Are you currently (or have you been) in a Clinical Trial?
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@rlschaller Ha! Dr. G asked the same. 😁
Express Investigations is an 11-book historical fiction/mystery series. It's meant to be read in order, but if you want my favorite and best one, it's Book 10 The Name is Squint . (That's the one Dr. G is reading.) It's a prequel, so you'll be able to follow it for the most part, but there will be a big spoiler if you decide later to start from the beginning.
I ran out of mystery ideas, so I switched to rom-coms under the pen name Cherilee Laurence. For the Love of Daisy Chamberlain is the best of those three. The other two are okay—actually you might like Piper Bigelow's Big Break.
I haven't been able to concentrate on a new book idea for the last four months, but now that I'm off the Datroway, I'm hoping to get something else going. Writing has been a great distraction from the cancer—I can sit for twelve hours and type away and not think of anything else.
Thank you for asking and feel free to message me if you have other questions. 🤗
CBL
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@cblaurenceauthor I’m so sorry to hear about your pneumonitis. I had that same reaction to a trial with ARV 471 and Afinitor. It was clearly the Afinitor. Datroway is one of the next options for me so I will have to think about that now and talk to my oncologist about it. Thanks so much for sharing. I am so happy to hear you will still potentially qualify for trials I was thinking the same thing for myself with a history of pneumonitis. I hope the Talzenna treats you well and knocks the cancer back.
I’m currently on Trodelvy. I am still trying to get pre screened for the radioligand trial at UCLA and the Breaker 01 trial. It’s been disappointingly slow so I started Trodelvy in the mean time. I don’t think Trodelvy is working my tumor markers are increasing and I can tell where I have some pain but it’s only been a month so I’ll give it a little more time. I’m hoping I can do the screening pet scan in the next few weeks for one of the two trials. I’m also going to look at City of Hope for trails. Usually UCLA is so on top of things so I don’t know why this has been so slow going… but hopefully I’ll have some answers soon.1 -
@mommacj Ugh. How frustrating. The "hurry up and wait" healthcare system at work. I hope it speeds up for you soon and in the meantime, the Trodelvy does its dang job. I'm trying to remember if Trodelvy worked quickly for me or not, but that was a few years ago.
My first bout with pneumonitis was because of Afinitor as well—a common side effect I was warned about. With the Datroway, it is somewhat rare, so no one made a big deal about it and I wasn't on the lookout. I'm not sure if once you have had pneumonitis you're more susceptible to it though so definitely something to consider. Dr. G also runs trials, so I'll take his word for it on the eligibility, but it sure seems to me like it would be limiting. Maybe we'll both be pleasantly surprised.
I'm actually healing a lot faster than I thought I would. I went off the oxygen after 11 days except to sleep, and on day 13 I stopped that too. My problem now is my weak muscles from laying like a blob in the hospital for so long. I'm still using the rollator for support and balance but hoping to be rid of that in the next few weeks as well. That, of course, is all up to me. If I do the PT exercises it will go a lot faster…sadly I'm a better procrastinator than exerciser, haha, so it might go a little longer.
The Talzenna has given me no issues at all so far, so fingers crossed that continues.
Sending peace & strength to you, and a kick in the rear to the trial coordinators—get with it, people!
CBL
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Thanks so much CBL I'm glad to hear Talzenna has been treating you well. My homework for this week is to get the trial team at UCLA to speed things up a bit. I may look into City of Hope as well.
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An exciting new finding came out this week from the ESMO oncology conference in Berlin! It is detailed in a new Nature publication which reports that the Covid vaccine very strongly enhances the effects of immunotherapy. They did a retrospective analysis of a large number of patients with metastatic melanoma or lung cancer and found that, for both cohorts, those who got the Covid vaccine either while taking immunotherapy or within 100 days of starting the treatment had an overall average survival of 37.3 months, compared to just 20.6 months for those who did not get the vaccine. Its hard for drug companies to show any overall survival advantage for drugs, let alone one so huge. And remarkably, they also got strong hints that adding a Covid vaccine might make cancers that are normally resistant to immunotherapy become sensitive to it (!!!), in part because the vaccine increases PDL1 levels in addition to activating macrophages and dendritic cells. The finding is based on earlier studies that mRNA is what stimulates the immune system, so traditional DNA-based vaccines would not have the same effect as the Covid vaccines. A phase 3 trial has just been started to see if Covid vaccines should be included in standard immunotherapy protocols:
The paper:
A great summary from the researchers:
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Thanks for sharing this, wow that is so interesting, and great news !
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Awesome, positive news! Thanks cure-ious.
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Dear @cure-ious , amazing findings! But now… are these only immune checkpoint inhibitors? Interesting… what about other "semi immune" drugs, like anti her-2, cdk4/6, ISACs, etc. ? Saulius
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Hi Saulius!! I wondered the same, and saw a couple of papers on PubMed that were one-off reports of patients who got the vaccine and had a great response to one drug or another. It's certainly possible to get a "boost" (pun intended) from a vaccine, but do remember they are talking about actual vaccine doses, which are higher than booster shots, and in one report the big benefit came after the second dose, and basically a strong reaction to the vaccine seems to correlate with general immune system mobilization. So it works on its own to give a systemic boost of immune activity, and if the cancer is already somewhat responsive to immune infiltration, etc, it boosts the effect of the treatment. But the real synergy is happening when immunotherapy is added- in part its because the immune system is increasing PDL1, thereby making the cancer more sensitive to Keytruda or other checkpoint inhibitors that work by blocking PDL1..
I really like the video in the link below, from the group at U-FLA who made this finding, they basically are working on cancer-specific vaccines and noticed that what was supposed to just be the control in their experiments (ie, an mRNA vaccine, Covid or just mRNA, not designed to target the cancer in any way) worked just as well as their anti-cancer vaccine, so it was just mRNA can boost the immune system…
There are other things this year that have popped up where drugs designed for other purposes can also stimulate immunotherapy, esp PCSK9 inhibitors (used for cholesterol) and SSRIs (anti-depressants) and so you wonder what would happen if you first got the full Covid vaccine, added immunotherapy, then the next month added PCSK9 inhibitor then another month later the SSRI, would they all work together? If you were strategic to only add one thing at a time and then check TMs to see if that one thing helped or not, that would be one way to check… Anyway, that's what I wonder, is it a case of the more the merrier? or could one of those things get in the way of how the others are acting? but, anyway, wow that all these things are available from your doctor right now, and we learned about all of them just recently…
Here is the video the lab put out:
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Dear @cure-ious, thanks, a nice video, a really nice explanation but to be frank… your explanations are even better:)D Now I am thinking… even for my Sandra who is on HP it would be pretty beneficial to get an annual Covid shot (which she does anyway)… And in what strange situation now people would get if they progress and MO's would put them on immuno-therapy… should they, knowing these results, immediately ask also for full dose Covid vaccine with PCSK9 and SSRI? Sounds like a plan:) Saulius
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Just sit right back and you'll hear a tale, a tale of a fateful trip…to the hospital…again…
Hello everyone!
Welp, I must've jinxed myself. I was in the hospital for the last week with chemo-induced colitis from the Talzenna. I was on it for about 12 days when the problem started. It's clearing up, but the main concern for me is rising bilirubin.
They did a liver MRI to check for blockages that could be causing it. A tumor is constricting a tiny bile duct, and initially they said they would do a procedure to unblock it. However, the next morning, the biliary team, the primary doctor, and my oncologist, Dr. G, all decided because of the location of the duct (higher up in the liver than they usually go) that the risk wasn't worth the potential reward, citing there were plenty of other ducts to drain the bile and the timing wasn't right.
When the resident came to explain everything, she showed me my liver MRI. It is packed with tumors. I knew there were innumerable tumors, but I didn't realize how big they were—I thought they were small. I asked her what percentage the tumors were, and she said she couldn't give me an answer, but it was "a lot."
I really don't like to be blindsided. The truth might hurt, but all this time I could've been searching for information with more urgency than I have been. Bottom line is I need a drug that will stop/shrink the tumors and it needs to work fast. It could happen, of course, but I don't have a good feeling about this development at all. With liver mets, things can change on a dime, and for the first time in this journey, I'm facing reality and scared.
I haven't spoken to the oncologist yet—his next appointment is December 5th which really doesn't work for me—but in the meantime, I'll have appointments with the PA and hopefully they will communicate well enough with him to answer my questions. I believe he'll leave me on full dose, but he might reduce the Talzenna. Not sure. I'm also not sure what he has up his sleeve for next line, hence the need for an earlier appointment. Ugh.
So my objective now is to read through this thread a bit, do some trial research, and try to come up with some alternatives, either for now or at a future date. Esther posted about a service that takes your biopsy report and analyzes the markers for available trials—Genomic Focus—so I did that this morning. At this point, I don't really care where the trial is if it's a great fit.
Anyway, that's the story from here.
Hope all is well in your worlds—wishing you all peace, strength, and good health.
CBL
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Lauren: I’m so sorry. I’d look into TACE, followed by histotripsy. There’s a FB group.
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@luce Thank you for the info. I've never heard of TACE, but I'm pretty sure I'm not eligible for histotripsy. If I had to guess, the liver is like 75-80% tumor right now. I'll look into TACE and maybe that will be the answer.
Thanks again,
CBL
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yep, would need to shrink tumors with TACE first . TACE is simply infusing chemo straight into luver.
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CBL, So, because of the problems you've had lately with colitis, following pneumonitis (!!!) I haven't followed how the cancer has been responding to your latest treatment. You were taken aback at the liver scan (I can't ever look at my scans either, its just feels too existential) but is it worse than when you started on the Talzenna? Have tumor markers gone down?
One thing could be to ask if something could be added to the Talzenna (possibly not till you've fully recovered, but as you say you want to move more quickly and making plans takes time)- for example, they are seeing that if you add immunotherapy to PARPinhibitors, the number of people who get a response is similar to what they see with either treatment alone, however the treatments seem to last much longer when you combine the two drugs, and the benefit is also seen for ER-positive and not just ER-negative tumors. If your cancer is ER-positive, it might also help to add an anti-estrogen rather than just rely on PARPi monotherapy, and anti-estrogen is also reported to be helpful for response to immunotherapy for ER-positive tumors? As I recall they see similar benefit (adding immunotherapy to PARPi) in other solid tumors, so long as there is some kind of BRCA defect ("BRCA-ness")
JAVELIN PARP Medley trial: Objective responses were mostly observed in patients with BRCA-altered tumors, with limited activity seen in patients with non–BRCA-altered DNA damage response (DDR)–positive tumors; however, prolonged duration of response was observed in patients with triple-negative breast cancer; hormone receptor–positive, human epidermal growth factor receptor 2–negative, DDR-positive breast cancer; and BRCA-altered ovarian cancer.
Here is a description from two years ago:
Plus who knows what else they might be testing in clinical trials. Dr Yap at MD Anderson does a lot with PARP inhibitors, could you just get a second opinion while you are waiting on your oncologist?
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@cblaurenceauthor I’m so sorry CBL to hear about the progression. I just had a scan and it looks like Trodelvy may not be working for me either but my oncologist is going to review the scans with the radiologist. I met virtually with UCLA yesterday and these are the trial options she suggested. I know you’ve done Bria cell but I’ll include the whole list she gave me as options in case it’s helpful.
- BREAKER-101 with PI3Ka:RAS breaker BBO-10203. No limit on prior # of therapies. https://clinicaltrials.gov/study/NCT06625775 -- there is waiting list at UCLA
- BriaCell vaccine trial -- but currently on hold because they don't have the pharmacy bandwidth. Is open elsewhere in this area. https://clinicaltrials.gov/study/NCT06072612- TRACY-1 with an SSTR-targeting radioligand peptide. Requires pre-screening pet scan for SSTR. https://clinicaltrials.gov/study/NCT06590857
- AVZO-023-1001 with a CDK2i after no more than 3 chemotherapies or ADCs --
Future options she suggested for me with her notes: I don’t know which ones you’ve had except Daytroway. But maybe this gives you more ideas.
Abraxane, gem/carbo, eribulin, vinorelbine, Doxil
Datroway- I know you’ve had this one.
Oral SERD + abemaciclib or ribociclib.
In the ELEVATE trial with elacestrant combination therapies, ribociclib 400mg + full dose elacestrant was safe.
Imlunestrant + abemaciclib is safe.
Those were her notes. I hope something on this list is helpful. I just said a prayer for you too.0 -
MommaCJ, wow!!! Thanks a lot for posting, I hope everybody can list any MO-recommended trials. I'm gonna keep track on those radioligand therapies, they are very new… Tho its still early, they seem to be getting good results with those drugs that break binding of PIK3CA to RAS…
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Thank you @mommacj and @cure-ious for the great information and posts. I researched all of these before my appointment this morning and put them on my list of questions to ask. I'll try to make this a short post but there's a lot to say.
It's more or less what I suspected...this Talzenna needs to work and it needs to work fast.
I didn't see Dr. Gruber today--I saw a PA I'd never met before, but I liked her and trusted her answers. I had a huge list of questions, and what she didn't know, she called Dr. G about and came back to tell me what he said.
My first question was what am I looking at if the Talzenna doesn't work? She said months. She couldn't or wouldn't tell me how many, but months. I'm guessing 1-3 if my lab numbers don't start coming down, but that's only a guess.
They've held the Talzenna for 16 days now, thinking it's the cause of the colitis. But I checked my calendar, and I had loose stool for 16 days (I thought it was from eating raisin bran, lol) and 5 of those days were before I even started the Talzenna. The bad diarrhea didn't start until day 12 of Talzenna, so bottom line is I don't necessarily buy that it's chemo-related.
They wanted to hold the chemo until a few more tests came back and to make sure the colitis and pneumonitis had resolved, then possibly reduce the dose. I said, That doesn't work for me. It'll be another 4 days before I can start a new dosage, and I don't want to wait that long. The colitis won't kill me, the pneumonitis won't kill me, but the liver will and I'm not willing to wait. I'll be honest, I have full dose pills at home and I will be taking those starting tonight, at least for the next four days. I don't mean to be an a**hole about it, but I can't afford to wait.
I also told her (long story short) I'd tried Fibercon to stop diarrhea the last time I had colitis, and it worked. Unfortunately this time it backfired and made it worse. I did more research and Metamucil (psyllium husk) is actually recommended as a diarrhea treatment, so I started that yesterday. I only took one dose, but already took a dose today and it has improved already. I also have a bunch of new drugs from my pulmonologist, but haven't had the opportunity to use them yet, which I will be starting today. They want to see me Monday to repeat labs and check to see if I'm feeling better, and I will do my damndest to make sure I am.
I asked her to review my list of possible trial options. A few might work, but because of the life span exclusions. I'm not sure I qualify for trials anymore, so that sucks. Tomorrow I'll be researching compassionate use drugs so I have another option. She did say that hormone blockers have run their course for me and in the metastatic setting, they usually don't do drug combinations. At this point, I feel like I don't have time to try much else—it's Talzenna or hospice pretty much. Possibly a CU drug if I'm lucky.
I'm still processing the news. I'm not big fan of toxic positivity which I believe can do more harm than good, but there's always hope that Talzenna will work like gangbusters and kick the cancer's butt for a while. It happened a few years ago with erubilin, and could happen again. There's also a chance I could win the lottery or appear on the swimsuit edition of Sports Illustrated too, so there's that...
Anyhoo, that's the story from here.
Thank you to everyone for your input, incredible research, and support. I've learned a ton, and I feel like I've been the best advocate for myself that I could be thanks to all of you.
CBL
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You have absolutely been your own best advocate. Your extensive research, keen analytical skills and reasoned judgment are impressive. Unfortunately, I have no substantive information to share, but hoping with all my might that Talzenna kicks butt. ❤️
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Hello-I am stage IV HER+/ER- MBC and I am on my 7th line of treatment winding up at DATROWAY and having horrible side effects, including possible liver toxicity. I am trying to research what to do with this as I have two oncologists at odds with what to do. Does anyone have any experience with DATROWAY -reduction, discontinuation and what are next steps? I need help as I feel like I’m the Lone Ranger trying to continue with something that may work and not getting good feedback from my oncology teams. Thank you so much!
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Oh, CBL, surely this can turn around, and given what they are telling you, I understand how you say there is such a disconnect with everyone being so slow but then saying the situation is dire?! What drugs are you considering for compassionate use? Can you ask them to try adding immunotherapy- didn't you have a high TMB at last check? please kick everyone hard and get them to move faster, and I hope hope hope that you are doing better right now…
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Thank you @eleanora
I think you're giving me too much credit as far as the research goes, but I will be a thorn in their side until I get the answers I need. If Talzenna kicks butt, then I can breathe a little easier, but I can't take it for granted and not be prepared for the next step. That's where I am now, and it's stressful as hell. C'mon Talzenna! Do your thing!
CBL
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I was recently on Datroway. The side effects (fatigue, gagging, nausea, etc.) were really hard to deal with, I agree.
In September, 9 days after dose 4, I developed a bad case of pneumonitis that put me in the hospital for 12 days. It was terribly scary. They scanned me a few times, and the liver had slightly progressed, but the lymph nodes had improved. The doctor seemed to be leaning toward a reduced dose, but in my case I refused. I wasn't going to risk a mixed response for that pneumonitis again. If it were reversed, with the liver improving, maybe I would've tried it, but the lymph nodes pale in comparison.
For me, the next step was Talzenna. I will say I had drug-induced pneumonitis from Everolimus a few years back (not as severe) and we tried a reduced dose and I was on it for another almost 2 years.
Anyway, reduced doses can work is my point. :)
Good luck with your decision!
CBL
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It's frustrating, isn't it? I 100% feel given up on and I'm not happy about it.
I have bits and pieces of information, but not enough for the whole picture. And the bits and pieces aren't even coming from Dr. G, but from surrogates. The answers to the most important questions: What's next? Do I have time for what's next if Talzenna doesn't work? What's the prognosis if I don't? (PA said months, I want to hear that from him) When are scans? etc. —need to come from his mouth. He's the guy with the authority to give the orders, I don't want a middleman.
I sent a whole new list of questions to Dr. G's office with a request for an appointment before my next scheduled on Dec 5th. (if I'm even alive by then). It can be a phone call, telehealth, in person, even a MyChart message at this point, but we need to move on this. If I have months to live, then I have months to try something else. My fear is that I won't have even a month and if we don't act now, I won't stand a chance. The problem is he's only in clinic on Fridays and communicates through PAs Mon-Thu. I knew that would be a problem, but I switched for his knowledge about trials and open mind. I gave up the sense of urgency my last oncologist had and it's becoming harder not to wonder if I did the right thing.
My next labs are Monday. I'm not expecting good news because the yellow in my eyes is spreading and darkening. I'm only willing to give Talzenna, or any drug, 30 days to work. If it doesn't work by then, either it won't work or won't work fast enough. I have a lot of options, but what good are they if I'll be dead before I can try them? The first week of December is 32+ days and my appointment is Fri 5, so the perfect week to scan and get the results in time to discuss them in person.
I did include immunotherapy as one of the possible options, as well as local treatments, expanded access trials, and compassionate use drugs. I'm willing to try anything. I haven't had the opportunity to do research on CU drugs yet, but plan to this weekend.
I figured out last night that 83 out of the last 229 days (April 1-ish) I've been off drugs due to side effects or waiting on approvals to start. That's 36%. Not anyone's fault, but we can do better. That has to have some kind of effect on the growth. A bright spot in this whole thing is the colitis seems to be gone. One less thing to worry about.
Anyway, that's it from here. Ugh.
CBL
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Short update:
Dr G's nurse received my list of questions and juggled a patient who was doing well so I'll be able to see Dr. G. next Friday. He said those are questions only Dr. G can answer (exactly!).
He was like, "Wow, she's really worried."
I said I saw my liver in the hospital and was shocked by the size of the tumors—I thought they were buckshot, but they were more popcorn-sized and everywhere.
He said, "Try not to worry until Dr. G tells you to worry. He's really good about that."
So anyway, I have slight reason to be more hopeful, and I'll have my answers on Friday. I might have jumped the gun again, but this time two health professionals confirmed my predicament, so I'm justified, haha.
That's it for now.
CBL
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So glad you've gotten the appointment with Dr. G and hoping he can chart a path forward. Also glad your colitis is gone. Mine is flaring up and adding to the daily drag.
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Hi @eleanora
Ugh. I feel you on the colitis and daily drag. I think that wore me out almost as much as the pneumonitis. Hope it resolves quickly for you…being tied to the toilet is no fun.
Feel better soon!
CBL
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Zetagen Therapeutics to Present Preliminary Results from Phase 2 Clinical Trial Targeting Metastatic Breast Cancer to Bone at the 2025 San Antonio Breast Cancer Symposium Provided by Business Wire Nov.4, 2025
Complete response in all treated lesions :Patients completing the study showed CR via the MD Anderson Criteria and RECIST v1.1 with no active tumor detected on MRI.
First of its kind single intertumoral injection for BC to the spine. Treated lesions showed full bone regeneration with reconstitution of trabecular bone, and no skeletal related events; mean lesion defect volume decreased by 87.9 per cent at day 180. Therapeutic spread extended to nearby non-treated lesions, also achieving complete response within same vertebral body.
Note: I had to hand type this as I have a very cranky old computer, no copy past usually just a waste of my typing as it disappears. Please track this down for more information, but I found this to be absolutely incredible news. Cure-ious please weigh in on the nuances and the big target items, both good and bad. We value your input above all else.
Irishlove
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Hi IrishLove,
I saw that report, its interesting! Its a compound that gets injected into the spine for lytic bone lesions that have created fractures or other problems causing severe pain. I think the active ingredient targets an opioid receptor, and it increases p21 and causes bone stem cells to differentiate and so both heals the bone and has anti-cancer activity. It also inhibits nearby mets in the same vertebra, so the fractures are repaired, the pain is gone, and the mets at that site haven't returned.
The phase 2 results they are announcing are from a trial on just ten patients, all of whom had this great result. The company has been working on this for ten years, so it seems to be going slowly?- OTOH, this is an FDA approved breakthrough therapy.
Since each met has to be injected and the compound acts locally its not a treatment for widespread bone mets, nor would it affect mets in other organs. But for people with skeletal problems and pain, or for people with oligometastatic disease to the bone, this sounds wonderful; the phase 2 trial they are reporting on was only at two sites in Canada, we'll see where this goes next…
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Hi everyone!
It’s your favorite dumb*ss reporting from the hospital…This time it’s all on me. When I freaked out and demanded full dose and didn’t listen to the guy with the medical degree, I wound up here with shortness of breath and general weakness. They wanted to keep me because of my rising bilirubin (now around 8) and I said I can’t do another hospital stay and considered going home against medical advice. (That’s the second time I was a dumb*ss.) Luckily I came to my senses.
Then they were discussing doing the stent procedure they wanted to do last visit. Put me on NPO after midnight. Then this morning biliary resident came in and told me they still needed to discuss so it wouldn’t be done today but they were leaning toward no. She said I’ll get back to you by noon. Didn’t hear back. Then the nurses said there were heparin orders and NPO again tonight. No official word but okay assumption it would be done in the morning. Shift change nurse said NPO was canceled so there would be no procedure tomorrow. I don’t know if it will be done Wednesday or not.
Third dumb*ass decision: My lungs were getting better yesterday but were worse by this afternoon. I self-diagnosed again and decided it was my new nebulizer meds since I started those Thursday and that’s when my lungs started to turn . But looking at my notes it was actually Tuesday they started acting up, so couldn’t have been the nebulizer.
Now my theory is Dr G was right and we should be doing a half dose of Talzenna. Imagine…the guy with medical degree knows more than i do!
So all of this nonsense could have been avoided if I didn’t make irrational, emotional, assumptions decisions, and freak out before I have all the facts. How much do you want to bet my situation isn’t as dire as I think it is? I’m going to feel like a real big dumb*ss at Dr G on Friday. And it’s not like I haven’t done this a dozen times…when will I learn and spare you all the dumb*ss stories?
(In my defense, I had two medical peeps tell me it was bad. )
Thanks for reading. I won’t update until I see Dr G. Actually I shouldn’t clog this thread and start my own “What Not To Do” conversation/group.Hmm…
CBL
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