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Can Binimetinib Be Bought Within The Country?

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Posted on Thu, 26 Oct 2017
Question: Hi Doctor Rommstein,

I will start chemo tomorrow on two drugs.Encornfenib (BRAF inhibitor) and Cetuximab but not Binimetinib the MEK inhibitor.The oncologist says what I am receiving is proven and the MEK inhibitor was added in one of the trials to see if any improvements were noted by adding that drug.Binimetinib is not FDA approved.Should I try to get this or travel to another country to get this drug?

Thanks,

XXXXXXX

Hi Doctor Rommstein,
I think I told you the BRAF trial starts tomorrow and it is the two drug test cetuximab and Encorafenib.My daughtrer sent me this and it shows that adding the MEK inhibitor increases the results.She told me there is a
https://www.cancer.org/treatment/treatments-and-side-effects/clinical-trials/compassionate-drug-use.html#.WcnRCyHdHXI.email
which allows a doctor to request a non FDA approved drug to be used on a patient.Have you ever heard of this? Would I qualify? If so I could have all three drugs which seem to be the most benificial.
Thank you, XXXXXXX
doctor
Answered by Dr. Iven Romic Rommstein (45 hours later)
Brief Answer:
hi XXXXXXX

Detailed Answer:
Nice to hear you again.
It is positive that you are starting with chemo finally, and I hope there will be a good response. It can be expected lot from BRAF inhibitor. I think that at this point it is not necessary to have MEK inhibitor by all means. You can start with this BRAF trial and after reeavulation if disease progression is found, you can look for ways to get MEK inhibitor. COmpassionate trials are not available very easy,especially for colon cancer since there are many chemo protocols which can be used before MEK inhibitor is indicates as a last option. SO, before trying BRAF trial, you would not be eligible for MEK study. ALso, they will probably require for you to cover all costs of medication and application and I dont think this can be so much better than Encorafenib.
Above answer was peer-reviewed by : Dr. Prasad
doctor
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Follow up: Dr. Iven Romic Rommstein (2 hours later)
Hi Doctor,
Thank you.My first treatment is today.One hour of infusion and four pills twice per day.Side effects should be much better than Folfox.Folfiri and Avastin.

I hope someday to come and meet you.
XXXXXXX

Hi Doctor,

While i was being treated my CEA level was between 9-20.After surgery 3.0 On Sept. 12 5.3 (mew tumors appeared.Today <0.2.How is this possible?
XXXXXXX
doctor
Answered by Dr. Iven Romic Rommstein (1 hour later)
Brief Answer:
Please see the detailed answer below

Detailed Answer:
Hi XXXXXXX

Maybe we'll meet someday, who knows. If I come to the USA, I'll give you a call :)
I hope that you'll be fine with chemo side effects. Try to have easier diet, take antinausea medicines and be positive. This should be better than FOLFIRI definitely. I know it is not easy to wait for first chemo results and this expectation is very stressful period. I'll study your case a bit more and discuss it with my colleagues and if we find some new idea, I'll write to you.

This CEA level is bit surprising, but this is not something unusual and there is no some significance of this since tumor may express less CEA molecules, especially after so long chemo and surgical therapy. It may indicate in some cases less tumor aggressivity (and I hope this is your case), but also doesn't need to mean anything. So this should not affect treatment plan considering the fact that metastases are obvious.

Regards




Above answer was peer-reviewed by : Dr. Arnab Banerjee
doctor
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Follow up: Dr. Iven Romic Rommstein (26 hours later)
Hi Doctor,

These are the best lab results I have ever had including pre cancer.According to my last cat scan compared to my surgery on 5/24 10 lesions have appeared in my liver.If so how can my lab reports be so good and my CEA drops from 5.3 on Sept. 12 to <0.2 two days ago?

Thank you, XXXXXXX

Below are your labs from Tuesday. They will eventually appear in My chart-just not sure when.
Component Latest Ref Rng & Units 9/26/2017
1:44 PM
Glucose, Ser/Plasma 60 - 99 mg/dL 80
Sodium 134 - 149 mmol/L 143
Potassium, Ser/Plasma 3.5 - 5.0 mmol/L 3.7
Chloride 95 - 108 mmol/L 110 (H)
Carbon Dioxide 23 - 30 mmol/L 18 (L)
Anion Gap 6 - 15 mmol/L 15
BUN 7 - 20 mg/dL 19
Creatinine 0.5 - 1.4 mg/dL 1.0
GFR Estimate (Calc) >59 mL/min/BSA 75
Calcium 8.4 - 10.2 mg/dL 9.3
Bilirubin, Total 0.1 - 1.0 mg/dL 0.6
Total Protein 6.0 - 8.3 g/dL 6.5
Albumin 3.5 - 5.0 g/dL 3.9
Alk Phos, Serum 50 - 150 U/L 144
AST (SGOT) 8 - 37 U/L 25
ALT (SGPT) 8 - 35 U/L 24
Differential Method Automated Differential (Neutrophils include Segmented and Band Neutrophils. Bands . . .
Neutrophils 39 - 75 % 65
Lymphocytes 16 - 47 % 21
Monocytes 4 - 12 % 10
Eosinophils 0 - 7 % 3
Basophils 0 - 2 % 1
Abs Neutrophils 1.12 - 6.72 10*3/uL 2.73
Abs Lymphocytes 0.9 - 3.30 10*3/uL 0.88 (L)
Abs Monocytes 0.16 - 0.92 10*3/uL 0.42
Abs Eosinophils 0.0 - 0.6 10*3/uL 0.13
Abs Basophils 0.0 - 0.21 10*3/uL 0.04
doctor
Answered by Dr. Iven Romic Rommstein (21 hours later)
Brief Answer:
hi

Detailed Answer:
Well, you have really very good findings. There are normal values of liver enzymes which is surprising. This all is good sign, it means that you are fit enough for aggressive chemotherapy and liver tissue is still healthy enough to hold on possible future resections.
Above answer was peer-reviewed by : Dr. Raju A.T
doctor
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Follow up: Dr. Iven Romic Rommstein (37 minutes later)
Hi Doctor,

That is good news but what also is very puzzeling to me is my CEA.My oncologist for over one year has told me that is a very important bio marker for metasticized colorectal cancer.Not to predict but after surgery to see if the cancer may return.

During treatment it went from 20-9 while my tumors were shrinking down to 3.0 after surgery and tjhe 12th of September 5.3 and two days ago <0.2 also CA 19-9 <2 u/mL.They are performing another biopsy.The only one I had was in Ju\ne of 2016 when my colon was operated on.MD XXXXXXX sufggested this.Maybe something has changed.I was MSS not MSI H but now ASCO in XXXXXXX feels optomistic that there may be immunotherapy for MMS when previously it did not respond just MSI-H.I am also told by the doctors my side effects from these two drugs will be minimal nothing like Folfox/Folfiri/Avastin so I guess my hair will not fall out.If you ever feel I should come to see you for additional observation/testing I would be glad to.I understand my insurance would not pay but that is O.K.

Thank you for everything
XXXXXXX
doctor
Answered by Dr. Iven Romic Rommstein (15 hours later)
Brief Answer:
hi

Detailed Answer:
Yes, usually CEA levels are increased in metastasized disease. CA 19-9 is marker for some other tumors so it is irrelevant now. CEA may fluctuate and its value depends on expression by tumor. SOme subtypes of colon cancers may express less CEA molecules and generally these are less aggressive. Even though there is disseminated disease even after surgery/chemo, this is still may be slow progressing tumor and in every case, low CEA is good sign.
I dont think that we can do some other tests or give some better therapy at this point since you are treated in some of the best worlds institutions. If something come on my mind I ll discuss it with you, but at this point, all I can do is to give advice and recommendations. Side effects will be less intensive than those from Folfirinox protocols, but more important than hair falling, is to have less nausea, weight loss and pain.

Above answer was peer-reviewed by : Dr. Nagamani Ng
doctor
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Follow up: Dr. Iven Romic Rommstein (8 hours later)
Hi Doctor,

2017 Asco meeting XXXXXXX XXXXXXX

ASCO 2016 Preview: Checkpoint Immunotherapy Activity in MSS

Hi Doctor,

MD XXXXXXX saw something that they thought I should have another biopsy of the tumor.the only one that was done was in XXXXXXX 2016 when my colon was operated on.Even XXXXXXX XXXXXXX did not do a biopsy.I jhave asked my local oncologist to do one, XXXXXXX said if the cancer reappeared I should have some type of genetic profiling.Could it be there may be something now that would explain the CEA level.?


Would genetic profiling be helpful if cancer comes back? MD XXXXXXX recommended this type of profiling because they saw some "neuroendocrine" (vs adenocarcinoma) features in the initial pathology slides. (I'm not exactly sure what this means)

Hi Doctor Rommstein,

Thank you for your reply.I have no side effects yet just a little tired from time to time.Ascot which you may know is a conference bringing doctors in from all over the world to discuss new cancer treatments. MSI H in BRAF is much easier to treat and reacts to immunotherapy.THe Ascot convention was held in XXXXXXX in XXXXXXX and they found some promising evidence that a certain immunotherapy may work on my cancer MSS.Here is a video of the conference in case you have not seen it.There are also new trials for BRAF.I will send you a link of the meeting.

Lets assume the clinical trial works and my tumors shrink and my CEA and blood work is still very good.What would the next step possibly be?Can the BRAF gene ever be killed forever.I often wonder if there was follow up chemotherapy after my surgery to kill the microscopic cells if that would have worked or at least allowed an infusion pump to be used to keep the cancer from returning.

When I went to MD XXXXXXX they saw something and suggested at some point I should have another biopsy as the

Thank you,
XXXXXXX
doctor
Answered by Dr. Iven Romic Rommstein (35 hours later)
Brief Answer:
hi

Detailed Answer:
Hi XXXXXXX

Yes, you have probably heard of so called anti-PD1 drugs which showed some promising results in immunotherapy of colorectal cancers. These are found to be effective only in one subtype of cancers which is seen in minority of cases and in only 2% of people with metastatic disease as you have. Still, this is not 0% and this genetic profiling that you mention would be able to detect if your tumor s MSI-H subtype which is sensitive on immunotherapy.

But as I said, considering the course of your disease, this is not likely. But if biopsy can be taken laparoscopically then this can be tried. Then, the newest liver metastasis should biopsied since this is the one that may be MSI-H subtype.

It is possible that new population of cancer cells has developed in liver which didnt express CEA molecule so more than one tumor subtype may exist synchronously. It means that chemo may work for some of these lesions. We simply must wait and see.

If so called "tumor downstaging" occurs then we can thing of next steps and there are several surgical and radiological methods, but at thi spoint we must simply wait and we should not assume anything.

It is hard to expect that whole tumor will be killed, I would say that there are negligible chances for it, but tumor growth control and stabil disease would be excellent result for a start.

Also, there is no point of thinking on "would could have been if". Maybe if you were my patient I would have recommended some other treatment strategy and more precise long-term surgical-onciological plan, still you have nothing to regret and I believe that your doctors gave their best and had their decision based on newest scientific results. Also, I didnt have all documentation, images and insight into your condition and of course I am not someone with such expertise as doctors in XXXXXXX or mayo are.

Regards
Above answer was peer-reviewed by : Dr. Kampana
doctor
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Follow up: Dr. Iven Romic Rommstein (10 hours later)
Hi Doctor Rommstein,

My local oncologist has ordered tissue samples from my Mat 24th liver surgery.I assume these are what you feel are necessary to determine if the initial biopsy has changed.I will also go to XXXXXXX Kettering, Doctor XXXXXXX Yaeger whio has been involved in mny BRAF clinical trials.According the the ASCO meeting in XXXXXXX of 2017 they saw promising poterntial in immunotherapy for MSS.

Thank you,
XXXXXXX

Hi Doctor,

It seems like there are many different tests that are available to determine what type of cancer you have.Is there a particular one I should ask for?

This recommendation is consistent with that of the National Comprehensive Cancer Network, which “strongly recommends genotyping of tumor tissue in all patients with metastatic CRC for RAS (KRAS exon 2 and non-exon 2; NRAS) and BRAF at diagnosis of stage IV disease.”40 Historically, testing for molecular alterations in patients with CRC was performed via molecular testing of individual genetic alterations in KRAS. Given the need for molecular analysis of multiple genes, including KRAS, NRAS, and BRAF, more comprehensive molecular testing is needed.41Options can include mutation-profiling assays to identify “hotspot” mutations that are seen frequently in these and other oncogenes, using technologies such as Sequenom™ mass spectrometric genotyping and polymerase chain reaction-based assays.42–44 Another more comprehensive option is the use of next-generation sequencing technology in targeted panels of important cancer-associated genes, including BRAF, KRAS, NRAS, and hundreds of others, to identify mutations as well as gene amplifications, deletions, and fusions.45–47 The clinical significance and treatment implications of many of these findings remain unclear in the standard care of patients with CRC.41,45–4

Thank you,
XXXXXXX
doctor
Answered by Dr. Iven Romic Rommstein (2 days later)
Brief Answer:
follow-up answer

Detailed Answer:
Hi,

Yes, genetic tests are valuable in some cases. I need some time to evaluate your question and future options with my oncologists and then I will answer more precisely.

Thanks for understanding


Above answer was peer-reviewed by : Dr. Arnab Banerjee
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Answered by
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Dr. Iven Romic Rommstein

General Surgeon

Practicing since :2008

Answered : 13870 Questions

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Can Binimetinib Be Bought Within The Country?

Brief Answer: hi XXXXXXX Detailed Answer: Nice to hear you again. It is positive that you are starting with chemo finally, and I hope there will be a good response. It can be expected lot from BRAF inhibitor. I think that at this point it is not necessary to have MEK inhibitor by all means. You can start with this BRAF trial and after reeavulation if disease progression is found, you can look for ways to get MEK inhibitor. COmpassionate trials are not available very easy,especially for colon cancer since there are many chemo protocols which can be used before MEK inhibitor is indicates as a last option. SO, before trying BRAF trial, you would not be eligible for MEK study. ALso, they will probably require for you to cover all costs of medication and application and I dont think this can be so much better than Encorafenib.