Are you currently (or have you been) in a Clinical Trial?
Comments
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Elizabeth, thanks for the update. Yes, enhanced immune systems can definitely increase any sort of skin issue, whether eczema, psoriasis or another unnamed issue. I hope to see success for you and other ER+'ers. The fact you are seeing bodily reactions indicates your body is responding. Fingers crossed.
Frisky, it sounds like your trial is looking for the maximum tolerated dose and the dosage is still way above that, even at the lowered dose. You are in a Phase 1 trial, correct?
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Elizabeth,
Thanks for the updates, hopefully the SEs calm down soon. Do you know if your cancer has PD1/PDL1 expression, or high tumor mutation burden was there another reason your oncs thought this might be a good trial (given that ER-positive MBC typically does not react). I am following closely, will be very excited when its finally my turn to get I-O, would like to work it in as early in treatment as possible.
Do you know if the cancer has IDO1 expression? If so (and maybe even if not) you could ask your MO about adding Celebrex or another COX-2 inhibitor, as it can make the solid/cold tumors more responsive to immunotherapy.
https://immuno-oncologynews.com/2017/07/22/cox-2-i...
https://www.ncbi.nlm.nih.gov/pubmed/28765120
Also, if you need any SBRT radiation to zap any mets that are giving you bone pain, now would be an excellent time to work that in, as there are many reports that radiation boosts the abscopal effect of I-O..
Good luck!!!
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Elizabeth, I hope you're feeling better now and the rash has subsided....big hug of strength and support coming your way!
Update on my Pfizer adventure.
Saturday I managed to take both pills and to keep food down....however I felt very weak and out of steam when I attempted to take a walk with my friends to Washington Square Park. I struggled getting there and walking around, although I had just taken the Ritalin....
when I got home I collapsed on the couch, and later on I took the second pill when I went to bed and managed to sleep deeply throughout the night. I also had to compromise my typical lunch plans, couldn't eat out at 12.30, but compensated when my dear friend went to the lobster place and returned with two amazingly delicious cooked lobsters and a bottle of Prosecco....no suffering there....
This morning, however, I had a conundrum to resolve...I had made plans to share lunch at an Indian restaurant with some other friends at 12.30, but I knew that if I took the pill I wouldn't be able to make it, because at that time I would be too fatigued and immobile, trying to not regurgitate, and since I was finally having normal bowels movements I was not going to mess that up by taking a zofran....
I decided the best solution was was to skip the morning dose and so I did.
Well let me tell you...the difference in energy, mood, and overall well-being was extreme, I realized that I had forgotten what it was like to be myself...I can't believe that a so called medication can be so much worse than the actual disease....sometime, I think I'm living in a nightmare where I get glimpses of the way my life was supposed to be, but I don't seem to ever wake up....and change the script...
I will take my evening dose.... but let me tell you....even at half the dose this is still a very unpleasant drug.
I just hope that all this misery has a payoff...but I'm willing to bet 300 to 1 that it's not gonna happen....of course deep down I'm willing to be wrong on this one. Time will tell...
JFL...yes it’s phase one,...
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Jennifer, So sorry you couldn't get on the CAR T trial. We are all waiting for an immuno therapy for ER+ MBC. Thank you so much for trying.
Just heard that my first scans after getting on Taxol (on the trial for oral Taxol but got the control group so taking IV Taxol) showed progression. Pleural effusion is gone but lung nodules are bigger. Strange mixed result. Feel very fatigued and the whole scheduling of my infusions was a nightmare. All for nothing. Looking for my next treatment.
Hope suggested A/C or Navelbine. I'm thinking no more chemo. My Chinese Traditional Medicine doctor told me not to take chemo and, at least with Paclitaxel, he was right. Xeloda seemed to work but no IV chemos. New trials of New ADP class of drugs will be starting in July. Hoping I can qualify.
Thinking of Aromasin and Affinitor next. Any thoughts about this combo? Or Keytruda + ? Seems unlikely to work if I'm HER2 equivocal.
Hugs, Susan
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Susan- bummer about the progression! I am on cycle 4 of AA after progressing on I/F - bone only. My TMs almost doubled between treatments! But, I also read that there is a flare of cancer when you stop a CDK. I am on 10 mg. The first month I had fatigue- but, that is gone now. I did use the steroid mouthwash four times per day for the first 2 months and got no mouth sores. My TMs have gone down a lot and I will have my first PET since starting AA in 2 weeks. The upside is that my anemia is better and my ANC is normal (ish), my parasthesias are better and muscle cramps are rare now. My FBS went from 85 to 95 so still normal and my cholesterol did go up, but, is ok.
Good luck with your choice. I just hope this one works for awhile because it is easy so far.
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Nkb,
Great to hear that you are doing well on AA! Thanks for posting about it.
Hugs, Susan
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Susan, sorry to hear about the taxane trial. I was hoping you would place in the oral taxol arm and that it would work well. All of the hoops that one has to jump through for a trial and then it doesn't work is demoralizing. Just went through that. So much wasted time and energy . . . .
I am glad to hear that AA is working for NKB!
I am currently on navelbine and tamoxifen, which has put my liver enzymes and alkaline phosphatase back into normal levels very quickly. My MO is targeting the bone mets with tamoxifen and liver mets with navelbine. Tamoxifen is a recycled medication for me. Navelbine is IV chemo but very tolerable with minimal side effects. I have a slight bit of neuropathy, although very mild and feel a slight bit fatigued on 1-2 days per cycle. Other than that, no side effects. I could stay on this for years. The infusion is only 10 minutes with no premeds. Europe has oral navelbine but it never made financial sense for any drug company to manufacture it in the US, sadly. A/C is pretty harsh. If you haven't done Doxil, I would strongly recommend trying Doxil before going to A/C. Doxil (liposomal doxorubicin), like Navelbine, is a very tolerable IV chemo with minimal side effects other than rashes and its own version of hand foot syndrome (what I like to call fire feet). Also, it is only administered every 28 days, which is so convenient compared to most other IV chemos. The infusion is 60 minutes and I didn't do any premeds after the first or second cycle. Doxil preferentially deposits into tumors versus healthy tissue and tumors are unable to clear the medication in the same way healthy tissue can. The liposomal delivery system of Doxil not only manages to eliminate nearly all "A"/adriamycin/doxorubicin aka red devil side effects but also manages to circulate in the the body undetected by the immune system for several weeks. Because of that, it does not need to be administered as often. I hope you can find another non-chemo option that you would feel comfortable taking though.
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JFL,
Thanks so much for your recommendations and your experiences with Doxil and Navelbine. I will ask my MO about the combo you are on, Navelbine and Tamoxifen. I was briefly on Tamoxifen when I was first diagnosed metastatic. Had a fantastic response to it but was switched to Xeloda when my tumors stopped shrinking. She said at the time that I might be able to get on it again since I didn't actually progress on it. Will also ask about Doxil.
Sorry if I am diverging from the clinical trial topic of this thread. Since most of us on trials have gone beyond the first-line treatments, I hope that this discussion is ok. This thread is so full of knowledgeable women, I don't know who would be better to ask!
Hugs, Susan
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Update on my Pfizer saga...
Received many compliments from my MO yesterday. The blood tests indicated that mybody is dealing very well with the SE of the medication. She was also extremely amused by my creativity in getting rid of all the other medications, such as zofran, colace and the rest of thelaxatives.
By the time I got back home, however, it was to late to take the morning pill. I was famished, after a 14 hours fast, so I ate.
Then, I had a crazy idea...I would take the night pill at 9 pm instead of 10 and since my last meal would be around 6pm....I could take the morning pill at 7 am, and eat around 10 am which would then free the whole day from the debilitating SE I was experiencing around noon, which were interfering with my social life and productivity—which was a huge drawback.
So, this morning, I put my plan in action and it worked out very well. Now I get to fast for 15 hours and there's nothing in my stomach to regurgitate when taking the pills.
Needless to say I'm very happy with this schedule and my new eating routine...sometimes I amaze myself!
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Frisky, No wonder they picked you for the trail!!! lol. You really go the extra mile. Happy for you. S
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Susan, I was on AA for 3 years, please let me know if I can help in any way. Side effects did wear off for me after a couple of months. I had to reduce the dosage to 7.5mg and take a daily probiotic which pretty much eliminated my mouth sores. I had the P13KA mutation an dI believe based on your Alpelisib trial, you might have it too. It worked really well for me. I hope it does for you also! Good luck!
Hugs!
Ann
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Ann,
3 years! That's amazing! I haven't been on anything that long.
I gave my MO the "don't want any more chemo" bit but she insisted that it was important to see some tumor shrinkage before going on AA. She wants me to get off of the oral Taxol trial and switch to Abraxane (nab-Paclitaxel) since it is easier to tolerate than regular Paclitaxel. She said she didn't want to give up on the taxol thing as a whole before at least trying Abraxane. She also said that Abraxane is less toxic than Navelbine or Doxil.
One weird thing was that we had decided that I had progression based on the Chest CT scan report but the RECIST report showed very small progression, within the limits of the trial. In other words, I don't have to get off the trial if I don't want to.
My other concern is that the CT scan showed enlargement of my right atrium. This has never come up before. Having an echo cardiogram tomorrow to get a better look. Spoke to the NP at the Interventional Radiology department where I had my port put in and she thought it was because of the Taxol. My MO thought it might be a blood clot (Yikes!). Anyone else experience this?
Frisky,
You're amazing! So glad you figured out how to deal with the scheduling of eating and medication! With these trials, it's important that we each do what we can to make it work since there are so few before us to hand down any advice. We also don't want a promising drug to fall off the approval list because no one could take the SEs, if there is a way to deal with them. Hoping that my experience with going on a keto diet during Alpelisib will help those whose blood sugar levels rise sharply on that drug. My MO said she reported my experience to her peers.
Hugs, Susan
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SusanSF, would a low carb diet also control sugar while on Alpelisib or does it have to be keto? Just keeping notes.
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Susan, for what it is worth, I disagree Navelbine and Doxil are harder than Abraxane, at least in my experience. However, Abraxane is not too bad other than the hair loss and neuropathy. No hair loss with Navelbine and Doxil. Out of all the chemos I have taken (both early stage and stage 4), I would rank them as follows, 1 being the most tolerable 1 - Xeloda, 2 - Doxil, 3 - Navelbine, 4 - Halaven, 5 - Abraxane, 6 - Adriamycin/Cytoxan (A/C), 7 - Taxotere. I only took 1 dose of Taxol for several minutes before going into anaphylactic shock so I don't know how Taxol falls in the mix. I took Abraxane for about 7 months. My neuropathy has improved but never fully recovered after Abraxane but I did take an unusually strong dose for mets - a power dose every three weeks. Most people do 2 or 3 weeks on, 1 week off at a lower dose which is more tolerable with less side effects.
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Susan, I completely agree with your assessment.....and the need to resolve as much as possible the SE associated with these medications. I'm also starting a restricted fasting routine and moving in the direction of a ketogenic diet, due to elevated insulin levels.
I was consuming and enjoying way too many carbs, albeit from fruits and complex sources. Now, I'm finding it so easy to fast for 16 hours without a problem..... and have no cravings, nor can I overeat....
I'm curious to see how these changes will affect my bloodwork next week....good luck with the results of your tests...I hope this get clearer for you.
JFL thank you for sharing your experiences with the various chemotherapy agents. It’s very valuable and useful information.
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Cure-ious--
To my knowledge my tumor does not express PD-1/PD-L1...it has been tested as part of the trial but I don't get the results.
I have pleomorphic lobular MCB with a moderate # of mutations (11--some known to be a associated with cancers of various types, some unknown.) There is a lobular researcher (Christine Desmedt) who I am in intermittent contact with both in person (I see her at SABCS) and via email who says she has looked informally at a small number of pleomorphic lobular specimens (11 or 13, I can't remember exactly what she said) and they are almost all in the "strongly immunogenic" category of lobular cancers (although those are Luminal A) that she has identified. It is too small of a sample to report in the literature, but she suspects that those of us with pleomorphic ILC **should** respond well to immunomodulatory drugs. The trial dose not require any % of PD-1/ PD-L1 and is open to any ER+ and/or PR+ MBC and also TN (they have to have androgen receptors.)
My rash, while still more extensive than in the past, is nowhere near as red and raised as it was the first few days after the infusions...will have to see how the second nivo (due next week) affects it. Otherwise I feel great. I know it's early, but I am grateful that it seems so easy so far. I do wake up some days with a headache (likely from the biclautamide) but that goes away after a short while.
I hope the rest of you are doing well on your current treatments--and I especially hope that Frisky's SE settle down SOON!
Elizabeth
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Greetings from Bilbao to all!! I am in Spain for a couple weeks vacation, we are just in Bilbao from Lison, and will be in Granada to see the Alhambra next week, finish up in Barcelona. I had scans before I left, but refuse to look at the results till I get back (and maybe won't bother then, either!) Life is very, very sweet!!!
I wanted to put a link to a story posted on inspire, which I rarely check out because their layout is so clunky, but this is a cool story. It turns out Halaven (eribulen) is a much simpler molecule based on a far more complicated molecule that was first isolated more than thirty years ago from a sea sponge in Japan- for more than thirty years, chemists were unable to synthesize more than a trace of the stuff. But then a group at Harvard approached a pharma in Japan saying they thought they could do it now, using some recent state-of-the-art advances in natural product synthesis. And turns out they were able to make more than ten grams, a collossal amount for that drug, and have started a phase 1 trial in Japan- very interesting! Will it be worth the effort- even better than Halaven?! stay tuned:
https://newatlas.com/chemical-synthesis-anti-cance...
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What a great vacation, so happy for you!!!
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Cure-ious, I am currently on the Halaven and wonder if this synthesis will make it effective for a longer period or at least modify the side effects? After the 4th cycle the side effects become stronger. It’s been very effective so far, more effective than anything else I’ve had.
What a wonderful vacation. Have a great time!
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Wandring, Halaven has been great for a lot of people, and wide relatively few side effects, and this new parental compound is so different that perhaps it could be possible to move to this drug following progression on Halaven? In the lab, it is super potent...
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I have always been fascinated by the infinite reservoir of chemical.compounds that nature harbours, especially poisonous/venomous creatures. Yet there is so little invested into it it's saddening.
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Cheers Cure-ious! Sounds lovely!
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Hi All....I've decided to get off the trial...SE remained a challenge and although I've tried—against the recommendations of my MO—to see if one pill @day could resolve the problems, I still found it unbearable to cope with.
My body simply kept on rejecting the medication no matter what I tried....Between the vomit, the constipation, the starvation, the depression, the stupidity, and sleepless nights...I simply felt that no matter how successful, this therapy could possibly turn out to be, it was UNSUSTAINABLE for someone like me.
I missed myself....I didn't know who I was anymore....I went from being an accomplished and greatly rewarded inventor/designer to becoming a depressed moron overnight.
I wish you all good luck with it when it gets approved....I hope it provides great benefits to you all, without the SE
Cureious...lucky you! Enjoy Spain!
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Cure-ious, enjoy your trip! I love Spain and Portugal. Interesting article about the Harvard researchers working with Esai (the maker of Halaven). Many of the best drugs available are new and improved, much more targeted versions of old drugs (Xeloda from 5-FU, Doxil from Adriamycin, Abraxane from Taxol). The issues seem not with the efficacy of the active ingredients of many cancer drugs but with the ability to get the particular ingredient from its source, then into the tumor, with as little collateral damage as possible.
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Frisky, I enthusiastically support your decision; you gave it your best shot! You know your body and mind and what your quality of life is from the inside out and how to decorate it. I raise my glass to you! Have a great week and if you ever go to Velselka, have a pirogie for me! - Katty
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Thank you Kattysmith....Veselka...what a great idea....I’m gonna definitely try their pirogis again
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Frisky-- I totally support your decision. Quality of Life. Maybe by the time they get the med to market they will have worked out the kinks and people can tolerate it. You gave it a good shot. I was worried about you. What now???
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I don’t know Candy...if I follow my MO instructions I will be doing Doxil infusions sometime next week...
I’m hoping for a miracle...some unexpected and unforeseen solution to my depressing predicament....
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Frisky, Taxol with Fenben helps each other. (forget the name begins with S) Isn't Doxil of the same family as Taxol?
Also, when Fenben kicks in and you become NED, Doxil will be a thing of the past.
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from your mouth to God's ear Snooky! May it come to pass....I have officially notified everyone involved I’m no longer taking the medication. What a relief
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