New Drug: Gilotrif - Any Experience Yet?

[Guest johnrandazzo]

Hello Everyone -

I am writing in to ask if anyone has yet had any experience with a new Chemotherapy oral drug, Gilotrif?

My mother, who was diagnosed with Non-Small Cell Lung Cancer in 06/2013 has been identified as a #1 drug choice as per her Foundation One Genetic test on her tumor type.

She did not have much success with the first line treatment chosen which was Carboplatin/Taxotere. Her radiated areas did respond for the most part, but the Chemotherapy drugs did not really act on her cancer cells well.

This new drug seems very promising, but it really has some major side effects like any other drug, but I am just wanting to see if there is any experience with it out there yet.

I appreciate you all more than you know... I will admit this is my first post, I have been really just reading your inspiring words, and so many questions have been answered for me just by reading through this community - so I thank you from the bottom of my heart.

John M. Randazzo

My mother Marie Randazzo

[RandyW]

anyone hear of this new drug?????

[Guest johnrandazzo]

Thank you so much for your kind words and thoughts! We had originally started this road with Chemotherapy in the form of Carboplatin and Taxotere. She had a really strange type of cancer and metastases. Initially it started back in May, 2013, in which she came home with a "bump" on her head that was not going away. After seeing her primary we originally thought it was a hematoma from her bumping it at work, but when another one appeared just next to it, we finally had a biopsy. The first turned out to be a Squamous Cell Carcinoma, and was treated as such with a Mohs surgery. On that day of the Moh's surgery, the other newer bump was biopsied, and after that came back, it was another Squamous Cell, but this time poorly differentiated. When that Moh's was done, it was such a large and agressive site, that it was touching her skull bone.

This really concerned all involved at that point and she was sent for an Oncology consult in June and after all testing, it was confirmed that she had a Squamous Cell Lung Cancer, with metastases to her right femur bone, the right pariteal scalp area (where the most agressive squamous cell was), her L5 area, and minute area in her gluteal muscle area.

We were unbelieveably overwhelmed. Nonetheless we started treatment immediately. The plan was to use the Carboplatin and Taxotere weekly, along with Radiation to her Femur Bone which greatly stopped what was at this time her only pain. There was also radiation to the Right Parietal Scalp area, and the L5 area.

In between all this, I did have a second opinion completed, and he agreed that the treatment seemed sound at the time, though he indicated he would not perhaps have started "with those drugs" but admits that those were a standard for lung cancer. He did tell me though, that he would for certain order a genetic test on her tumor type.

We did in fact decide to order that genetic test from Foundation Medicine, and they ran it on the metastatic site that was seemingly the most agressive (the second scalp area).

After 9 Chemo treatments and the radiation treatments were complete, we recently had another full body PET Scan, and MRI to her Chest and they found that the Chemo treatment was not effective. Though the lung mass did not enlarge, it was still active, and now, there were new metastatic spots behing her left thigh, and at her groin area.

We were just a mess... I cannot believe all this happened so quickly....

In any case, right about this time, the genetic test came back and identified her tumor type to be that of the EFGR mutation, and it showed the Gilotrif as a potential #1 drug for treatment. Interestingly enough, it did not show Carboplatin or Taxotere anywhere on the report...

There were other secondary drugs listed to try but that they were not specific to her tumor type...

As of now she is in alot of pain behind her left thigh, and the groin area, so the Radiation Oncologist is treating those areas NOW. He is also finally treating the lung as well.

I can never really understand WHY (or could never really get an answer fully) about why the lung was not radiated in the beginning anyway...

So ALOT of work later, we have finally gotten the Gilotrif, but this was after 3 appeals, and after me personally contacting the Boelinger-Ingleheim's CEO and making an enormous plea to get these pills. (They are in pill form).....

So we will start the pill in the next few days, and I am praying, hoping, as everyone, that this will start to get this under some better control...

She has been so strong through all this, I just hate the painful areas right now. So I am hoping the radiation will sort of kick in soon.... This is so hard, and although I feel like this has felt like about 3 years so far and really it's been only 5 or so months, it's just so hard...

I am thankful that there are places like Lungevity to share the hope with and to have such wonderful people to share with.... I am very appreciative of you and thank you for letting me share...

John Randazzo

[dianew]

I'm so sorry that your mom is going through this and I hope the radiation quickly takes care of the pain. She has been through a lot in the past 5 months, but it is good news that she has an EGFR mutation. As a rule, they don't usually expect people with squamous cell to have the EGFR mutation, and some doctors don't even encourage testing for squamous cell. I am very glad you have posted your mom's story as it shows that you just can't assume anything - there are always exceptions and if you are one of those exceptions it can mean a lot. I hadn't heard of Gilotrif, so the fact that there is another treatment option available is great news. I know they all have side effects, but not everyone suffers from all of those - some people just breeze through, and others just have a few issues. Hopefully your mom will have an easy time with it and a good response.

Please let us know how you are both doing.

[Guest johnrandazzo]

I'm so sorry that your mom is going through this and I hope the radiation quickly takes care of the pain. She has been through a lot in the past 5 months, but it is good news that she has an EGFR mutation. As a rule, they don't usually expect people with squamous cell to have the EGFR mutation, and some doctors don't even encourage testing for squamous cell. I am very glad you have posted your mom's story as it shows that you just can't assume anything - there are always exceptions and if you are one of those exceptions it can mean a lot. I hadn't heard of Gilotrif, so the fact that there is another treatment option available is great news. I know they all have side effects, but not everyone suffers from all of those - some people just breeze through, and others just have a few issues. Hopefully your mom will have an easy time with it and a good response.

Please let us know how you are both doing.

THANK YOU so very much for your kind words Diane - they mean ALOT! I am really so HAPPY to have found this forum... What beautiful people and support!

[Guest johnrandazzo]

Just in case anyone else is starting or on Gilotrif....

My mom has been on the Gilotrif since 10/16/2013. It's really hard to know if it is doing what it needs to as we have not gotten any more scanning as of yet and the Oncologist tells us (as well as what I have found out from the clinical trials) to wait about 6-8 weeks for it to even start to work....

Side Effects: I feel like she has gotten most of the side effects! In the first 10 days, she started with Diarrhea this has been very well controlled, though, with Immodium, and when she does have it, it occurs usually no more than 2 times in a day. I think we have found that pushing the extra fiber and giving metamucil may help but not totally sure.. It may be coincidence but she has not had any for over a week now... Over the next few weeks she started to have some NAIL issues with them becoming a little dry and subsequently crusted on the edges of two if them. The Eucerin Lotion and Neosporin helped with this. She then got HIVES at different parts of her body.... Originally we thought it was the addition of Folic Acid because every time we took the new Folic Acid away, they stopped, but the Oncologist insists its from the Gilotrif... That's another conversation! Anyway, for the Hives, we had some good relief from using AVENO Calamine and Premoxine HCI Lotion over the counter... We rubbed this all over and it's like an eraser to the hives! What finally stopped the hives, though, was the addition of 24 hour Zyrtec at bedtime.

So here we are about almost 6 weeks into it, and she is stable with her side effects.... I am just hoping that this is doing something in her! I hate the not knowing part....

As a summary this is what we are doing for her symptoms:

DIARRHEA: 1st Loose Stool = 2 Immodium, followed by 2 Gatorade Bottles, and general increase in fluids (water, popsicles, jello) NO DIET CHANGE

2nd Loose Stool = 1 Immodium, followed by another bottle of Gatorade or Pedialyte, and general increase in fluids (water, popsicles, jello) NO DIET CHANGE

3rd Loose Stool (rare for us) = 1 Immodium with another Gatorade and change over to BRAT diet for the rest of the day... I pretty much give her White Rice and Chicken Broth for the duration....

SKIN ISSUES: The KEY is using Lotion daily... We use Eucerin all over her body. We have also used COPIUS amounts of Vaseline with socks over them at night on her feet since they were already DRY!

For HIVES: Try the Aveno used for Poison Ivy/Oak lotion. It has Calamine Lotion and Pramoxine in it. Lastly we had great success keeping the hives completely away (so far) with adding Zyrtec 24 hour at night.

FOR LIPS: We are using Vaseline on her lips as it seems to help the best...

FOR NAIL ISSUES: We are making sure to keep them SHORT! (The Gilotrif is GROWING her nails!) and clean and lotioned.

Hope this helps some.... I would be more than happy to be contacted for more questions, but EQUALLY more happy for you to share your experiences and keep this conversation going.... I hgave found that on occasion I know more than the doctors from my reading and keeping in touch with the company Boelinger/Ingleheim. I keep in close contact with a nurse at Solutions Plus every week without fail about her side effects, and I also am able to talk to the medical team while on that call if I have technical questions... This has been a tremendous help...

Since the drug is so now, I find that the support staff in the doctors offices are a bit vague on things...

Thank you all for your support - This is so tough... but with discussion areas like this, somehow I get greater comfort from feeling helpless and alone.... Much love to you all and god bless....

John Randazzo

[AnnH]

I have been battling adenocarcinoma for 2.5 years. I had two surgeries so ultimately my left lung was removed. I went through two rounds of chemo as adjuvant therapy. Now there are nodules in my right lung. My doctor is starting me on Gelotrif this week. I have two EFGR gene mutations-T790M and Leu858Arg. They've told me about side effects but I don't know anyone who is on this drug and would like to know if someone has experience with this drug. Thanks.

[RandyW]

thanks for sharing this with us also.. is nice to have the knowledge and experience of people who are trying new things in the field these days.... very important for new patients as well....

[AnnH]

I've been on the Gilotrif for two days and so far haven't had side effects. The docs have me on a low dose antibiotic to help with the rash that they tell me will develop. I also expect diarrhea but it hasn't shown up yet. I know there are usually nail and cuticle issues on the hands and feet so I'm using a good moisturizing lotion on both when I go to bed and hope it helps. Other than that I'm hoping I'll be able to function somewhat normally. I'll have a scan in two months to see if it's having any effect. I'll post my experience. I hope it might help someone else in my situation. I know there's a lot of current research in targeted therapy with gene mutations so there is some hope.

[RandyW]

thank you so much for sharing this.. with new drugs most of us do not have the knowledge of side effects to guide people.. every little bit shared helps..... Very much appreciated.....GOOD LUCK in continuing forward!!!

[Gage]

I've been on Gilotrif for 3 weeks now.  I've had the trifecta of side effects; diarrhea, rash, and sore mouth.  That said, I'm feeling better overall.  Rib cage pain went away after only 3 days, I'm not short of breath, sleeping well and energy level is up. 

Diarrhea comes and goes.  My oncology nurse told me, after a long bout, to take 2 immodiums followed by 1 every 2 hours for up to 48 hours.  That's way more than the package recommends but who cares since it works.

The rash is mostly on my face and scalp, but it seems to be on the decline.  I sleep with cold packs on my head.  I'm taking doxycycline.  I'm told it has some not understood rash benefits beyond what would be expected of an antibiotic.

Mouth sores are not too bad although I haven't been able to have an alcoholic drink in quite a while because it makes my throat burn.  Remember Brandy Alexanders?  I tried one last night and managed.  I use a prescription called "Magic Mouthwash".  I also use a homemade mouthwash made of 20 ounces of water with a teaspoon each of sea salt and baking soda.

My Gilotrif is the 40 mg strength which is the strongest.  Doctor says we can reduce the dose or even take a pill vacation if the side effects aren't tolerable.  So far, so good.

Someday we'll "do a scan" but  we already know Gilotrif is working because I feel so much better.  Also someday "the cancer will find a way around the pill, but who knows - maybe there's  be a new pill by then".  The quotes are from my oncologist.  I like his attitude.  He told me at our first meeting that even though I quit smoking 40 years ago, "I had smoked enough".  After the biopsy he had to admit that my cancer is only seen in non-smokers.  So there!

The Gilotrif website describes a clinical trial between Giltotrif and chemo.  Gilotrif patients averaged 28 months of progression free survival so that's my current planning horizon.

I'd like to keep posting as time goes by and I'd love to hear how it's going for others.

[BobbieA]

Hi Gage, thought I would share that I have been on Gilotrif since December 2015 and today received results from the scan I had on Monday. The primary tumor in my right lung is gone. For some reason my onc didn't order a scan for my abdomen as he usually does, but nothing was seen in the liver or spleen areas they could see where I had mets when dx. I started on 40 mg. which was adjusted to 30 mg. in March.  According to reports online the efficacy of 40 and 30 mg. is about the same. And the side effects are much more tolerable at 30. I think that the progression free survival average is about a year rather than 28 months. And, there is a new pill after Gilotrif. 60% of patients with acquired resistance to Gilotrif are positive for T790M mutation and can be treated with Tagrisso. I, too, am a former smoker. I quit 34 years ago, the day my mother-in-law was dx with lung cancer.  She survived 8 months. You should definitely have a scan about every three months. My first after starting treatment was at two months. I was like you, I knew it was working as my symptoms quickly improved. May we continue to do well!

[Gage]

BobbieA, thank you for your posting and congratulations on your latest scan!

You've given me a lot to think about.  I immediately went back to look at my biopsy results and didn't see anything about a T790M mutation.  What it did say was - "A deletion mutation is identified in EGFR gene, exon 19 between codon 746 and 750. The presence of EGFR E746-A750del5 mutation is reported to correlate with responsiveness to EGFR tyrosine kinase inhibitor therapies in patients with non-small-cell carcinoma." 

Do you think that you will move on to Tagrisso at some point?
 

[BobbieA]

Hi Gage,  When the time comes that there is progression while on Gilotrif, you will have a new biopsy to check for the T790M mutation.  My onc told me they will do a liquid biopsy (blood draw) first and if that comes back negative (there can be false negative results) they will do a tissue biopsy.  I have the same dx you do, EGFR+ Exon 19 deletion.  Gilotrif is most effective if you have the Exon 19.  If you google Tagrisso, you will find out more about it.  No point in worrying about whether or not you will have the T790M.  Enjoy the time Gilotrif is giving you!  But educate yourself so you will know what options are out there, don't depend entirely on your oncologist to know everything.  Are you on Facebook?  If so there are a number of cancer organizations to follow, including Lungevity, that post a lot of information about new treatments.  Lungevity also has a Group for patients with the EGFR mutation. 

[Gage]

Thanks again, BobbieA.  I've taken your advice and asked to join the Lungevity EFGR group.

[Tom Galli]

Gage,

Welcome here!

I'm glad you found someone who has experience with Gilotrif.  When I was administered an EGFR inhibitor (Tarcevia), I also experienced severe and bothersome diarrhea.  On complaining of this symptom on an cancer blog, a survivor suggested I eat a bowl of plain steamed rice first thing every morning (even before having a drink of water).  I added just a little salt for flavor and the rice did the trick.  My Tarcevia laughed at Imodium but respected the rice.  I could eat and drink normally and sleep soundly at night.  One more thing, you have to use the real-deal rice.  Minute rice or other instant brands of rice did not work.

Stay the course.

Tom

[Gage]

Tom, I'm eating a plain bowl of steamed rice...  a little warm milk and some sugar would be better but I'll try it your way.

I'm reminded of when we lived in Japan.  If we were staying at an inn they'd ask if we wanted an American or a Japanese breakfast.  The American one would have toast and fried eggs but for some reason they'd cook it the night before and serve it ice cold.  If you went for the Japanese breakfast you'd get a piece of dried fish and a bean dish called natto.  Natto was stinky, slimy fermented beans.  I bet it could stop diarrhea too...

[Tom Galli]

Gage,

Sounds like Natto would stop anything.....

Stay the course.

Tom