Rectal Cancer: Habr-Gama Watch and Wait Strategy to Avoid Surgery

[MadMed]

I hope this isn't too late.

I'm not familiar with the concept of using signatera for CCR management so I can't really comment. My doctor who is very pro WW has never mentioned this method of managing before and I don't think I've come across any research that uses signatera to make judgment of whether one should proceed with WW or not. How did you come about with this idea? Did you read about it somewhere?

You can see from my signature that my doctor basically uses MRI + scope check (for site check) + biopsy to triangulate the positive results once every 3 months in the first year of WW. It was then spaced out to once every 4 months and now in my 2.5 years in of WW, it is being spaced out to once every 6 months. PET was also done as regularly as possible ( once every 9-12 months) to keep track of any stray cancer cells in the body.

A lot of us here have low CEA that are unreliable and I believed that has never been a good tool for WW to begin with. I'm not familiar with signatera but my feeling is that you can't beat a management that includes MRI + scope (and biopsy) + PET scan on regular basis. Hope this helps.

Hi Jolene,
I don't believe what i described is an accepted protocol, at least not by my oncologist. It just made sense to me that signatera could be used in addition to the regular WW protocol. On this board some have already gotten the test and it seems to affect the frequency of the watch part. When you say doctor in your case, is that your surgeon or your oncologist. My surgeon is very anti-biopsy, not sure why.

I agree with you on the MRI/Scope and Biopsy, i believe that's the right approach. I was looking at Signatera as a replacement for CEA since CEA is not super reliable.

[Jolene]

Hi Jolene,
I don't believe what i described is an accepted protocol, at least not by my oncologist. It just made sense to me that signatera could be used in addition to the regular WW protocol. On this board some have already gotten the test and it seems to affect the frequency of the watch part. When you say doctor in your case, is that your surgeon or your oncologist. My surgeon is very anti-biopsy, not sure why.

I agree with you on the MRI/Scope and Biopsy, i believe that's the right approach. I was looking at Signatera as a replacement for CEA since CEA is not super reliable.

Hi Ismail,

Sorry if I missed the mention of using signatera on this board.. I will look into it again then! The doctor mention is the colorectal surgeon, it's just that I've not undergone any surgery (yet!) and it always feels weird to call him my surgeon but yes my surgeon is very pro WW for cases that he thinks have a chance at it. My oncologist on the other hand isn't all that keen but respected my wish to go ahead with it.

There could be a few reasons for being anti-biopsy which was explained to me by my surgeon. There has always been the argument that when surgeons extract samples within an infected area, there is always the chance of it being random. My surgeon usually picks 6 samples each time to the best of his sight while doing the scope and there is a chance that he might have picked in areas that don't have the cancer cells. He could have picked more than 6 samples but then there is the argument that he didn't pick deep enough as cancer cells could be lying underneath the surface. He could have picked a lot deeper and perform something called Transanal Endoscopic Microsurgery (TEM) but this could induce pain and recovery problems which he isn't keen on. This then turns into a cycle of counter-argument that the area picked on isn't wide nor deep enough in all cases anyway, so why not just cut the whole damn thing away which is precisely what WW wants to avoid ! Lol

Hence apart from the biopsy, he would also do the MRI and PET scan at the same so that we can triangulate all 3 sets of evidence together to make a judgment of whether the CCR is under control. I agree that just doing only the biopsy is insufficient, it should be accompanied by other tests.

MRI and PET scans are not cheap at all and access to these scans may be limited for some people in some countries. I was fortunate that my insurance covers all of it so that means my doctor has the whole kitchen to himself as he sees fit at any time he determines. He would even throw in ultrasound from time to time just to be on the safe side. I suspect the availability of such tests/procedures without the financial constraint may have helped him to feel more confident offering it. Saying that, he has mentioned that while he is pro WW it is still not as mainstream as it should be and that there will be many surgeons out there who will be against it as it is a fairly radical concept albeit gradually gaining momentum. Perhaps seek a second opinion ? Someone who is familiar with WW and is pro WW to see what they can offer. A doctor who is not familiar with WW cannot confidently offer you that solution. You may want to ask whether he has managed any WW cases before?

I know some people on this board do not engage in all of the above tests each time. Some use only MRI and scope at alternate timing and it has worked for them so far. There was also a lady who did a TEM and it worked for her too but my surgeon wasn't keen and prefers to go down the biopsy + MRI/PET route.

[MadMed]

Hi Jolene,
You're lucky your surgeon is pro-WW. It seems that surgeons favor cutting for the most part. The odds they cite for NO local recurrence are usually in the 90+%. But there's trials now for organ preservation that show it's a viable path.
The protocol you are on sounds very good, i hope to be lucky enough to get there.

I am now on FOLFIRINOX, after 6 more sessions, i'll go through chemoradiation and then we'll see where things are.

Did you mean TEM instead of TME. I think TME is when they remove the rectum.

edit: corrected the recurrence odds. Meant to say that after TME with good margin local recurrence is extremely low.

[Jolene]

Hi Jolene,
You're lucky your surgeon is pro-WW. It seems that surgeons favor cutting for the most part. The odds they cite for local recurrence are usually in the 90+%. But there's trials now for organ preservation that show it's a viable path.
The protocol you are on sounds very good, i hope to be lucky enough to get there.

I am now on FOLFIRINOX, after 6 more sessions, i'll go through chemoradiation and then we'll see where things are.

Did you mean TEM instead of TME. I think TME is when they remove the rectum.

Hi Ismail - Ops.. Yes, it's TEM !! I revised my post. Thanks for highlighting.

Cutting it off is the gold standard because most doctors don't like veering off. It's like that colleague we have who doesn't like changes and experimenting with new methods and techniques. That old "if it's not broken, don't change it" adage. Lol.

I suspect it could also be internal politics and the pressure to keep up their KPI if they have bosses and board of directors above them who frown upon cutting-edge practices unless you are MSK (memorial sloan kettering) who is an advocate for WW.

My surgeon has his own private practice which basically means he is his own boss and I'm guessing that provides a lot of leeway in offering some cutting-edge ideas to patients and also why doctors set up their own practice instead of "working for the group". He presents regularly in conferences even with his own practice so he is quite an active researcher in a sense and often on top of new research papers being published.

As for the odds of local recurrence, it's not 90%+ .. it's more along the line of 30%! This is on the basis of a published paper by Dr Habr-Gama in 2013. Unless he is referring to other statistics but don't take my word for it, you may want to check this paper out on Google Scholar or just Google to see if you can have access to it. > Local Recurrence After Complete Clinical Response and Watch and Wait in Rectal Cancer After Neoadjuvant Chemoradiation: Impact of Salvage Therapy on Local Disease Control

Check out MSK website with follow-up research since > https://www.mskcc.org/news/how-watch-an ... ality-life

Another tip. Dr Habr-Gama use an 8 weeks bench mark to determine her WW candidates. My surgeon modified the framework and had me wait up to 12 weeks for the tumor to completely disappear. He mentioned that there are updated research out there that had patients wait up till 16 weeks and still made the cut for being a WW candidate. If he had follow the 8 weeks benchmark, I would have to undergo surgery then. My tumour was still lurking around at week 8 but was completely gone by week 12. It takes time for the radiation to work.

All the best for your treatment. Please keep us posted !

[MadMed]

Hi Jolene,
Yikes, i totally miswrote the local recurrence. I'll update my post.
What I meant to say is surgeons expect that there will NOT be a recurrence for high 90% of TMEs with good margins. That's what my surgeon talked about in terms of "local" cure.
You're right about veering course, i guess standard care is there for a reason, but it resists new possibilities. Just look at how long they pushed back on WW.

Thanks for sharing the study results on local recurrence after cCR. I tend to be cautious about old clinical trials, same with prognosis. All that is backwards looking and does not account for new standard of care and improvements in treatment and surgical techniques. It's certainly good data, but maybe foolishly i expect things to have improved from 2014.
I think the most interesting thing going on right now as far as WW is the OPRA trial which should conclude in November and has published preliminary results.

Thank you for the details on how long after chemoradiation you waited. My surgeon said 8 to 12 weeks. I'll have to see how things are going when I get there.

[prs]

Hi Ismail,

Jolene is giving you great advice! I notice your tumor is very low just like mine. In fact the lower part of my tumor was into the sphincter muscles. My surgeon told me that if she had to do any cutting that involved the sphincter muscles it would likely have a major impact on my quality of life. She didn't even take samples for biopsy because she said the sample would be so small the odds of collecting any remaining cancer cells was low. However the odds of causing permanent damage to the muscle was high, and so not worth the risk. If your tumor is into your sphincter you might want to think hard about a TME, and discuss with your surgeon.

I don't know if you've read everything in this thread, but there's lots of info there about all this stuff. Sounds like you have time to plough your way thru it before you get your results. We all wish you the best of luck!!

[MadMed]

Hi Ismail,

Jolene is giving you great advice! I notice your tumor is very low just like mine. In fact the lower part of my tumor was into the sphincter muscles. My surgeon told me that if she had to do any cutting that involved the sphincter muscles it would likely have a major impact on my quality of life. She didn't even take samples for biopsy because she said the sample would be so small the odds of collecting any remaining cancer cells was low. However the odds of causing permanent damage to the muscle was high, and so not worth the risk. If your tumor is into your sphincter you might want to think hard about a TME, and discuss with your surgeon.

I don't know if you've read everything in this thread, but there's lots of info there about all this stuff. Sounds like you have time to plough your way thru it before you get your results. We all wish you the best of luck!!

Thanks prs, I agree. Jolene and in general this board has helped me quite a bit. Lots of practical, lived experience that everyone shares freely. For example, i learned from this board about emend. I asked for it, and my second chemo was nausea free.
At present, it has not invaded the sphincter. I am hoping that between chemo and radiation it will shrink enough to give me options at surgery time. I just finished my second chemo, 6 more to go and then radiation. If all goes well, i'll know in september/october what my surgery options are. I am definitely going to read everything I can about WW, it seems like a tough decision to make right now.

[skb]

Ismail,
I wish you best of luck in getting a complete Clinical Response. Here is my story with Wait and Watch. Maybe this is of some help to you.


June 28, 2017 (5 weeks after completion of chemoradiation with oral Xeloda and daily radiation for about a month): MRI Scan:
Approximately 10% of the mass demonstrated tumour signal intensity, with the remainder appearing to represent fibrosis. This corresponds to a tumour response grade of 2. No suspicious lymphadenopathy.

June 30, 2017: Flexible Sigmoidoscopy with biopsy:
A nodule/bump was all that remained in the place where the tumor used to be. A biopsy of deep tissue from where the tumor used to be revealed no evidence of adenocarcinoma.

August 7, 2017: (10 weeks after completion of chemoradiation): MRI Scan:
Approximately less than 5% of the mass demonstrated tumour signal intensity, with the remainder appearing to represent fibrosis. This corresponds to a tumour response grade of mrTRG-2.

August 9, 2017: (10 weeks after completion of chemoradiation): MRI Scan and PET scans as part of a study at Mayo clinic:
MRI report: No evidence of primary tumor. No evidence of distal metastasis

August 11, 2017: Oncologist at University of Minnesota Masonic Cancer Center calls the above reports an excellent response and places me in Wait and Watch Program if I am interested. I choose the Wait and Watch program after understanding risks and after signing up for an intensive follow up program.
August 17, 2017: Mop-up Chemotherapy to start. IV infusion of Folfox with Oxaliplatin. Every two weeks for approximately 5 months.

USEFUL INFORMATION FOR OTHER PATIENTS
========================================
Wait Period between completion of neoadjuvant therapy and surgery or evaluation for surgery:

Just by looking at my case, it appears that the chances of a complete tumor erasure are better if we wait longer after the completion of neoadjuvant chemoradiation. Some physicians recommend a waiting period of 4 weeks, some 5 weeks, the landmark Habr-Gama trial kept a waiting period of 8 weeks and some places wait about 10 weeks or more. There are studies going on regarding this. At least in one research paper, I read that the chances of tumor responding to neoadjuvant chemoradiation diminish after 10 to 12 weeks of completion of neoadjuvant chemoradiation. I was evaluated at 5 weeks and also at about 10 to 11 weeks.

[prs]

I had missed my five year follow up exam last year because of Covid, so drove to LA for my six year anniversary follow up last week. The flex-sig and MRI results were both very good. My surgeon said she now considered my CCR as permanent.

In our chat afterwards I mentioned I had read that some treatment centers were now doing the chemo before radiation. She said they too had switched to that protocol because it gave a higher percent CCR. She also mentioned they were trying short course radiation, but the total radiation dose was the same as the long course. I remember my radiation burn on the long course was very painful during the last couple of weeks and extraordinarily painful the week after it ended. Speeding up that process just to get it over with sooner might be a plus for the patient, as long as the burn isn't any worse! If it also increased CCR rates, that would be great.

[lakeswim]

Oh my, I haven't been on here in at least a year but just received a rare email notification (not sure why I don't get them more often) that you posted and what a time to pop in and see this first thing. CONGRATULATIONS, PRS! This is truly AMAZING to read! Thank you so much for sharing it with us.

Do you have any LT side effects or do you feel as good as new? (I know I have some - only a few years out - so wondering about how you feel - besides ecstatic right now, obv.)

I need to update my signature and update the group (and will soon) but suffice to say for now that this is wonderful news and I'm thrilled for you, PRS!

- Lakeswim

p.s. I had chemo before radiation.

I had missed my five year follow up exam last year because of Covid, so drove to LA for my six year anniversary follow up last week. The flex-sig and MRI results were both very good. My surgeon said she now considered my CCR as permanent.

In our chat afterwards I mentioned I had read that some treatment centers were now doing the chemo before radiation. She said they too had switched to that protocol because it gave a higher percent CCR. She also mentioned they were trying short course radiation, but the total radiation dose was the same as the long course. I remember my radiation burn on the long course was very painful during the last couple of weeks and extraordinarily painful the week after it ended. Speeding up that process just to get it over with sooner might be a plus for the patient, as long as the burn isn't any worse! If it also increased CCR rates, that would be great.

[prs]

Oh my, I haven't been on here in at least a year but just received a rare email notification (not sure why I don't get them more often) that you posted and what a time to pop in and see this first thing. CONGRATULATIONS, PRS! This is truly AMAZING to read! Thank you so much for sharing it with us.

Do you have any LT side effects or do you feel as good as new? (I know I have some - only a few years out - so wondering about how you feel - besides ecstatic right now, obv.)

I need to update my signature and update the group (and will soon) but suffice to say for now that this is wonderful news and I'm thrilled for you, PRS!

- Lakeswim

p.s. I had chemo before radiation.

Thank you @lakeswim! Yes I do feel great, and even though it's six years out I still see signs of gradual improvement in my recovery from treatment. In particular my rectum is decreasing in sensitivity and the frequency of those sudden urges to use the bathroom have all but gone. I think I can safely say my toilet habits are just about back to normal. Unfortunately this has been offset by the old man's prostrate problem of needing to take leaks much more frequently!

The only long term effect I see is the continued low blood counts from the effect of radiation. These have been pretty constant the last five years and I do not expect them to ever change. All my numbers were well into the normal range before treatment began. I get a blood test every time I do a follow up visit with my local oncologist. Here are the last week's results versus the Kaiser "normal range".

WBC 3.2 vs normal of 4.0-11.0
RBC 4.05 vs normal of 4.7-6.1
HGB 12.9 vs normal of 14.0-18.0
HCT 39.6 vs normal of 42.0-52.0
Platelets 144 vs normal 130-400

These low numbers don't really have any effect at all on my ability to lead a normal life. The only real impact I've seen is I can't exercise with the same intensity level as I once did. My heart rate gets too high and my legs get tired much sooner, presumably because my blood can't carry the same amount of oxygen as it did before treatment. Of course I'm also getting old so that isn't helping either!

I skipped the five year follow up visits because of Covid, but now that I'm six years out from CCR both my surgeon and oncologist said I would be switched to annual follow up visits from now on.

[jsbsf]

Hi all, I wanted to check in. Sorry, Peter (prs) for not responding sooner. I don’t get notifications and don’t check in as often.

DH just crossed the 2 year mark from the time of diagnosis. His last treatment, 1 week course of radiation, was in late July 2020 - more than a year ago. He was getting quarterly check ups, that have always been very good. His most recent CT scan was on 6/14, and his last blood tests were on 5/3.

His blood test results were all within normal range. One aberration was in a test in 11/2020 where his ALT spiked to 149 U/L, and AST was 84 U/L. Around this time he had some discomfort and abdominal swelling. So he began taking an entecavir prescription which he had been given several months earlier, but had never taken. Follow up blood tests were on 12/30 and 5/3, where both of these numbers fell back into range: ALT=15 U/L AST=19 U/L. he actually felt much better only a day or 2 after starting the entecavir.

He gradually reduced the entecavir from daily to every other day to every 3 days until around May or June, when he stopped taking it altogether.

The oncologist feels like he’s cured. He recommended to get his checkups every 6 months. DH likes that, so I’m not going to argue. He doesn’t like the scanxiety. The oncologist really thinks he’s home free and that the scans are unnecessary, I guess they emit some amount of radiation? Probably not a great reason to forego checkups, but we are both on board with the oncologist’s decision since he’s been pretty good to him so far.

I asked him a couple days ago how he feels. As far as I am aware, he’s never had an accident. He says he definitely isn’t completely back to normal but seems to feel pretty close, and has noticed gradual improvement. So, it’s really good to know it can still get better.

One thing I want to mention. It’s a little somber, but it’s not something we read, or were aware of early on, and that’s probably a good thing . On 9/5/2019, the prognosis was clear: he wasn’t expected to survive and his care was expected to be palliative just to improve what little time he had left. I’m really glad we didn’t know that because I feel like it would have made us less hopeful. But here we both are 2 years later and aside from the emotional scars, it’s really almost like he was never sick. I couldn’t be happier. I’m hoping that if others are given a poor prognosis, this information might help lift their spirits some.

As far as supplements, he still gets his Turkey tail, MCP, tumeric, and aspirin. Just not as regularly. We’ll most likely continue that regimen for at least another year.

[prs]

Hi all, I wanted to check in. Sorry, Peter (prs) for not responding sooner. I don’t get notifications and don’t check in as often.

DH just crossed the 2 year mark from the time of diagnosis. His last treatment, 1 week course of radiation, was in late July 2020 - more than a year ago. He was getting quarterly check ups, that have always been very good. His most recent CT scan was on 6/14, and his last blood tests were on 5/3.

His blood test results were all within normal range. One aberration was in a test in 11/2020 where his ALT spiked to 149 U/L, and AST was 84 U/L. Around this time he had some discomfort and abdominal swelling. So he began taking an entecavir prescription which he had been given several months earlier, but had never taken. Follow up blood tests were on 12/30 and 5/3, where both of these numbers fell back into range: ALT=15 U/L AST=19 U/L. he actually felt much better only a day or 2 after starting the entecavir.

He gradually reduced the entecavir from daily to every other day to every 3 days until around May or June, when he stopped taking it altogether.

The oncologist feels like he’s cured. He recommended to get his checkups every 6 months. DH likes that, so I’m not going to argue. He doesn’t like the scanxiety. The oncologist really thinks he’s home free and that the scans are unnecessary, I guess they emit some amount of radiation? Probably not a great reason to forego checkups, but we are both on board with the oncologist’s decision since he’s been pretty good to him so far.

I asked him a couple days ago how he feels. As far as I am aware, he’s never had an accident. He says he definitely isn’t completely back to normal but seems to feel pretty close, and has noticed gradual improvement. So, it’s really good to know it can still get better.

One thing I want to mention. It’s a little somber, but it’s not something we read, or were aware of early on, and that’s probably a good thing . On 9/5/2019, the prognosis was clear: he wasn’t expected to survive and his care was expected to be palliative just to improve what little time he had left. I’m really glad we didn’t know that because I feel like it would have made us less hopeful. But here we both are 2 years later and aside from the emotional scars, it’s really almost like he was never sick. I couldn’t be happier. I’m hoping that if others are given a poor prognosis, this information might help lift their spirits some.

As far as supplements, he still gets his Turkey tail, MCP, tumeric, and aspirin. Just not as regularly. We’ll most likely continue that regimen for at least another year.

Great news, particularly on the blood counts! Looks like doing the radiation after chemo is a much improved mode of treatment.

I do want to point out that my colorectal surgeon, who knew a lot about W&W, insisted on quarterly check ups for the first two years after she saw the complete clinical response. Her point being that if there was a recurrence, she wanted to catch it before it had a chance to grow.

I understand why your DH might like the idea of twice per year, but perhaps three times per year, every four months, might be a good compromise?

[roadrunner]

I would be concerned about taking this relaxed an approach. The standard in most practices is 90 days. Even so, some studies show that recurrences happen in 15%+ percent of cases. Approximately 85% of these are “salvageable,” but the earlier they are caught, the better—there is less risk of an unsalvageable recurrence and greater potential for less radical salvage surgeries. Both benefits may be lost with additional time between scans and flex sigs. I understand “scanxiety”—believe me—but frankly, In my opinion it’s a small price to pay. And the cancer doesn’t care if you’re nervous.

Even more concerning, from the signature there appears to have been metastatic disease in this case. If so, that would suggest a need for increased monitoring, not reduced monitoring. Finally, while it sounds nice, I would be wary of an oncologist who uses the word “cured” under these circumstances (if he/she did) and within a year of the last known existence of disease (if I’ve read the information correctly).

I’m not trying to be negative or discouraging, and I just did a flex sig complete with scanxiety, but a little toughness and resolve now may pay huge dividends down the road. It’s a couple days of worry every 90 days for a couple of years in return for optimal management of disease and possibly many years of life. Just my view, but I think the benefits of frequent, comprehensive monitoring far outweigh the challenge of nervousness over what a scan or exam may show. Good luck!

[prs]

I would be concerned about taking this relaxed an approach. The standard in most practices is 90 days. Even so, some studies show that recurrences happen in 15%+ percent of cases. Approximately 85% of these are “salvageable,” but the earlier they are caught, the better—there is less risk of an unsalvageable recurrence and greater potential for less radical salvage surgeries. Both benefits may be lost with additional time between scans and flex sigs. I understand “scanxiety”—believe me—but frankly, In my opinion it’s a small price to pay. And the cancer doesn’t care if you’re nervous.

Even more concerning, from the signature there appears to have been metastatic disease in this case. If so, that would suggest a need for increased monitoring, not reduced monitoring. Finally, while it sounds nice, I would be wary of an oncologist who uses the word “cured” under these circumstances (if he/she did) and within a year of the last known existence of disease (if I’ve read the information correctly).

I’m not trying to be negative or discouraging, and I just did a flex sig complete with scanxiety, but a little toughness and resolve now may pay huge dividends down the road. It’s a couple days of worry every 90 days for a couple of years in return for optimal management of disease and possibly many years of life. Just my view, but I think the benefits of frequent, comprehensive monitoring far outweigh the challenge of nervousness over what a scan or exam may show. Good luck!

+1
@jsbsf I was being too nice!