughts for you:

1) I am not sure what interim results they have talked to you about, but you may want to ask about results of the trial combination for smokers vs. non-smokers. From what our oncologists has told us (and some things I have read subsequently) it appears that the immunotherapies in general tend to work better for smoking related NSCLCs than for non-smokers (Opdivo did not work for my wife, but it does indeed work for some non-smokers). You may want to see if there are any interim results for the combo that show the same thing.

2) As JimC said, you may also want to talk to your oncologists about the extent of your mother's NSCLC, and also talk with the trial coordinator in terms of how long they would want your mother to be on the trial drug combo. Generally you can go off the trial any time you want if it's not working, but you want to make sure it would be long enough to know whether or not the combo was effective. And as he said, you could go from the trial to standard cargo/alimta, but you need to find out if doing one treatment negates the possibility of the other.

3) I also found Dr. West's discussion on molecular markers and immunotherapy (http://cancergrace.org/lung/2015/10/10/value-of-pdl1-testing) and some other comments I found through searching Cancer Grace on deciding on the timing of clinical trials versus conventional chemotherapy very useful.

The important part is asking all the questions you have with your oncologist so that you can feel as comfortable as possible in making the decision. I wish you al the best, and may your mother find effective treatment in whatever path you take.

Reply # - July 9, 2016, 10:40 AM