Breaking Research News from sources other than Breastcancer.org
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Jenny - man that stuff has some bad side affects.
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HomeMom,
Thankfully, I don't meet their definition of "high-risk", so I won't be adding this to my treatment regimen. But if I did, I would be happy to know that this was an additional option to help prevent metastatic recurrence.
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FDA is Moving Away from the Maximum Tolerated Dose!
The decades-long paradigm of leveraging the highest and most toxic dose of a cancer drug, called the Maximum Tolerated Dose (MTD), will be coming to an end.
Shortly after the PCDI's presentation about MBC patients' treatment-related side effects at ASCO's 2021 worldwide conference, Richard Pazdur, Director of the FDA's Oncology Center of Excellence, stated that the FDA will start requiring drug companies to test the efficacy of multiple drug doses during clinical trials instead of identifying and moving forward with the MTD.
This is a game-changer because the MTD, which is identified in Phase 1 clinical trials that focus solely on toxicity, is the dose that generally causes the most severe side effects. In today's world, whenever patients with MBC begin a new treatment, they are generally prescribed the MTD unless there's a medical contraindication. But in tomorrow's world, at least two doses will be identified in Phase 1 clinical trials for further study so that ultimately the optimal dose - based upon a balance of efficacy and toxicity - will be given to patients.
If this subject interests you, please consider joining a webinar hosted by Friends of Cancer Research on Wednesday, Nov. 10th at 12PM ET. Panelists including the FDA, pharmaceutical companies, Friends of Cancer Research, and the PCDI, will be discussing the transformation of MTD-based oncology studies.
You may register here for the free conference!
Thank you,
Anne Loeser, Author,Founder PCDI
{The above is from an email dated 11/6/2021 from Anne Loesser. Some of you may have received it. This is great news IMO. Less toxicity while maintaining efficacy is what we all want. I believe that the Friends of Cancer Research session on Patient Centered Dosing is only one hour long.}
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Hi Lumpie, re MTD can I just jump in and say that I have NEVER tolerated the Max Dose of pretty much any cancer drug. I’ve had a few now and they have always required reductions because the side effects are just awful. So far we’ve managed to get to a reasonable level albeit with plenty of side effects. I agree that we should not be accepting the max dose just because that’s where the clinical trials are pitched. Much more research required!
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the discussion about max dose jogged a memory. I was told that it is known that a lot of people won’t be able to tolerate the max dose and it is expected that there will be dose reductions. I can’t remember the exact reason, but studies are done at max dose because it’s easier to dose reduce than to get approval for a dose increase. Meaning, you can always prescribe it for a lower dose than it’s approved for use for, but you can’t prescribe it at a dose it wasn’t tested and approved for ( higher). Therefore the starting dose is often higher than what some people can tolerate.
This is from my memory of when I was on Xeloda and had to do a dose reduction and from discussions I had. When I was in a clinical trial.
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I saw a very interesting presentation on the steps in a clinical trial and exactly how they determine the maximum tolerated dose and it had discussion about determinations around what dose reductions are "officially" permitted. It was a really good presentation. If I can find a link, I will post it, but ... I don't know... it's been a while....
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If you missed the Friends of Cancer Research presentation on....
Maximizing Benefit and Improving Tolerability for Patients Through Dose Optimization
Here are the links:
Click HERE to Watch
Click HERE to access the Pre-Conference White Paper.It is about 1 hour long.
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Treatment landscape of triple-negative breast cancer — expanded options, evolving needs
Nature Reviews: Clinical Oncology Nov 2021
covers early stage as well as metastatic setting. Link is publishers complimentary access - might expire at some point. main link: https://www.nature.com/articles/s41571-021-00565-2 & doi https://doi.org/10.1038/s41571-021-00565-2
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Atlas of Lobular Breast Cancer Models: Challenges and Strategic Direction
https://www.mdpi.com/2072-6694/13/21/5396/htm0 -
Dear All, a very interesting summary on ongoing/future research in ADCs with tables of main clinical trials: https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21705#caac21705-bib-0119
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News > Medscape Medical News > Conference News
Survival Doubled in 2 Types of Met Breast Cancer, Says Expert:
Unfortunately I can't seem to send a link. However you can join medscape for free to read the article. Recent update on survival trends.
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Tinkerbell, thanks for posting that.
https://www.medscape.com/viewarticle/962953#vp_1
For those who can't access it, the positive trends are ER+ and HER2+ - not a real surprise is it?
"Patients with two of the three major types of advanced breast cancer now have a median overall survival of at least 5 years, which is roughly a doubling of survival time over the past decade, says an expert."
The only positive thing said about TNBC was that trodelvy improved our survival by 5 months. Not much of yippeee for mTNBC
Honestly, I feel like throwing up - I'm so tired of triple neg. I'm so tired to of mbc support groups being dominated by people with more favourable diagnosis. If I hear thriver one more time I'm going to scream. Oh dear, maybe this should be in the steam room.... But yay, I'm glad for the ER+ and HER2+ peeps!
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Moth, aren't you ER+ now? I am sorry if I am mistaken but from your signature, it seems that you moved to ER+, and hopefully, letrozole will keep it under control for a very, very long time.
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Lilly, no, I have one met which tested faintly er+ but so faint that they consider me triple neg still. We added the letrozole just in case but honestly nobody thinks it's doing anything and it was debatable whether I should have started it.
My original biopsy also had a very faint trace of er+ which they struggled to categorize. Oncotype has me as triple neg and we've been treating as triple neg.
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Moth: Thanks for adding to my failed attempt with sending a link. I attended a virtual conference on Sunday for MBC. There was positive chatter for mTNBC, especially w PARPi and Pik3 mutation (utilizing PIqray if + positive for the mutation.) besides or in combo with immunotherapy.
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I'm sorry Moth. I had this hope of having ER+ in order for letrozole to work. Hugs.
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alas,I've been tested & have no somatic or germline brca or pik3ca mutations. I have had a good run on immunotherapy + chemo. By mTNBC standards I've done well so I shouldn't complain but you know how it is...5 years is the stuff dreams are made of for me.
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I am sorry, moth. The article about the doubling of the survival time arrived to my Inbox a couple of days ago, and my first thought was of compassion towards every patient out there reading this who has triple negative mbc. I specifically thought of you, because although I don't know you, I always read your insightful advice and comments in this forum. I send you a big, big hug, sister. You are not alone. Very very sorry. You had such bad luck. Here is for your dream becoming true, for you making it to the five years, and then for some breakthrough drug that tames that cancer freaking beast that we hate so much. And yes, you absolutely can complain.
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Moth, LaughingGull said everything I wanted to say (except SO much better than I could have written.) I always read your posts because they are so insightful and filled with useful information. You make a difference - probably to a lot more people than you can imagine. Thank you for that. Sending you a virtual hug, to be used any time you need it and for as many times as you need it.
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Dear All, ESMO Immuno-oncology has amazing seminars on 08-11/12/2021. I find day 2 (9th) very intriguing, especially TIL, TCR, CAR-T, and multi-specific engagers in solid tumors. Please, whoever has time, follow: https://cslide.ctimeetingtech.com/immuno2021v/attendee/confcal/session/calendar/2021-12-09
Cell therapies and bispecific agents in the pipeline
Date: Thu, 09.12.2021, Time: 14:30 - 16:00 Room Room A, Chairs: Marco Donia (Herlev, Denmark)0 -
Saulius,
Thanks for posting. Odd that ESMO overlaps with SABCS? I thought they generally ran at different times.
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awww, LaughingGull & Tess, thank you so much. You made me cry - but in a good way, kwim...
BevJen, I did a double take at that too because I was sure I'd followed some ESMO sessions this year...then I thought maybe that was last year & I'm really out of it? But no, main ESMO is over already. They have an immunology mini congress. I'm signed up for SABCS so not sure how I'll organize my time. (and fit in all my hallmark xmas movies!!! priorities!... lol)
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regarding the Bayer ErSO, just saw a screenshot of someone else's correspondence & it's bad news - they're NOT proceeding to Phase 1 trials at this time https://twitter.com/LibbyMbc/status/14606547735022...
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Thanks, Moth, for passing on this information about ErSO. What a lucky turn of events. Looks like only mice have a cure.
I have an appointment at Dana Farber to see what further treatment I should pursue and to see if I might qualify for the ErSO clinical trial. I probably should cancel it since I can now clearly see the path of maybe 3 different CDK4/6 inhibitors and then nothing.
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That's disappointing news about ErSO. Makes you wonder sometimes.
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https://link.springer.com/chapter/10.1007/978-3-03...
Systematic Review of Exercise for Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy
"The 10 randomized studies collectively suggest that exercise is beneficial for the treatment and prevention of CIPN with little to no side effects. However, these studies tend to be either rigorous yet small or large yet simple and exploratory, with no Phase III randomized studies published or pre-registered"
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Dear BevJen, SABCS does not overlap with ESMO - this is just small four day routine event for immuno-oncology... Europe does a lot in this field, so that is why.
Also... very disappointing for ErSO. This is so typical... I know a few drugs (classical example is oral Taxane - Tesetaxel) that "drowned" in the pool of financial turmoils:/ Hopefully there will be another investor but they have wasted so much time with Bayer. Crap!
Saulius
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I would travel to Europe, if I could figure out where to go to get the drugs that the FDA won't approve. I wonder if the problem with ErSO is that it would put a big dent in the profits of the other pharmaceuticals as well as doctors so a backroom deal was made to squash the study. Do you think Europe is different when considering the actual welfare of common people?
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The issue isn't that the FDA isn't approving the drug. It's that Bayer won't invest in it. I really think if they thought they could make money off it, they'd do it. I think pharmacorp thinking is 1. is this drug good 2. how much do we need to invest to get it through trials 3. how much profit will we make.
If the drug is good but not spectacularly better than a different drug already on market or in pipeline, then dependng in financial positions, a company might decide to not proceed. I'm guessing that's what happened with atezolizumab/tecentriq in the US. It's not that it isn't a good drug - it is, but trodelvy is probably better so the market share would have been smaller.
The obvious way around it would be for governments to bring drugs to market, rather than relying on pharmacorps whose responsiblity is to their shareholders. or at least for governments to subsidize certain drug development --- that's an issue especially with rare diseases because the market there is so small, companies won't invest in the drugs.
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genentech almost didn't fund herceptin and in fact, Dr Dennis Slamons was lucky enough to catch the attention of someone who knew the wife of the head of Revlon Cosmetics and that's how he raised money to continue some of his early research!
So, yeah, just because pharmacos are being dick heads doesn't mean the drug is ineffective.
Wonder if Systems Oncology will continue pursuing this...hope so.
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