ctDNA test pros and cons?

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Maelleous
Posts: 127
Joined: Tue Nov 01, 2016 8:13 am
Location: FL

ctDNA test pros and cons?

Postby Maelleous » Fri Feb 26, 2021 8:56 am

Hi everyone,

Been a long time since I have posted here. I just got my 4.5 years CT Scans bill of clean health (Stage 3C rectal cancer survivor who had adverse cardiac event from 3rd round of chemo and did a clinical trial to avoid reoccurrence)

My oncologist at Cleveland Clinic Florida recommended I get the ctDNA test and I am scheduled to do the bloodwork on March 10th. I have been doing some reading online and searching this forum but having a hard time finding much information on it. My concern is false positives I have read that may occur. I am FINALLY getting to a point where I am starting to believe I made it and it isn't likely to come back this far out. Is there any data on false positive rates etc? Just wanted to see if anyone here has gotten one and if you would recommend it. Thank you!
M 35 yr
DX Rectal Cancer, 10/16 (symptoms Feb 2016)
Dx stage 2 - Surgery Oct 25 201 Loop ileo w/ j-pouch
Close margins within 1mm
9/38 lymph nodes involved on path / Stg IIIc,pT4, pN2 B, p.M0. MSS, K‐ras, NRAS, no mutation
Started Folfox - 3rd Treament, Dec 30th 2016 Cardiac Arrest - Lucky to be part of the 6% to survive!
S-ICD installed / Port Removed
Vaccine Clinical trial at UPMC - last shot June 2017
Reversal 8/1/17 - Praying this is it!
Still NED

polluxx
Posts: 68
Joined: Thu Jul 10, 2008 9:41 pm

Re: ctDNA test pros and cons?

Postby polluxx » Fri Feb 26, 2021 1:16 pm

I’m not an expert. Initially, my doctor told me that the cons are expense, difficulty getting insurance to pay for it and not really knowing what a positive result means as far as treatment options.

My research showed that even if I had a positive result, the information could actually be used to point to what protocol would be most effective against my specific cancer.

So I made up my mind that I would change oncologists until I found one that would fight to get me a ctDNA test. As I was getting up the nerve to tell my doctor that I regretfully needed to fire her, she said, “Remember that test you wanted? I got you into a study so that you can have it every 3 months and not need to pay for it.”

Fortunately my first test came back negative which did so much to relieve my anxiety and actually let me start living the post chemo life that I want to live.

I’m also 3c. CAE is not a good indicator for me at all. I don’t want the stress and radiation from getting a scan every 3 months instead of 6. So for me, the ctDNA test is just what I needed to feel like I’m getting the best surveillance possible. Now, I might feel differently if my results were different, but I’m the kind of person who feels better the more information I have, so maybe not.
Stage 3c
2/2020 Right colon hemicolectomy (invasive adenocarcinoma with micropillary features)
Moderately differentiated
Tumor size: 4.4 in greatest dimension Metastatic Carcinoma in 12 out of 28 lymph nodes
Extranodal extension identified
Margins negative

3/2020 Began 12 rounds of FolFox
9/2020 Finished FolFox
12/2020 PET Scan-NED
1-2021 ctDNA Test negative
5-2021 ctDNA Test negative

saltygirl
Posts: 10
Joined: Sun Feb 07, 2021 4:46 pm
Facebook Username: Salty.girl

Re: ctDNA test pros and cons?

Postby saltygirl » Fri Feb 26, 2021 8:06 pm

I am stage 4. My test was also negative. Not sure what it means for the future. I did have full pathological response to chemo before surgery. Surgery found 0 cancer cells. Now I am finishing my post surgery chemo. My test in Jan was negative.

Maelleous
Posts: 127
Joined: Tue Nov 01, 2016 8:13 am
Location: FL

Re: ctDNA test pros and cons?

Postby Maelleous » Tue Mar 02, 2021 8:49 am

saltygirl wrote:I am stage 4. My test was also negative. Not sure what it means for the future. I did have full pathological response to chemo before surgery. Surgery found 0 cancer cells. Now I am finishing my post surgery chemo. My test in Jan was negative.


Personally I would take that as great news.

Ok, thank you both for the responses. I am going to move forward with it, apparently my insurance will cover it, so cost isn't a factor. Knowing is better then not knowing. I'm also concerned about the repeated radiation exposure from increased scans, (which my Onc said he would do every three months if positive) I am scheduled to go back to once a year post five year marker.
M 35 yr
DX Rectal Cancer, 10/16 (symptoms Feb 2016)
Dx stage 2 - Surgery Oct 25 201 Loop ileo w/ j-pouch
Close margins within 1mm
9/38 lymph nodes involved on path / Stg IIIc,pT4, pN2 B, p.M0. MSS, K‐ras, NRAS, no mutation
Started Folfox - 3rd Treament, Dec 30th 2016 Cardiac Arrest - Lucky to be part of the 6% to survive!
S-ICD installed / Port Removed
Vaccine Clinical trial at UPMC - last shot June 2017
Reversal 8/1/17 - Praying this is it!
Still NED

Rock_Robster
Posts: 556
Joined: Thu Oct 25, 2018 5:27 am
Location: Melbourne, Australia

Re: ctDNA test pros and cons?

Postby Rock_Robster » Tue Mar 02, 2021 10:37 pm

My onc (who is also a prominent ctDNA researcher) doesn’t recommend it to his general stage IV patients like me yet. His rationale is:

- the commercial test methods available currently aren’t accurate/repeatable enough to be reliable (despite what the companies marketing them might say), therefore
- we can’t rely on the results you get in either direction
- A negative result may give you some comfort, but you would still have to do the same surveillance anyway as we can’t rely on ctDNA alone (not to mention it is too costly and involved at present to do more frequently than CEA/scans anyway)
- A positive result will cause significant anxiety and probably reduce quality of life, but may not actually be a problem as we don’t know exactly what “positive” means (esp in stage IV NED), and
- We would not change treatment protocols (eg start/change chemo) etc on the basis of ctDNA alone anyway - you would always be followed-up with scans to confirm (and if no changes to scans it’s very unlikely treatment would change)
- There is virtually no data available for ctDNA in the stage IV setting, all research to date has been in stage II-III.

So I would say if you are stages I-III then you could definitely consider doing it, but it would be unlikely to change your treatment protocol and you’d probably be best to do it as part of a trial for the best accuracy and data. At stage IV, I can’t see a strong rationale to do it for surveillance outside of a trial (unless perhaps monitoring mutation burden during treatment in the case of things like v600e, etc).
39M Australia
10/2018 Dx RC, 12cm high
Mod diff, EMVI+ LVI+. 4 liver mets
pT3N1aM1a Stage IVa. MSS NRAS G13R
CEA: Nov-18= 14, Mar-19= 2.4, Aug-19 <2.0, Mar-20=2.2, May-20=1.9, Jun-20=2.1, Sep-20: 2.1, Dec-20: 2.3, Mar-21=2.5
11/18 FOLFOX x6
3/19 Liver resection
5/19 25x pelvic radiation; complete met. response
07/19 ULAR w ileo, 1/27 LN+
08/19 Found liver spot
08/19 FOLFOX x1, FOLFOXIRI x1, FOLFIRI x5
12/19 Liver resection
02/20 Ileo reversed
03/20 NED (CT/PET/MRI/scope) - latest scans Mar ‘21

I_will_fight
Posts: 72
Joined: Mon Jun 29, 2020 3:38 pm

Re: ctDNA test pros and cons?

Postby I_will_fight » Thu Mar 04, 2021 2:20 am

Hi all,

Stage 2a (T3N0M0) with risk factor PNI.

I have a "non-specific" small lesion in liver, I will have TC-SCAN in two months to check evolution.

I am considering having the Signatera done, but i hesitate.

My CEA was very low at DX so I guess it wont be a good indicator.

If the results are negative it will certainly provide relief, but I will have to undergo the same follow up (CT-SCANS, MRIs and Colos...)

If the results are positive it will increase my already high anxiety and my oncologist is saying that he does not see how it impact treatement or follow up. He does not like the idea of making CT scans more frequent (perhaps he could recommend other imaging methods, but that's it). I really like my onc but I might consider getting a second opinion in this case.

Signatera is pricey here in Spain but not quite as much as to make it a strong deterrent.

What do you guys think?
46 yo male Spain
06/20 - 6cm T3N0M0 CC splenic flex
No liver mets, 3 and 4 mm lung dots (unlikely to be mets)
lymp 0/37
MSH6- other MMR+
KRAS mt G13D
V/LNI absent
PNI present
07/20 - hemicol surg, 13cm clear margins, optimistic surgn.
08/20 - CAPOX regime, 4 cycles.
11/20 - CAPOX completed. CAT scan: lesion in liver, suspect hemoangioma, no changes lung dots.
12/20 - Clean colonoscopy
02/21 - MRI liver lesion is nonspecific, stable.

Sunnycd
Posts: 28
Joined: Fri Feb 26, 2021 10:36 am

Re: ctDNA test pros and cons?

Postby Sunnycd » Fri Apr 09, 2021 12:46 pm

I am on the same boat. I am on my 2nd cycle of Capox out of 4. Signatera contacted me because my previous oncologist had referred me. I spoke with my current oncologist and she would not recommend it. Her rationale is that it is data that you can’t act upon, so, why bother and potentially increase your anxiety level.

On the other hand, I wonder...if the results are good, wouldn’t that give you some peace of mind? And if the results are bad, sure, you wouldn’t change your actual cancer treatment, but wouldn’t you try harder on the nutrition, cancer fighting foods, alternative medicine stuff that you wouldn’t otherwise have been so keen on? I am, of course, worried about false positive/negative, but aside from that, if cost is not a factor, I would go for it...
DX 02/21 CC IIB @ 51
01/21 ER surgery, temp. colostomy
Sigmoid, adernocarcinoma
T4aN0MX, G2
0/24 lymph nodes
LVI: indefinite
PNI: not identified
Margins: clear
3/21 started 4 rounds of CAPOX

Sunnycd
Posts: 28
Joined: Fri Feb 26, 2021 10:36 am

Re: ctDNA test pros and cons?

Postby Sunnycd » Fri Apr 09, 2021 8:23 pm

I am also wondering....Why isn’t this test offered before you undergo preventative chemo? I had a surgery that supposedly took the tumors out, and I am currently undergoing CAPOX “just in case” there are any wandering cancer cells. Well, why is the test being offered while I am in the middle of chemo. If I had taken it before, and there were no lingering cancer cells, it would have saved me from having to do chemo? I am confused as to why the doctors say it is data that can’t be acted upon, when it seems that it could have been acted upon if tested at the right time?
DX 02/21 CC IIB @ 51
01/21 ER surgery, temp. colostomy
Sigmoid, adernocarcinoma
T4aN0MX, G2
0/24 lymph nodes
LVI: indefinite
PNI: not identified
Margins: clear
3/21 started 4 rounds of CAPOX

User avatar
Green Tea
Posts: 367
Joined: Mon Oct 24, 2016 10:48 am

Re: ctDNA test pros and cons?

Postby Green Tea » Sat Apr 10, 2021 7:29 am

Sunnycd wrote:I am also wondering....Why isn’t this test offered before you undergo preventative chemo? I had a surgery that supposedly took the tumors out, and I am currently undergoing CAPOX “just in case” there are any wandering cancer cells. Well, why is the test being offered while I am in the middle of chemo. If I had taken it before, and there were no lingering cancer cells, it would have saved me from having to do chemo? I am confused as to why the doctors say it is data that can’t be acted upon, when it seems that it could have been acted upon if tested at the right time?

According to a recent February 2021 article , this objective ("adjuvant chemotherapy de-programming for patients with undetectable, post-operative ctDNA") is under serious consideration but insufficient research has been done so far to allow it to become a standard for general use. It is expected that it will evolve eventually as a standard as soon as enough clinical trials have been done to establish its value as a standard.

There are in fact some clinical trials in existence right now for establishing this kind of data, for example, clinical trial NCT04264702 , which started recruiting 1000 Signatera patients in 2020 and which will conclude no sooner than 2022 with some preliminary data testing their objective #3
    Objective 3. Evaluate survival in patients treated with adjuvant versus no adjuvant chemotherapy in patients with SIGNATERA™ negative test results [Time Frame: 2 years]
    Proportion of patients with a negative SIGNATERA™ ctDNA test post-surgery that are still alive the end of the trial (during surveillance) treated with adjuvant versus no adjuvant chemotherapy
Presumably, the final data showing how many patients were still alive after the normal 5-year period of post-surgery surveillance will not be available until at least year 2025. This is what they mean by, "...Once ctDNA technology evolves to fulfill this promise...". It will not evolve to the required level until at least 5 years of clinical-trial based survival data has been accumulated, hence, not until at least 2025 at the earliest. NCCN will not list this as a viable treatment choice until clinical-trial data like this has been validated. This is why the test is not yet offered as an option in 2021.

Mugenabe
Posts: 17
Joined: Sat May 30, 2020 6:38 am

Re: ctDNA test pros and cons?

Postby Mugenabe » Sat Apr 17, 2021 6:20 am

I’ve tried to talk to my oncologist about getting ctDNA testing done but he said it will provide no benefit and they are just looking for $. Results will not change treatment, and will likely just cause more anxiety. Not sure if I agree but if it won’t change treatment, I’m not sure if I want to know. My next CT Scan and colonoscopy is next month and I’m already going through so much anxiety. I feel like every pain/symptom I feel is cancer :( . If I had a positive ctDNA test, then couldn’t do anything about it until the next scan, then it would just freak me out I think.
5/13/20 colonoscopy, CT Scan - 5cm tumor found in sigmoid colon, no evidence in other organs, confirmed cancer
5/21/20 colectomy (partial resection) - waiting for staging
6/2/20 Pathology results 7/25 nodes positive Stage 3C T4aN2b
6/25/20 CAPOX 4 rounds CEA 2.5
11/16/20 CT Scan Clear! CEA 2.5


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