Hi, I'm trying to find the forum which discusses my drug.
I'm a stage 2a resected nsclc undergoing the final several months of a year-long stage 3 clinical trial for MEDI 4736. I've had no apparent confirmed side effects except a couple of curious and possibly un-related things. That's somewhat unsettling because...
I'm in a double blind study and that's part of my problem...am I getting or not? I had surgical removal of my superior right lobe in March 2015 and feel pretty healthy, active, still working, am 68 years. I want my full term of life expectancy! My daughter hasn't had grandkids yet and I'd like to make it that far. Plus..Life is good. I'm fortunate. I want more :-)
When I studied MEDI 4736 upon my surgeon's suggestion, it seemed a no-brainer. The lead doctor here in Canada referred to the drug twice in a public radio interview in Fall 2014 as a cure. Doctors don't often use that word in the same breath with the cancer word. Compared to standard chemo, how could I Not do this?
So, here I am, started in May 2015, will finish in May 2016 and like participant Mike said, I'm a boring patient. One good thing is I get to travel and meet people... (I must travel back and forth from my home in Labrador to St. John's every - now - four weeks for infusion) I'm extremely happy to hear of (other) Mike's success with this drug and I'd like to see where he is in it all now as I could only follow his posts up to July 2014. Sure hope he's doing fine?
I would love the opportunity to follow and correspond with other recipients of MEDI 4736 and share my experience. I am the only guinea pig in my province taking this drug.
Presently I'm on a double dose 20? mg / Kg at 4 week cycles.
Sincerely
Mike K
Reply # - January 18, 2016, 01:06 PM
I don't think there is any
I don't think there is any indirect way to know whether you are receiving the study drug, unless you request to be unblinded. Now it is true that patients on various PD1 inhibitors will often have mildly elevated amylase levels, for reasons we don't quite understand. So if your levels were elevated, that might be indirectly informative. Hope this helps. More importantly, the adjuvant trial you are participating in, could be a landmark change in the way we treat lung cancer, so I am grateful to you for volunteering for this. kudos!
Reply # - January 18, 2016, 01:32 PM
Hi Doc:
Hi Doc:
I won't drop out just to find out, I will complete the regime because I believe in this drug and it's potential to affect many lives. I guess I'm just thinking beyond as I get near the end. If I'm getting the placebo, I could go on to progress. If I am getting the drug, it could save my life, depending on the PDL-1 staining and how my chemistry reacted. I asked my Co-ordinator today about that and that is also blinded even to them. Just feeling a bit low about the possibilities you know. I'll come out of this :-) But I won't give up and I won't go easily!
Thanks for your helpful comment.
Mike
Reply # - January 18, 2016, 03:39 PM
My understanding is that
My understanding is that under certain circumstances, the sponsor can un-blind your treatment assignment if it is critically required for medical decision-making. So in the future, if another PD(L)1 drug is being considered, you could pursue this option. It is not pertinent now though.
Also, it is usually possible for your trial coordinator to ask the study sponsor what your PD-L1 tumor score is.
Reply # - January 18, 2016, 04:11 PM
Hey Ben,
Hey Ben,
Ok, let me understand this... so are you saying, if I am finished my infusions and for example, five months later it is discovered that my cancer is in progression, that could be considered a medical emergency and the study unblinded?
Of course, having the cancer start up could mean I was receiving the placebo or didn't have a strong staining for the PDL-I etc. and therefore in either case the drug wouldn't have made a difference.
Now if I had had a strong reaction to the PDL-1 and was getting the placebo, the system might still not necessarily put me on monoclonal treatment (though the drug could have conceivably could have killed off the cancer cells in my body). I think they randomized the first 600 regardless of staining.
I've been told that the standard treatment if I get sick later would probably be regular chemo. So, I'd have lost the opportunity to stay clean and possibly survive. I see standard chemo compared to this as only a 'maybe" not a "cure". I guess That's the conundrum as I see it. I'm talking Canada's health system too and they may go with different rules regs and standards than in the States. I see the States is fast-tracking the drug for use in 2016.
All in all, as attractive as it seemed at first I don't think I like this double blind stuff!! I don't like being a lab rat so much now!
Mike
Reply # - January 18, 2016, 06:15 PM
Hi Mike,
Hi Mike,
I think the point is that if you have disease progression after you complete the trial treatment, you would want to know whether (1) you had high expression (such that a PD-(L)1 inhibitor would be a good choice for your next treatment, especially if you were getting the placebo) and (2) whether you were getting the trial drug and progressed on it (which might make another PD-(L)1 inhibitor a less attractive option).
I also think that if you progress on the trial treatment, the statement about your next treatment likely being chemotherapy is more accurate than if you progress on the placebo. It's also true that not all patients, even those with high PD-L1 expression, respond well to the PD-(L)1 inhibitors, while many patients do well, some extremely well, with standard chemotherapy agents.
Wishing you good luck with the trial.
JimC
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