ASCO 2024

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Palex80

Palex80

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With ASCO 2024 just around the corner and abstracts (not LBA!) released yesterday, here are some interesting stuff


Addition of stereotactic body radiotherapy (SBRT) to systemic chemotherapy in locally advanced cholangiocarcinoma (CC) (ABC-07): Results from a randomized phase II trial.​

SBRT did not show any meaningful impact.


Intra-treatment hypoxia directed major radiation de-escalation as definitive treatment for human papillomavirus-related oropharyngeal cancer.​

Intriguing results, looking forward to the full publication. This could potentially one day be practice changing bearing in mind the low toxicity of 30 Gy.


Radiation dose escalation and local control for intermediate-risk rhabdomyosarcoma on ARST1431: A report from the Children’s Oncology Group​

More dose is not necessarily better.


Re-irradiation in recurrent glioblastoma: PET- or MRI-based? Results of a prospective randomized clinical trial.​

PET not useful for GBM-reirradiation.


Results from METIS (EF-25), an international, multicenter phase III randomized study evaluating the efficacy and safety of tumor treating fields (TTFields) therapy in NSCLC patients with brain metastases.​

I frankly did not expect this one to come out positive. Impressive.


A randomised, controlled, multicentre trial of imiquimod versus radiotherapy for lentigo maligna.​

Bear in mind, this is a negative trial for imiquimod!


Feel free to add more!
I will not attend the conference, I hope some of you will have the chance to catch up.
I will be in ESMO later this year!
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Palex80 said:
With ASCO 2024 just around the corner and abstracts (not LBA!) released yesterday, here are some interesting stuff


Addition of stereotactic body radiotherapy (SBRT) to systemic chemotherapy in locally advanced cholangiocarcinoma (CC) (ABC-07): Results from a randomized phase II trial.​

SBRT did not show any meaningful impact.


Intra-treatment hypoxia directed major radiation de-escalation as definitive treatment for human papillomavirus-related oropharyngeal cancer.​

Intriguing results, looking forward to the full publication. This could potentially one day be practice changing bearing in mind the low toxicity of 30 Gy.


Radiation dose escalation and local control for intermediate-risk rhabdomyosarcoma on ARST1431: A report from the Children’s Oncology Group​

More dose is not necessarily better.


Re-irradiation in recurrent glioblastoma: PET- or MRI-based? Results of a prospective randomized clinical trial.​

PET not useful for GBM-reirradiation.


Results from METIS (EF-25), an international, multicenter phase III randomized study evaluating the efficacy and safety of tumor treating fields (TTFields) therapy in NSCLC patients with brain metastases.​

I frankly did not expect this one to come out positive. Impressive.


A randomised, controlled, multicentre trial of imiquimod versus radiotherapy for lentigo maligna.​

Bear in mind, this is a negative trial for imiquimod!


Feel free to add more!
I will not attend the conference, I hope some of you will have the chance to catch up.
I will be in ESMO later this year!
Click to expand...
Thanks for writing this up and posting.
 
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medgator said:
Feeding tube dependence. Great metric. No way to massage that
Click to expand...

Yea... but it got done! [Applause]

1716555309068.png
 
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Also of interest:

Adjuvant chemotherapy following concurrent chemoradiation (CRT) in patients with high-risk early-stage cervical carcinoma following radical hysterectomy: Results of NRG oncology/RTOG 0724/GOG-0724.​

Addition of chemotherapy following adjuvant CRT without any benefit. Results in contrast to the INTERLACE study (although different situation here: adjuvant. not primary CRT).


NRG Oncology/RTOG 0848: Results after adjuvant chemotherapy +/- chemoradiation for patients with resected periampullary pancreatic adenocarcinoma (PA).​

I've written something on the Twitter thread here.
Of note, is that merely 26% of patients were node negative, so this exploratory, non pre-planned analysis and any assumptions based on it, come from a subset of 92 patients...
 
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SU2C-SARC032: A randomized trial of neoadjuvant RT and surgery with or without pembrolizumab for soft tissue sarcoma.

Improved PFS for radiotherapy + pembro compared to radiotherapy alone in localized sarcoma of the extremity (high grade, histology restricted).

This is very exciting to me. The biggest problem in these patients is DM and chemo offers only PFS benefit with a lot of toxicity. This will be a nice option in a space where there are none for many patients. I would be recommending this in every patient eligible for this trial.
 
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Palex80 said:
Also of interest:

Adjuvant chemotherapy following concurrent chemoradiation (CRT) in patients with high-risk early-stage cervical carcinoma following radical hysterectomy: Results of NRG oncology/RTOG 0724/GOG-0724.​

Addition of chemotherapy following adjuvant CRT without any benefit. Results in contrast to the INTERLACE study (although different situation here: adjuvant. not primary CRT).


[
Click to expand...
Better luck with IO I suspect, like in locally advanced which was approved earlier this year
 
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Palex80 said:

Results from METIS (EF-25), an international, multicenter phase III randomized study evaluating the efficacy and safety of tumor treating fields (TTFields) therapy in NSCLC patients with brain metastases.​

I frankly did not expect this one to come out positive. Impressive.
Click to expand...
Yo...that ish works. And people hate it. Referring Neuro-Onc specialists been denigrating the GBM data for years.

Only 67% utilization and about 4 months median usage....maybe just some TTF is valuable.

Patients get sick of wearing it. That is for sure. Counseling them to at least try may be a real beneficial intervention?
 
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Palex80 said:
Bear in mind, this is a negative trial for imiquimod!
Click to expand...
This is a "negative trial for imiquimod" like the Great Depression was great for America.

Results:Between August 2015 and November 2021, 126 patients were randomised from 8 centres (imiquimod 60, radiotherapy 58 in final analysis). The median age was 72 years and 94.9% of lesions were on the head and neck area. Median follow-up was 27 months (range 3-62 months). Six (10.5%) patients in the imiquimod group and 12 (24.0%) patients in the radiotherapy group developed recurrence within 24 months (OR 2.68, 95% CI, 0·92-7.8, p = 0.063). Median time to recurrence was not reached in either group. Treatment failure was significantly different within the subgroup of patients who had reflectance confocal microscopy (RCM) follow up of the LM (imiquimod 4/46, 8.7% radiotherapy 13/52 25.0%; OR 3.50 95% CI 1.05-11.65, p = 0.033). Only one RCM feature was associated with failure at 24 months and significantly different between treatment groups : the presence of atypical round cells at the dermal-epidermal junction (6.9 % of imiquimod failure and 27% of radiotherapy failure: p = 0.035). There were no differences between trial groups in patient-reported skin symptoms (itching, burning/stinging, pain, irritation), skin-specific emotional and functional QOL impacts, or generic QOL at any time points.

Conclusions:Both imiquimod and radiotherapy are valid, well-tolerated and efficient non-surgical options for LM. There is no significant difference in the acute or long term QoL for the two treatments. Clinical trial information: NCT02394132.
 
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communitydoc13 said:
Yo...that ish works. And people hate it. Referring Neuro-Onc specialists been denigrating the GBM data for years.

Only 67% utilization and about 4 months median usage....maybe just some TTF is valuable.

Patients get sick of wearing it. That is for sure. Counseling them to at least try may be a real beneficial intervention?
Click to expand...

Applauding the openly gamed proton H&N trial but ignoring multiple level I pieces of evidence for TTF... SO RAD ONC.
 
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Palex80 said:
With ASCO 2024 just around the corner and abstracts (not LBA!) released yesterday, here are some interesting stuff


Addition of stereotactic body radiotherapy (SBRT) to systemic chemotherapy in locally advanced cholangiocarcinoma (CC) (ABC-07): Results from a randomized phase II trial.​


​

Click to expand...
This continues to support consolidation in locally advanced cholangio despite a large number of more challenging hilar cases.

“median OS time was 23.4 (95% CI: 14.6, 27.7) months for SBRT and 17.2 (95% CI: 10.2, NR) months for CG-only arm. ”

And ablative RT reduced hepatic failure which is also why we offer this (eg: reasonable to offer RT to liver dz in metastatic cases) “hepatic failure (0 vs 3, 13%) for the SBRT and CG-only arms, respectively.” thats with 2x patients on RT arm.

With better systemic now (+durva) local control will be even more important
 
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The feeding tube endpoint might be relevant if they can show that proton therapy improved sparing of an OAR that might correlate with feeding tube dependency (i.e. pharyngeal constrictors, larynx) and that the IMRT plan genuinely attempted to spare these structures. HNC is such a diverse disease though. Presumably the important question is whether or not proton therapy can spare a specific OAR in a specific patient better. Steve Frank talks a lot about sparing the oral mucosa and has some nice photos showing that in his talks. But its not clear (to me) if oral cavity sparing is really better (in terms of clinical toxicity, not DVH) with proton therapy. And IMRT keeps getting better - 6DOF, adaptive planning, real time monitoring. As far as I know, the PBT machines dont offer these new gadgets, which similarly may not be needed but also are not ramping up the cost of care like PBT.
 
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StIGMA said:
This continues to support consolidation in locally advanced cholangio despite a large number of more challenging hilar cases.

“median OS time was 23.4 (95% CI: 14.6, 27.7) months for SBRT and 17.2 (95% CI: 10.2, NR) months for CG-only arm. ”

And ablative RT reduced hepatic failure which is also why we offer this (eg: reasonable to offer RT to liver dz in metastatic cases) “hepatic failure (0 vs 3, 13%) for the SBRT and CG-only arms, respectively.” thats with 2x patients on RT arm.

With better systemic now (+durva) local control will be even more important
Click to expand...

1. The trial is negative.

2. The fairy tale „when systemic control becomes better because of better systemic treatment, RT becomes even more important because local control is crucial“ has to end.
It does apply sometimes, see M1 nasopharyngeal cancer or M1 (oligo) prostate cancer. But it may also turn things around.
See pancreatic cancer, rectal cancer, breast cancer.
Systemic treatment became so good, that the benefit of RT in terms of local control became irrelevant.
 
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Palex80 said:
1. The trial is negative.

2. The fairy tale „when systemic control becomes better because of better systemic treatment, RT becomes even more important because local control is crucial“ has to end.
It does apply sometimes, see M1 nasopharyngeal cancer or M1 (oligo) prostate cancer. But it may also turn things around.
See pancreatic cancer, rectal cancer, breast cancer.
Systemic treatment became so good, that the benefit of RT in terms of local control became irrelevant.
Click to expand...


See esophagus cancer and pending CROSS vs FLOT results to exemplify the point
 
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Palex80 said:
1. The trial is negative.

2. The fairy tale „when systemic control becomes better because of better systemic treatment, RT becomes even more important because local control is crucial“ has to end.
It does apply sometimes, see M1 nasopharyngeal cancer or M1 (oligo) prostate cancer. But it may also turn things around.
See pancreatic cancer, rectal cancer, breast cancer.
Systemic treatment became so good, that the benefit of RT in terms of local control became irrelevant.
Click to expand...
It’s not practice changing. Data is data. What treatment would you really want?

Agree w #2 and in this setting, based on this trial, imo favors consolidation. I would not ignore the OS difference/signal.

I am not surprised at all about the PFS and think that was a shortsighted endpoint.
 
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Ray D. Ayshun said:
So we're not getting post op pancreas. We still have sarcoma!
Click to expand...

I personally disagree. Continuing to move the goal posts when the trial took 16 years to just get a damn presentation is really useless. If we're going to ignore a positive trial (at least for pN0) why did we even run it???
 
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evilbooyaa said:
I personally disagree. Continuing to move the goal posts when the trial took 16 years to just get a damn presentation is really useless. If we're going to ignore a positive trial (at least for pN0) why did we even run it???
Click to expand...
To allow residents to contour a whipped abdomen in order to learn all the new anatomic connections for boards.
 
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evilbooyaa said:
I personally disagree. Continuing to move the goal posts when the trial took 16 years to just get a damn presentation is really useless. If we're going to ignore a positive trial (at least for pN0) why did we even run it???
Click to expand...
Well, the trial is, strictly speaking, not positive.
It‘s an unplanned subgroup analysis. We don‘t even know if the groups were balanced, at least until we see the data.
 
evilbooyaa said:
I personally disagree. Continuing to move the goal posts when the trial took 16 years to just get a damn presentation is really useless. If we're going to ignore a positive trial (at least for pN0) why did we even run it???
Click to expand...
This is on RTOG/NRG. They should have shut 0848 down when the erlotinib arm closed, then opened a new study with modern chemo. Instead we have a gacked up Frankentrial, it's better than a fully negative study but will be very easy to discount the results given the design problems.
 
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My view is that this trial results were about as good as a rad onc could have hoped for. There’s a lot here

RT is not dead in this space


Preop esoph is a diff story
 
Palex80 said:
Well, the trial is, strictly speaking, not positive.
It‘s an unplanned subgroup analysis. We don‘t even know if the groups were balanced, at least until we see the data.
Click to expand...
While skepticism for 'advances' in pancreatic cancer has historically been warranted, remember that medical oncologists will continue to gleefully recommend FOLFIRINOX without radiation no matter how many neoadjuvant randomized trials end up negative.

pubmed.ncbi.nlm.nih.gov

Neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer (NORPACT-1): a multicentre, randomised, phase 2 trial - PubMed

Norwegian Cancer Society, South Eastern Norwegian Health Authority, The Sjöberg Foundation, and Helsinki University Hospital Research Grants.
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov

Adjuvant Gemcitabine Versus Neoadjuvant/Adjuvant FOLFIRINOX in Resectable Pancreatic Cancer: The Randomized Multicenter Phase II NEPAFOX Trial - PubMed

Although the analysis was only descriptive owing to small patient numbers, no safety issues regarding surgical complications were observed in the perioperative FOLFIRINOX arm. Thus, considering the small number of patients, perioperative treatment approach appears feasible and potentially...
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
 
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drowsy12 said:
I’m more talking about the asco trial that has more impact for a decreased role - the FLOT vs CROSS
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Waiting to see. It’s the plenary, so we know FLOT is at least as good as CROSS. In some regions, it’s over. Where I practice, our med oncs will not change unless it’s superior. Not a lot of question that for most people, 6-8 cycles of FLOT is more toxic than cross. And with a lot worse chronic neuropathy.

But we’ve seen this episode before. PROSPECT compared CRT to chem. Showed chemo was non-inferior but more toxic. It was proclaimed a win by some because it avoids the “brutal” radiation toxicity (which apparently has less grade 3+ toxicity than chemo alone in this RCT…but those are just details). The difference here is there is no organ preservation for esophagus. The impact of prospect was somewhat limited in many regions because TNT smokes both the German and PROSPECT arms in terms of CR and organ preservation. I have no doubt that many of you are out of esophagus regardless of what it shows ☹️
 
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Recently saw an esophageal cancer patient get flot then developed cidp now he can’t walk scope
Shows residual 3 cm tumor and no longer surgical candidate…
 
medgator said:
Flot isn't a US thing at least nowhere I've been at
Click to expand...

There are a few med oncs in our mutli-county greater urban area who give flot for pre-op esophagus and never refer the patients to rad onc. One even claims flot has never once failed, which is a ridiculous fabrication given that the failures make their way to us eventually.
 
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I’m going to wait until the data is out before liking that tweet, as we don’t know yet. But if there’s an OS benefit with FLOT, which is what I expect, then yes.
 
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radiation is out of gi by the end of the decade. A better less toxic regimen will eventually replace flot
 
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Neuronix said:
There are a few med oncs in our mutli-county greater urban area who give flot for pre-op esophagus and never refer the patients to rad onc. One even claims flot has never once failed, which is a ridiculous fabrication given that the failures make their way to us eventually.
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Yeah, all you can do is smile and nod. It’s been standard for gastric for a while and is anything but a fail safe cure. Esophagus won’t be any different. If it were, subset analysis from NEO would have shut this conversation down entirely. But obviously, not even close to 100% of the subjects who got FLOT (around 30%) are still alive and disease free.

RickyScott said:
radiation is out of gi by the end of the decade. A better less toxic regimen will eventually replace flot
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I’ll take that bet. Medicine doesn’t move that fast. Even if this novel combo had already finished early phase testing in any site (let alone a few), it would be minimum 5-7 years to complete and read out if it started today. Now if you said mostly out in 15-20 years…we could have a more serious conversation. The long term trajectory is not great.
 
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ramsesthenice said:
I’ll take that bet. Medicine doesn’t move that fast. Even if this novel combo had already finished early phase testing in any site (let alone a few), it would be minimum 5-7 years to complete and read out if it started today. Now if you said mostly out in 15-20 years…we could have a more serious conversation. The long term trajectory is not great.
Click to expand...
We had the same discussion when arguing about NeoAegis
forums.studentdoctor.net

PACIFIC-2 is negative

https://www.astrazeneca.com/media-centre/press-releases/2023/update-on-pacific-2-phase-iii-trial-for-imfinzi.html Thoughts?
forums.studentdoctor.net forums.studentdoctor.net
MATTERHORN, Keynote-585, DANTE will soon read out. And the medonc argument will be:

"Since NEOAEGIS showed that radiochemo is as good as chemo, and since those 3 trials showed IO-chemo is better than chemo alone, we can safely abandon radiochemo."
Click to expand...

The argument will then likely be:

Since ESOPEC showed that FLOT is at least as good as CROSS and perhaps even superior, and since those 3 trials showed that IO-chemo is better than chemo alone, we can safely abandon radiochemo and embrace IO-chemo.
 
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Palex80 said:
We had the same discussion when arguing about NeoAegis
forums.studentdoctor.net

PACIFIC-2 is negative

https://www.astrazeneca.com/media-centre/press-releases/2023/update-on-pacific-2-phase-iii-trial-for-imfinzi.html Thoughts?
forums.studentdoctor.net forums.studentdoctor.net


The argument will then likely be:

Since ESOPEC showed that FLOT is at least as good as CROSS and perhaps even superior, and since those 3 trials showed that IO-chemo is better than chemo alone, we can safely abandon radiochemo and embrace IO-chemo.
Click to expand...
It’s not even that complicated in some (many) places. When ESOPEC shows FLOT is at least equivalent to CROSS, many centers will abandon cross. But there are a decent number of at least American oncologists who have already said they will only switch to FLOT if it’s superior…which it might be. I’m a little suspicious the results would be kept this quiet if FLOT truly dominated CROSS, but we will see. My guess (100% guess) is statistically FLOT doesn’t win but there is a trend and post hoc will show something along the lines of a benefit in people who got at least a minimum dose intensity. Which, ok, if only 1/3rd of people can tolerate getting that much, the issue speaks for its self. That said, since you don’t know who they are ahead of time, that will be enough to push FLOT to the front for most potential esophagectomy candidates. And in truth, enough for me to ask what I would want if I were in good shape and had an EAC.
 
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I’m still waiting. After neoaegis came out the consensus (at least in my center) was that cross won out due to the higher path cr rate and nodal clearance. FLOT may be a bit better than magic, but we’ll see.

Happy to eat crow.
 
Doctorer said:
I’m still waiting. After neoaegis came out the consensus (at least in my center) was that cross won out due to the higher path cr rate and nodal clearance. FLOT may be a bit better than magic, but we’ll see.

Happy to eat crow.
Click to expand...
Same. At least ranch makes everything better right? Just in case 😊
 
ramsesthenice said:
The difference here is there is no organ preservation for esophagus.
Click to expand...

There is organ preservation (chemoradiation +/- IO) for esophagus but nowhere near as developed as it is for rectum.

Plus there’s always patients unfit for esophagectomy, or who refuse surgery. They get chemoXRT too.

PROSPECT is dumb option for most patients.

www.ncbi.nlm.nih.gov

Long-term outcomes of an esophagus-preserving chemoradiotherapy strategy for patients with endoscopically unresectable stage I thoracic esophageal squamous cell carcinoma

To assess the long-term outcomes of a multimodal approach for maximum esophagus preservation in operable patients with endoscopically unresectable stage I thoracic esophageal squamous cell carcinoma (ESCC).The medical records of patients with stage I ...
www.ncbi.nlm.nih.gov www.ncbi.nlm.nih.gov


 
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yesmaster said:
There is organ preservation (chemoradiation +/- IO) for esophagus but nowhere near as developed as it is for rectum.

Plus there’s always patients unfit for esophagectomy, or who refuse surgery. They get chemoXRT too.

PROSPECT is dumb option for most patients.

www.ncbi.nlm.nih.gov

Long-term outcomes of an esophagus-preserving chemoradiotherapy strategy for patients with endoscopically unresectable stage I thoracic esophageal squamous cell carcinoma

To assess the long-term outcomes of a multimodal approach for maximum esophagus preservation in operable patients with endoscopically unresectable stage I thoracic esophageal squamous cell carcinoma (ESCC).The medical records of patients with stage I ...
www.ncbi.nlm.nih.gov www.ncbi.nlm.nih.gov


Click to expand...
Correct you are and hopefully we get there. I just have yet to meet a cardiothoracic surgeon even willing to talk about it. There is a pervasive belief that local failures rapidly metastasize because the esophagus is not anatomically confined like the rectum. But as you point out, there are plenty of people who refuse surgery or don’t get it for one reason or another who do eventually have local recurrences (though many don’t) which do ok on chemo without mestasasizing for months or longer.

There is another not so small issue. Every rectal TNT trial showed TNT is much better than either CRT or chemo alone with respect to pCR or cCR. Unless EAC ends up drastically different than gastric/GEJ, the CRITICS trial suggests it may not be as useful since adding preop CRT to periop chemo didn’t really improve anything. It’s not a perfect trial but it was unexpected just how negative it was.
 
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I might see a patient that can actually get (or consent to) esophagectomy once every two years. Different strokes and my patient population is an especially unique and unhealthy breed. While it doesn't speak for national trends, I know my role is safe for a while.
 
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metallica81788 said:
I might see a patient that can actually get (or consent to) esophagectomy once every two years. Different strokes and my patient population is an especially unique and unhealthy breed. While it doesn't speak for national trends, I know my role is safe for a while.
Click to expand...
I'd say my population is closer to 60-70% getting surgery. But the number not getting it/refusing is pretty high so I suspect we will continue with a combination of chemo and radiation for these folks regardless.

I think where my GI volume is different from most is pancreas but I suspect that is partly because I live in a rural state and we are the only center who routinely does Whipple resections so a huge proportion end up getting evaluated and treated here whether they do surgery or not. I still treat a ton unresectable patients as consolidation after chemotherapy. Our surgeons are also very big on preop RT if there is more vascular involvement than they would like after FOLFIRINOX for borderline patients. They are pretty aggressive with IRE and have been very impressed with control rates when doing IRE after long-course chemoradiation (as have I). Like everyone else, I am basically completely out of the upfront resectable patients or those who convert after FOLFIRINOX alone. But my pancreas volume is quite healthy which is definitely a double-edged sword. On the one hand, I do think we are doing patients good and it is gratifying to be a part of their care. FOLFIRINOX is exciting and no doubt people are living a good bit longer than they used to. I would say living 2-3 years after surgery is more the rule than the exception now and a decent number of unresectable patients hang on 18-24 months which is very different from when I was in training. Unfortunately, it ends up feeling like false hope sometimes because pretty much everyone still ends up dying eventually. Its such a bad disease and it really burns me up when I meet people (ie, med oncs) who act like FOLFIRINOX has "fixed" the problem. Because it hasn't.
 
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ramsesthenice said:
Like everyone else, I am basically completely out of the upfront resectable patients or those who convert after FOLFIRINOX alone. But my pancreas volume is quite healthy which is definitely a double-edged sword. On the one hand, I do think we are doing patients good and it is gratifying to be a part of their care. FOLFIRINOX is exciting and no doubt people are living a good bit longer than they used to. I would say living 2-3 years after surgery is more the rule than the exception now and a decent number of unresectable patients hang on 18-24 months which is very different from when I was in training. Unfortunately, it ends up feeling like false hope sometimes because pretty much everyone still ends up dying eventually. Its such a bad disease and it really burns me up when I meet people (ie, med oncs) who act like FOLFIRINOX has "fixed" the problem. Because it hasn't.
Click to expand...
This trial is currently running in Europe and I have high hopes for it.
pubmed.ncbi.nlm.nih.gov

Preoperative treatment with mFOLFIRINOX or Gemcitabine/Nab-paclitaxel +/- isotoxic high-dose stereotactic body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma (the STEREOPAC trial): study protocol for a randomised com

The study was registered at ClinicalTrails.gov (NCT05083247) on October 19th, 2021, and in the Clinical Trials Information System (CTIS) EU CT database (2022-501181-22-01) on July 2022.
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
 
Palex80 said:
This trial is currently running in Europe and I have high hopes for it.
pubmed.ncbi.nlm.nih.gov

Preoperative treatment with mFOLFIRINOX or Gemcitabine/Nab-paclitaxel +/- isotoxic high-dose stereotactic body Radiation Therapy (iHD-SBRT) for borderline resectable pancreatic adenocarcinoma (the STEREOPAC trial): study protocol for a randomised com

The study was registered at ClinicalTrails.gov (NCT05083247) on October 19th, 2021, and in the Clinical Trials Information System (CTIS) EU CT database (2022-501181-22-01) on July 2022.
pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov
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No elective nodal coverage mandated in the protocol. Trial will be negative with significant nodal/marginal failures in the SBRT arm. Only one of two lessons learned from the ALLIANCE trial which they do cite in their protocol.
 
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evilbooyaa said:
No elective nodal coverage mandated in the protocol. Trial will be negative with significant nodal/marginal failures in the SBRT arm. Only one of two lessons learned from the ALLIANCE trial which they do cite in their protocol.
Click to expand...
If I read the abstract correctly, there shouldn't be any more failures in the SBRT arm. Looks like they will get the same number of chemo cycles (just 2 -> RT -> 2 as opposed to 4 in the no SBRT arm). So, I like that aspect of the design. But I share your concerns about the SBRT part. No so much the nodal coverage issue, but just the fact that SBRT is not for the faint of heart and I expect a lot of people to end up getting underdosed and I'll be (pleasantly) surprised if it ends up being a positive trial. I have become a much bigger fan of the hypofractionated approach where you use more generous margins and SIB the gross disease to 67-75 Gy in 15-25 fractions. Totally anecdotal, but I have tried both approaches and feel like I see fewer in-field failures now than I did with SBRT (even taking 60-70% of the ITV to 50 Gy/5 fx).
 
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Neuronix said:
There are a few med oncs in our mutli-county greater urban area who give flot for pre-op esophagus and never refer the patients to rad onc. One even claims flot has never once failed, which is a ridiculous fabrication given that the failures make their way to us eventually.
Click to expand...
Not exactly the same, but seeing someone tomorrow who was, in my opinion, mismanaged by someone not thinking critically. True gastric AC treated with perioperative FLOT who had NO pathological response to 4 cycles of FLOT. The outside med onc recommended...MORE FLOT. Which, Im sorry, WTF? If you have pathological evidence its not working, why keep doing it?

There are pretty much the only adjuvant gastric cancers that I treat anymore. Our med oncs prefer to switch to adjuvant CRT if someone has no response to FLOT since there are really no good options that are not derived from one or more agents in FLOT and oh by the way, we have a mountain of data that post-op CRT can be effective for gastric cancer patients. 4/5 the last 5 remain controlled so I like to think we are doing something.
 
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