The ARTful Dodger (Stolen Lung)

[TheWallnerus]

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He strikes again.

We lost postop Stage III lung today. Unless you wanna hem and haw and say the trial was wrong etc and PORT is still SOC.

I liked to quote the PORT meta analysis in tumor boards. I knew the data by heart.

Postoperative radiotherapy versus no postoperative radiotherapy in patients with completely resected non-small-cell lung cancer and proven mediastinal N2 involvement (Lung ART): an open-label, randomised, phase 3 trial​

 

[deleted1111261]

He strikes again.

We lost postop Stage III lung today. Unless you wanna hem and haw and say the trial was wrong etc and PORT is still SOC.

I liked to quote the PORT meta analysis. I knew the data by heart.

Postoperative radiotherapy versus no postoperative radiotherapy in patients with completely resected non-small-cell lung cancer and proven mediastinal N2 involvement (Lung ART): an open-label, randomised, phase 3 trial​

The academic RadOnc community baffles me about this.

- no good data in 1980s, but some thought it may help
- PORT meta analysis shows no benefit - despite caveats (bad RT, heterogeneous doses, too many low risk patients). Seems to hurt N0-1, may not hurt N2, but possibly may help. LR improved, no appreciable survival benefit.
- then Lally and ANITA analyses - prospective for chemo, non-randomized for RT and freaking standard of care changes based on this
- then recently Lung ART is presented and people still defending PORT and “let’s wait for publication”
- then second study presented, and still people contorting themselves to defend PORT
- now LungART published.

PORT built on house of cards. Big #radonc looks incredibly silly on this one.

If you’re treating post-op because of pN2 disease, you’re “doing it wrong”

 

[TheWallnerus]

The academic RadOnc community baffles me about this.

- no good data in 1980s, but some thought it may help
- PORT meta analysis shows no benefit - despite caveats (bad RT, heterogeneous doses, too many low risk patients). Seems to hurt N0-1, may not hurt N2, but possibly may help. LR improved, no appreciable survival benefit.
- then Lally and ANITA analyses - prospective for chemo, non-randomized for RT and freaking standard of care changes based on this
- then recently Lung ART is presented and people still defending PORT and “let’s wait for publication”
- then second study presented, and still people contorting themselves to defend PORT
- now LungART published.

PORT built on house of cards. Big #radonc looks incredibly silly on this one.

If you’re treating post-op because of pN2 disease, you’re “doing it wrong”

Our referring physicians will save us from looking silly I am quite sure. If we can’t understand the data they can.

 

[Radonc90]

 

[elementaryschooleconomics]

Using the Lally data to justify PORT in N2 lung is one of my "favorite" (using that sarcastically here) RadOnc quirks:

Lally is a SEER study. The ANITA data, in this context, is an unplanned secondary analysis of a trial studying something else. The patients from ANITA were treated from 1994-2000.

LungART is a Phase III RCT enrolling several hundred people. Methods:
"Lung ART is an open-label, randomised, phase 3, superiority trial comparing mediastinal PORT to no PORT in patients with NSCLC with complete resection, nodal exploration, and cytologically or histologically proven N2 involvement. Previous neoadjuvant or adjuvant chemotherapy was allowed. Patients aged 18 years or older, with an WHO performance status of 0–2, were recruited from 64 hospitals and cancer centres in five countries (France, UK, Germany, Switzerland, and Belgium)."

Anyone who continues to support PORT in N2 lung is saying a SEER study from the mid 2000s and an unplanned secondary analysis of a chemo trial performed in the 90s have more weight than a Phase III RCT from the modern era.

Thought experiment: you're a RadOnc resident in 2021 on a breast rotation. You propose a treatment regimen for a patient you just saw in clinic to your attending which is supported by 15-year-old SEER data and unplanned secondary analysis data from patients treated 30 years ago, but the opposite of what modern Phase III RCT data supports. How would that conversation go for you?

 

[TheWallnerus]

Using the Lally data to justify PORT in N2 lung is one of my "favorite" (using that sarcastically here) RadOnc quirks:

View attachment 346856

Lally is a SEER study. The ANITA data, in this context, is an unplanned secondary analysis of a trial studying something else. The patients from ANITA were treated from 1994-2000.

LungART is a Phase III RCT enrolling several hundred people. Methods:
"Lung ART is an open-label, randomised, phase 3, superiority trial comparing mediastinal PORT to no PORT in patients with NSCLC with complete resection, nodal exploration, and cytologically or histologically proven N2 involvement. Previous neoadjuvant or adjuvant chemotherapy was allowed. Patients aged 18 years or older, with an WHO performance status of 0–2, were recruited from 64 hospitals and cancer centres in five countries (France, UK, Germany, Switzerland, and Belgium)."

Anyone who continues to support PORT in N2 lung is saying a SEER study from the mid 2000s and an unplanned secondary analysis of a chemo trial performed in the 90s have more weight than a Phase III RCT from the modern era.

Thought experiment: you're a RadOnc resident in 2021 on a breast rotation. You propose a treatment regimen for a patient you just saw in clinic to your attending which is supported by 15-year-old SEER data and unplanned secondary analysis data from patients treated 30 years ago, but the opposite of what modern Phase III RCT data supports. How would that conversation go for you?

Simul and you have given a great data summary. will add that the rationale for lung PORT even older than 30y. The OG data for lung PORT is the meta analysis. Which includes trials like this:

Postoperative supervoltage radiotherapy was tested in a controlled clinical trial in an attempt to improve the survival for patients with bronchogenic carcinoma. Radiation therapy began 3 to 4 weeks after surgery; three fields were used giving a dose of 6,000 rad in six weeks to the mediastinum from a Co 60 unit. Between 1966 and 1975, 224 patients were included in this study

 

[Lamount]

The academic RadOnc community baffles me about this.

- no good data in 1980s, but some thought it may help
- PORT meta analysis shows no benefit - despite caveats (bad RT, heterogeneous doses, too many low risk patients). Seems to hurt N0-1, may not hurt N2, but possibly may help. LR improved, no appreciable survival benefit.
- then Lally and ANITA analyses - prospective for chemo, non-randomized for RT and freaking standard of care changes based on this
- then recently Lung ART is presented and people still defending PORT and “let’s wait for publication”
- then second study presented, and still people contorting themselves to defend PORT
- now LungART published.

PORT built on house of cards. Big #radonc looks incredibly silly on this one.

If you’re treating post-op because of pN2 disease, you’re “doing it wrong”

LungART and PORT-C have made many in academics rethink the use of PORT across the board. I know it has for me. However, I would not go quite so far as to claim that it plays NO role for N2/N3 disease.

Firstly, the trials are both somewhat flawed... but it is too early in the morning to wax philosophic about the predictable toxicity with treating all patients to 2 cm below the carina with 3D techniques (LungART) or hanging your hat on an IIT analysis with 25% non-compliance in the RT arm and 6% of the control arm receiving RT (PORT-C).

Nonetheless, PORT certainly isn't a slam dunk anymore. In those folks who have N2 disease and had a thorough dissection with 1-2/8-10 LNs involved (no ECE), lungART has made me more comfortable omitting RT. However, for those "surprise N2" folks who have 5/6 LNs involved on dissection (+/- ECE), or for those with adenosquamous, I will continue to offer PORT. These are usually the cases where the surgeons tell me they are concerned about recurrence... and if they are concerned, so am I.

 

[SneakyBooger]

I haven't done PORT in years...

 

[TheWallnerus]

LungART and PORT-C have made many in academics rethink the use of PORT across the board. I know it has for me. However, I would not go quite so far as to claim that it plays NO role for N2/N3 disease.

Firstly, the trials are both somewhat flawed... but it is too early in the morning to wax philosophic about the predictable toxicity with treating all patients to 2 cm below the carina with 3D techniques (LungART) or hanging your hat on an IIT analysis with 25% non-compliance in the RT arm and 6% of the control arm receiving RT (PORT-C).

Nonetheless, PORT certainly isn't a slam dunk anymore. In those folks who have N2 disease and had a thorough dissection with 1-2/8-10 LNs involved (no ECE), lungART has made me more comfortable omitting RT. However, for those "surprise N2" folks who have 5/6 LNs involved on dissection (+/- ECE), or for those with adenosquamous, I will continue to offer PORT. These are usually the cases where the surgeons tell me they are concerned about recurrence... and if they are concerned, so am I.

Is the theory here that by making the fields smaller and tighter when there’s a lot of LNs involved it will make the LC better and kill less people from RT (so DFS is better too). The therapeutic window is very very narrow for lung PORT, and if the window is not hit it doesn’t wind up just not being unsuccessful, but survival decreasing. And what if the patient is treatable by ADAURA, something that TRULY improves DFS… no hubris or bribing a statistician required.

 

[elementaryschooleconomics]

LungART and PORT-C have made many in academics rethink the use of PORT across the board. I know it has for me. However, I would not go quite so far as to claim that it plays NO role for N2/N3 disease.

Firstly, the trials are both somewhat flawed... but it is too early in the morning to wax philosophic about the predictable toxicity with treating all patients to 2 cm below the carina with 3D techniques (LungART) or hanging your hat on an IIT analysis with 25% non-compliance in the RT arm and 6% of the control arm receiving RT (PORT-C).

Nonetheless, PORT certainly isn't a slam dunk anymore. In those folks who have N2 disease and had a thorough dissection with 1-2/8-10 LNs involved (no ECE), lungART has made me more comfortable omitting RT. However, for those "surprise N2" folks who have 5/6 LNs involved on dissection (+/- ECE), or for those with adenosquamous, I will continue to offer PORT. These are usually the cases where the surgeons tell me they are concerned about recurrence... and if they are concerned, so am I.

I mean, sure, if you want to invoke case-by-case clinical nuance in this discussion, I completely agree with you. For similar reasons I have pursued things like concurrent chemo in cutaneous SCC based on a patient's presentation, despite knowing the data.

 

[Lamount]

Is the theory here that by making the fields smaller and tighter when there’s a lot of LNs involved it will make the LC better and kill less people from RT (so DFS is better too). The therapeutic window is very very narrow for lung PORT, and if the window is not hit it doesn’t wind up just not being unsuccessful, but survival decreasing. And what if the patient is treatable by ADAURA, something that TRULY improves DFS… no hubris or bribing a statistician required.

Unless ADUARA has an OS survival benefit, I am guessing it will lose it's shine very quickly. The primary question is: is there any advantage to adjuvant Osi vs. Salvage Osi... and there are many in the medical oncology community who think the answer is going to be "No!". So you are potentially giving 2 years and $500k worth of drug to a population who either 1) never needed it to begin with, or 2) would have done just as well if you wanted until recurrence. As far as I know, a TKI has never cured anyone who had any macroscopic or microscopic disease.

Consider a patient with what was thought to be a stage I NSCLC (EGFR mut) but incidentally had 4/6+ N2 LNs. You can do one of the following
1) Offer chemo and then PORT, reserving Osi for metastatic disease
2) Offer Osi adjuvantly and call it a day.

Let's say, in both cases, the patient does fine without every having a recurrence. In scenario 1) you just saved the system ~400k and the patient 1.5 years of treatment.

Now let's say, in both cases, the patient mets out.
In scenario 1), you can still give Osi and get 1-2 years of disease control.
In scenario 2), not a whole lot of great options
...now maybe the patient who got adjuvant osi takes longer to met out, and the differences wash out in the end, but you certainly didn't do much to help.

The difference between PORT and Osi in EGFR+ is that PORT isn't the last line of defense. Now if ADAURA shows a OS benefit, THAT is an entirely different conversation... but looking at the initial curves, that seems unlikely

 

[deleted1111261]

LungART and PORT-C have made many in academics rethink the use of PORT across the board. I know it has for me. However, I would not go quite so far as to claim that it plays NO role for N2/N3 disease.

Firstly, the trials are both somewhat flawed... but it is too early in the morning to wax philosophic about the predictable toxicity with treating all patients to 2 cm below the carina with 3D techniques (LungART) or hanging your hat on an IIT analysis with 25% non-compliance in the RT arm and 6% of the control arm receiving RT (PORT-C).

Nonetheless, PORT certainly isn't a slam dunk anymore. In those folks who have N2 disease and had a thorough dissection with 1-2/8-10 LNs involved (no ECE), lungART has made me more comfortable omitting RT. However, for those "surprise N2" folks who have 5/6 LNs involved on dissection (+/- ECE), or for those with adenosquamous, I will continue to offer PORT. These are usually the cases where the surgeons tell me they are concerned about recurrence... and if they are concerned, so am I.

Then you are practicing non-evidence medicine. What prospective data do you have to support your treatment? Goalposts are moving - IMRT is necessary for a benefit ? Since when does IMRT change survival ?

 

[Mandelin Rain]

The problem was they didn't use protons.

Proton PORT (PPORT) standard of care, IMO.

 

[deleted1111261]

The problem was they didn't use protons.

Proton PORT (PPORT) standard of care, IMO.

Seriously. They will do a VMAT trial with smaller volumes and then claim “but protons!”

 

[Mandelin Rain]

ConPORTionist

 

[deleted1111261]

ConPORTionist

What’s so irritating is for whatever reason, they want to make sweeping claims in things like Choosing Wisely, but this has a meta analysis against it, two recent RCTs and yet… clinging to an outdated prayer that PORT does anything to change survival.

 

[Lamount]

Then you are practicing non-evidence medicine. What prospective data do you have to support your treatment? Goalposts are moving - IMRT is necessary for a benefit ? Since when does IMRT change survival ?

If you want to make an assessment in black-and-white, I have the DFS benefit in per protocol analysis of PORT-C, which is only augmented in the "as-treated" analysis which counts those 6% of control arm patients who got PORT as actually getting PORT. Can't one reasonably conclude that those who actually get PORT have better DFS than those who don't.

"Evidence-based medicine" is too often used as a means of terminating a conversation. LungART certainly makes me less likely to reflexively offer PORT in all N2... but if you aren't considering each case indiviually, you aren't giving patients the full benefit of your intellect and reason.

 

[deleted1111261]

If you want to make an assessment in black-and-white, I have the DFS benefit in per protocol analysis of PORT-C, which is only augmented in the "as-treated" analysis which counts those 6% of control arm patients who got PORT as actually getting PORT. Can't one reasonably conclude that those who actually get PORT have better DFS than those who don't.

"Evidence-based medicine" is too often used as a means of terminating a conversation. LungART certainly makes me less likely to reflexively offer PORT in all N2... but if you aren't considering each case indiviually, you aren't giving patients the full benefit of your intellect and reason.

It’s not terminating a discussion. I have never seen standard of care changed based on a chemo trial subset analysis + SEER database positivity, when there are two negative RCTs and negative meta-analysis.

My intellect and reason are secondary to two negative trials.

The data is the data.

 

[deleted1116990]

There is no role for PORT in N2 disease.

 

[Lamount]

It’s not terminating a discussion. I have never seen standard of care changed based on a chemo trial subset analysis + SEER database positivity, when there are two negative RCTs and negative meta-analysis.

My intellect and reason are secondary to two negative trials.

The data is the data.

Do you consider PORT-C negative?
I would argue that this inappropriately assumes SOC when the trial was being conceived was to omit PORT. Only when you are considering the benefit of adding a treatment to the SOC is it reasonable to disregard a PP analysis and only look at IIT.

To get back to our conversation about reason... the IIT analysis counted the 6% of the contorl arm that got RT as still being in the control arm!. If you compare the per protocol analysis (which omitted the 24% of the RT arm who "chose" to forgo RT and the 6% of "no-RT" arm who got PORT) to the as-treated analysis (comparing those who got PORT vs. those who didn't), the disease free survival benefit only deepened. How do you interpret these data?

 

[Palex80]

There is no role for PORT in N2 disease.

We would still consider treating for multilevel N2 / ECE on nodes. But then again, these are very rare cases that generally do not go for surgery. Bear in mind that a good portion of LungArt-patients were single station / incidental N2.

 

[deleted1111261]

Do you consider PORT-C negative?
I would argue that this inappropriately assumes SOC when the trial was being conceived was to omit PORT. Only when you are considering the benefit of adding a treatment to the SOC is it reasonable to disregard a PP analysis and only look at IIT.

To get back to our conversation about reason... the IIT analysis counted the 6% of the contorl arm that got RT as still being in the control arm!. If you compare the per protocol analysis (which omitted the 24% of the RT arm who "chose" to forgo RT and the 6% of "no-RT" arm who got PORT) to the as-treated analysis (comparing those who got PORT vs. those who didn't), the disease free survival benefit only deepened. How do you interpret these data?

Are we going to start doing this kind of manipulation for all studies, or just those that we want to be positive ?

 

[Mandelin Rain]

55% of PORT-C patients had no smoking history (with no mention of driver mutation analysis/treatment) and 40% had known N2 disease at time of surgery.

I'm not sure I'd use it to justify much in this country.

 

[temujim]

Our referring physicians will save us from looking silly I am quite sure. If we can’t understand the data they can.

No dog in this fight since don't treat much lung... but quick question -- aren't there multiple studies showing no benefit to upfront surgery in known N2 disease? Why are surgeons even cutting on these patients?

And second... a lot of snark about trying again with VMAT or protons or whatever. I say go for it. Cisplatin had something like 90+ trials in H&N before a meta-analysis finished the debate. 90 frickin bites at the apple. Why give up (trials anyway) after just a few negative one if we have a new radiation "drug"? Don't be quitters.

 

[Lamount]

Are we going to start doing this kind of manipulation for all studies, or just those that we want to be positive ?

If you are asking me if I advocate reading more than just the last sentence of the abstract of all studies, I do.

You never answered me. How do you interpret PORT-C?

 

[medgator]

Not sure I'd ignore considering port in someone who went to surgery with bulky n2 nodes, do we just ignore ece/residual disease these days?

 

[deleted1111261]

Not sure I'd ignore considering port in someone who went to surgery with bulky n2 nodes, do we just ignore ece/residual disease these days?

I think that’s different ?

 

[deleted1111261]

You never answered me. How do you interpret PORT-C?

Negative study

 

[Lamount]

Negative study

That's interesting... and if the authors had reported the same results by called the study "positive" because the PP analysis was positive, would it then be "positive study"?

 

[deleted1111261]

That's interesting... and if the authors had reported the same results by called the study "positive" because the PP analysis was positive, would it then be "positive study"?

No, because that would be cheating
Have to follow science rules

 

[Mandelin Rain]

When I see a non-smoking, likely EGFR mutant (but untested) patient with known N2 disease go to surgery, I'd feel that there may be some modest benefit to them getting PORT, assuming they don't get osi.

This represents 0% of my practice.

 

[Lamount]

No, because that would be cheating
Have to follow science rules

When arguing to escalate standard of care, you should use IIT. When arguing to de-escalate SOC, you should use per-protocol. You may not have considered PORT standard of care for N2, but I would say that most of us did.

 

[deleted1111261]

When arguing to escalate standard of care, you should use IIT. When arguing to de-escalate SOC, you should use per-protocol. You may not have considered PORT standard of care for N2, but I would say that most of us did.

You’re comfortable using Big Data and chemo study subset analysis to create standards of care?

 

[Lamount]

You’re comfortable using Big Data and chemo study subset analysis to create standards of care?

Sure...

Have you ever treated post-op tonsil cancer with RT? I recall being shocked to discover in residency there had never been a positive RCT supporting post-op RT in H&N for anything but buccal mucosa. Correct me if I am wrong

What about neoadjuvant CRT for gastric cancer?

I am badgering you because you are being dogmatic. There is no reason to oversimplify. As I have said numerous times, I wouldn't recommend PORT across the board anymore, just in cases where the surgeon is concerned and/or pathology reveals high risk features (i.e. someone who probably shouldn't have had surgery to begin with). I do PORT maybe a once-a-month, and half the time I am doing it for R1/R2 resection.

 

[deleted1111261]

Sure...

Have you ever treated post-op tonsil cancer with RT? I recall being shocked to discover in residency there had never been a positive RCT supporting post-op RT in H&N for anything but buccal mucosa. Correct me if I am wrong

What about neoadjuvant CRT for gastric cancer?

I am badgering you because you are being dogmatic. There is no reason to oversimplify. As I have said numerous times, I wouldn't recommend PORT across the board anymore, just in cases where the surgeon is concerned and/or pathology reveals high risk features (i.e. someone who probably shouldn't have had surgery to begin with). I do PORT maybe a once-a-month, and half the time I am doing it for R1/R2 resection.

I don't think you are badgering at all, I think you are doing it politely.

Re; Tonsil -

Is there a meta-analysis showing RT doesn't work? Are there two (even flawed) RCTs showing RT doesn't work?
There are positive trials for head and neck showing that chemoRT is better than RT, so I'm convinced.
Is there data showing BCS = mastectomy in DCIS? No, but there is data showing RT benefit vs no RT in patients treated with lumpectomy.

I think it's different.

 

[Lamount]

I don't think you are badgering at all, I think you are doing it politely.

Re; Tonsil -

Is there a meta-analysis showing RT doesn't work? Are there two (even flawed) RCTs showing RT doesn't work?
There are positive trials for head and neck showing that chemoRT is better than RT, so I'm convinced.
Is there data showing BCS = mastectomy in DCIS? No, but there is data showing RT benefit vs no RT in patients treated with lumpectomy.

I think it's different.

How does chemoRT being better than RT convince you that the RT was necessary H&N? Would you be convinced if PORT + adjuvant chemo was better than PORT alone in lung?

I think it all comes down to the calculation of risk and benefit.

PORT decreases the chance of mediastinal relapse (in lungART, this was 46% vs 25%; and in PORT-C IIT analysis, there was a LRFS HR 0.7 p=0.03), but this could potentially be offset by increased toxicity from treatment. If I have a patient who's risk of relapse appears to be higher than average (e.g. ECE, aggressive histology or high ratio of resected LNs) and I can reasonably spare the heart/esophagus more than they did on lungART (which is sadly not that difficult to do), I reason that the benefits outweigh the risks. While I understand why some may think this is "ignoring the evidence", I think I am doing just the opposite.

 

[communitydoc13]

Is the theory here that by making the fields smaller and tighter when there’s a lot of LNs involved it will make the LC better and kill less people from RT (so DFS is better too). The therapeutic window is very very narrow for lung PORT, and if the window is not hit it doesn’t wind up just not being unsuccessful, but survival decreasing. And what if the patient is treatable by ADAURA, something that TRULY improves DFS… no hubris or bribing a statistician required.

PFS here is almost certainly real, sometimes the curves just look right (separate after time, keep separation, trend appropriately with rational change in evaluable patients) even when the P value a little large. Non-cancer deaths (largely by XRT) eat into the number. By radiating mediastinum, probably saving one in eight patients a mediastinal failure in this population.

But, I'm going to very rarely do it if at all. I radiated 1/3 post-op N2 patients referred to me this past year. (Level 7 positive and no mediastinal dissection superior to level 7 with equivocal mediastinal nodes on imaging) and they got a pneumonitis of some sort during last week of treatment and were hospitalized post-op week 1. Now OK but somewhat diminished.

But in the community, Stage III non-small cell lung CA pretty rare (lots of 1s and 4s) and post-OP stage III even rarer. Median age of my Stage III patients 74 y/o. A full decade older than those enrolled on the Pacific trial.

Competing risks just too high and cost of treatment not-insignificant. (I'm convinced the post-op lung patient much more vulnerable.) Post-op immuno now entering SOC.

I'll treat mediastinal failures when they occur.

 

[TheWallnerus]

Unless ADUARA has an OS survival benefit, I am guessing it will lose it's shine very quickly.

Do you consider PORT-C negative?

You do adjuvant PORT because it's got an OS benefit whereas ADAURA does not? And yes, PORT-C must be called negative insofar as PORT for N2 could not have been called standard of care on the basis of evidence. Here's a data dump of all known randomized studies looking at PORT in lung cancer that I could cobble together today. It's interesting.

You be the judge.

(BTW, PORT-C IMRT patients did not seem to do quite as well as LungART 3D patients.)

While I understand why some may think this is "ignoring the evidence", I think I am doing just the opposite.

On the basis of the above evidence, it appears we can only clearly recommend PORT in Stage I lung cancer. Or, maybe, PORT for no one.

 

[Mandelin Rain]

Looking at the data, I'm definitely recommending Osi for EGFR positive (younger, nonsmoking, east asian i.e. the MAJORITY of PORT-C) patients.

 

[theradiator]

Let me propose a radical idea. Wait for the patient to fail and then salvage.

 

[Lamount]

You do adjuvant PORT because it's got an OS benefit whereas ADAURA does not? And yes, PORT-C must be called negative insofar as PORT for N2 could not have been called standard of care on the basis of evidence. Here's a data dump of all known randomized studies looking at PORT in lung cancer that I could cobble together today. It's interesting.

You be the judge.

(BTW, PORT-C IMRT patients did not seem to do quite as well as LungART 3D patients.)

On the basis of the above evidence, it appears we can only clearly recommend PORT in Stage I lung cancer. Or, maybe, PORT for no one.

OS is a more relevant endpoint for Osi because we already know it works. We already know it prevents progression. The question with Osi is whether giving it adjuvantly is ANY better than giving it at the time of progression.

Comparing KM curves in unmatched studies is... if nothing else... colorful.

Again, the data from PORT-C, using contompary techniques. One could even argue that if there study was powered to account for their awful compliance rate, it might have even met statistical significance in the IIT analysis.

 

[Palex80]

More developments in Stage Ib-IIIA NSCLC

Merck’s KEYTRUDA® (pembrolizumab) Showed Statistically Significant Improvement in Disease-Free Survival Versus Placebo as Adjuvant Treatment for Patients With Stage IB-IIIA Non-Small Cell Lung Cancer Regardless of PD-L1 Expression - Merck.com

First Positive Study for KEYTRUDA in Adjuvant Stage IB-IIIA NSCLC Merck (NYSE: MRK), known as MSD outside the United States and Canada, the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) today announced that the Phase 3...

www.merck.com

 

[TheWallnerus]

A med onc I deeply respect, and who has never shown anything but the utmost love for radiotherapy, read this trial and texted me: "Did you see this. You're going to be out of a job soon jk." I think he texted me this from his X6 M.