Nerlynx Approved by FDA to Treat Early-Stage, HER2-Positive BC
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So I went through the process of getting and taking Nerlynx after it received FDA approval. I heard about the drug receiving FDA approval so I brought it up with my onc. She told me at my stage she wouldn't recommend it due to the side effects, but she would let me do what I felt like I needed to do. I have recurrence anxiety so I decided I would try it. My philosophy during treatment is that if my cancer came back wanted to be able to say I did everything I could to fight it. I thought if the side effects get too bad I can quit. I obtained the drug through Walgreens specialty pharmacy. So I took it on a Thursday. As someone mentioned you have to take the Loperamide three times a day to go with Nerlynx each time you take it. the first couple of days I was fine. I was like this won't be so bad. Then the six day came, and it was awful. When I say everything ran through me, everything ran through me. My body wouldn't hold anything. It was violent diarrhea. It was so bad I was worried I was becoming dangerously dehydrated and might have to be hospitalized. I can't say I wasn't warned about the side effects, I just thought with the Loperamide they would be manageable. I should say I've had diarrhea before numerous times. This was a million times worst because it was un-treatable for a couple of days after I quit Nerlynx. I basically decided to quit the medicine, which my onc agreed with. Everyone has to do what's best for them, but for me those side effects weren't worth it. I'm hopeful that my treatment protocol was enough to keep my cancer at bay. I just wanted to give my perspective since I did take Nerlynx, albeit for a week lol. Maybe I'm an extreme outlier but this medicine was worst than anything I experience while undergoing chemo. I think it's awesome this drug is a new tool in the arsenal for battling HER-2 positive breast cancer, I just wish there was a drug with less strenuous side effects.
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Wow Nclark - and yikes! Curious, during the days of awful big D, did your MO upgrade you to lomotil or just keep you on the imodium which wasn't working? Also your 'signature line' doesn't say what targeted therapies you took. I'm guessing Herceptin, to be eligible for this, but did you do Perjetta also? WARNING - I'm now going to get graphic, as I am supposed to start next week. If so, did you have 'd' or 'the big D' with it. For the D with Nerlynx, was it painful, or just like peeing out your bottom? If you had Perjetta, did the 'D' burn your bottom? Did it permanently stain the underside of your toilet seat? What about Nerlynx? Also, how did you avoid being hospitalized for dehydration.
Tadover - you too are a July 14 chemo sister, thank you for your willingness to be part of the trial. Do you have any insight? I'm on a FB page about Nerlynx and people are saying take it with a protein shake. Did you have the nausea too? When did you take it (am/pm)?
I'm stressing over starting this and could use all the information I can get - THANKS!
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Ding dong here - I now see the Herceptin under Targeted Therapies... So sorry for the confusion Nclark
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knmtwins - I took it in the mornings with breakfast usually. I had a little nausea when i first started taking it, but it tapered off. Sorry I can't be more helpful. I actually started feeling better when the Imodium was reduced. I stopped taking the Imodium completely as soon as I could. But the nurse coordinator at my facility said I was the only one of her patients to do it, and most were unwilling to even try. I think my system is just completely different from most folks, I seem to be opposite from everyone else.
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LKC,
Can you shed some light on the quality of life for the patients who had to manage the major side-effect of diarrhea. Do you have any patient stories?
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Thank you for sharing this Nclark6. I am sorry to hear your story but at the same time this helps many of us understand that new treatments are not always the best. I hope alternatives work for you and you stay strong and healthy.
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Hi! Following this is as my onc has mentioned this Med to me. Curious how other ER- folks are being advised? Is there anyone hormone negative who is now taking this and what is your onc saying about the study results?
Thanks
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We had the patients start the drug and Imodium simultaneously, which helped. Sometimes doing down on the drug was indicated.0 -
Guys, so thankful for this thread. Synopsis, my DD has stage IV ER+PR+HER2+ FISH positive Her2neu. She is 33yrs old, a young mom. I am at the stage IV thread mostly, she is very assertive and lively young woman, but does not wanna deall with this monster details, so that's where i come in. She totally depends on me to get her on the right track.
She was on most treatments i'd say, even being on 2 trials this year already. Last week she had Hematuria, grossly ignored and mismanaged by her doctors and Hospital, but because of her symptoms after much suffering they ordered a CT and then they saw progression from just 3 weeks ago. They were able to cauterize the area, they took a biopsy they said it's a benign Hemangioma. She is off that trial. Onco left her high and dry, this is a chapter on it's own.
Current homework and hopefully new doctor, is recommending Neratinib. Actually they mentioned it would be on it's own, not with Herceptin. She has been on Herceptin for over a year at least, till June when she entered this new trial. And Xgeva. She is scheduled for a new PET/CT this week and Brain Mri. Her mets are in the brain also. Maybe maybe they would look into Keytruda instead. Was anyone here, that was offered Neratinib also had maybe a chance to be on Keytruda and opted one over the other?
I sure hope the Insurance won't give it hard time to confirm. I am very freaked out - BTW for you ladies that were offered this drug, is this something that is being offered sooner than in treatment, and not waiting for it to be a salvage tx?
The former Onco is not even bothering to follow up, my DD is so stunned that as soon as the heat is on, they are running away. Shame shame
Tadover thanks for being in the trial – good luck for u
Nclark, thanks so much for the heads up, so sorry it was so hard for u. What could be the right dosage for lomotil?
Knmtwins u made me laugh!! Big D or little d. Graphic is important, it's the reality, and it could help others.
I only read the last page so far, any info is gonna be great. Thanks.
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Also Neratinib is not the same as ONT 380 right?
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momallthe time - Neratinib is an FDA approved drug, which has now been approved to be given to early stagers after completion of their year of Herceptin - thus the announcement by the Mods and this thread.. The way it is administered for stage IV patients could be different and possibly in conjunction with other targeted therapy or chemotherapeutic agents. I am sure hoping it does some good for your daughter and that you can get the doc situation straightened out for her - you are doing a great job in difficult circumstances. ONT-380 - or Tucatinib - is an investigational drug, but has not been fully approved yet and is still in trials. Like neratinib, it is also a tyrosine kinase inhibitor. Here is some info on it:
https://www.sciencedaily.com/releases/2017/01/170111091449.htm
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Hello: ER/PR- Neratinib taker update.... I started about 1.5 months ago. My major complaints are fatigue and D. Fatigue: I was dead tired for several days after starting. Super fatigue, which has weened down a lot. I started drinking caffeine again
I took the 6 immodiums, but that was too much. I took none, that was too little. I think 1 a day is about right for me. Do I still have "oh crap" moments? Occasionally, but it really is manageable. My not obvious SE is high liver emzymes (AST, ALT). They are obviously from this medicine, but not dangerously high. My MO is keeping a close eye on me. I suppose if they get to high, I'll quit. I would encourage people to try (I'm not a doctor, just saying if you want to try but are scared of SE's). While its not the best time I could be having, the SE's are and tolerable (for me) and its short term in hopes for a longer future. I still don't know if this will do anything for my hormone status but as someone mentioned I have to try everything I can. So, 10.5 months to go!
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hi--i asked my oncologist about neratinib. She said that she isn't giving it to ER negative patients and the benefit is for ER positive patients only. Please let me know if the oncologists of any ER negative ladies is saying that it gives ER negative ladies benefit --if so, i will ask my oncologist again with this information
Thank you all ladies for sharing your experience
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I am ER- and my onc has talked about me having it. I will also clarify with him because I am not really confident that he has read all the info on it and I have seen mixed messages up here.
I'll see him again in another 2 weeks, so I'll be sure to ask him then.
Hoping others will comment as this is a big question for me
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I am ER-. My oncologist is part of the trial study team for this drug. She has recommended this drug as being beneficial to reduce my risk of recurrence
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I am triple positive and started this drug 10 days ago. My doctor gave the Imodium dosing instructions to take along with it that are recommended by the manufacturer. I did not have a problem with D so I tried cutting back and eventually stopping the Imodium on my own. So far so good. I do have a lot of queasiness through out the day. This second week I've had some pretty extreme fatigue as well... which sucks bc I feel like I'm on chemo again. Hoping it subsides as my body adapts to it.
The worst part for me has been uti symptoms. I tested negative for infection and usually don't have a problem with them. The nurse told me it was basically from the chemicals being so potent as they pass through my urine. I was given Pyridium to ease the pain but I'm finding that it's not working very well. I know I never drink enough water and the nurse advised me to work on that so I'm trying. Hoping it improves so I can finish the full course treatment. Just wanted to share for anyone wondering about SEs. :
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If you haven't already, join the FB Nerlynx group. Hope to see you there!
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I was diagnosed with Stage I DCIS/IDC, Left breast, 1cm, Stage IA, Grade 3, 0/4 nodes, ER+/PR+, HER2+ on November 7, 2016. I went through six rounds of Carboplatin (Paraplatin), Taxotere (docetaxel), and Herceptin and then 11 more Herceptin infusions. I am about to finish my last Herceptin infusion on November 10, 2017. I also had a lumpectomy in May 2017 and short course of radiation (16 treatments with 4 boost). I also currently started taking Tamoxifen in July 2017. I responded well to all of the treatments and even had a complete pathological response from the lab work from my lumpectomy. I had very few complications and feel 100% again.
I though that I was coming to the end of my year of treatment and now my oncologist is recommending that I start Nerlynx in December for a year. I am not sure if I should take it. The drug was just approved in July 2017 and I don't know what patients experience with it is. Is there anyone else that is HER2+ that has been perscriebed Nerlynx and can tell me what to expect if I decide to go on this drug regiment?0 -
I met with my MO today for a 3-month followup after my final Herceptin treatment. He did not mention Nerlynx but I asked about it. It took him a minute to recognize what I was asking about. He described it as having just come into approval within the last couple of months. He did not have any patients taking it yet but recalled hearing that it may be beneficial.
We left it that he's going to research it more and we will talk early next month.
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I finished herceptin in Feb 2016. When I saw my onc today for a 6-mo follow-up visit she told me about Nerlynx & recommended it for me. She said even though I am ER/PR neg, it would potentially cut my chances for recurrence by about 32%, especially since I also had a positive node at dx. She told me that it helps those who are ER/PR pos even more, but that it does benefit those who are ER/PR neg as well. She participated with & had patients who were part of the trial. She gave me info to read & as soon as I got home today, I started reading this site to get the full scoop as far as SEs, etc. I'm leaning towards giving it a try if my insurance covers it, no way I can afford it if it doesn't
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Misslil. I agree with you. I had BC 18 years ago, her2 neg. here I am again. Her2 positive this time. I am a nurse, my chemo nurse is two years post diagnosis, same diagnosis as mine, meaning stage, etc.She is taking nerlynx and I will too. She gave me a heads up on the diarrhea. I am a visiting nurse without access to a bathroom for immediate need. I will at least try nerlynx. I do well in the SE department so I will hope for the best. I also had precancerous issues due to tamoxifen. I feel the need to take whatever I can to not face round three! One is enough for anyone.
Tadover thank you for participating in the trial.
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Interesting info. I am past the 2 years and also ER/PR negative, but always good to follow new treatment protocols. Below is a link for an oncologist opinion posted yesterday in Forbes. It appears she is mostly negative about the drug, but I am unable to access page 3 to see the final conclusion. Can anyone else see the final conclusion?
https://www.forbes.com/sites/elaineschattner/#29b1...
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BTW - Along with lots of other people, I don't so Facebook either. Thanks to those of you who are keeping the discussion going on the BCO threads.
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MinusTwo. Just sent you a pm with page 3. Now I am on the fence again...
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Kim: Thanks. Sounds like it's a better fit for those who are ER/PR positive. I too had a recurrence. That definitely makes us look at things differently. I did the first 6 rounds with Perjeta included and lost 60 lbs due to diarrhea. When do you finish the Herceptin? Please do keep us in the loop as you make your decision
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I talked to two oncologists around the time that Nerlynx hit the market. Neither recommended it for me. I was in agreement as the benefit didn't seem like much considering the potential side effects. Both doctors said that at this time they were recommending it for patients who did not have a good response with chemo/Herceptin/Perjeta. I had a good response, not complete but almost. It will be interesting to see how this plays out over time
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Minustwo, yes, I agree with you about Facebook and appreciate the posts on BCO.
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You are welcome MinusTwo...I will definitely keep you in the loop as to what I do. I am ER/PR positive as well but will be on an AI after Taxol. I have only had 4 of 12 weekly Taxol/Herceptin so far. Then will continue to a year every three weeks with Herceptin once Taxol is finished. Today is 3 weeks and 2 days since first Taxol and had to buzz the hair off today - coming out in clumps
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I'll have to see of course what my MO says. My thought on the D issue is if that happens with me, it may be controllable based on what the study results seemed to show. Or worst case I could drop out of the drug.
I'm meeting with my MO in early December. One thought that has occurred is trying it around the holidays (I know, lol ugh) where if I have D issues I'd be more at home than at work, and able to experiment to see if I could get it balanced between the drug and imodium or other recommendations. I did have D issues during TCHP especially the middle rounds, it tapered off toward the last couple treatments. It was not great, but it was mostly in the mornings and did not affect me if I went in late to work after taking some extra time at home to get through it.
One goal in 2018 is to travel as I was not able for a year going through all the BC steps. With this is if it does induce D episodes, am curious if you could you take a break from it for a week or two then resume later. Would that mitigate the D for important times, would it breach the effectiveness?
Looking at the Forbes paper and quotes like this: "The question for patients with early-stage HER2+ breast cancer is if it's worth taking a treatment (Nerlynx) that lowers the risk of distant recurrence by less than 2% at 5 years, and which has not yet been studied over the long term."
If you think you are in the 90% who are fine after 2+ years - the improvement probably seems marginal. If you think you have a significant risk of being in the 10% bad luck situation, the improvement benefit strikes me as a lot better. If 10% have odds to recur with invasive disease and that reduces by 2% in absolute terms, it's a 20% reduction in the unfavored group. And then some subset of that risk is "distant recurrence" which would extremely serious / life-threatening, so the chance to reduce risks of that outcome would be very valuable.
Or am I looking at this wrong.
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Just chiming in here to ask if you have been diagnosed with early-stage (I-IIIC) HER2+ breast cancer, would you consider taking this 5-10-minute survey to help us understand your feelings about risk of recurrence? https://outins.az1.qualtrics.com/jfe/form/SV_dnHqm55c5qWzRlz
Thanks so much!
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