To trial or not to trial (MonarchE / Verzenio)

Sorry beeline, I see you already been in touch. Looking for MonarchE study.

Hi, I’m currently enrolled in MonarchE, although I was randomized to be in the control group so I am on hormonal therapy alone, not including the 2 years of Verzenio. It was an easy decision for me as I’ve heard so many positive things about CDK4/6 inhibitors and how they may be the future of BC treatment for many of us.

In terms of logistics, the visits at the beginning are very two weeks so if you’re shifting provider and it’s out of the way then it could add the burden of lots of travel for you. Now that I’m 12 weeks in my doctor got a waiver from Eli Lilly to make my visits every 3 months instead of every month. So not too bad.

Since I’m not on the Verzenio I can’t speak to the side effects although my doctor said diarrhea is almost assured, at least in the beginning.

Good luck in your decision! I too have small kids and am the primary breadwinner—I’m throwing as much at this as I can.

beeline— the visits I’ve had are just bloodwork, QOL/SE questionnaires, physical exams. No scans so far, so no anxiety. For me it just means seeing more of my MO who I like and trust anyway.

That’s an interesting point about getting (free?)access to the drug if a recurrence happens while enrolled in the trial. I’ve never asked, but now I will!

Beeline, I went to Case High School! My folks still live in the same house, not far from the Regency Mall. Ovarian suppression can be a challenge. Since you are so young, has anyone suggested genetic counseling?

Hi, there from Finland! I'm in this trial, in control group and my nurse said that there is no access to drug if you relapse during trial. In many trials there is that advantage, but i guess not in this one than. That would have been a great plus since the drug is not even in the market in Finland.

They do scans only if you have any syptoms. And I think that's a good thing, since I tend to get the worst scananxiety. Bloodwork (evey 3 months at the moment for me) and appointments with onc or phonecalls from nurse, that's all at the moment. I did get into ultra sound really quickly after I found a swollen lymphnode from my chest (cancerous side). Turns out it wasn't a lymph node, maybe just fat tissue, but we're going to monitor that now and hope that whatever that is, it's nothing harmful. I think that without this trial I wouldn't have been this alerted to check myself and get it checked so quickly.

If you get the drug, they do dose reduction and monitor your side effects. And my onc even said that I would start drugs for diarrhea same time that starting the verzenio. What I have heard, it is very well tolerated, so you might get away with very little side effects.

You can always quit the trial, no questions asked, so maybe if you enroll and make decisions depending on which arm you're on? Or try it for a while and quit if it's not good for any reason? Best of luck with whatever you choose

Hei Minniesi - did you notice the tiny Finnish flag next to the white poodle in my signature? My mom’s grandfather was born on Hailuoto island. She and my sisters made a trip there but I have yet to visit.

There are so many rare diseases in that area due to the small, isolated population. Some labs don’t even test for the uncommon genetic mutations.

It seems like a long time until May for beeline to wait on getting into the trial. Perhaps there is a lot of paperwork or quite a few others who enrolled earlier that are being processed...

beeline - I am in the MonachE trial too and just found out today that I was randomized into the drug arm. Will get chemo education again for this drug on Wednesday and will start on Thursday. I'm post-menopausal so I'm taking Arimidex for the endocrine therapy (started it about 3 weeks ago). I was so torn as to whether to participate, but like you, I want to do whatever I possibly can to prevent a recurrence.

vlnrph - thanks for the tips on dealing with the diarrhea! I have to travel for business about 11 days after I start and I'm hoping by that time I'll have figured out what I need to do to deal with it.

Linda2119 - The clinical coordinator said that dose reduction happens fairly often with this trial and usually after the first 2 weeks. You're about a month ahead of me. Anything in particular I should ask during my chemo education meeting?

Good luck to everyone!

Kim

I'm so happy to have this forum to exchange ideas.

Vinrph - I took your advice on the fibercon and it seems to be helping. I really haven't had diarrhea in a few days - a miracle, really! Last week was the worst for me, but I was also dealing with some personal stuff, so maybe stress contributed? But thank you for the fibercon recommendation.

Other than the GI issues, I'm not having any problems with the verzenio. Kim - hoping your experience is good.

Stay in touch!

With the FiberCon or generic calcium polycarbophil, be sure to swallow the tablets with a good amount of liquid, as the package advises. If you take it ‘dry’ it could swell up and block your throat/esophagus. I find it helps firm things up enough sothat peristaltic action in the intestine doesn’t automatically progress to loose, watery stool.

Another way I decided to cope with Verzenio diarrhea is to invest in a supply of disposable undergarments designed for fecal incontinence. I intend to wear them on airplane flights, once through security (in order to avoid getting a pat down from a TSA agent!) or anytime ready access to a bathroom may be difficult...

Kim, do they having you starting on 150mg twice a day?

Verzenio diarrhea supposedly starts around day 6. I copied the following from our stage IV thread:

“DIARRHEA AND ITS MANAGEMENT
To put the adverse events into a bit of perspective, although it is true that with Verzenio, all-grade diarrhea was between 86 - 90%, yet serious (Grade 3+) incidence was 13 - 20% but this is aggregated across the trials, and note further that diarrhea incidence is concentrated during the first month, and more narrowly the MTO (median time to onset) of the first diarrhea event was 6 days, lasting a median duration of just 6 days for Grade 3. Furthermore, for the most recent MONARCH-3 RCT, grade 4 diarrhea was zero, and grade 3 diarrhea was just 9.5%.

An aggressive proactive regimen of:

- high-dose loperamide/Imodium (4 mg but NOT ever de-escalated down to 2mg (and up to 16 -32 mg daily);
- "Big Pink" (Petpto Bismol Extra Strength) used in "priming" mode (started on day 4 and also used for immediate relief during loperamide dosing;
- budesonide (Symbicort) for recalcitrant cases;
PLUS "adjunct interventions:
- high-dose probiotic (28 billion microorganism count in two divided doses), and
- electrolyte powder (most of the refractory diarrhea was analyzed to be secondary to disturbed microflora and electrolyte imbalances)
- at least 12 8 oz glasses of fluid daily, 8 of which should be electrolyte-enhanced

brought the rate of diarrhea-related drug omission or dose reduction down from 22% (MONARCH 1 and 2) to under 1 - 2% in the cohorts run by my research teams in India and the Middle East.
NOTE: We found that the adjunct interventions of Big Pink, high-dose probiotic, electrolyte rebalancing, and assured fluid intake were at least important as the conventional agents, and in cases that seem intractable, converted to success, given that therapy-driven diarrhea inevitably causes GI tract flora, and electrolyte, imbalances, aggravated by inadequate hydration. Also critical was "through-and-through" loperamide dosing: 4 mg at each episode, but NOT de-escalating - as current protocols do - down to 2 mg after first (that de-escalation regimen we found indifferently effective, with large numbers of failures.

And although not reported to date, I note that in the MONARCH 3 trials the incidence of ANY grade diarrhea dropped to just 2% (courtesy of data provided by Levi Garraway at Lilly).“

The suggested loperamide dose was too much for me. Calcium is good to take for bone health when on an aromatase inhibitor like anastrozole. A little magnesium is fine but extra can contribute to loose stool. I read something about biotin recently which I will try to find again. All things in moderation is probably safe advice.

I took Verzenio for about a week in October 2018 then had a break prior to dose reduction then another hiatus the following month due to radiation. I’ve only been on continuous dosing since early December.

The biotin info I read recently was regarding the ability of milligram amounts to interfere with lab tests, especially thyroid assays. Stick to lesser amounts (microgram range) or hold off on taking it a day or two before blood draws.

Note: except for calcium which is too bulky to add in significant quantity to an average tablet, your general multivitamin/mineral combination should provide sufficient back-up to a well rounded diet. Unfortunately, most of our food comes from depleted soils so many of us can benefit from supplements.

Hi, Kim and vlnrp,

Vlnrp - thanks so much for all the info. It's a bit overwhelming - that's quite a protocol.

I've started taking consistently 1/2 of an Imodium with my night dose and 1 fibercon with my morning. It has significantly reduced my diarrhea, so far so good. I have an episode every third or fourth day - quite tolerable.

Kim - how's it going for you? Please send us an update.

Take care,

Linda

Hi Linda,

So glad you've been able to manage the diarrhea! Been a busy week, just got back from my business trip last night. Today is day 15 and I've had 3 episodes of diarrhea. Fortunately only one was during the business day on my trip. I took Imodium after the first episode on day 9, but not after the other 2. I'm going to try the FiberCon starting tomorrow morning to see if I can head off future episodes. Had my first follow up visit today after starting and they'll look at my labs to determine if I need a dose modification - I'm taking 150 mg twice daily. Forgot to ask about the probiotic today.

Just started having some twinges of joint pain a couple of days ago, but I've not been exercising or walking so I'm hoping once I get that going again it'll help alleviate the still somewhat minor pain.

Overall, I'm relieved that the diarrhea has not been too bad so far - the prospect had me really worried! I travel again next week and then will be home for at least a week.

Hope your weekends are SE free and not too cold or snowy!! We're expecting 3 - 7" of snow tomorrow!!

Kim