Study on Regret

I came across this study recently. Not sure if it has been posted before

http://ascopubs.org/doi/full/10.1200/jco.2016.70.6317

Overall, 14.6% of the entire group expressed some treatment regret — 16.6% of the radiation-treated men, 15% of the surgically-treated men, and 8.2% of the men treated conservatively. Among the causes of regret, treatment-related bowel and sexual problems were cited most frequently. Surgically treated men reported the highest rate of significant sexual side effects (39%), while radiation-treated men reported the highest rate of significant bowl problems (15.6%). Remarkably, complaints over urinary incontinence differed little between the groups, ranging from a low of 15.5% for the conservatively-treated men to a high of 17.6% among men treated with radiation.

No surprise: "Increasing age at diagnosis was inversely related to regret....These authors hypothesized that the age effect could be related to a greater impact from adverse effects for younger men; older men may have already been aware of and accommodated to declining functional status."

Also no surprise, and consistent with other studies of "regret": "Lack of informed decision making was highly associated with regret, regardless of whether the patient reported being cancer free..." Furthermore on this high association with regret (later in the same paragraph): "This is particularly noteworthy given the high proportion of men who are diagnosed with low-risk disease for whom active surveillance is now considered the appropriate option given concerns about overtreatment."

This study was meaningful in that it included long-term follow-up, which would in most cases include the onset of "late-term" side effects from radiation therapy. Many of the regret (or side effect) "outcomes" studies only gauge short-term outcomes within 2-years and fail to include "late-term" effects, and are therefore incomplete or maybe meaningless for anyone under about age 65 or so...which is about half of all newly diagnosed men. After being diagnosed at age 49, the late-term effects of radiation therapy were a key factor in my personal decision to pursue surgery as a treatment mode...I didn't want to be "dripping" from my butt by the time I was 60...of course, the trade off (higher risk for surgery than for RT patients) is that now I've been using tadalafil for 10-years (turning 60 next birthday).

Post Edited (Blackjack) : 3/15/2019 2:33:21 PM (GMT-6)

“What is most interesting to me is the very close statistical parallel between radiation treated men and surgically treated men...”

It isn’t surprising to me that many men would view any form of PCa treatment as regrettable. It all sucks!

https://m.youtube.com/watch?v=ciys9eqwkxg

Post Edited (Saipan Paradise) : 3/15/2019 9:05:22 PM (GMT-6)

IMHO, this study is worthless and should be ignored.

Why? Because the patients were treated 25 years ago. That was long before the use of modern RT technology. Actually, robotic surgery was not FDA approved until 2000.

The actual value for today’s men faced with treatment decisions comes from the five and ten year studies with Cyberknife and with protons. The recurrence rate for intermediate risk men is 6 percent versus about 35 percent for surgery,

ASAdvocate said...
IMHO, this study is worthless and should be ignored.

Why? Because the patients were treated 25 years ago. That was long before the use of modern RT technology. Actually, robotic surgery was not FDA approved until 2000.

The actual value for today’s men faced with treatment decisions comes from the five and ten year studies with Cyberknife and with protons. The recurrence rate for intermediate risk men is 6 percent versus about 35 percent for surgery,

I agree 100 percent.

SBRT has made intermediate grade prostate cancer nothing more than an inconvenience. Cure is almost 100 percent guaranteed. No lasting side effects. Nothing more than a week or few of inconvenience. For all intents and purposes, SBRT has effectively cured this type of cancer. What I can't understand is, with this kind of news, why isn't this on the front page of USAToday? Why hasn't it been hailed as a cure all for anything but the most virulent types of prostate cancer on the evening news?

Finding a cure for this type of cancer is no small deal. And with no pesky lingering side effects to boot. I just shake my head in disbelief at the unethical behavior of the medical industry. Hospitals are still offering treatment modalities other than SBRT. That, is obviously, unethical. And they know this. They know the study referenced here. Yet, they continue to offer treatments with 500 percent worse outcomes.

I believe the people who know this (the AUA, ASTRO, ASCO, etc) know about these studies. And yet, they continue to insist that surgery is a valid option. By virtue of the fact that they know this, it's not unreasonable to classify this level of egregious malpractice as criminal.

A 500 percent difference in outcomes. And yet, surgery is still offered as a legitimate alternative.

That's more than malpractice. That's criminal.

I think SBRT is promising, but we won't have this type of data on it for another 10 or more years. It is possible that the late-term effect data may not be that different from other modalities of radiation given that the total dose is similar.

Even though the authors of the paper found that the amount of regret was higher than previous studies, the fact that only about 15% of men expressed long-term regret was actually quite positive to me. If only about 1-2 people out of 10 regret their treatment, whether radiation or surgery, 15-20 years down the road, whatever you choose, you will probably be happy with it.

While I congratulate the SBRT-treated forumers who are so happy with the short-term side effects of their treatment, it would be useful if you all stuck around for another 10 years or so to tell us how you feel about SBRT down the road.

It appears that the PC regret studies are similar to other regret studies indicating that regret is associated with poor decision-making. Taking your time for treatment decisions is good advice and appears to reduce regret. Also I believe you need to watch out for "herding or group think" where you select a treatment just because that is what folks think is best. Similar to buying stocks when the market is high. Island Time SBRT may be as beneficial as IMRT, see 7 year study https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4211385/ , but not necessarily at better treatment for PC. The longest study is 7 years. It is, of course cheaper and quicker, but not a cure. Although if you had a 3+3=6 or a low risk 7 it might be worth comparing the results of SBRT to AS see MD Anderson study https://www.mdanderson.org/publications/oncolog/active-surveillance-for-prostate-cancer.h16-1591413.html I would think that the higher intermediate or advanced may want to look at traditional treatment options with additional interventions including ADT etc..I know I did.

69 yrs., marathon runner, 44 3D-CRT/IMRT Radiation delivered via 3D-CRT in 1.8 Gy minimum dose fractions to a total of 79.2 Gy., 3.2.19 PSA .04, T.Tot 440, 10.5.18. PSA .012, 8.12.18, 1.42 June 18, 2018 (Lupron 5.21.18 & 8.15.18), 12.7 May 2018, 13.7 Jan. 2018, 2.1 May 2012 TTot 686 ng/gl. SpaceOar 9.6.18, testosterone <.7, 8.15.18, Tot Mayo 19 ng .17 testosterone Free 6.18.18, May 21, 2018 T. Tot 686ng/dl; Gleason 3+4=7 involving 15% of the right apex and 15% of the right mid, 3+3=6 prostate cancer involving 5% of the left base. Pathology interpretations by John Hopkins, UNM Cancer, and SF Path 3+4=7 or 4+3=7 MD Anderson Proton Center w/o %. T3 MRI w/ contrast 1.8 lesion left side 5P, Neg. Bone Scan. Prolaris test 3.5 consistent with intermediate and a PTEN test negative. Father PC age 78 RT & ADT now 94 yrs. Neurogenic bladder due to lumbar disk disease and recurrent bladder neck contracture with urinary retention man. 20 years doing catheterizations. TURP & scaring 2003, Finasteride 5 milligrams daily since 2002.

One needs to be careful when looking at a study of this type--dismissing it because "it's too old" or otherwise doesn't fit one's ideas of what it should look like is very risky.

I'll say it again, and I know I will be dismissed because I'm "lucky" or something: Surgery is not the catastrophe that many in the anti-surgery camp make it out to be, nor is radiation the "no issues" situation that many in the pro-radiation camp make it out to be.

I agree with others: the best way to avoid treatment regret is by education and learning and truly making an informed decision (and the definition of THAT is really up to the individual). Not everyone needs to consult with 4 or 6 specialists and visit several major facilities-for many, that's not even feasible. Shaming people who couldn't go to that level is not helpful.

ASAdvocate said...

Sure.

For Cyberknife/SBRT:
https://www.redjournal.org/article/S0360-3016(18)31271-9/pdf?fbclid=IwAR3kFvTN9GroIfnltFdsfLpOltPrajScDISGxkY22LZ_wd42PL20XI-nEkg

For Protons:
http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.6_suppl.97

For Surgery:
https://medivizor.com/blog/SampleLibrary/prostate-cancer/examining-the-risk-of-disease-recurrence-more-than-10-years-after-prostate-surgery/

Essentially, you took 3 separate, incomparable studies to make the assertion "The recurrence rate for intermediate risk men is 6 percent versus about 35 percent for surgery".

First of all, the surgery study was not intermediate risk as it includes high risk. In fact, 25% were >= Stage 3. Second, you cannot compare BCR for surgery to BCR for radiation. For Surgery, the definition is PSA > 0.2, whereas for radiation it is NADIR + 2.0. BCR or Biochemical Recurrence, is not the same as Clinical Recurrence as most who BCR do not proceed to clinical recurrence. You are using relatively small study 6-year SBRT data to compare with large > 10-year surgery data. It has also been suggested that the radiation BCR definition produces smaller rates short-term and higher rates long-term compared to the surgery BCR definition. These BCR definitions are simply made up by some committee for treatment and are not meant to be compared. For example surgery BCR is often followed up by radiation, whereas radiation BCR is often followed up by chemotherapy or hormone therapy.

Your assertion that recurrence (I assume you mean BCR) of 6% for intermediate risk SBRT is just plain wrong. It's for the whole cohort including low risk men. The actual BCR risk in the larger SBRT studies for intermediate risk men is currently 10%, while for unfavorable intermediate risk men, it is 15%. There were no high risk men. I note that Kishan in his 2019 published article only had 6 yrs of data for intermediate risk men and the 10 & 15% were 7-year projections so its really early days.
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2723641

In summary, you are using a 7-year SBRT study (including statistical projections) of low and intermediate risk men to compare with a long-term surgery study where 25% were high risk. Additionally BCR definitions of surgery & radiation are like apples and oranges.

The proper way to compare surgery with SBRT is a long-term randomized clinical trial. The PACE trial is exactly that trial comparing SBRT, conventional radiation and surgery. It is ongoing and initial results will be published around 2022. We might have to wait until 2030 or so to properly compare clinical recurrence of cancer between the treatments.

One thing which came out from the PACE trial this year is there is no difference in early stage rectal or urinary side effects between SBRT and EBRT. Obviously, there is no data for late stage yet.
http://ascopubs.org/doi/abs/10.1200/jco.2019.37.7_suppl.1?af=r

While I think you are doing a good job overall in advocating active surveillance, might I gently suggest that your SBRT advocacy should be based on more careful study.

I didn't look at your links on Proton because SBRT seems to be of interest here. I was just looking at whether your statistical claims on SBRT vs surgery are true or false.

Currently SBRT is not a "Standard of Treatment", but it is an approved option that men are free to choose. The PACE trial will determine whether it becomes a standard of treatment. Preliminary data looks good.

I'm not demanding long studies on robotic surgery. They already exist and cure rates are extremely high. PACE will determine if SBRT cures cancer at the same high rate as other forms of radiation and surgery by current medical standards. That is currently unknown. Also unknown is late term side effects of SBRT. As far as I have seen, all SBRT researchers agree on this.

Your opinion on SBRT and claim that surgery is a very damaging legacy treatment is your own. Currently, it is not borne out by the standards of current medical research. PACE will tell us its effectiveness in about 3 years and its late term toxicity in about 10 years.

I would also note that for you, at 75, on AS with very slow growing G6, there is very little reason to ever consider treating your PC, even if you have to come off AS, not even with SBRT. Why risk any side effects at all.

Regrets, I've had a few
But then again, too few to mention....


Go ahead and belt it out loud because all of us have done it our own way.