Phase 1 trial.

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stu
Posts: 1600
Joined: Sat Aug 17, 2013 5:46 pm

Re: Phase 1 trial.

Postby stu » Fri Dec 09, 2022 4:54 pm

I for one am holding out that the CEA drop is reflective of the cancer being reduced .
I will look forward to hearing how you get on .
You take care ,
Stu
supporter to my mum who lives a great life despite a difficult diagnosis
stage4 2009 significant spread to liver
2010 colon /liver resection
chemo following recurrence
73% of liver removed
enjoying life treatment free
2016 lung resection
Oct 2017 nice clear scan . Two lung nodules disappeared
Oct 2018. Another clear scan .

Markdale
Posts: 61
Joined: Wed Dec 02, 2020 4:45 pm

Re: Phase 1 trial.

Postby Markdale » Fri Dec 09, 2022 8:52 pm

Thank you
09/20:Diagnosed after colonoscopy for bleeding.
MRI and ct scan confirmed tumor at rectosigmoid junction aswell as lung nodules in RLL (1X1.2cm) and RUL (3X.5cm)
10/20: LAR tumour t3n2m1 4/24 lymph nodes.
11/20: pet scan confirmed Mets
11/20: folfoxiri - 10/6/21. 12 rounds in total
12/20: ct lung biopsy of lung nodule Biopsy unsuccessful
1/1/21 thoracotomy 1 met removed that wasn’t noticed on ct
2/2022 sabr to 2 lung nodule
09/22 PET scan progression of sabr’d nodules
10/22 phase 1 trial bispecific antibody

roadrunner
Posts: 347
Joined: Sun Jan 12, 2020 8:46 pm

Re: Phase 1 trial.

Postby roadrunner » Sat Dec 10, 2022 12:53 am

Are the other three nodules doing anything? Are those likely mets or not?

Also, did both SBRT treatments fail or just one (there seems to be some inconsistency on that above)?

I also agree that the apparent slight reduction and CEA drop are good signs. PFCCR is right that stable is good.
7/19: RC: Staged IIIA, T2N1M0
approx 4.25 cm, low/mid rectum, mod. well diff.; lung micronodule
8/19-10/19 4 rds.FOLFOX neoadjuvant, 3 w/Oxiplatin (reduced 70-75%)
neoadjuvant chemorad 11/19
4 rounds FOLFOX July-August 2020
ncCR 10/20; biopsies neg
TAE 11/20, tumor cells removed
Chest CT 3/30/21 growth in 2 nodules (3 and 5mm)
VATS 12/8/21 sub-pleural met 7mm.
SBRT nodule 1/22
CT 3/22: Clear
Chest CT 5/19/22 Clear
6/20/22 TAE rectal polyp benign
CT/MRI 9/11 Clear
11/9/22: Rectal exam/scope Clear (2 yrs.)

Markdale
Posts: 61
Joined: Wed Dec 02, 2020 4:45 pm

Re: Phase 1 trial.

Postby Markdale » Sat Dec 10, 2022 6:25 am

They believe the 2 nodules treated with sabr are mets and are progressing and for the purpose of the trial they are being measured to see if the trial drug is having any effect on them. We believe the sabr didn’t work because the pet scan that we did showed activity at both sites that were treated and the cea had been increasing, it doubled in a 3 month period from I think 11 to 23. I asked if both could be a result of inflammation and they said no.
The other 2 nodules they think are Mets too but I’m not sure if they’re 100%.
09/20:Diagnosed after colonoscopy for bleeding.
MRI and ct scan confirmed tumor at rectosigmoid junction aswell as lung nodules in RLL (1X1.2cm) and RUL (3X.5cm)
10/20: LAR tumour t3n2m1 4/24 lymph nodes.
11/20: pet scan confirmed Mets
11/20: folfoxiri - 10/6/21. 12 rounds in total
12/20: ct lung biopsy of lung nodule Biopsy unsuccessful
1/1/21 thoracotomy 1 met removed that wasn’t noticed on ct
2/2022 sabr to 2 lung nodule
09/22 PET scan progression of sabr’d nodules
10/22 phase 1 trial bispecific antibody

roadrunner
Posts: 347
Joined: Sun Jan 12, 2020 8:46 pm

Re: Phase 1 trial.

Postby roadrunner » Sat Dec 10, 2022 11:08 am

Thanks for the clarification. Are they watching the (untreated) suspected mets to check for response? I assume from the lack of focus on those that they are stable as well, but did they show interval growth in the past? Also, have you discussed repeating the SABR on the two treated mets?
7/19: RC: Staged IIIA, T2N1M0
approx 4.25 cm, low/mid rectum, mod. well diff.; lung micronodule
8/19-10/19 4 rds.FOLFOX neoadjuvant, 3 w/Oxiplatin (reduced 70-75%)
neoadjuvant chemorad 11/19
4 rounds FOLFOX July-August 2020
ncCR 10/20; biopsies neg
TAE 11/20, tumor cells removed
Chest CT 3/30/21 growth in 2 nodules (3 and 5mm)
VATS 12/8/21 sub-pleural met 7mm.
SBRT nodule 1/22
CT 3/22: Clear
Chest CT 5/19/22 Clear
6/20/22 TAE rectal polyp benign
CT/MRI 9/11 Clear
11/9/22: Rectal exam/scope Clear (2 yrs.)

roadrunner
Posts: 347
Joined: Sun Jan 12, 2020 8:46 pm

Re: Phase 1 trial.

Postby roadrunner » Sat Dec 10, 2022 11:40 am

Mark:

Thinking some more about your situation, and I feel I should ask a few more questions. First, I recall only parts of your history and, of course, the signature only can convey so much. Second, some of this is about your team’s approach, so please understand that this is just an attempt to help, to make sure you’ve got all bases covered—I know how irritating questions from folks who have just a small part of the picture can be to us patients.

But anyway, with that caveat and all humble apologies in advance, here goes: Are you fully confident in your team? I believe you had a failed biopsy and (if I recall right) thoracotomy and now apparently a failed SABR treatment (well, really two). Also, the last may be related to the size of the two treated mets. Of course, those events may just be bad luck or specific to your situation. But you’ve been under treatment for a while. I assume you had multiple scans during that period. Why did they wait until the mets reached the size they did to try SABR? (Not that size necessarily forecloses SABR, or repeat SABR, but it is often a factor in success.)

It is good news that yours still appears to fall within the category of oligometastatic disease. Are they approaching you that way, or is their strategy different? Have you gotten a second opinion, if possible?

Finally, I believe you’re in Australia. I’ve been chastened in the past for assuming flexibility and options in countries with nationalized health care systems, so I also apologize if your options are limited. This is just a potential “food for thought” post. May be way off base. Sorry if it is.
7/19: RC: Staged IIIA, T2N1M0
approx 4.25 cm, low/mid rectum, mod. well diff.; lung micronodule
8/19-10/19 4 rds.FOLFOX neoadjuvant, 3 w/Oxiplatin (reduced 70-75%)
neoadjuvant chemorad 11/19
4 rounds FOLFOX July-August 2020
ncCR 10/20; biopsies neg
TAE 11/20, tumor cells removed
Chest CT 3/30/21 growth in 2 nodules (3 and 5mm)
VATS 12/8/21 sub-pleural met 7mm.
SBRT nodule 1/22
CT 3/22: Clear
Chest CT 5/19/22 Clear
6/20/22 TAE rectal polyp benign
CT/MRI 9/11 Clear
11/9/22: Rectal exam/scope Clear (2 yrs.)

Markdale
Posts: 61
Joined: Wed Dec 02, 2020 4:45 pm

Re: Phase 1 trial.

Postby Markdale » Sat Dec 10, 2022 7:50 pm

It’s no issue at all road runner. Helps get everything clear in my head when I write it down.

For the biopsy not sure if failed is the correct word, abandoned might be more appropriate. I was put in to position then had a ct so the radiologist could locate it but he said the nodule was hollow and that it would be almost impossible to get a sample. the radiologist was an associate professor and said his success rate was in the high 90s for this procedure.

The thoracotomy was where I am most disappointed. The initial surgeon I spoke to was confident that he could get all the nodules but here you don’t always get the surgeon who discussed the operation with you. He took a lymph node and a nodule that turned out to be a different met and closed up. His reasoning was he couldn’t find them with out taking excess lung tissue. If that operation was a success I would’ve avoided the sabr and the trial.

When I had sabr the Mets really hadn’t grown much, at diagnosis the larger RLL was 1.2cm and the upper was .5cm. Just before sabr I think they measured 1.5cm and .8cm. The sabr was not too long after the thoracotomy either. As you probably know they put a margin around the met of a cm or 2 and now the met is measuring I think 3.2cm for the RLL and approx 2.5cm for the met in RUL.

I had regular ct scans after sabr and it naturally showed inflammation which is normal for a couple of scans but when they measured cea it was approx 10 then 3 months later 23. That triggered a pet scan and it showed significant uptake in the RLL nodule that was next to the met that was surgically removed and some in the RUL nodule. They didn’t think that inflammation could explain the high cea and pet results.

The 2 nodules which have not been treated shrunk considerably after chemo so I’m assuming they are Mets, I’m not sure why they are not a target of treatment.

It’s frustrating that I don’t see the same oncologist all the the time but they work in a close team and everything I have requested they have followed through with and they have put to an mdm many times. So ultimately I’m happy with the team overall just the thoracic surgeon I need to adjust, and I believe I do still have the option of surgery if no more Mets show up. I’m still classed as oligometastatic.

I really appreciate that you’ve taken the time to read my posts and ask questions. I hope i have cleared some of the details up.
09/20:Diagnosed after colonoscopy for bleeding.
MRI and ct scan confirmed tumor at rectosigmoid junction aswell as lung nodules in RLL (1X1.2cm) and RUL (3X.5cm)
10/20: LAR tumour t3n2m1 4/24 lymph nodes.
11/20: pet scan confirmed Mets
11/20: folfoxiri - 10/6/21. 12 rounds in total
12/20: ct lung biopsy of lung nodule Biopsy unsuccessful
1/1/21 thoracotomy 1 met removed that wasn’t noticed on ct
2/2022 sabr to 2 lung nodule
09/22 PET scan progression of sabr’d nodules
10/22 phase 1 trial bispecific antibody

User avatar
Jacques
Posts: 646
Joined: Sun Dec 28, 2014 10:38 am
Location: Occitanie

Re: Phase 1 trial.

Postby Jacques » Sat Dec 10, 2022 9:56 pm

On October 24th, Markdale wrote:I’ve started the phase 1 trial today for 2 drugs [ BGB-A425 and Tislelizumab ?] . One binds to CEA producing cells and the other to an immune cell. My dose was the 2nd lowest at 15 mg weekly and will stay at that level for 8 weeks then a CT will evaluate if it’s been effective. If the Mets have progressed then they will offer another immunotherapy.

Hi Mark,

It sounds to me like the decisive evaluation of this stage of your treatment will be coming up in a couple of weeks or so. Is that still the plan?

Do you have any idea exactly how they will do the evaluation? How are the measurements of the target lesions actually done? Is the evaluation of the measurements done with paper-and-pencil calculations by the radiologist? Is it done with a programmable spreadsheet that contains the measurements of the target lesions? Is it done automatically by an artificial intelligence (AI) module that comes with the CT scanner?

And how long will it take them to do this evaluation and make a decision on what to do next?

I'm a bit confused about how these kinds of evaluations are actually done and who actually does them, and whether the persons involved in the original baseline evaluation are the same ones involved in the final evaluation. Any ideas?

According to the RECIST 1.1 evaluation criteria, there are 4 possible categories of response
  • CR = Complete Response
  • PR = Partial Response
  • SD = Stable Disease
  • PD = Progressive Disease

Markdale
Posts: 61
Joined: Wed Dec 02, 2020 4:45 pm

Re: Phase 1 trial.

Postby Markdale » Sun Dec 11, 2022 2:43 am

Hi Jacques,

They assessed after 6 infusions (2cycles) and decided it was stable. We decided to keep the same dose until the next scan.
For this study it is through a public hospital in Victoria australia but I am going to a private clinic for the scans. This may be so the same radiologist does it every time. Normally I use the hospitals machine for routine scans.
For the measurements I really don’t know how they do it but AI from the scanner sounds like the most reliable. I can ask the onc tomorrow. Sorry I couldn’t answer in more detail
09/20:Diagnosed after colonoscopy for bleeding.
MRI and ct scan confirmed tumor at rectosigmoid junction aswell as lung nodules in RLL (1X1.2cm) and RUL (3X.5cm)
10/20: LAR tumour t3n2m1 4/24 lymph nodes.
11/20: pet scan confirmed Mets
11/20: folfoxiri - 10/6/21. 12 rounds in total
12/20: ct lung biopsy of lung nodule Biopsy unsuccessful
1/1/21 thoracotomy 1 met removed that wasn’t noticed on ct
2/2022 sabr to 2 lung nodule
09/22 PET scan progression of sabr’d nodules
10/22 phase 1 trial bispecific antibody

roadrunner
Posts: 347
Joined: Sun Jan 12, 2020 8:46 pm

Re: Phase 1 trial.

Postby roadrunner » Sun Dec 11, 2022 11:05 am

Mark: Thanks, that does clear things up. It sounds like the 2 and 3 cm sizes are just the “impact zones” or met-plus-margin zones from the SABR, with any remaining cancer likely a much smaller area. That definitely threw me off; seemed like there was a lot of growth of the nodules themselves. I would also note that perhaps your signature contains a typo, as it shows about a year between the thoracotomy and the SABR.

In any case, my remaining questions are: (1) Can you repeat the SABR on the two mets? This is usually doable and often successful (based on my review of the literature) if there wasn’t too much toxicity the first time, though central location (if there in your case) could cause some hesitation. (2) More a comment, but I’d discuss the untreated nodules very specifically with them. My guess is that your folks aren’t focused on them because *for the purposes of the trial they don’t exist* (since not confirmed as mets or for other reasons related to the trial). But as you say, the nodules’ prior behavior is highly suggestive, so for you, those nodules may be very important as to how the drug is doing. With trials IMO, it’s always very important to consider the team’s mindset and incentives carefully, because those can differ from those in ordinary care, as they are influenced, and often driven, by the trial goals and parameters. Still, your team should IMO give you information on the untreated nodules. In the final analysis, those nodules should at least be watched carefully regardless of how the drug is doing/the trial, because you need to address them optimally going forward (whether surgically, with ablation, or with systemic therapy).

At least, that’s my read. Again, could be off given incomplete info. Hope this helps, at least in terms of brainstorming.
7/19: RC: Staged IIIA, T2N1M0
approx 4.25 cm, low/mid rectum, mod. well diff.; lung micronodule
8/19-10/19 4 rds.FOLFOX neoadjuvant, 3 w/Oxiplatin (reduced 70-75%)
neoadjuvant chemorad 11/19
4 rounds FOLFOX July-August 2020
ncCR 10/20; biopsies neg
TAE 11/20, tumor cells removed
Chest CT 3/30/21 growth in 2 nodules (3 and 5mm)
VATS 12/8/21 sub-pleural met 7mm.
SBRT nodule 1/22
CT 3/22: Clear
Chest CT 5/19/22 Clear
6/20/22 TAE rectal polyp benign
CT/MRI 9/11 Clear
11/9/22: Rectal exam/scope Clear (2 yrs.)

Markdale
Posts: 61
Joined: Wed Dec 02, 2020 4:45 pm

Re: Phase 1 trial.

Postby Markdale » Sun Dec 11, 2022 1:08 pm

Thanks again road runner. I appreciate the advice.
09/20:Diagnosed after colonoscopy for bleeding.
MRI and ct scan confirmed tumor at rectosigmoid junction aswell as lung nodules in RLL (1X1.2cm) and RUL (3X.5cm)
10/20: LAR tumour t3n2m1 4/24 lymph nodes.
11/20: pet scan confirmed Mets
11/20: folfoxiri - 10/6/21. 12 rounds in total
12/20: ct lung biopsy of lung nodule Biopsy unsuccessful
1/1/21 thoracotomy 1 met removed that wasn’t noticed on ct
2/2022 sabr to 2 lung nodule
09/22 PET scan progression of sabr’d nodules
10/22 phase 1 trial bispecific antibody

Markdale
Posts: 61
Joined: Wed Dec 02, 2020 4:45 pm

Re: Phase 1 trial.

Postby Markdale » Sun Jan 15, 2023 6:12 pm

Had another scan last week and got the results today.
Scan shows that the disease is stable ( no growth in nodules), however cea increased to 18 from 13. Cea was 23 when trial started. There has been no other growth anywhere else in over 2 years now
I’m disappointed in the increase in cea.
I have organised a 2nd opinion from a thoracic surgeon outside the centre that I’m being treated at that regularly cuts out Mets and also has a good reputation here.

Mark
09/20:Diagnosed after colonoscopy for bleeding.
MRI and ct scan confirmed tumor at rectosigmoid junction aswell as lung nodules in RLL (1X1.2cm) and RUL (3X.5cm)
10/20: LAR tumour t3n2m1 4/24 lymph nodes.
11/20: pet scan confirmed Mets
11/20: folfoxiri - 10/6/21. 12 rounds in total
12/20: ct lung biopsy of lung nodule Biopsy unsuccessful
1/1/21 thoracotomy 1 met removed that wasn’t noticed on ct
2/2022 sabr to 2 lung nodule
09/22 PET scan progression of sabr’d nodules
10/22 phase 1 trial bispecific antibody

roadrunner
Posts: 347
Joined: Sun Jan 12, 2020 8:46 pm

Re: Phase 1 trial.

Postby roadrunner » Mon Jan 16, 2023 12:57 pm

Is that enough of a move in the marker to be of clinical significance?

Either way, congrats on the disease control, and good on you for steering your own course with the surgical consult. Good luck there as well!
7/19: RC: Staged IIIA, T2N1M0
approx 4.25 cm, low/mid rectum, mod. well diff.; lung micronodule
8/19-10/19 4 rds.FOLFOX neoadjuvant, 3 w/Oxiplatin (reduced 70-75%)
neoadjuvant chemorad 11/19
4 rounds FOLFOX July-August 2020
ncCR 10/20; biopsies neg
TAE 11/20, tumor cells removed
Chest CT 3/30/21 growth in 2 nodules (3 and 5mm)
VATS 12/8/21 sub-pleural met 7mm.
SBRT nodule 1/22
CT 3/22: Clear
Chest CT 5/19/22 Clear
6/20/22 TAE rectal polyp benign
CT/MRI 9/11 Clear
11/9/22: Rectal exam/scope Clear (2 yrs.)

Markdale
Posts: 61
Joined: Wed Dec 02, 2020 4:45 pm

Re: Phase 1 trial.

Postby Markdale » Mon Jan 16, 2023 11:10 pm

Thanks road runner. They only focus on the size of the Mets they are measuring to determine where to go with the trial. I think you were right in the previous comment about the docs mindset.
Mark
09/20:Diagnosed after colonoscopy for bleeding.
MRI and ct scan confirmed tumor at rectosigmoid junction aswell as lung nodules in RLL (1X1.2cm) and RUL (3X.5cm)
10/20: LAR tumour t3n2m1 4/24 lymph nodes.
11/20: pet scan confirmed Mets
11/20: folfoxiri - 10/6/21. 12 rounds in total
12/20: ct lung biopsy of lung nodule Biopsy unsuccessful
1/1/21 thoracotomy 1 met removed that wasn’t noticed on ct
2/2022 sabr to 2 lung nodule
09/22 PET scan progression of sabr’d nodules
10/22 phase 1 trial bispecific antibody


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