Ribociclib, exemestane, everolimus clinicial trial

Mama2twins,

I was able to get ribociclib (Kisqali) even though it's my seventh line of treatment. Generally once a drug is FDA approved it can be used outside of the initial recommendation. Actually, I've only progressed on three treatments; the other three had side effects that were hard to deal with. I had terrible Hand Foot Syndrome with Xeloda, so I hope you have better luck with that. I stuck it out for a year until we had to reduce the dose so much I had a slight progression.

I just started Kisqali April 26 so I can't tell yet if it's working, but I'm not having any trouble with side effects. It's over a month since I stopped Abraxane and maybe I have a little fuzz on my head if you look at it in the right light, but Kisqali can cause hair loss and thinning, too. I'll let you know how things go for me.

Alissa, so sorry about the liver function tests, but it simply appears that ribo and A/A are not for you. I guess it sometimes happens that way. Hope Xeloda treats you better.

Davenport, maybe being off the meds for a while will keep the mouth sores from coming back? One can always hope.

Madrid was sunny and warm-in-the-sun-cold-in-the-shade. I enjoyed myself a lot. The conference was better than last year, I refrained from drinking too much wine and I got enough sleep. Saw friends I only get to see now and then and didn't need any of the pharmacy I took with me (except the one antacid) A win all the way around. So glad to get out of the house and office.

So far cycle 3 is treating me well. A few weirdnesses but nothing to complain about. After all, I just spent a week in Spain on someone else's dime.

Thanks for all of the love ladies!! Xeloda has not been to bad to me, yet!!

Z- every time I try to update my history, it erases things! I did Ibrance for 16 months after my de novo dx. That is why my insurance said no way to Ribo, they already paid big $ for them any months of Ibrance.

Pajim, so glad you enjoyed your trip!!

Deanna, I am hoping for good results like that, gives me hope, thank you!!

I hope everyone is having a great day today!!

Alissa

Davenport -

I don't know if I would re-do most treatments. They fail because the cancer has mutated into a resistant form. It's not an unreasonable position for insurance companies to take. However, with CDK 4/6 inhibitors you really don't know if the hormone suppression failed or the CDK 4/6 inhibitor failed.

Clinical trials showed that Ibrance had no effect as a single therapy. It only works with effective hormone suppression. So if, say, letrozol stops working it stands to reason that the CDK 4/6 inhibitor will stop working too. If you switch to a different hormone suppression strategy, like a SERD, I think the CDK 4/6 inhibitor could become effective again. I've read smart researchers speculate along these lines, but the trials have to be done before insurance will pay.

For this reason, I encourage people to get into trials of CDK 4/6 inhibitors that accept patients that have already taken a CDK 4/6 inhibitors. It seems like it could be a reasonable strategy... and its the only way you will get a second shot at a CDK 4/6 inhibitor right now without paying out of pocket (not going to happen).

That said, there is a whole argument for coming back to hormone suppression after chemo. One strategy could be to go on to chemo and than back to hormone therapy plus a second round of CDK 4/6 inhibitor at that time. Maybe it will be approved by that time ... it's on my list of strategies based on my research. Few doctors recommend going back to hormone suppression after you have been on chemo for a while despite the research. One of the many things about how we treatment cancer that baffles me, although not actually the most disturbing thing... I expect to be taking my own path through the cancer maze as the herd is not always doing the most sensible thing.

>Z<

Three weeks into cycle three I had a semi-nasty week. Just felt really "off" and developed my first mouth sore. Maybe jet lag, maybe something else. Sigh. Here's hoping this coming week will be better. The excellent news is whenever I feel 'off' Advil solves the problem. That's sort of odd but the way it is.

My tumor markers keep rising. Next [CT] scan in five weeks.

On the plus side after 3 weeks of rain the sun is due to come out tomorrow. We're a gonna get summah! (That's what they say in Boston) That should make me feel better no question.

Glad Xeloda is treating you OK and I hope the blood work is spectacular.

Davenport, it seems strange to me that you would be allergic to dexamethasone because steroids are used to quell allergic reactions, are they not? But look at the other ingredients in your dexa solution. Dyes, flavorings, preservatives, etc. Perhaps you could ask your onc about trying a different brand. I compared two brands and they had a very different set of inactive ingredients.

Hi Hawkfan, go ahead and start one!

Is anyone besides me still taking A/A and a 'ciclib'? Tamera?

At the end of cycle three [for me] I don't know if there will be a cycle 4. Four days in to a set of antibiotics for recurrent fevers, the fevers have not receded. Sigh. On the plus side, all my mouth sores have healed up!

My MO is not a happy camper. Current diagnosis: everolimus-related pneumonitis (inflammation of the lung). I started the steroids this morning. Scans have been moved up to next week. Meantime exemestane only.

He's looking for an excuse to pull me out of the trial and hoping that because my tumor markers are still rising the scans will show progression and it'll be automatic. I told him last night that I could simply withdraw consent LOL.

Basically I think Afinitor screwed me up.

So sorry this combination does not seem to be working.  We are all so hopeful for these trials.  I'm in a clinical trial for an unnamed SERD LSZ102 and Ribociclib.  I'm only 5 days into it.  How long before you guys started to notice side effects on your protocol?

Hi Davenport1,

The study drug doesn't have a name yet.  It is a SERD (Selective Estrogen Receptor Down-regulator) referenced by LSZ102.  It blocks and destroys estrogen receptors (similar to faslodex but an oral delivery). 

Having already been on Palbociclib/Ibrance I'm familiar with the side effects of CDK4/6 inhibitors.  Ribo is slightly different from palbo but close enough. 

I was just wondering how quickly you noticed side effects.  I get that we are talking apples and oranges.  Just anxious as each day passes.  I know it took at least a couple of weeks on ibrance\letrozole before I noticed anything when I was on that protocol.

Thanks Pajim, I'll check out the faslodex/ibrance thread.

Pajim - thanks for the update. It seems there are people who tolerate Afinitor and those that don't. If you are not tolerating it, I believe it is best to move on. Xeloda often works well for a long long time.

>Z<