Recently I posted a reply about a pembrolizumab (Keytruda) Trial that showed only a small 3-6% of patients had a "response", and then noted OS was less than 10 months. It occurs to me that my attitude in that post was stupid and un-generous. For that I now apologize.
All participants in cancer clinical trials are heroes. They are putting their lives literally on the line to advance the knowledge that will hopefully add some measure of knowledge to this very complicated fight that we share. And yes there is the hope that the trial will provide a personal benefit in their own fight. Yet, those who participate in controlled randomized trials know that they may not even receive the study treatment. This is especially humbling to consider in trials where the holy grail of results is being evaluated: OS or Overall Survival advantage of significance.
Every data point in an OS statistic is a life. And a death. They are all-in, these heroes. PSA responses and PFE, Progression Free Survival and its permutations are fine. But we do not truly know a treatment is effective until we have that most important measure of prolonged survival. And that requires participants who are willing to go all-in. And this does not apply only to the trials that show a positive impact on OS. It applies equally to trials that result in no measurable advantages over SOC or comparing any other two arms. For the negative results showing that a particular intervention does not extend survival is just as important. All of these takes our knowledge and our tools and our weapons in this fight further. It serves all of us now and those who will come after.
I shall never again read a research article or abstract that reports on OS without pausing for a moment to honor those brave heroes, our brothers and sisters in arms in the fight against cancer. OS research heroes I honor and bow to you.
Written by
MateoBeach
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I always remind myself that every successful drug we have was once only available on a clinical trial. I'm on Zytiga now and so far it looks like it will give me an extension of good quality life. But not long ago it was unavailable, then only to those who were on a clinical trial.
Well said this time. Some times hard to think of all the time with side effects and misery for only a couple of mo. OS added to your life. Currently on Xtadi after Taxatere neither of which were available just a few short years ago. Yay to the trial heros !!
Eventually, the scientists are going to find out exactly who is going to benefit from any particular therapy. When they do, they'll be able to pinpoint who the 3-6% are that can get help from it and will only select those patients, causing the numbers to go up to 50-100% for the people who get the drug.
But that's not the end. They'll also eventually find out why some people didn't benefit. Then they'll create new drugs that help them too either to benefit from this drug or from other drugs.
It's a long hard slog. The science is unbelievably complex - working at the molecular level with chemicals that are too tiny to see in a microscope and that interact in an environment with tens of thousands of other chemicals that can be somewhat different for different patients. But they keep making progress. Each new generation will do better than the last. Ain't science great?
Well said MateoBeach. I have had similar thoughts as well. The armamentarium of old and new diagnostic methods, drugs and precisely aimed x-rays that we now benefit from were all qualified through the patient and heroic participation of so many brothers in trials. And this applies to all cancers treatments and both genders. I salute and thank them. Phil
Thanks for your encouraging words. Much appreciated. I participated in a pembro trial and it had partial success in stabilizing the beast. They took many blood samples and biopsies I'm hopeful they learned from my case. (Unfortunately I was one of the <1% that got type1 diebetes...)I have now started soc docetaxel, treatment#2 is end of this week. I'm starting year 10 of a fierce battle. Staying positive and hopeful that my brave brothers in clinical trials will one day help me too! 2010 Gleason9 metastatic to lymph nodes. Battle On my brothers! And a very merry Christmas and happy new year!
I joined a trial of Zytiga in 2012. It was a new approach then, giving it at diagnosis. As I was stage 4 with a PSA of 571, it wasn’t a difficult choice for me. I’m still in the trial 8 years later.😀
Experimental Trial for me with Pembrolizimab...I'm in the small percentage that got response, Genomic Sequencing of pathology was a match due to rare POLE mutation with a High Burden Mutation.. Negative for PDL1 and MSS...not MSI , prerequisites for effective response....we are all different.
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