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Topic: Abemaciclib Verzenio for Stage IV

Forum: Stage IV/Metastatic Breast Cancer ONLY —

Please respect that this forum is for members with stage IV/metastatic breast cancer only. There is a separate forum for caregivers and friends: Caring for Someone with Stage 4 or Mets.

Posted on: Jan 1, 2018 05:03AM - edited Jun 18, 2018 12:19AM by zarovka

zarovka wrote:

Luckylegs and friends on Abemaciclib - I am bumping the Verzenio discussion in the hopes that more people have started abemaciclib. We need to get a community going. I have not started abemaciclib but it is on my short list. Like many I am very interested in how people do on this treatment do, both as a monotherapy and in combination with hormone suppression and other treatment. I am hoping that this thread can capture the experience of everyone on Abemaciclib in whatever combination. This is a very important treatment option that we all need to be evaluating.

I would expect more people on the drug given the significant advantages of abemaciclib over the first generation CDK 4/6 inhibitors. However, the FDA has approved abemaciclib for only limited indications. We have not established its use as a first line treatment nor as something to switch to from Ibrance. At the same time, they haven't made it clear that the drug can and should be used after Ibrance. As a result, the setting for using abemaciclib is supremely unclear.

I believe abemaciclib can be used either instead of or after palbo/ribo depending on whether you view abemiciclib as another class of drug or the same class of drug with significant improvement. One can make arguments for either strategy. If you've already done palbo/ribo, it is certainly worth trying abemaciclib. If you haven't done palbo/ribo, the current guideline that you start with the first generation CDK 4/6 is reasonable, but not necessary IMO. A lot depends on the side effect profile you can tolerate the best as the drugs have significant differences in side effects and also whether you are at risk of brain mets. Abemaciclib is better at crossing the blood brain barrier.

The following summary of abemaciclib data taken from a thread started by Constantine on Inspire. I moved his entire discussion from three posts because it's that good. Thank you Constantine.

ABEMACICLIB (VERZENIO)
Preliminary data from a phase I study of abemaciclib [SABCS 2014] in patients with five different tumor types including HR-positive metastatic breast cancer, with I note a median of seven prior systemic therapies (outliers out to 11 lines) found an objective response rate of 19% and a disease control rate (including stable disease (SD) under RECIST definition of >24 weeks of ) of 81% for HR-positive MBC patients. This Phase I study was expanded to evaluate abemaciclib plus fulvestrant in HR-positive MBC [ASCO 2014.] with patients having a median of four prior systemic therapies (and outliers out to the eight line), finding an objective response rate of 62% confirmed PRs.

A subsequent Phase I study [Tolaney et al, J Clin Oncol 2015;33(Suppl 1).] of abemaciclib in combination with different endocrine therapies for HR-positive MBC (median lines of treatment = 3, with outliers out to 8) demonstrated a disease control rate (CR + PR + SD) was 67% for those on abemaciclib + AI therapy, and 75% for those on abemaciclib + tamoxifen.

The phase II MONARCH-1 trial evaluated abemaciclib MONOTHERAPY in HR-positive, HER2-negative MBC patients with a median of 3 lines of prior therapy for advanced disease, including a median of 2 lines of chemotherapy (as opposed to endocrine or biological therapy) for advanced disease, yielding an objective response rate (ORR) of 17.4% and a clinical benefit rate (CBR) of 42.4%.

What's important to remember about MONARCH-1 is that many women in the study had already received multiple lines of endocrine treatment (median 3 - 5 previous lines in the metastatic setting, with outliers beyond that), developed resistance and were refractory to all of these treatments, AND progressed, many of whom also received chemotherapy, and these results were for MONOTHERAPY in a heavily pretreated population, which as I determined through examination of historical controls with any other agent achieves at best only 10 to 20% clinical benefit rates - half of that achieved by single-agent abemaciclib, and with responses of short duration.

Hence, the collective results of these trial, including MONARCH 1 (MONARCH-2 (with letrozole) and MONARCH-3 (with fulvestrant) are exceptionally exciting breakthrough in breast cancer therapeutics.

BREAKTHROUGH SURVIVAL
In addition, for me, the overall survival (OS) of these heavily pretreated MBC patients was 17 months, and that compares to historical control I review from all clinical trials to date, as significantly better than other survival results, which are usually are at best 13 months. Thus, consider that for the current champ, eribulin chemotherapy in this setting, the EMBRACE trial achieved a median overall survival (OS) was 13 months, we clearly have here a major advance and improvement in overall survival in the highly challenging later-line settings (past at least 3 lines of therapy).

HIGH TOLERABILITY
The major limiting constraint with all CDK4/6 inhibitors to date, like palbociclib (Ibrance), is their most common adverse effect, that of myelotoxicity via neutropenia (low WBC neutrophils), with palbociclib (Ibrance inducing some degree of neutropenia in over half of women on it, with associated dose interruptions and sometimes dose reductions, a toxicity that so fat from the available data seems to also afflict ribociclib.
But abemaciclib (Verzenio) evades a good deal of this because although strictly a CDK4/6 inhibitor, it is more specific in inhibiting CDK4, that is it is CDK4-selective, and myelotoxicity including neutropenia is primarily associated with CDK6, making the incidence of neutropenia on abemaciclib significantly lower and more manageable.

CLINICAL LESSONS ON ABEMACICLIB (VERZENIO)
And unlike palbociclib (Ibrance):

1. abemaciclib has strong single-agent activity in HR–positive MBC,
2. has durable response in later line settings,
3. a good tolerability profile with reduced neutropenia, and
4. to date the highest OS in these challenging heavily pretreated settings of any oncotherapeutic agent, whether endocrine therapy, chemotherapy, or biological therapy.

SOME NUANCES
1. The ESMO-reported MONARCH 3 Trial found an response rate of 48.2% for all patients, BUT for the subgroup of patients with measurable disease, a response rate (ORR) of 59.2%, these being the highest ever response rates achieved to date for ANY endocrine therapy in breast cancer.
2. And although data needs to mature further for survival outcomes, it is anticipated based on exploratory analyses that PFS will weigh in at an improvement of close to 12 months, again an extraordinary gain.
3. In addition, Verzenio was most effective in challenging populations like those with visceral metastases (especially liver) and those with rapidly recurrent (short disease-free-interval (DFS)) patients.
4. Finally, 16 patients across two of the three MONARCH trials were NED (complete response (CR)), likely to increase once the MONARCH-3 data matures, more still I anticipate when results are reported from the MONARCH PLUS and other trials.

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).

ACTIVITY IN LOBULAR CARCINOMA
The trials largely fail to report to date differential invasive-type stats, but the impression from conversations with some principals is that lobular breast cancer subjects are unlikely to experience significant decrement, and I also extrapolate from some hints surrounding the PELOPS (Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study) Trial another CDK4/6 inhibitor palbociclib (Ibrance), as well as from some molecular considerations (the p27 gene is a key regulator of certain types of progression (G1 to S-phase) and it appears that lobular carcinomas tend to have higher p27 which in a complex way under contextual effects can have either positive or negative effects on phase progression), but we have to await sub-group analysis to report on this issue explicitly. I am cautiously confidant of little differential outcome, which I think may be confirmed across the general class of CDK inhibitors. In addition, both the lobular and the ductal groups appear to have benefited from the addition of palbociclib (Ibrance) in the PALOMA-/TRIO-18 Trial, but I note that the difference observed in PFS in that trial is likely to be an artificial artifact of the small patient in the subgroup with lobular carcinoma arm (n = 18/19) compared to n = 117 in the ductal subgroup, so this is a small sample size effect not a robust finding, an impression in agreement with that of the principal investigators (Richard Finn and UCLA and colleagues). As we learn more about lobular BC and abemaciclib in particular, I will offer further clarifications.

DEGREE OF DIFFERENCE - IBRANCE v VERZENIO
Given the dramatic 14-fold (!) greater CDK4 activity in abemaciclib (Verzenio) compared to palbociclib (Ibrance) and ribociclib (Kisqali), as MONARCH 3 lead author Angelo Di Leo has established and noted in interview, and other consequent fundamental molecular pathway differences, I view these as only shared-class (CDK), but therapeutically distinct, agents, more like the difference between third-generation capecitabine (Xeloda) versus first-generation 5-FU although these are both fluoropyrimidines.

So: More different than same as witness also the high degree of relative invariance of efficacy and durable response in later-line treatments for Verzenio compared to that of Ibrance (see my original posting, above). These differences are sufficient warrant for me to classify palbociclib (Ibrance) as a first-generation CDK inhibitor, and abemaciclib (Verzenio) as a second-generation CDK inhibitor. The devil - as always - is in the details.

CNS (BRAIN) ACTIVITY
We have preclinical data [Raub et al. Drug Metab Dispos. 2015] of the cross-BBB (blood-brain barrier) capability of Verzenio, as witness the remarkable benefit in GBM (glioblastoma, being even non-inferior to temozolomide (TMZ), the standard of care in cross-BBB activity, and this although not a human clinical, was an in vivo, not just in vitro, study. And the Dana-Farber JPBO human clinical trial (I3Y-MC-JPBO) under Sara Tolaney is investigating single-agent abemaciclib in patients with ER+/HER2+ brain metastases, where I fully expect clinically relevant CNS benefit to be confirmed, with first phase interim results reported in June at ASCO 2017 showing 2 patients (8.7%) out of 23 having confirmed partial response (PR).

I should point out that there has been some provisional data on palbociclib (Ibrance) having potential cross-BBB activity in brain metastasis, but I hasten to note that strong in vivo data show a 10-fold greater cross-BBB activity for abemaciclib than palbociclib, with abemaciclib brain levels being more efficient at substantially lower doses than palbociclib and also active for longer duration, and finally abemaciclib was active as monotherapy, palbociclib was not.

Finally, as to leptomeningeal metastases, no explicit data bears on this question directly, but as to date all agents active in brain metastases have also been active in leptomeningeal metastases, activity would be expected.

THE ISSUE OF SWITCHING
It remains an open question whether patients who have progressed on or after another CDK inhibitor like palbociclib (Ibrance) may derive significant benefit from continuance of CDK4/6 inhibition by using a following CDK inhibitor like abemaciclib (Verzenio), with many in-progress trials like TRINITI-120 (and NCT0185719319 and NCT0263204521, among others) exploring the issue. But there is some plausible extrapolation from some preclinical data which has suggested non–cross-resistance among CDK4/6 inhibitors. A Barts Cancer Institute study reported at SABCS 2016 found that some palbociclib(Ibrance)- and ribociclib(Kisqali)-resistant cell clones were sensitive to abemaciclib (Verzenio).

For patients now on Ibrance (or Kisqali) but who have NOT PROGRESSED , is it motivated to switch to abemaciclib (Verzenio)? This is an issue that needs to be thrashed about candidly with your oncology team and is a highly individual decision, but my own sense at this time is that it may be more optimal in the long run to stay the course, and consider abemaciclib (Verzenio) for recourse upon progression either off-label until the FDA expands its approval, or on one of the many abemaciclib (Verzenio) clinical trials available.

I would however entertain some specialized exceptions in which a switch now, off of Ibrance or Kisqali, onto abemaciclib (Verzenio), might be motivated; for example:

1. If a patient is experiencing repeated difficult-to-manage neutropenia, occasioning multiple drug interruptions or reductions (neutropenia being dramatically less with abemaciclib (Verzenio)), but the patient must weigh the associated countervailing issue of higher incidence - but still manageable I would argue - diarrhea on abemaciclib (Verzenio).
2. If a patient is in advanced later-line setting (say, more than 5 to 7 lines or so of treatment in the metastatic setting already completed), where it is suspected that abemaciclib (Verzenio) may be somewhat more consistent and durable in response and benefit in such challenging contexts. This is a difficult one to judgment-call, and I would tend to want to weigh each patient's circumstance and their complex treatment history and individual pathology to assist in the decision, since we have no hard data to be dispositive on this decision.

Yes, these are arguable and have to be intensively debated (as in a tumor board setting), but they are not wholly unreasonable. Outside of these exceptions, however, I do not see sufficient motivation to prematurely abandon Ibrance or Kisqali, as these have strong track records of efficacy and should be push to progression.

FDA APPROVAL

Abemaciclib is currently approved ...
1. as combination therapy with fulvestrant (Faslodex) for the treatment of women with HR+/HER2- advanced or metastatic breast cancer who experience disease progression AFTER ENDOCRINE therapy.

2. as monotherapy for the treatment of women with HR+/HER2- advanced or metastatic breast cancer who experience disease progression AFTER ENDOCRINE therapy AND prior CHEMOTHERAPY in the metastatic setting.

(Z) MO's have latitude to prescribe outside of these indications and there are strong arguments for doing so. My MO appears to have wide latitude to prescribe Abemaciclib and get insurance approval in other settings.

EXPANDED ACCESS:
Abemaciclib continues to be available through Lilly's attractive Expanded Access Program (EAP):
https://clinicaltrials.gov/ct2/show/NCT02792725?term=abemaciclib&rank=24
which is active and recruiting currently in several US locations (California, Florida, Minnesota, Missouri, Texas, and West Virginia), more being added. However that is for patients who have not as yet progressed on a previous CDK inhibitor like palbociclib (Ibrance), that is, for "switchers" who may want to explore the improved benefits of abemaciclib (Verzenio) over Ibrance (assuming the patient meet the other trial criteria); but not for patients who have already progressed on Ibrance.

RECHALLENGE

In several cases I have known, I counseled that although someone progressed on Ibrance, to reintroduce it after a hiatus of 3 - 6 months, and in many cases this washout appeared to resensitize the tumor cells to Ibrance, which upon re-introduction was newly effective. It is a variant of a trick I have counseled and seen working not infrequently with other agents like capecitabine (Xeloda) where after progression on it, I advised a trial on a new metronomic schedule (low-dose, continuous, daily, capecitabine) and seen again it newly effective despite previous progression, just by this shift I schedule (there is some provisional data for this, but not decisive). But these are beyond convention and reserved for highly special circumstances.

MARKERS THAT PREDICT RESPONSE TO CDK 4/6 INHIBITION
I am not convinced that there is any biomarker - protein or otherwise - that reliably identifies responsivity to CDK inhibitors, and Fabrice Andre of the Institut Gustave Roussy and colleagues, as reported in their presentation at ASCO 2017, were unable to identify any such biomarkers of response: neither Rb levels, p16 protein levels, Ki-67 cell proliferation, CDKN2A, CCND1, nor even ESR1 gene expression, all the usual suspects, and others, had any response-predictive value whatsoever. To date the only established biomarker for response to CDK4/6 inhibitors, remain hormone receptor positivity (HR+). Of course not everyone responds, but response rates remain historical high - and higher than any other treatment to date - and as long as one is HR+, one has the potential to benefit from a CDK inhibitor.

Constantine Kaniklidis
Director, Medical Research, No Surrender Breast Cancer Foundation (NSBCF)
Oncology Reviewer, Current Oncology [journal]
Society for Integrative Oncology (SIO)
Member, European Association for Cancer Research (EACR)

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/16/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Jan 9, 2018 11:10AM Cure-ious wrote:

Some progress is being made on identifying biomarkers for response to CDK4/6 inhibitors (and luce-there is no way only 14% of luminal A cancers respond to drugs like Ibrance, don't know the number but it would have to be waaaay higher to get a doubling of response in the trials)

Here is a recent paper showing that certain mutations in Cyclin D1 gene, in breast and other cancers, can cause it to get amplified and those cancers respond particularly well to Abemaciclib.

https://www.ncbi.nlm.nih.gov/pubmed/29232554


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Jan 9, 2018 01:06PM - edited Jan 9, 2018 01:10PM by luce

Zarovka: Thanks for your informative reply regarding monitoring! Yes, I agree on the immune system stimulation and involvement, and that it is the key. That's why it greatly concerns me what abemaciclib is doing to the gut microbiome, where the immune system presumably resides. One of my doctors (an MD, not an ND) believes that generally, the gut microbiome is the key to being, becoming, and staying healthy and alive. He recommends a high-dose bifidobacteria supplement. (Not that that is a cure at this time, of course.) Abemeciclib riding roughshod over the GI tract might ultimately not keep us alive longer, nor offer any chance of an actual cure, I worry.

Dx 12/12/2016, ILC/IDC, Left, Stage IV, metastasized to bone/lungs/other, Grade 2, 0/3 nodes, ER+/PR+, HER2-
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Jan 9, 2018 05:59PM zarovka wrote:

Luce - It is interesting that you mention Abemaciclib's effect on the gut. My primary treatment is immunotherapy at the moment so anything I do needs to complement the immunotherapy (enhance not depress the immune system). I've seen strong arguments in favor of Abemaciclib because of the PDL-1 inhibition ... takes the breaks off the immune system. I considered doing it as a single agent through the treatment. However, the gut issue is a concern. For the moment I am watching and waiting.

Probiotics are one way to go. The problem is that the bacteria are never really going to set up shop and thrive in your got with the constant armageddon going on. Same problem with chemo. I take a Japanese product called Chitsu which is basically lactus bacteria broken down by enzymes found in soy. Basically the product is broken down bits of bacteria. It gives you some of the effect of these good bacteria even if your gut cannot support the ecosystem.

Viome is an interesting test. The provide the most comprehensive profile of the gut that I have seen. Something to consider if you want to know if your gut is getting in the way of your health. You may find you have a healthy biome in there despite the diarrhea. That may give you some piece of mind.

I have had mild to extreme diarrhea for 3 months, ever since September and I haven't been on an standard of care. I haven't had time to figure out what is going on. Will be doing a Viome test soon.

It would be interesting to study what Abemaciclib is doing to the gut lining and how that might effect absorption and the immune system. So many things I would like to study ...

The truth is that we often don't see improvements in overall survival from treatments that are pretty good at getting rid of lesions. Like you, I suspect that the side effects are one reason for that.

>Z<

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/16/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Jan 9, 2018 06:24PM aem65 wrote:

Thanks so much for creating this post! I'm new to Abemaciclib (started a few days ago) after progressing on Faslodex/Zometa. I was bone-only for a decade until a recent scan showed a few small spots in my liver...hence, the med switch. I consulted with an IR at City of Hope yesterday who has requested an additional MRI to assess the full extent of the mets. That said, he recommended giving the Verzenio 6-8 weeks to determine efficacy before exploring localized treatment (I'm hoping for RFA). Upon the first dose of Abemaciclib, I had extreme nausea/headache/dizziness that was akin to motion sickness. I was fully expecting diarrhea based on the data from the Monarch-2 trial and I have an rx for Lomitil on hand. Didn't need it initially but I was sidelined by the nausea so took a couple days break and now I'm reattempting today with Zofran. My gut (pun intended) is telling me that this med may not be optimal as I too am underweight and not thrilled about compromising the microbiome. I'll be following this thread faithfully and will keep you posted on my SEs.

Dx 1999 IDC Stage 2, ER/PR+, Her2- Dx 7/09 Stage IV mets to bone
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Jan 9, 2018 06:41PM Cure-ious wrote:

Luce- The most recent studies show that Abemaciclib works synergistically with immunotherapy, and that immunotherapy in turn is very dependent on good gut bacteria and strongly stimulated by probiotics that have bifidobacterium, so your ONC sounds right. Apparently, we will hear updates from the first year of Abemaciclb-Keytruda next month, but for anyone taking immunotherapy its probably a good idea to add probiotics as well .

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Jan 9, 2018 07:04PM luce wrote:

This is the probiotic my doctor recommends and I use: http://www.customprobiotics.com/five-strain-bifido...

I've looked but not found anything comparable anywhere. (I had been hoping to order at cost through my ND friend from one of her suppliers, but haven't found a brand that combines that many strains of bifidobacteria, or anywhere near that potency.)

Dx 12/12/2016, ILC/IDC, Left, Stage IV, metastasized to bone/lungs/other, Grade 2, 0/3 nodes, ER+/PR+, HER2-
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Jan 9, 2018 09:14PM Cure-ious wrote:

interesting, Luce! Are you taking Abemaciclib now? Because the probiotic/Bifido in preclinical studies had the same effect as a low dose of immunotherapy- and if Keytruda were also added, that combo might be very effective. Is your doctor part of a clinical trials hospital?

One question is whether we will even be allowed to take Abemaciclib after failure on the Ibrance-Femara combo, I'm certainly hoping so



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Jan 9, 2018 09:15PM Cure-ious wrote:

Z- What is up with you?! Still in Siena? When do you go back to Japan, world traveler?!!

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Jan 9, 2018 09:30PM Cure-ious wrote:

Also, Luce, did you notice any increase in neutrophil levels when taking the probiotic?

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Jan 9, 2018 10:04PM Cure-ious wrote:

Here is one of the 2015 papers that identified bifido as tumor fighting- note however it is for melanomas, which respond well to immunotherapy whereas MBC does not.

https://www.ncbi.nlm.nih.gov/pubmed/26541606


This shows bifido bacteria stimulate immune system function, including tumor killing activity, and helps patients get more benefit out of immunotherapy. Might do the same thing in combination with Ibrance/Abemaciclib, and all three could be better?


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Jan 9, 2018 11:26PM luce wrote:

Cure-ious: No, I am not on abemaciclib yet although I got my first prescription filled. I am still hesitant to take it. I am the type of person who before cancer (I had primary bc four years ago; the recurrence, a year ago) didn't even take an aspirin; I believe in holistic health, so messing with my gut and while blood count, etc., seems very counterintuitive. On the other hand, I'm dying of cancer (have been given less than six months, perhaps much less--I didn't ask for details), so something went very wrong with my body despite decades of presumably-healthy (who knows what actually IS healthy. In the 90s, it was soy) living.

I haven't had any bloodwork since starting those particular probiotics in November. Before then, I had been taking Garden of Life probiotics on-and-off for years, so not sure hoe much of a difference the new ones might make.

Not part of any medical trial; I refused standard-of-care treatment (tried Tamoxifen when I first was diagnosed but couldn't tolerate it, so zero interest in endocrine therapy. iI is unfortunate that my estrogen fuels my cancer, but the rest of my body needs my estrogen to be comfortable. No estrogen, no quality of life), so there are very few trials I qualify for. In fact, I haven't found one yet. I'm interested in immunotherapy, vaccines, oncolytic viruses...possibly metronomic chemo. But, again, for almost all trials, one has to be pretreated with standard-of-care chemo and such.

While some new meds should be available to us outside of trials on a compassionate-use basis, none of my doctors is willing to try to access them that way.


Dx 12/12/2016, ILC/IDC, Left, Stage IV, metastasized to bone/lungs/other, Grade 2, 0/3 nodes, ER+/PR+, HER2-
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Jan 10, 2018 07:25AM zarovka wrote:

Luce - That is a really interesting product but expensive. It's more than 4 times as expensive as the already expensive product I am using and probably 10's of times more expensive that making yogurt from a starter with bifido bacteria.

One question is whether all 5 strains are needed. In the study that Cure-ious mentions, the strains of Bifido that were found to be associated with tumor regression were B. breve, B. longum, and B. adolescentis and these 3 strains accounted for 99% of the bacteria.

I take Super Bifido Plus more or less daily. It includes three strains of Bifido (bifidum, breve and longum) plus the key lactobacilus and costs $35 per 30 capsules (100billion cells). I also make yogurt from live bacteria culture, various strains. The one that I linked to has all five bifido bacteria. Fresh yogurt is by far the cheapest way to flood your gut with good bacteria.

I am not sure why I take the probiotic, actually, after reviewing the impact of the fresh yogurt I make. I've seen estimates that you get 400M to 1B per gram of yogurt. I don't think I am getting 300Billion cells per day this way but I don't think more is necessary. I monitor my gut biome with regular testing. On this regime I generally find that 2-3% of my gut biome is Bifido bacterium.

Budgeting for what is important is key since a lot of the important treatments are out of pocket.

>Z<


Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/16/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Jan 10, 2018 07:48AM zarovka wrote:

Cure-ious - Thanks for asking about me. I am in between trips to Japan ... going back in February. I am on ovarian suppression which is keeping my estrogen below detection levels. I am also going to Mayo to work with a researcher on SBRT to my sternum and liver with the hopes scaring a few tumors into releasing neo-antigens prior to my return to Japan. I will get a zometa shot next week, ostensibly to address the bone mets, but really because of its immune-modulating effect. I considered beginning abemaciclib prior to the immunotherapy treatment. I am concerned about the gut issues; however, it's on the short list for a maintenance standard of care therapy after Japan.

Otherwise I am sticking to non-standard of care strategies to enhance the immune system and control the cancer between treatments. I am concerned that the remaining standard of care options are immune suppressing. It's an interesting test of whether the strategies work. I will scan before I leave for Japan and we'll see how I did controlling cancer without following the standard of care.

Luce - I think very much like you do but, as you say, we have a serious disease and it isn't going to be controlled by sitting under a pyramid and drinking green tea. I have a strong complementary regime but I have been integrating certain standard of care strategies that I believe provide an overall advantage. The CDK 4/6 inhibitors are among the best in terms of efficacy vs damage. It is not the moment for me to take abemaciclib but I expect to start it in a few months and see if I can manage the gut issues. Odds are they can be managed with time through diet and supplements and perhaps some time under the pyramid. Seriously, managing stress is a big factor because stress alone can cause many of these symptoms.

In my opinion, based on the results we are seeing from trials, abemaciclib is the best FDA approved treatment for MBC available. I would go ahead and take it and see how you do. We are each very different in how we respond, one person will be able to make it work while another won't. I believe you will figure it out simply because of the way you think. You need to give it several months, 5-9 months. My experience with Ibrance was that the side effects were bad in the beginning but my body and the drug achieved a truce after a while.

What dose are you on? Be aware that is something that can generally be adjusted if you are having troubles.

>Z<

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/16/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Jan 10, 2018 10:11AM JFL wrote:

Luce, thanks for the info about the probiotic. Expensive! But it looks good. I went heavy on probiotics on Xeloda (for 14 months) and avoided the nasty GI issues that most people get. It seemed to make a huge difference - when I stopped for 4 days, the GI issues flared up with a vengeance. Would recommend daily yogurt in addition to probiotic supplements. The yogurt seemed more impactful than the expensive, high-dose probiotics I used (I would rotate brands for more diverse pro-biotic exposure).

Curious and Z, very interesting about the immunogenic effect of probiotics. I have heard a bit about that and am convinced probiotics play a large part in many aspects of health, although it seems that it is not yet understood exactly the optimal balance in the "orchestra" of GI flora, as it is such an intricate, delicate balance. I wish there were just a simple recipe for that! There has to be a friendly bacteria out there that kills cancer cells or prevents their proliferation. I suspect the ultimate "cure" for cancer will be something much more simple than all of the intricate meds which are the focus now.

Z, for your return trip to Japan, will you be doing a full blown course of NKC therapy as you did before or some sort of maintenance or add-on therapy? Do you have any indications whether the first round "worked" or does that still remain to be played out?




Chart your own course. Dx at 30. Dx with mets at 38 while pregnant - extensive liver & bone involvement. Currently on Enhertu & XGeva. ER+/PR+, HER2-low (IHC equivocal, +2/FISH negative). Y90 liver radioembolization in 2018. Dx 9/2006, IDC, Right, 1cm, Stage IIB, Grade 3, 1/16 nodes, ER+/PR+, HER2- (FISH) Surgery 9/22/2006 Mastectomy: Left, Right Chemotherapy 11/6/2006 Adriamycin (doxorubicin), Cytoxan (cyclophosphamide), Taxotere (docetaxel) Hormonal Therapy 3/15/2007 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Dx 12/2014, IDC, Stage IV, metastasized to bone/liver/other, Grade 3, ER+/PR-, HER2- Surgery 12/26/2014 Prophylactic ovary removal Hormonal Therapy 12/26/2014 Aromasin (exemestane), Faslodex (fulvestrant) Targeted Therapy 6/18/2015 Ibrance (palbociclib) Chemotherapy 3/10/2016 Xeloda (capecitabine) Hormonal Therapy 5/14/2017 Aromasin (exemestane) Targeted Therapy 5/14/2017 Afinitor (everolimus) Chemotherapy 8/18/2017 Abraxane (albumin-bound or nab-paclitaxel) Chemotherapy 3/23/2018 Doxil (doxorubicin) Chemotherapy 4/26/2019 Navelbine (vinorelbine) Hormonal Therapy 4/26/2019 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Chemotherapy 11/27/2019 Gemzar (gemcitabine) Hormonal Therapy 8/25/2020 Faslodex (fulvestrant) Targeted Therapy 8/25/2020 Piqray (alpelisib) Targeted Therapy 10/2/2020 Enhertu (fam-trastuzumab deruxtecan-nxki)
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Jan 10, 2018 12:48PM zarovka wrote:

This is an interesting trial to consider with many locations.

A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (MORPHEUS)

This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with metastatic HR-positive, HER2-negative breast cancer who have progressed during or following first-line metastatic treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.

JFL - Certain strains of bacteria turn on the immune system ... drugs fail without them and work with them. The presence of these bacteria has been shown to be as effective as a line of treatment on their own (follow Curious's link). The critters are generally but not always in the Bifido family. The data regarding the gut and immune response is already consistent and actionable. Any cancer treatment strategy that engages the immune system needs to start by focusing on their overall health which includes the gut. Why isn't this integrated into the clinic? No big pharma behind these amazing critters because there is no way to protect and monetize the idea that you need to make your own yogurt during immunotherapy.

The question of overall gut health is more complex but very important and also has answers. The overall gut biome can be evaluated and modified with diet and supplements. IMO, Viome does the most comprehensive analysis of the biome and provides a clear actionable report. I like Viome both because of the quality of the test and reporting and because because their strategy for manipulating the biome focuses on food rather than supplements. However, doctors have been using these studies for years. There are many solid tests and solid doctors using them. It is complex and probably not something one can figure out on one's own. I am pretty pro-active but depend on my practitioners for guidance on gut health.

Thanks for asking about me. I had a strong partial response to the first round of NKC therapy. I had a response that one would be happy to see from a round of chemotherapy, but the treatment was not considered successful because NKC count did not reach therapeutic levels. This means the response is unlikely to be enduring.

The low NKC may have been because I had an undiagnosed UTI during treatment. UTI's draw NKCs to the bladder where they get beaten up and killed by huge nasty urinary tract bacteria (or so I imagine it). Seriously, there is a paper on this. UTI's are nasty for the immune system and every cancer patient needs to watch for them. In any case, I had a decent response given that the immune response did not reach a level the doctor considers therapeutic. I feel its worth going back and trying again for a therapeutic dose.

I'll be better prepared, also. The doctor is focused on the NKC therapy and doesn't provide an integrated treatment plan designed to promote a response. This is not a cancer spa, it's a researcher with one particular tool that he is trying to perfect through working with patients in a clinic. The integration of the treatment into a larger plan is left to the patient. I didn't understand the treatment or how to potentiate the response as well as I do now. There is a huge cultural and communication barrier arranging the treatment. I knew coming in I wasn't getting all the info I needed for a successful treatment and I knew the only way to get it was to just go. You can consider the next trip a return, a re-do an add-on or just the second phase of a treatment that will, in my opinion, take 3 courses to complete.

>Z<



Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/16/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Jan 10, 2018 03:27PM luce wrote:

zarovka: thanks for all the good info. i used to make kefir and yogurt and all kinds of other ferments for ten years but recently stopped because I'm too tired and also not very interested in food (and note: my daily homemade kefir did not prevent my recurrence), so taking probiotic supplements (and/or store-bought yogurt) is easier. I'll see if I can order the probiotics you take at cost through my ND friend; that would really help. I opted for those very expensive ones at this time since I am trying to enhance an immunotherapy treatment I had in Mexico in November and that cost me $40,000. Yes, I wiped out myself and my mom financially. That feels really shitty as that money could have bought her more ease in her retirement, and it looks like I'm still dying. The doctor had warned me that there was a 50% chance I wouldn't respond at all, so I'm not feeling cheated or anything, just sad.

I agree about stress relief but our lives can become extra stressful on top of even the cancer: For example, my boyfriend left me for someone else just before Christmas because he couldn't handle seeing me getting worse, although at the time there was a real chance of me getting better due to the treatment. Since then, it seems like my body has given up.

Dx 12/12/2016, ILC/IDC, Left, Stage IV, metastasized to bone/lungs/other, Grade 2, 0/3 nodes, ER+/PR+, HER2-
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Jan 10, 2018 07:39PM zarovka wrote:

Luce - Yogurt didn't stop progression last fall either but what you are looking for is the right combination of things. It's all a game of odds, as you know very well, and homemade yogurt is one of the cheaper ways to improve the odds.

That said, you've got the best standard of care drug that I am aware of sitting on your shelf. There is reason to be hopeful.

>Z<

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/16/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Jan 10, 2018 09:48PM Cure-ious wrote:

I made yogurts decades ago, but it seems now is the time to get back to it!

Luce's probiotic is expensive, but good, however I wouldn't want to take it continuously for a year or so, given that it could be blocking out growth of other good bacteria- too much of a good thing can be a bad thing? But I would take it if I really wanted a strong potential immunological boost when combined with some limited-time treatment that includes immunotherapy

Like Z, I'm pinning a lot of hopes on Abemciclib and for some good numbers to come out by combining it with Keytruda. Among checkpont inhibitors I like Atezo better than Keytruda, so perhaps that combo would work even better. And then just throw in some Faslodex!

So many different irons have been in the fire with regard to clinical trials we should be hearing definitive results (pro and con) soon-with luck we'll be able to look back and see that 2018 was a tipping point for us...

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Jan 10, 2018 09:49PM Cure-ious wrote:

Z- I'm guessing that your daughter cannot come with you to Japan?! And I bet she's really bummed about that!

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Jan 10, 2018 10:52PM zarovka wrote:

Oh hell yeah my daughter is coming. I am not going by myself and at 11 she is the only one with a schedule that allows it. She's get trained tomorrow on how to access my port. It's been quite a journey for the little munchkin.

>Z<

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/16/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Jan 11, 2018 12:35PM luce wrote:

Does anyone have a good guess as when to take my twice-daily probiotic now that I'm taking abemaciclib? The bedtime probiotics dose is easy: just before I go to bed, probably an hour or two after my last dose of abemeciclib and other meds. But I used to take the morning dose a half hour before food or other meds, just after getting up. Now I'm wondering if like with antibiotics, the probiotics ought to be taken, say, an hour or two after abemaciclib, once it's moved through my GI tract and been absorbed. Thanks!

Dx 12/12/2016, ILC/IDC, Left, Stage IV, metastasized to bone/lungs/other, Grade 2, 0/3 nodes, ER+/PR+, HER2-
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Jan 11, 2018 08:56PM Cure-ious wrote:

Fabulous, Z!! She sounds exactly like my daughter!! Totally in control of her life and mine!! When she was 13 she went with me on a meeting to Xiamen China (3-day science meeting) because they then treated us to a 5 day trip to xi'an and an area near Tibet, flew back home for two days to pick up my son who was graduating from middle school, then we all went to Killarney for another science meeting and had a week in Prague afterwards! On that trip I had her in charge of the maps- she'd lead us around and through the airport as well, just to learn how to travel and to show her that she could do it- what a blast that was!! Now she's 22, and just as together and successful figuring out her life as she was back then. Trips and travel always stay with you! Surely she's not in Italy too?!

Luce- so he suggests two probiotic doses a day? I would guess that means morning and night and that you would take it together with or before the Abemaciclib- the immune stimulation requires dendritic cells drift through the gut and be stimulated by interaction with the bifido bacteria.

I did order a bottle of your bifido- I'm going to take it once a day for a month and see if it does anything to my neutrophil counts and to my energy levels.


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Jan 11, 2018 09:34PM - edited Jan 11, 2018 09:37PM by luce

Cure-ious

Let me know if the 5-strain supplement does improve your neutrophil count! I am not having those kind of blood tests but am of course interested in any possible effects.

The oncologist who prescribed the abemaciclib (I only started it today) is a different doctor from the one who recommended the probiotics months ago. I am no longer under the care of the one who recommended the probiotiocs, and my current oncologist has no opinion as to their dosing. Hence seeking advice on the forum. Thanks for yours!

Dx 12/12/2016, ILC/IDC, Left, Stage IV, metastasized to bone/lungs/other, Grade 2, 0/3 nodes, ER+/PR+, HER2-
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Jan 11, 2018 09:45PM - edited Jan 11, 2018 09:46PM by luce

Cure-ious

It'll last you a lot longer than a month if dosed once a day. While it's very expensive, it is a powder, so the total volume is much more than in, say, a bottle of 30 capsules. I'm not advertising it--I am always interested in and open to a less-pricey alternative, and may try Zarovka's, especially since it seems to have all the pertinent strains--I'm just pointing out that the cost isn't all that outrageous for what you get. The small bottle lasts 1 1/2 to two months if one takes an adult scoop twice a day. And as for the concern about too much of a good thing someone had: I am not sure but I think I read that that doesn't happen with gut bacteria, a bifidum overgrowth. Even at high-level supplementation, It'll only make up a certain ratio of your total gut flora. Can anyone confirm that?

Dx 12/12/2016, ILC/IDC, Left, Stage IV, metastasized to bone/lungs/other, Grade 2, 0/3 nodes, ER+/PR+, HER2-
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Jan 11, 2018 11:40PM Cure-ious wrote:

Luce I think you are correct, its why you have to keep taking probiotics,for the most part they just pass through you without reseeding the gut flora, altho I am not sure why that is so hard to accomplish?, given how fast gut bacteria content can change quickly following a change of diet...

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Jan 11, 2018 11:51PM spicedlife wrote:

Just popping in to say hello before going to sleep. I want to get caught up on our Verzenio thread. I take one pill tommorow morning and that completes my first seven days. Like so many have already posted, I do deal with nausea but it is manageable. Today I had my first suprise diarrea attack and I do mean attack. If I had been at work I would have died. My point is that side effects are not at all what I expected. I believe I will do very well on this treatment. Love and Good Night Ladies......Jenny

Surgery 3/5/2012 Lumpectomy: Right; Lymph node removal: Right, Sentinel Surgery 4/16/2012 Lymph node removal: Right, Underarm/Axillary; Mastectomy: Right; Prophylactic mastectomy: Left; Reconstruction (left): DIEP flap; Reconstruction (right): DIEP flap Chemotherapy 6/4/2012 Cytoxan (cyclophosphamide), Taxotere (docetaxel) Hormonal Therapy 10/8/2012 Femara (letrozole) Surgery 11/5/2012 Reconstruction (left): DIEP flap, Nipple reconstruction; Reconstruction (right): DIEP flap, Nipple reconstruction Surgery 3/16/2013 Reconstruction (left): DIEP flap, Nipple reconstruction; Reconstruction (right): DIEP flap, Nipple reconstruction Dx 11/30/2017, IDC, Stage IV, metastasized to bone, Grade 2, 1/15 nodes, ER+/PR+, HER2- (FISH)
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Jan 12, 2018 12:02AM Cure-ious wrote:

Spiced- The company says that the GI problems abate after a few cycles, so please let us know if it gets better as you go along!! We have high hopes for this drug!!

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Jan 12, 2018 12:09AM - edited Jan 12, 2018 12:10AM by ShetlandPony


I read recently that it is recommended that loperamide (Imodium) be taken especially for the first 28 days of one's abemaciclib treatment, to prevent severe diarrhea. And that once the body adapts, the loperamide can possibly be tapered off. I can't find the exact place I read this, but in the source linked below it says for the ESMO 2016 abemaciclib trial that "Patients received prophylactic loperamide concomitantly with abemaciclib."

https://medi-paper.com/esmo-2016-breast-cancer-pal...


I am following this thread, and fascinated. Cure-ious, thank you for the links. I have put them in my notebook. I'm pleased that I can add abemaciclib, possibly with Keytruda, to my list of future treatments.

Z, oh my, your daughter is one amazing eleven-year-old. Why does she have to access your port? No port-trained nurses where you are going?

2011 Stage I ITCs sn, premenopausal, Oncotype 16. 2014 Stage IV mets breast,liver. TaxolNEAD. Ibrance+letrozole 2yrs. Fas+afinitor nope. XelodaNEAD 2yrs. Eribulin,Doxil nope. SUMMIT FaslodexHerceptinNeratinib for Her2mut NEAD 1 1/2yrs. GI/perit mets Dx 2011, ILC, 1cm, Stage IA, Grade 1, 0/1 nodes, ER+/PR+, HER2- Dx 2014, ILC, 2cm, Stage IV, metastasized to liver/other, Grade 2, ER+/PR+, HER2- Hormonal Therapy Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Radiation Therapy Whole-breast: Breast Surgery Lumpectomy
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Jan 12, 2018 01:26AM letmywifelive wrote:

Z -

A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer (MORPHEUS)

I asked my wife's MO today about this trial at UCSF. Seems it is not ready yet but will be soon. The MO was not extremely enthusiastic about it though, since this is a immuno treatment for ER+ patients.

My wife recently progressed on Halaven. Her MO suggested her to move to Abemaciclib + Faslodex combo, assuming insurance approves it. Although she progressed on Ibrance + Letrozole before, we were told that a CDK4/6 combo with Faslodex can still work.

Dx 10/2013, ILC/IDC, Left, Stage IIB, 2/2 nodes, ER+/PR+, HER2- Dx 2/2016, Stage IV, metastasized to bone, ER+/PR+, HER2- Dx 1/2017, Stage IV, metastasized to liver, ER+/PR-, HER2- Radiation Therapy Whole-breast: Breast, Lymph nodes Radiation Therapy External: Bone Chemotherapy AC + T (Taxol) Hormonal Therapy Femara (letrozole) Targeted Therapy Ibrance (palbociclib) Hormonal Therapy Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Chemotherapy Xeloda (capecitabine) Chemotherapy Halaven (eribulin)
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Jan 12, 2018 08:39AM - edited Jan 12, 2018 03:51PM by zarovka

Shetland - The nurses are pretty amazing and trained in ports, but we're just not sure they use this particular port in Japan. To be sure, I am bringing the needle and the tubing with us and we're learning how to start it. Or rather, DD will learn how to start it. I literally blank out at the thought of stabbing myself with anything pointy that might produce blood. First lesson went well yesterday.

LMWL - I am happy to hear from you, although sorry about the progression. Knowing the team that you have, it's good to hear they are suggesting abemaciclib and faslodex. I also progressed on ibrance and letrozol. I hope that you hang out here and let us know how abemaciclib goes. It's really important that we gain some collective experience with this new drug.

Jenny - We're hanging on every word. Please check in periodically with your experience. So glad to find you are doing well, but we want to hear the good the bad and the ugly.

>Z<

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/16/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)

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