Ribociclib trial + T-DM1

Hi mainegirl,

I was in a trial for ribociclib, but not T-DM1. The trial (monaleesa-7) looked at ribociclib/placebo with anastrozole/letrozole and goserelin. I was only in for a few months until I developed a crazy auto immune response, not necessarily due to the meds but possibly, which saw my liver enzymes skyrocket. My doctor had me unblinded and found I was receivingthe ribociclib. Only speaking to the ribociclib/anastrozole combo, it was easy for me to tolerate and I saw a partial response within the first two months.

Sorry I couldnt help more!

Hi artist, I wouldnt look at my experience with ribociclib being the norm, at least I hope! The doctors are pretty positive its an autoimmune response (technically autoimmune hepatitis, where my immune system is attacking the healthy liver cells) and not drug induced toxicity. For example, the enzymes continued to still rise five weeks after stopping the ribociclib (I had an ALT over 900 at that point!). Now whether the ribociclib/anastrozole triggered an underlying immune disorder or the immune response was due to the drugs, no one knows. But I wouldnt get down on ribociclib because of me!

I'm taking prednisone and azathioprine, an immune suppressant, which is bringing my enzymes back down quickly. And funnily enough, once they're normal again, my oncologist wants to put me on pablociclib. So I am nervous to see how it goes. I follow the liver mets thread and have seen some of the challenges you've been going through. I am only just now getting brave enough to post!

The first Monaleesa trial (there are several) for ERPR+ HER2- advanced breast cancer patients ended in May because they met the relevant clinical endpoint for FDA approval and they want to start the FDA application. We don't know the results yet because they are still being prepared for publication, They did publish side effects, which seem similar to palbociclib, no liver autoimmune reaction reported:

The most common all grade AEs for patients on Ribociclib were neutropenia (85%), nausea (39%), leukopenia (39%), fatigue (23%), anemia (23%), lymphopenia (23%), and increased creatinine (15%). The most common grade 3/4 AEs were neutropenia (46%), lymphopenia (23%), and leukopenia (15%), which were all suspected to be study treatment-related.

I've heard from random people on forums that the ribociclib is well tolerated. Here are the palbociclib Adverse Effects for comparision. Ribociclib had a slightly higher rate of neutropenia but much lower fatigue.

The most common adverse reactions (≥10%) of any grade reported in Study 1 of IBRANCE plus letrozole vs letrozole alone included neutropenia (75% vs 5%), leukopenia (43% vs 3%), fatigue (41% vs 23%), anemia (35% vs 7%), upper respiratory infection (31% vs 18%), nausea (25% vs 13%),

What is most remarkable to me were the results in the phase I ribociclib trial where the average patient had had 3 previous lines of treatment. IOW this was a tough crowd.

One patient experienced a partial response (7.7%) and 3 had stable disease, for a disease control rate of 31%. An additional 5 patients were without measurable disease or progression and 3 had progressed.

Based on the way Batfax's oncologist is thinking, the phase I results and what i read from participants, I suspect the word out among oncologists is that monaleesa trial showed that ribociclib is more effective than palbociclib. I am a happy palbociclib patient but I'll be happier still if ribociclib can your help your wife, Batfax.

There is someone who posts to the bone mets forum named Wendy who is on a ribociclib trial in canada. She is doing well. You might look for her on that thread.

>Z<

Those interested in targeted therapies for ER+/HER2- metastatic breast cancer including ribociclib, palboclib and everolimus may want to read this free full text medical article:

http://bmcmedicine.biomedcentral.com/articles/10.1...

The charts and graphs would be accessible for those who usually skip these sorts of articles.

be well, be smart, my friends, Stephanie