Keytruda Adverse Event and Rechallenge
Hello fellow TNBCers,
I am reaching out for help regarding a situation I am in. I was recently diagnosed with TNBC back in January 2024. Invasive Ductal Carcinoma, Stage 2B (maybe A, 4x lymph nodes lit up on my petscan, but the axillary node which was biopsied 2x, one as FNA and a repeat with a core needle, both came back negative for malignancy), Nottingham grade III/III.
As per the diagnosis, I am on the Keynote 522 treatment plan. 12x weekly carbo/taxol, followed by 4x cycles of AC every 3 weeks.
I started my first cycle of treatment on February 14, where I received the Keytruda, Carbo + Taxol. The next 2 weeks I just received the Carbo/Taxol.
Week 4 I had my more comprehensive bloodwork done, and my liver levels were significantly elevated. ALT 530, AST 354. My MO believed this to be a immunotherapy induced autoimmune hepatitis, and as such, my MO referred me for an abdominal ultrasound to look at my liver + other organs, and to a hepatologist as well. I was also immediately put on a course of steroids, 75mg/day for the first week.
When I met with the hepatologist, she said if the steroids worked for me, she would feel comfortable rechallenging Keytruda once I am weaned down to 10mg/day prednisone and ALT below 120.
After 1x week on 75mg, my ALT was down to 113. My AST was within range. My MO hugged me and said it was a best case scenario.
After 1x week at 60mg/day (first week of my graduated weaning schedule), ALT 54, AST within range again.
At the current rate, I won't be back to 10mg/day of prednisone until Cycle 4 of my chemo (the last 3 infusions of taxol/carbo) and therefore won't be able to even have a chance to rechallenge the keytruda until then.
I am obviously concerned on missing at least 2x immunotherapies during this crucial neoadjuvant therapy. Admittedly, my oncologist said some of the other oncologists wouldn't even rechallenge keytruda at all given the adverse event, but she would be up to discuss it when the time comes. I am further concerned about missing keytruda altogether if they believe it is too risky to put me back on it. They also said there are not enough wide scale studies with data on how much keytruda is enough or not.
So, for anyone who has had an adverse event, have you had keytruda rechallenged? For those with adverse events that were too dangerous and keytruda was removed altogether, did you achieve PCR? How many keytrudas did you have before your adverse event/removal of keytruda?
Am I putting too much weight into the immunotherapy? My doctor also mentioned some people genuinely do not need as much keytruda to "activate" the immune system, and sometimes only 1 dose is enough for some patients. Have any of you heard similarly? I am desperate to find information so I can be a good advocate for myself as a patient, and would love any and all help in this matter!!
Thanks in advance!
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I also had a liver reaction with raised levels, comparable to yours, or even a bit higher after one dose of Pembro. My doc did not re-challenge although there was some initial discussion about doing that. Weirdly, this was during treatment for a local recurrence of tNBC. In my initial diagnosis three years earlier, I was actually put on a study in which I was given two doses of Pembro, along with radiation boosts before my regular treatment of chemo, surgery, radiation. This was before Pembro was standard of care. At that point, I had no adverse reaction, and in fact in the study, they did biopsies to check if the Pembro was working and it was! All very unexpected and disappointing to have this adverse reaction when given pembro several years later for the recurrence . I finished my treatment for the local recurrence a year ago and so far so good without it. Keep me posted if you do the rechallenge. Good luck!
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My doctor started me on Keytruda post surgery, plan was for 3-4 rounds. Had to fight with my insurance to get it approved (as I'm sure most people can relate, I fought throughout my treatment to get what my doctor's felt was the best course to follow). After my second round I ended up with pretty severe pneumonia, which is apparently a possible side effect, so my treatment was stopped. I was very disappointed, as I desperately wanted this immunotherapy to help me fight the reoccurrence of my cancer. My doctors won't consider letting me finish the intended course of it though, due to my reaction.
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I’m on my way to triple negative but not quite there yet. I qualified for a study which required some degree of hormone receptor positivity. The initial infusion blew up my liver, where I already had metastatic disease. AST/ALT hit the 300s but my alk phos left them in the dust by going over 500. This incident pulled me out of the trial.
Oral prednisone at 50mg daily did not help so I was hospitalized exactly a year ago for a course of IV steroids. That treatment worked but I was discharged without a taper. That error landed me in the ER 72 hours later after a fall out of bed & cracking my clavicle. I got an order for 40mgx2 doses, 30mgx2, 20mgx2, 10mgx2 then stop.
All this was happening during the time between my mother’s death and following her memorial service. I then went on my 1st IV chemo. The steroids caused my cataracts to “ripen” so those were taken care of in autumn. April, I’m happy you were tenacious with the insurance company. The only way they make money is to deny claims…
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