June 21, 2019 at 3:49 pm #25379
Melanoma Network of CanadaKeymaster
The Melanoma Network of Canada (MNC) is gathering information from patients diagnosed with cutaneous Squamous Cell Carcinoma (cSCC) to help prepare a group submission to the pan-Canadian Oncology Drug Review (pCODR) on the experiences and opinions of patients and their caregivers for a new treatment therapy being proposed for patients. The drug under review is cemiplimab (Libtayo) which is an anti-pd1 immunotherapy indicated for the treatment of patients with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or curative radiation.
Cutaneous squamous cell carcinoma (cSCC), is one of the most common types of skin cancer and is generally treated through topical aids, surgery or radiation. However, in certain cases, the cancer can spread and become life threatening. A drug review is imminent to assess whether provinces should fund this new breakthrough immunotherapy cemiplimab (Libtayo) for locally advanced or metastatic cSCC patients.
If you are a patient or caregiver your point of view will make a real difference and help inform decision making for (cSCC) patients in Canada!
July 4, 2019 at 2:21 pm #25550
Hello, my family member begins cemiplimab treatment next week for locally advanced CSCC. Since the manufacturer’s clinical trials and US FDA approval last fall, do you know of any recent information about treatment and outcomes? Thanks!
July 4, 2019 at 3:53 pm #25551
Hello and thanks for your question. I am glad you found us! We have Health Canada approval of the drug therapy now since April. However, this generally only means that if it is prescribe, people can pay out of pocket for it, as it has yet to go through the reviews to determine if the provinces should cover the cost. Fortunately, the drug company has provided compassionate access in the interim, which is absolutely great news for patients and family members affected by this disease.
Anecdotal accounts from patients we have been in contact with has been a real eye opener. I am absolutely amazed at the results we have seen from people that had horrible, debilitating and life threatening spread of the disease. And then to see pictures of them only months, and sometimes, weeks later that show almost clear of the cancer. It is truly beyond words. Not everyone is going to respond, as is the case with most drug therapies, but this is the first therapy that provides hope and may lessen reliance on disfiguring surgery and radiation.
The most recent information about clinical trial results would have been presented last month at the meeting of the American Society for Clinical Oncology (ASCO) and in summary, this information was released by Sanofi about their trials:
It shows that complete response rates are between 13 and 17% and partial response around 32%. So overall response rates are between 45 and 50% approximately. This is significant progress in the treatment of this disease where nothing else has really worked to control or eliminate it.
I hope you will take the time to complete our survey to help us gain coverage of this treatment for patients in the future and I really hope your loved one responds well. So far, most side effects that we have heard of directly from patients is flu like symptoms, aching joints and fatigue but so far all of them would recommend treatment and found side effects very manageable. If your family member would like to speak with someone that has been on therapy we can arrange it through our peer support. Or if you would like to be connected with another caregiver, let us know as well. Best to your family.
July 9, 2019 at 3:49 pm #25592
Thank you very much, Annette. It’s lucky that I browsed back to this site (after just receiving a standard form email from Jane about the survey, which I had done already — unless I managed to untick the notify box, there is no notification sent of replies in the forum, just fyi).
Yes, those are the data I had seen from the trial; odd that metasized seems to respond better than locally advanced. We’re going with the 50/50 rough odds, and are frankly not extremely hopeful (cetuximab starting last October had minimal effects after 6 months). She is not a candidate for surgery, and has suffered a bone fracture from the tumour. This is the last chance saloon.
She was fretting considerably about potential side effects, but they do seem likely to be minimal, and I will let her know what you have said here.
I will talk to her about connecting with someone who has been receiving the therapy. Her treatment starts in three days.
I’m afraid that the only things that would really help the caregivers in the family — my siblings and I — are more money, more hours in the day, and fewer miles to travel. 😉 I have a disabled partner, one sibling has a young adult child with a complex chronic illness, three of us live many miles away, and life really does just suck.
I will also pass on news of the results of her treatment to the Melanoma Network and also to the Save Your Skin Foundation. My dad died of metastasized melanoma 16 years ago …
I will also check how the cost is being covered for her, so I can let you know that. I’m not sure whether it is OHIP or the pharmaco, but I suspect the latter. It is being administered at a private infusion clinic and that cost is apparently being covered one way or another.
July 9, 2019 at 4:11 pm #25593
Thanks for the update. I am glad she is starting. It sounds like you really do have such significant challenges – the whole family. We truly empathise. So many have to travel great distances and costs, and provide countless hours for supportive care. You are often the unsung heroes. Just make sure to look after yourselves as well.
The costs of the drug are currently being covered by the pharmaceutical company, which is bridging access until such time as the therapy makes its way through the fed/provincial pCODR review (which hasn’t started yet and is why we are conducting a survey to get feedback for that submission, and then hopefully it will continue until a positive recommendation and potential coverage by the various provinces.
The good news is you are getting it and it is covered. Hoping it works – it is a terrible disease when it has spread and our hearts go out to you and your family. Side effects should be very tolerable. Keep us posted.
July 16, 2019 at 6:31 pm #25705
Thanks and hello again, Annette. I wonder whether you might have the answer to a question.
My mum’s pain in the last week has gone beyond unbearable, but hopefully the increased meds starting today will help. Her pain management person, a NP, has suggested she check in to hospital for pain assessment.
When she was receiving cetuximab, we were told that entering hospital would result in exclusion from treatment. I have a hunch that this would not be the case for the cemiplimab, particularly if the hospital admission were for pain assessment and not because the person’s medical needs have become too high.
I think my mum may be a bit of a perfect case for the pharma company — locally advanced, not a candidate for curative surgery or curative radiation for a variety of reasons — and it would maybe not be eager to exclude her.
My mum thought the NP was a little bit to quick to say that admission would not affect eligiblity and may not have had a basis for it. Would you happen to know about this? No rush and I don’t want to put you to any trouble over this. For now, we are crossing fingers that the increased meds will make a difference.
I did mention to her the availability of peer support, but she is just in too much distress at present to consider this.
- This reply was modified 2 months ago by keb.
July 17, 2019 at 9:08 am #25707
Hello again. I can only imagine how difficult this is. However, never ever hesitate to take her to the hospital for any reason – side effects, pain management – any of it is reason enough. If someone is telling you otherwise, I don’t think that is sound advice. With any of these drugs there can be side effects. With the disease, there can be other complications. With advanced age, there can often be comorbidities and other health challenges that need to be managed on an individual basis. Treatment with immunotherapies is given both in-patient and out patient – of course the intravenous part is administered in hospital or at an approved clinic.
If your mom is having significant pain that cannot be controlled, she should be seen at the hospital by a pain management team. There is no need for out of control pain. Hoping the increased meds help, but if not, do not hesitate to contact her doctors and arrange for an assessment to potentially manage pain more effectively. I am hoping she can try this new therapy and that she responds and can turn this around for all of you. Best.
July 23, 2019 at 2:06 am #25768
Hi Annette, sorry, no notice of your reply again.
My mum does have a whole pain management team that has been on this ride since it began, and it is the NP who has now apparently given the word that hospital admission would result in denial of the cemiplimab. I won’t specify her pain meds here, but believe me, she has got the whole shebang. She did spend time in hospital back in the fall having the meds gradually increased to the tolerable effective level. I’m afraid it’s easy to say there’s no need for out of control pain, but when the only alternative is sleeping day and night, with the pain still present, there really isn’t any control to be had.
Next infusion (second) is next week. Still keeping fingers crossed, but things are pretty bad still this week.
On the subject of side effects, something did just occur to me that I’d forgotten: she had a TIA back in the fall while receiving weekly cetuximab. I don’t think I saw that listed as a possible side effect with cemiplimab. Just thought that was maybe worth mentioning. I don’t know whether it’s associated with cemiplimab, but anyone who experiences symptoms like facial drooping or slurred speech (basically, stroke symptoms) should get attention right away, of course.
So that did send us to the ER immediately by ambulance. Unfortunately, it also left us sitting in chairs for a lot of hours while waiting for a CT scan, as every staff person I accosted insisted there was no way to provide a stretcher for someone in unbearable pain who had been unable, for a long time, to stay sitting upright for more than a few minutes. I occasionally wonder where I left my backbone, as I’m not prone to tolerating that sort of crap.
July 23, 2019 at 9:57 am #25769
Hi again – and so sorry that you are not getting the notifications. It seems to be working for others I have checked with. You could call our office and speak with Jane to see if there is a problem that can be fixed.
Yes, unfortunately, pain management has not kept up with the US as far as I can tell, and we do assume that pain can be controlled – but there are so many cases we know of where it cannot or has not been managed. There is now a federal task force looking into this issue – which at least they are acknowledging that there is an issue, but of course, that changes nothing for your current situation. For reference: https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/canadian-pain-task-force.html
As far as receiving the drug therapy – yes, if your mother’s health has declined (usually referred to as the ECOG status), to a level where the doctors feel the drug will not be effective or may cause harm, then she could be denied further treatment with immunotherapy. And the drug doesn’t work for everyone unfortunately. I am hoping that she will at least get a second round and that there is a positive response for her and for all of you. I can only imagine how difficult, emotionally draining and stressful this is. I hope you can hang in until next week, get the infusion, then speak with her doctors about her declining health and come up with a plan or agreement as to what the future path is – is it palliative, is there a means to reduce her suffering or improve her quality of life. Please let me know if she is able to get a second round of the drug and we hope for better results. Thanks for the update on the side effects – I put in our submission yesterday.
August 13, 2019 at 6:33 pm #26161
Hi Annette. Just to let you know the second infusion was last week, so the next/last one is in two weeks, I think. I have not been there recently but will be going in a few days for a week so I’ll have a better idea. I get the feeling her pain is under a bit better control. Emotionally, another story. No need to reply, will keep you posted!
If there are any other reports coming in of how Ontario patients are making out with the treatment, it would be interesting to hear, of course. Thanks again.
August 14, 2019 at 5:18 pm #26208
Hi again – hoping the next round goes well for her and they can tell you if they feel it is working. She must feel a bit of relief to have the pain lessened. If she needs peer support or would like to speak with another that has gone through treatment, we likely could find someone for her to speak with.
I will certainly remember to post any new results on this therapy as they come through. I sincerely hope it works for your mother.
August 19, 2019 at 12:20 pm #26504
So — two weeks ago, my mum was in the depths of pain and despair. That was when she had her second treatment. Then … she began feeling better 5 days ago. Her condition has now made the same night-and-day change that happened when she had been on cetuximab for several weeks, around this past New Year.
I arrived yesterday and we were up until after midnight, sitting on her balcony talking while an enormous thunderstorm went on around us, watching lottery dream houses on television, visiting with my cat, eating turkey and stuffing and asparagus and chocolate cookies … Once again, me mum astounds the world. Her use of her pain pump has plummeted … and the home care nurse, who seriously overstepped her bounds last week by pushing a conversation about MAID, came today and was amazed too.
There’s no saying how far or how long it goes, we know. But hope means a lot to her.
Now my question. I had been understanding that the treatment itself consists of three infusions. My sister said they have not had that impression from the oncologist — only that any effects might not be felt until after the third treatment. Am I mistaken? Is Libtayo something that will continue being administered as long as it seems to be effective? I haven’t been able to find a definitive answer.
Pleased to bear some potentially good news for a change, and thanks as always for bearing with us. 🙂
August 19, 2019 at 12:48 pm #26506
And answering myself…
“350 mg IV q3Weeks infused over 30 min
Continue until disease progression or unacceptable toxicity”
So I think that means continue after first 3 infusions … indefinitely??
August 19, 2019 at 1:15 pm #26507
Well what amazing news! I was so hopeful you would see some results. Thank you so very much for sending this update. It gives others hope too! The regimen is prescribed for intravenous infusion every 3 weeks – until progression or toxicity. This was also very common application with some of the immunotherapies used in melanoma, when they first came out. After some period of experience, the provinces eventually settled on a maximum of 2 years. Some patients were taken off earlier as the response was so thorough and lasting. I hope it will be the same for your mom. Please keep us posted on her progress and if you have pictures to share that won’t compromise her privacy, those would be wonderful to see as well. We have seen some absolutely impressive results. I hope this will last longer the the other, as this is specifically indicated for cSCC. Wonderful news.
August 19, 2019 at 4:27 pm #26527
As soon as I finish up some work, I’ll send before & after photos this evening from Canada Day Weekend and last week. They’re always taken in a way that protects privacy and just shows the site (well, and my mum’s still naturally blonde hair!), so no worries.
August 26, 2019 at 2:46 pm #26609
Hi Annette. I did send you an email at the firstname.lastname@example.org address last week with photos as promised. I can send another pic showing the improvement since then, even.
Unfortunately, the “fatigue” is overwhelming at times since the Libtayo started, both physical unwellness and pretty serious mental and emotional difficulty. As Spitting Image used to sing: Every silver lining has a cloud.
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