NavDX positive test
Comments
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Chill, congrats, this is without a doubt the best news a person can receive. I am so glad for you that the NavDX blood tests are coming through negative for cancer. Now continue forward, enjoy life and let's celebrate your good fortune. Literally a new lease on life.
Take Care, God Bless-Russ
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That is awesome! Congrats. Good to know that there is an option for me if my rib-bone-met radiation treatment doesn't do the job. I did a post-radiation NavDX approx 10 days following the spot rads, and it came back at 17... which is down considerably from the previous score of 78 prior to starting spot treatment on the rib met. I bet my NavDX score was well over 100 by the time I started treatment because my # was climbing fast. My oncologist said that she wouldn't expect a 'negative' result so soon after treatment since it takes a while for the radiation to continue doing its complete job. We'll see about that since I am going in for a scan and follow-up NavDX towards the of the month.
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LuvnTN, thank you for starting this very informative post and wishing you luck.
Two weeks ago, had left tonsil surgery and neck dissection at Mayo Jacksonville, 5 hours from me. Pathology showed negative margins and 1 of 31 lymph nodes positive, 3 cm with an extranodal extension (ENE). So standard of care involves follow up radiation/chemo. Local care folks recommend 60gy to the throat, 70gy to the positive lymph node area and 60gy to rest of neck over 6+ weeks. Mayo is doing a clinical trial (DART 2.0) involving Navdx with 39gy, 2 rad treatments per day with 2 chemo treatments over a 2 week period. I'm waiting to see if I can be in that trial.
But I'm also trying to find out if negative post surgery NavDx tests may mean I could consider not doing the adjuvant treatment. My pre surgery NavDx test was 31 and I have another NavDx blood draw scheduled for tomorrow. Last week I called NavDx and after some phonetag, I was able to talk to a NavDx staff MD yesterday. He said the NavDx result number is used as a relative number. They see up to 15,000 but are really looking to see where the numbers go over time. I asked if I came back with 2 or 3 negative NavDx results in a row, wouldn't that indicate the surgery was successful and I would not need follow on radiation? I did not get a clear answer. He talked about sensitivity and specificity percentages and proceeded to hurt my brain. So I did some research.
- Sensitivity is the ability of a test to correctly classify an individual as ′diseased′
- Specificity is the ability of a test to correctly classify an individual as disease- free
- Positive predictive value (PPV) is the probability that a patient with a positive (abnormal) test result actually has the disease.
- Negative predictive value (NPV) is the probability that a person with a negative (normal) test result is truly free of disease.
Quoting from a nih.gov article: "Published NavDx clinical performance characteristics in patients with recurrent HPV-associated OPSCC demonstrate positive and negative predictive values (PPV and NPV) of 97.9% and 95.7%, along with sensitivity and specificity of 90.4% and 98.6%"
I don't understand the exact difference between NPV and specificity and if the percentages are overall or per single test. If the % is per test, taking the lower NPV 95.7% and given 2 negative test, the combined % would be:
1 - (1 - 0.957) × (1 - 0.957) = 1 - (0.043 x 0.043) = 1 - 0.001849 = 99.8151%. And 3 negative tests is 99.992%.
I'm planning to continue to research and have an appointment with a Mayo oncologist 5 Jul. Does anyone have any info or source for advice/comment?
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Hello PJR and welcome to the CSN H&N discussion forum. This subject on the NavDX test showing low numbers was brought up and discussed very recently with another member on here and the answers we have were validated from Mayo, I don't know if it is the same Mayo you are referring to. I am of the understanding that following surgery if your doctors recommend follow-up radiation and or chemo also you should follow their recommendation. The reason they do this is to mop up any remaining cells at the micropsic level that can't be seen in the tissue. Even when they operate and get clear margins there can be visibly impossible cancer cells left over that can only be seen with a microscope. I will put the link to the recent post down below with the original discussion. The other member that mentions Mayo is rpclark1988.
What is an example of microscopic?
Skin cells, bacteria, and some kinds of algae are all microscopic, or too small to see without a microscope. Use the adjective microscopic to describe things that are so tiny you can't see them.
The previous discussion of this subject started June 20 you can read it here--
Here is my comment and my understanding of follow-up treatment after surgery. Also, I was thinking if your main cancer was removed by surgery wouldn't that alone lower the NavDX blood test readings? but there could and probably are errant cells at the surgery site. You only want to do this once and get it the first time.
wbcgaruss Member Posts: 1,813 Member
Hello, rpclark, and welcome to the CSN H&N discussion board.
With few exceptions, individual cells are too small to be seen with the naked eye, so scientists use microscopes to study them. A microscope is an instrument that magnifies an object. Most images of cells are taken with a microscope and are called micrographs.
The reason they do radiation follow-ups after surgery is even the best surgeon cannot be sure they have removed all the cancer down to the cellular level. You know how small a cell is it takes a microscope to see it and stray cancer cells can be left post-surgery. So the surgery gets as much of the cancer as possible and the radiation is a mop-up procedure to eradicate any stray cancer cells that were missed thus leaving you cancer free.
I go back to before they had the NavDX test. And sometimes I think this test muddies the water a little. I can see where you could have a low NavDX test which is monitoring levels in your bloodstream but still have errant cells left in your body from the surgery which are too small to see. The errant leftover cancer cells will still be there no matter what your NavDX test says and the idea of the radiation is to eradicate any missed or remaining cancer cells to leave you cancer free.
This is my understanding of it and I would recommend getting the radiation if your doctor is prescribing it. Your care team and your radiologist treat cancer every day and know the correct procedure to use for each situation.
This is very common and standard procedure in dealing with cancer in general to do a follow-up or as some call it a mop-up of errant cancer cells after surgery with radiation. I believe sometimes they use chemo and radiation.
The thing is as my radiologist told me this is a one-shot deal, you want to do what is necessary to get it the first time around. Now that they identified cancer and surgically removed all they could you want to go by your doctor's recommendations and get this cancer done and gone. Believe me, you don't want this coming back if at all possible and these days surgery and radiation and chemo have advanced so much that there are a lot of cancer-free people walking around now that would otherwise not be here.
Here is rpclark's answer referring to Mayo
rpclark1988 Member Posts: 4 Member
Thank you for the explanation Russ! That makes sense and that is what Mayo explained to me yesterday. I was hoping I could just do the NavDx test every 3 months but I still have to do the radiation for the reason you explained.
Starting Monday daily through August 14th!
Wishing You the Best Am Wishing You the Best
Take Care, God Bless-Russ
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Alright, I finally got my latest NavDX results back. To recap, I had a 'negative' 6-months post treatment, and a 'positive' (value of 14) 1-year post-treatment. PET scan revealed a met to 5th rib bone that was there, but undetected, on original diagnosis PET in 2021. 3rd test was 'positive' value of 78. Treatment for rib met was 5-session SBRT 'spot' radiation treatment. about 4 weeks after that, 4th test was 'positive' at 14. My oncologist said it is going as expected.. but, would take a little longer to complete effects of radiation. Just got the 5th test result, and they were 'negative'. So, the SBRT spot treatment did the job. Feeling good right now for sure! Also, got a 'addendum' to my initial biopsy report that shows the specific type of indicator that responds to the Keytruda treatments if needed in the future. Apparently, if the HNSCC tumor is postive for PD-L1 expression, it should respond favorably to Keytruda. If I have that wrong, someone please correct me. My oncologist has not seen this addendum yet.. it was just provided to me by my primary last week.
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Sorry new here. Does the higher the number in this test reflect a higher grade of cancer? For example if it was 100 versus your 78? Assuming the 78 is a better number to have?
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That 31 seemed like a super low number prior treatment but what I’m gathering from you is that number is insignificant and the only thing that matters if you are positive or negative?
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Sorry confused. I have been told you could only do radiation once in your lifetime but that’s not true?
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This is from the company that provides the test:
"NavDx® is a blood test that aids in the detection of human papilloma virus (HPV)-associated cancer. NavDx isolates circulating cell free DNA from plasma and subjects it to droplet digital PCR using 17 biomarkers. Millions of single HPV DNA fragment containing droplets are computationally allocated to 16 size pool clusters. An algorithm generates a tumor-tissue modified viral (TTMV) HPV DNA prognostic risk score for cancer recurrence. Importantly, NavDx® distinguishes TTMV-HPV DNA from other, non-cancer associated sources of HPV DNA. "
In the effort of early detection, the lower the number.. the earlier it was detected - and vice-versa. The value range for the test goes from 0 - 10,000. So.. it is a very big range. Here is some more info from the company:
"Indications for Use:
♦ Pretreatment – NavDx Provides an important baseline TTMV-HPV DNA Score and identifies the tumor- associated HPV strain. 1
♦ During Treatment – NavDx monitoring of TMV-HPV DNA Scores provides insight into treatment effectiveness.
♦ Post treatment Surveillance – NavDx Positive test results identify patients who would benefit from follow-up imaging. "
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Someone else can probably speak better to this than me. From what I sort of understand.. I think it pertains to treating an area that had already received radiation in the past. It would depend on the dose levels and # of treatments received the first time to determine whether, or not, they can treat same spot again. In my case, my first radiation was to my head and neck area... the second was to a rib-bone metastases. So, first-time treatments for both spots.
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With respect to a "re-radiation" treatment for a local recurrence, my oncologist said it was not an option (there are other options but poor prognosis (50/50)). Just finished 3rd week of chemo (cisplatin)/ radiation and had discussed with her the possibility of suspending the chemo due to having 3 negative NavDx results and issues with ringing in my ears, chemo brain, balance and potention kidney damage. She said another option is to change the chemo but the alternate also has it's side effects and cisplatin is the better approach.
Same day talked with my radiologist and he said that going without any post surgery chemo and just doing radiation, there is a 1 and 20 chance of local recurrence so 80% chance of success. I think it is 90% to 95% with the full chemo treatment. He said my prognosis is very good and plan as of now is one more week of chemo and two of radiation.
With respect to the low initial NavDx (31), for some reason it is a worse prognosis than someone with a 250 or greater according to the data. I have asked why and there is no answer. May be sometime to do with proteins was mentioned. Mayo is conducting a de-escalation clinical trial called DART 2.0. I was not eligible to participate because of my low NavDx number. The participants will get a 4 week treatment plan with less overall radiation and chemo to see if that increase quality of life while still maintaining effectiveness.
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Well that sucks because my navdx number prior to treatment was also low. Frustrating but praying that you beat this completely the first time!
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PJR, sorry to hear you are having issues with the chemo treatment. I am hoping your team can find a way to continue this treatment to give you the 90%-95% success rate that would be the best. I did have radiation twice around the H&N area but it was not a recurrence it was a new cancer, lymph node cancer and my first radiation was for throat cancer. I had surgery for lymph node cancer and follow-up rads.
Apparently, they are basing a lot on the NavDX number in some places these days. Back when I had cancer there was no such thing so I am wondering without that would they treat you in the same way? Way back in the old days they had scans and everything they do now except the NavDX test and many were treated successfully. Call me a skeptic but I am not 100% sold on the NavDX concept but I am still looking and learning.
No matter what all our cancer cases are unique in their involvement and area they are exactly in etc. and your care team knows every bit of your case so trust in them and finish the full chemo run if at all possible. I am hoping but mainly praying you can sustain yourself completely and get through these treatments and come out the other side cancer free. God is watching over all of us and having the advantage of prayer is a blessing and is there for us to partake in. It has sustained me many times. So I pray for you and for God to watch over your situation and to lead and guide your medical team through it all.
Wishing You The Best
Take Care, May God Bless & Watch Over You-Russ
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I’ve seen Weiss but my main Oncologist has been Dr Sheth. Marco has been our coordinator/facilitator and he has been AMAZING!!!! I’m going in on Wednesday for my first set of post treatment scans and NavDX, hoping and expecting a clean bill of health!
Just out of curiosity, were they your 2nd opinion or your first when you returned for treatment?
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They were technically my 4th I think? I was treated at a UNC affiliate for my original treatment. They referred me to Duke, but I seen a Wake Med Dr for my second. I was given a grim prognosis by Duke. I reached out to another warrior on Facebook group that had went through radiation twice, and they were treated with the same team. My surgeon was Dr Patel, brut he also left, ending up at the Mayo Clinic in Florida. Now I see Blumberg in the surgical side. since Chera left the week he mapped me out I seen Shen during treatment. I think I was Dr Chera’s last mapping at UNC. I was told by the Drs that Him and Patel were kind of forced out because of the NAVdx.
I’ll be praying for you on your scans. I was just there this past Wednesday and got clear NAVdx and clear scope, so I do not go back till November for my annual CT scan.
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