currently doing docetaxel had second infusion on 09/13/22
suffers from plaque psoriasis
Nubeqa
has been shown to be an effective therapy August 5, 2022, the Food and Drug Administration approved darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).Found this online:How effective is Nubeqa?Nubequa treated patients survived an average of 40.4 months without evidence of metastases compared to only 18.4 for individuals treated with ADT alone. Nubeqa resulted in a 31% reduction in the risk of death from prostate cancer.Aug 11, 202NUBEQA® (darolutamide) is a prescription medicine used to treat adults with prostate cancer: that has not spread to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (nmCRPC)
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Shorehousejam
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A supplemental new drug application and a Variation Type II application have been submitted to the FDA and the European Medicines Agency, respectively, seeking the approval of darolutamide (Nubeqa) plus docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC).1
The applications were supported by findings from the phase 3 ARASENS trial (NCT02799602), which showed that the addition of darolutamide to docetaxel and androgen deprivation therapy (ADT) reduced the risk of death by 32.5% vs docetaxel plus ADT (HR, 0.68; 95% CI, 0.57-0.80; P < .001).2 The 4-year overall survival (OS) rates in the investigative and control arms were 62.7% (95% CI, 58.7%-66.7%) and 50.4% (95% CI, 46.3%-54.6%), respectively.
Is Nubeqa added to Docetaxel at treatment infusion and my husband stays on Firmagon @ 28 days and Zytiga and Prednisone, Our apologies, as my husband has recently been diagnosed, so we are confused.
Is it added or replacing one of the therapies above?
Nubeqa is an androgen receptor inhibitor so I would expect it would replace Zytiga + Pred. So the triplet therapy is Firmagon plus Nubeqa plus Docetaxel. Your CO should be able to confirm.
I was diagnosed in May 2022 with lymph node mets and one bone met. Originally, I was on Eligard (3 month) injections, abiraterone (Zytega generic) and 5 mg prednisone daily.
After getting second opinions, we decided to get triplet therapy with docetaxel and change to darolutamide (Nubeqa). Abiraterone/ prednisone was stopped and darolutamide was started. (Still on Eligard). I will get docetaxel cycle 5 on 03 October.
The only thing I’ve noticed is that my systolic blood pressure went from around 130-135 while on abiraterone then after about 5 days went down to around 110 (my normal before being on abiraterone/prednisone).
Thank you for sharing, my husband will do his 3rd chemotherapy on 10/4/2022, we are surprised our MO a top medical oncologist from a top NY Hospital did not go this route…
My MO did not initially suggest it either. None of the Kaiser physicians even mentioned triplet therapy (even the so called uro-oncology “expert” I saw). When I went and got my second opinions, triplet therapy was suggested by two outside physicians. Fortunately, when I shared the NEJM article about triplet therapy with my MO and said that was what I wanted, he agreed.
I think the likely reason in my case is cost. Nubeqa is vastly (4x) more expensive than abiraterone and not available in generic. Aside from the PCa benefits, I think Nubeqa may also have a better side effect profile than abiraterone as well as not requiring the additional prednisone.
So I took a look at your numbers in your profile, and you seem to be doing well on abiraterone /prednisone plus Firmagon and Docetaxel... not sure why you would replace abiraterone with darolutamide or want to based on results... I guess you are in contact with his Endocrinologist about his blood sugars...
The thing that I would consider is using SBRT to treat his oligometastatic HSPCa... I also have lytic lesions and this has worked well for me... If you have not consulted with an RO, then maybe you should.... I posted an article a while back on SBRT-see below:
Sorry I replied days late, but I have been busy getting ready for winter--doing outside projects, and have not checked the forum in a few days... May you continue to respond well to treatment...best of luck...
thank you so much for your expansive reply, we still have to get my husband a new primary physician as well as a Rheumatologist and Endocrinologist (never had one), this is just us, trying to put this all together…
We are concerned that we would be missing out on the results Nubeqa would give as opposed to zytiga and prednisone
Because the study and trial stated it gives good results for longevity and life, if used in the beginning after first diagnosed as such is the case of my husband
Definitely going to asked for a referral to RO,
I can’t thank you enough for saving me a lot of research my sharing all that information about SBRT
Not sure if you saw the results from STAMPEDE for abiraterone started from the beginning, but it too provided expanded OS. There are no head to head trials for abiraterone vs darolutamide, so consequently, no one can say that one is superior to the other. They are both ARPI (Androgen Receptor Pathway Inhibitors) drugs.
Ultimately, the choice is yours... Taking a proactive stance helps. Too many poor souls listened to their urologist and only did Lupron from the beginning....ended up castrate resistant... failed meds....and died...
Best of luck on this hell ship... It is a journey, but you are not alone..
Anyone whom would you have any studies, or any information on how long men are on zytiga before it fails etc, or needs to be changed. We are trying to figure out what the number would be, in the Nubeqa trial,
“ If” I read it correctly, men were still on Nubeqa after 48 months….
Please, would anyone clarify or link some information ?
There was evidence of nonproportional hazards (P=0.001), so we present restricted mean failure-free survival time: 43.9 months in the combination group and 30.0 months in the ADT-alone group in the first 54 months after randomization, a difference of 13.9 months (95% CI, 12.3 to 15.4). The effect of abiraterone on failure-free survival was noted in all subgroups (Figure 1D and Figure 1F and Figure 2B).
My advice--read the article and talk with your MO. As I recall, there is lower success when changing from a lutamide to abiraterone when castrate resistant, than when switching from abiraterone to a lutamide. That is also something to discuss with your MO.
Don, what’s really bothering my husband and I, is that we feel after reading about Nubeqa and it’s success, he missed an opportunity to fight this terrible cancer, by being prescribed zytiga instead of Nubeqa ….
But, my thought as I explained to myself and my husband, that our Terrific Medical Oncologist who was once the chair at this NYC teaching hospital, did a risk assessment and used proven zytiga with prednisone to start off with especially with such a high PSA of 942.40 as opposed to Nubeqa, even though studies shown that Nubeqa was shown to achieve fantastic results with docetaxel.
No studies have been conducted with zytiga and prednisone against Nubeqa with the SOC
oh I was asking for his view, I didn’t know he wasn’t on this page too, good to know he is not, we are new….we are learning about the nuances of personalities here
I am on lupron ADT, and Nuqeba (darolutamide) ARInhibitor. I have low volume mHSPC with 2 locations above diaphragm. I have not done other ADT nor other inhibitors. From what i have read the triplet therapy is for high volume disease.
Here is a VERY good article on the mechanisms of resistance for each ARI (Androgen Receptor Inhibitors)
Darolutamide is really the one to get if you can. There is only one known AR resistant mutation while abiraterone, apilutamide, and enzalutimde have many more mutation resistant AR.
Emergent AR mutations in men with advanced PCa treated with ARPI promote CRPC progression. The incidence of AR mutations was estimated to be around 15% for CRPC patients [4] and the availability of circulating tumour DNA assays now provide a sensitive method to serially detect (and treat) the emergence of resistant AR mutants. This current work expanded the list of experimentally evaluated AR mutants with 44 additional examples (bringing the total to 68) and quantified their response to four major endogenous steroids and three clinically used AR antagonists, including darolutomide. Among these, only darolutamide demonstrated complete inhibition of 67 out of the 68 studied AR mutant variants, with no significant signs of partial of full activation at even higher concentrations.
I wrote a post for “A Case For Darolutamide “ but i cant find any of my posts. I tried.
Indeed... that is correct... I am using abiraterone for the 2nd time... Stretch each drug out for as long as possible. There are new drugs coming, but 3-5 years away. In the event abiraterone starts to fail, making a switch from prednisone to dexamethasone has allowed people to stretch out using abiraterone for additional time... even years... it is a chess game..
"I wrote a post for “A Case For Darolutamide “ but i cant find any of my posts. I tried."
kocopr - to find all your previous posts just click on YOUR member name at the top of this reply and it will take you here: (where you will find all your posts & replies)
a few reasons; it is expensive, fairly new drug with not any approved applications (completed clinical trials). Not enough people asking for it. I asked for it and since i am seen at a Major Hospital that does many clinical trials they were very familiar with it, and i got an early prescription.
We are in NYC in a top teaching hospital with excellent physicians, this is why we are asking about why my husband was Not prescribed Nubeqa. We will find out when we talk to the medical oncologist and asked him why and what was his decision based on…I’m sure it will make sense as disappointed as we are
We are so grateful, to be kept above water, by the constant floats thrown to keep my husband and I in the loop of understanding and not mis- interpreting results…especially on this boat, (site), there is a mighty set of a navigators…
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BAT therapy/muscle pain.
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