Articles to use against Proton radiotherapy for prostate cancer

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XRT_doc

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What articles do you usually site to sway patients away from proton therapy for prostate cancer?
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Lodge et. al. A systematic literature review of the clinical and cost-effectiveness of hadron therapy in cancer. Radiother. Oncol. 2007: 110-22

Sheets paper linked above.

Yu et al. Proton Versus Intensity-Modulated Radiotherapy for Prostate Cancer: Patterns of Care and Early Toxicity. J Natl Cancer Inst. 2013 Jan 2;105(1):25-32

NCCN guidelines

ASTRO model policy

It is noteworthy that the registry studies do have some serious flaws (read the editorials on the Sheets paper ).


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NCCN guidelines now has specific language dedicated to proton therapy. They state "The NCCN panel believes no clear evidence supports a benefit or detriment to proton therapy over IMRT for either treatment efficacy or long term toxicity."

If SEER data isn't your thing, UPenn did a pretty good case matched analysis showing no difference: http://www.ncbi.nlm.nih.gov/pubmed/25423899

We've discussed this at length here before, but even with data, a shiny new proton facility, aggressive marketing, and shady ways of presenting the benefit of protons will trump any peer reviewed journal article any day for the vast majority of patients.

The phase III trial will help, but how much bias will sneak into measurements of toxicity either on the physician side or the patient side when completing subjective toxicity forms like EPIC or AUA IPSS forms? I don't know the intricacies of the trial design, so maybe this has been addressed. But, will the patients randomized to photon perceive they're at a higher risk for toxicity? Will physicians with a financial stake enrolling patients tend to up-grade toxicity for photon patients?
 
We need to stop bashing each other and go after the real monsters... Urologist!

I was at a conference where the guy pretty much guaranteed superior outcomes without any toxicities using a robot in high risk patients! All the PCP's ate it up like it was the gospel.
 
I recently saw a patient who had RALP for cT3b, GS8, PSA 74 disease.
 
seper said:
I recently saw a patient who had RALP for cT3b, GS8, PSA 74 disease.
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Happens in the community quite often. I saw a 71 y/o M for rising PSA (initial post-op PSA of 0.4) a year after undergoing RRP pT3b G4+5=9 disease which was delayed for a CABG, pre-op PSA 40.
 
Because of less PSA screening, seems like we are getting much larger proportion of high risk patients, and many post-op cases that are very high risk. I think urologists have less and less patients to operate on, and are no longer being very selective, especially the ones that don't have their greasy, lizard like hands in an Uro-rad venture. Urologists tend to be vile, manipulative, deceitful vipers, and if you look closely at them, many have horns/tails (used to do seeds, and would see them in the OR).
 
http://www.oncologynurseadvisor.com...er-proton-therapy-use-doubled/article/483357/

Results showed the rate of proton therapy use increased from 2.3% in 2004 to 5.2% in 2011 to 4.8% in 2012.

Researchers found that EBRT was much more likely to be delivered at an academic compared with nonacademic center. In addition, proton therapy was more likely to be given to patients who were white, younger, healthier, from metropolitan areas, from areas of higher median household incomes, and who did not have advanced-stage or high-grade disease
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After adjusting for confounding factors, the study demonstrated that black and Hispanic patients were significantly less likely to receive proton therapy than white patients.

“Long-term follow-up is needed to determine whether the increased use of proton therapy for prostate cancer is justified, and ongoing efforts should be made to ensure equal access to resource-limited oncologic therapies,” the authors conclude
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In my opinion, operating on pT3b G4+5=9 disease, PSA 40 is plain mutilation. Even XRT is a stretch.

medgator said:
Happens in the community quite often. I saw a 71 y/o M for rising PSA (initial post-op PSA of 0.4) a year after undergoing RRP pT3b G4+5=9 disease which was delayed for a CABG, pre-op PSA 40.
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seper said:
In my opinion, operating on pT3b G4+5=9 disease, PSA 40 is plain mutilation. Even XRT is a stretch.
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XRT and Hormones is proven to be better than ADT alone in locally advanced and high risk prostate cancer. Adding Radiation cuts the prostate specific mortality in half (24 to 12%) and improves OS! All radiation oncologists should know this study: My pneumonic is WidMARK - Place the MARKS on the Patient! Yes you can argue that the long term hormone therapy was not the best, but these results are very positive. Radiation works, defend it. :)

http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(08)61815-2.pdf
 
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Sure, but > 80% had PSA below 30 in this study. Does not apply to "ultra-high risk".

Phantom1 said:
XRT and Hormones is proven to be better than ADT alone in locally advanced and high risk prostate cancer. Adding Radiation cuts the prostate specific mortality in half (24 to 12%) and improves OS! All radiation oncologists should know this study: My pneumonic is WidMARK - Place the MARKS on the Patient! Yes you can argue that the long term hormone therapy was not the best, but these results are very positive. Radiation works, defend it. :)

http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(08)61815-2.pdf
Click to expand...
 
seper said:
Sure, but > 80% had PSA below 30 in this study. Does not apply to "ultra-high risk".
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Remember, a high PSA doesn't always equal high risk, sometimes the worst cancers are so poorly differentiated they don't even produce PSA but overall I do agree with you.
 
What I like about the above study, is that it did not treat pelvic nodes.
 
Absolutely should treat these patients
Someone said "mutilation" to operate on GS 9, while another says to treat with local treatment for M1. Interesting conflict for a feeble mind like my own ... If one local treatment is mutilation for advanced patients, while another local treatment is curative for metastatic patients. Thank goodness dum dums like me have some guidelines for guidance!
 
I did say XRT was probably futile in untra-high risk localized PCa. If one chooses local treatment for these patients, after 70 Gy they at least don't have to wear diapers unlike post-prostatectomy.
 
Gave the patient all the info of the lack of necessity for Protons. He still decided to drive the distance to get Protons. So much for the battle between real data and nice marketing pictures and loads of radio ads!
 
RadOncDoc21 said:
We need to stop bashing each other and go after the real monsters... Urologist!

I was at a conference where the guy pretty much guaranteed superior outcomes without any toxicities using a robot in high risk patients! All the PCP's ate it up like it was the gospel.
Click to expand...

Finally a rationale voice. Urologist are the scum of medicine and all we do is go after our own. Urologists would never go after their own like this. Get over your egos and start speaking up against urologists that dont give 2 ****s about data. And why should they, our older predessors bow to them for referrals. "Oh you robot' d a guy with gleason 9, psa 49 now he has post op psa of 1 and 2/2 positive nodes and 6 pad incontinence? No problem thank you thank you for referring this interesting consult. Can you believe those other rad oncs are using protons?! Can you believe it?!" Hypocrites. Target the the scum urologists
 
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Easier said than done. Unlike lung masses, breast ca, rectal ca etc, generally urologists are the ones making the diagnosis and having first crack at management. Let's be realistic here.

Also, the proliferation of protons have put our specialty on the map and NOT in a good way.
 
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Speaking of operating on high risk and "ultra-high" risk PCa, are there any modern data regarding QOL outcomes?
 
Sanda, et. al published in NEJM in 2008, and that's sort of the gold standard about QOL in prostate cancer after treatment with each modality. The only thing different now might be that many patients getting laparascopic +/- robot and recovery times may be shorter, so some of the domains outcomes may change. Definitely seeing more and more high risk and ultra high risk patients s/p surgery. Hardly saw GS10, and now seeing that quite frequently.

So, okay in tumor board, hypothetical discussion occurs about this high risk patient. What can you really do when the patient has been told that surgery will be better? Say, "Nuh uh, it's not. It's the same."? I guess. But, we've had those discussions for years, and even with data indicating this is true for lower risk patients, most of them still will not admit it. There is some literature saying surgery is better (First author radonc! That's capitulation WWII style), but most of the data says both treatments (RT + long term ADT vs surgery) are probably equal. It's hypocritical to say that you shouldn't do one or the either. They are both radical definitive treatments with their pros and cons. Many will need additional therapy after surgery with adjuvant/salvage RT, but there aren't good studies recording how many get it/need it. Adjuvant RT just isn't believed by urologists. Incredulously, after the publication of the positive trials showing DFS and OS benefit, the national use of adjuvant RT went down, the percentage went from low teens to single digits. Triple therapy has very good outcomes, and with the results of the ASCENDE-RT trial, it might be better to push that for high risk patients, because dose escalation with brachtherapy is unmatched by any other RT modality.

The trials won't happen. Urologists are the gatekeepers of prostate cancer, and admittedly are slimy, slithery, manipulative and vile deceitful vipers. But, kiss most community practices goodbye if you you don't maintain cordial relationships with them. I think at Harvard, Tony D does the biopsies himself. You could consider learning how to do biopsies and then contacting PCPs to do them, but that's going to start all out war.

Incidentally, JCO just published the 73.8 Gy/41 fx vs 70 Gy/28 fx trial. "Non-inferior but a bit more toxic" seems to be what they are saying, but that sounds a lot like "Inferior" to me. The conclusion is a good read, with some finer points about fractionation/toxicity/outcome. Had no idea data showed 2.0 Gy/fx is worse than 1.8 Gy/fx at the higher dose levels. The one thing about this study that bugs me is the design of non-inferiority. That's just not going to sway people. They should have went with a one-tailed test saying that HF was better than CF, with radiobiology (high a/b ratio for prostate cancer) as the rationale. The lines look like they are separating, and maybe at 10 years there would be significant biochemical control benefit, but as designed, this will probably toss 70 Gy/28 fx into the dustbin of history. Anyone use it?
 
This will probably toss 70 Gy/28 fx into the dustbin of history. Anyone use it?
Click to expand...


I use it extensively, particularly in low-risk patients and have been doing so for years based on original Cleveland Clinic publication. In my experience use of highly conformal IMRT/VMAT + daily CBCT + appropriately low PTV expansions = completely acceptable (and low) incidence of toxicity.
 
What I'm thinking, a lot of high and ultra risk patients which are operated on, also get lymphadenectomy, postop XRT (often to pelvic nodes) and/or long term hormones. This has to be pretty brutal and incomparable with surgery alone for GS 6 disease. If anyone has good data, please share.


Damn_Daniel said:
Sanda, et. al published in NEJM in 2008, and that's sort of the gold standard about QOL in prostate cancer after treatment with each modality. The only thing different now might be that many patients getting laparascopic +/- robot and recovery times may be shorter, so some of the domains outcomes may change. Definitely seeing more and more high risk and ultra high risk patients s/p surgery. Hardly saw GS10, and now seeing that quite frequently.

So, okay in tumor board, hypothetical discussion occurs about this high risk patient. What can you really do when the patient has been told that surgery will be better? Say, "Nuh uh, it's not. It's the same."? I guess. But, we've had those discussions for years, and even with data indicating this is true for lower risk patients, most of them still will not admit it. There is some literature saying surgery is better (First author radonc! That's capitulation WWII style), but most of the data says both treatments (RT + long term ADT vs surgery) are probably equal. It's hypocritical to say that you shouldn't do one or the either. They are both radical definitive treatments with their pros and cons. Many will need additional therapy after surgery with adjuvant/salvage RT, but there aren't good studies recording how many get it/need it. Adjuvant RT just isn't believed by urologists. Incredulously, after the publication of the positive trials showing DFS and OS benefit, the national use of adjuvant RT went down, the percentage went from low teens to single digits. Triple therapy has very good outcomes, and with the results of the ASCENDE-RT trial, it might be better to push that for high risk patients, because dose escalation with brachtherapy is unmatched by any other RT modality.

The trials won't happen. Urologists are the gatekeepers of prostate cancer, and admittedly are slimy, slithery, manipulative and vile deceitful vipers. But, kiss most community practices goodbye if you you don't maintain cordial relationships with them. I think at Harvard, Tony D does the biopsies himself. You could consider learning how to do biopsies and then contacting PCPs to do them, but that's going to start all out war.

Incidentally, JCO just published the 73.8 Gy/41 fx vs 70 Gy/28 fx trial. "Non-inferior but a bit more toxic" seems to be what they are saying, but that sounds a lot like "Inferior" to me. The conclusion is a good read, with some finer points about fractionation/toxicity/outcome. Had no idea data showed 2.0 Gy/fx is worse than 1.8 Gy/fx at the higher dose levels. The one thing about this study that bugs me is the design of non-inferiority. That's just not going to sway people. They should have went with a one-tailed test saying that HF was better than CF, with radiobiology (high a/b ratio for prostate cancer) as the rationale. The lines look like they are separating, and maybe at 10 years there would be significant biochemical control benefit, but as designed, this will probably toss 70 Gy/28 fx into the dustbin of history. Anyone use it?
Click to expand...
 
seper said:
What I'm thinking, a lot of high and ultra risk patients which are operated on, also get lymphadenectomy, postop XRT (often to pelvic nodes) and/or long term hormones. This has to be pretty brutal and incomparable with surgery alone for GS 6 disease. If anyone has good data, please share.
Click to expand...

GF- totally right. That study didn't use IMRT for everyone. Had full 1cm margins for PTV for a lot of patients. They haven't done the 3D vs IMRT analysis yet. But, unlike you, most people aren't going to look at the outcome and offer 28 fractions. It will be more justification for more fractions.

Sep - yeah, like 2/3 of the people in the surgery arm in the MSKCC data ended up getting RT, and only half of the RT alone 3-6 months ADT (the rest got none!), so maybe it's a comparison between 1. surgery + RT 2. Inferior form of RT+ ADT. Don't think there is data on lymphadenectomy vs a more limited surgery.
 
I sent a patient to get fiducials to be placed by a urologist... Haven't seen him back yet... :(
 
RadOncDoc21 said:
I sent a patient to get fiducials to be placed by a urologist... Haven't seen him back yet... :(
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Time to start doing your own fiducials. Just need to find an ultrasound company with techs who have a TRUS. Never expected to be giving hormones or putting fiducials in practice but that's how it goes
 
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I wonder if I need to start doing my own mediastinal staging also for lung cancer patients. My neighborhood Thoracic surgeons haven't started drinking the SBRT kool-aid yet and some even still consider it "experimental."... Ugh Surgeons!
 
I also was very surprised when I saw zelefsky on that paper. Its worth watching his talk to spring refresher though where he tears apart the Wallis retrospective and basically calls surgery up front for these patients a total sham. He also rips into the MSKCC data on that, his own study. But that said, even he has trouble at tumor board for these patients.

Ultimately it will take an appeal to the community and to PCP's who actually do care about their patients, but just dont know better. If there are popular prostate blogs out there or message boards it would be good to throw severe caution to people choosing this strategy. Zelefsky also says outcomes will result from PROTECT later this year.
 
Which papers you guys are talking about exactly?
 
To be fair, if a patient is fit for mediastinoscopy, then wedge resection + hilar node sampling is probably an option. In that scenario, SBRT as a replacement for surgery is experimental, sorry.

RadOncDoc21 said:
I wonder if I need to start doing my own mediastinal staging also for lung cancer patients. My neighborhood Thoracic surgeons haven't started drinking the SBRT kool-aid yet and some even still consider it "experimental."... Ugh Surgeons!
Click to expand...
 
seper said:
To be fair, if a patient is fit for mediastinoscopy, then wedge resection + hilar node sampling is probably an option. In that scenario, SBRT as a replacement for surgery is experimental, sorry.
Click to expand...

There is new data to support SBRT over a lobectomy for surgical candidates- (http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)70168-3/fulltext?rss=yes.)

SBRT for lung has been around well over 10 years with sufficient data to support its use and it's recommended in NCCN guidelines so no it's not experimental! Not only that, but they are using that upfront for stage I surgical candidates in Europe and using surgery as a salvage option. Better quality of life for the patients.
 
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Yes, I saw that study. It does not change the standard of care, which is surgery for operable patients. When I came out of residency, I was excited about SBRT, but a few years of experience can be pretty sobering.
Also, the entire published experience of surgical salvage after SBRT consists if something like 15 cases in the world.


RadOncDoc21 said:
There is new data to support SBRT over a lobectomy for surgical candidates- (http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(15)70168-3/fulltext?rss=yes.)

SBRT for lung has been around well over 10 years with sufficient data to support its use and it's recommended in NCCN guidelines so no it's not experimental! Not only that, but they are using that upfront for stage I surgical candidates in Europe and using surgery as a salvage option. Better quality of life for the patients.
Click to expand...
 
58 total patients in that study. 6 died in the surgery arms. Could have been anything. Study shouldn't change practice. I'd take that Lancet article with a cup of salt. NCCN does not recommend it for any operable patients. Wouldn't trust the Europeans, except Paleo. That cat seems alright. Are y'all offering it to operable patients? That's ballsy.

5 year locoregional failure of RTOG 0236 from Bob "The Tumor Man" Timmerman was 38%. That's pretty high. If these people live, they are failing in the lobe and the mediastinum.
Also, if the surgical principal for stage T1N0M0 is to take out the lobe and check the nodes, I wonder why the radiation principle is to treat GTV=CTV+5mm? And, most of them don't get mediashtinal staging via med or EBUS/Bx.
 
The operable morbidity and mortality is real and yes NCCN does not recommend it for operable patients but to consider SBRT "experimental" is not justifiable.

I think the best evidence will come from the VA study that is currently accruing since the community surgeons will never enroll enough patients to truly compare the data.
 
SBRT is the standard of care in medically inoperable patients. SBRT is vastly inferior to surgery for those who can tolerate VATS. If you argue otherwise at a respectable tumor board, you'll be laughed at.
 
I'll assume your "respectable" tumor board consists of physicians who have been practicing for over 30 years+ and still refer to small cell lung cancer as oat cell carcinoma.
 
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No, respectable means a good pulmonologist + sane surgeon, who carefully select patients for VATS, keeping operative mortality under 3%. They will run circles around your SBRT results. Don't worry, you'll see plenty of peripheral lung nodules in half-dead people. This is your bread and butter.
 
VATS the matter with you guys???
Hee hee hee.

Can't believe arguing with a category 1 recommendation by NCCN. It's like talking to a urologist.
 
Resection is *the* standard of care as it more adequately stages the patient and has the best long term track record. SBRT is a suitable alternative standard of care with apparent equivalent survival and control outcomes. The morbidity profile is different so an informed decision by the patient is ideal. Many patients want it out and don't want to deal with anxiety of an unresected lesion. Many won't want to deal with post op recovery.

A meta-analysis of fewer patients than treated in a rural clinic is reassuring in that SBRT did not fare poorly but as DD says doesn't convincingly show superiority.


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Damn_Daniel said:
58 total patients in that study. 6 died in the surgery arms. Could have been anything. Study shouldn't change practice. I'd take that Lancet article with a cup of salt. NCCN does not recommend it for any operable patients. Wouldn't trust the Europeans, except Paleo. That cat seems alright. Are y'all offering it to operable patients? That's ballsy.

5 year locoregional failure of RTOG 0236 from Bob "The Tumor Man" Timmerman was 38%. That's pretty high. If these people live, they are failing in the lobe and the mediastinum.
Also, if the surgical principal for stage T1N0M0 is to take out the lobe and check the nodes, I wonder why the radiation principle is to treat GTV=CTV+5mm? And, most of them don't get mediashtinal staging via med or EBUS/Bx.
Click to expand...

My patient is an operable candidate who refused surgery. I still get staging of the mediastinum on all my patients although I am starting to see a push against that now. I am not arguing for or against the standard of care which is surgery (a lobectomy not a wedge), but to say that today the use of SBRT for early stage lung cancer is "experimental" is offensive. We have done more in regards to validate our treatment decisions in many other disease sites with a lot less data.

Now with all that said, I'll be awaiting the VALOR study once it gets going.
 
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RadOncDoc21 said:
My patient is an operable candidate who refused surgery. I still get staging of the mediastinum on all my patients although I am starting to see a push against that now. I am not arguing for or against the standard of care which is surgery (a lobectomy not a wedge), but to say that today the use of SBRT for early stage lung cancer is "experimental" is offensive. We have done more in regards to validate our treatment decisions in many other disease sites with a lot less data.

Now with all that said, I'll be awaiting the VALOR study once it gets going.
Click to expand...
With ebus? I doubt most surgeons will do a med on someone who is not a surgical candidate
 
medgator said:
With ebus? I doubt most surgeons will do a med on someone who is not a surgical candidate
Click to expand...

Hence, what got this thread down the SBRT path when I suggested I might have to do my own mediastinal staging for stage I lung cancers.

They have done it for both operable and inoperable patients. I have seen some rad oncs not even get a workup for the mediastinum and would just use the PET.
 
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radiaterMike said:
Resection is *the* standard of care as it more adequately stages the patient and has the best long term track record. SBRT is a suitable alternative standard of care with apparent equivalent survival and control outcomes. The morbidity profile is different so an informed decision by the patient is ideal. Many patients want it out and don't want to deal with anxiety of an unresected lesion. Many won't want to deal with post op recovery.

A meta-analysis of fewer patients than treated in a rural clinic is reassuring in that SBRT did not fare poorly but as DD says doesn't convincingly show superiority.


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Click to expand...
Sure, but resection is a very generic term.

Oncologically, lobe > segmentectomy > wedge. Personally, I'd take sbrt over a wedge any day of the week
 
Agree and retrospective and population based registry data support that outcomes with SBRT similar to lobectomy.

With respect to EBUS, I agree that it is helpful. But if no nodes are seen on CT then the yield is unacceptably low for EBUS. With resection and nodal sampling you get better staging even if outcomes are not significantly affected in studies. On an individual basis better staging and appropriate post op therapy (chemo if node +) may make a difference.


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EBUS and bronchoscopic bx is not "helpful". It's is a standard of care as regarded by NCCN and UpToDate. If you don't believe in it, that's unreasonable and you are now basically a urologist, however experts and those that write the guidelines (not always the same people) agree that EBUS/BronchoscopicBX are legitimate staging techniques. Please send some data this way that they aren't. Especially those contradicting NCCN guidelines.

radiaterMike said:
Agree and retrospective and population based registry data support that outcomes with SBRT similar to lobectomy.

With respect to EBUS, I agree that it is helpful. But if no nodes are seen on CT then the yield is unacceptably low for EBUS. With resection and nodal sampling you get better staging even if outcomes are not significantly affected in studies. On an individual basis better staging and appropriate post op therapy (chemo if node +) may make a difference.


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