pT3N0 proximal rectal during COVID

Started by Mandelin Rain
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Mandelin Rain

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pT3N0. Thought to be sigmoid pre-op. 1 cm below reflection at surgery. 2mm fat invasion. Well-differentiated. No LVSI. Margins widely negative. Don't believe it was TME because approach was for sigmoidectomy.

Treating? Deferring? Observing?

What you think?
 
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This is cT3 or already had surgery pT3?

We used to mandate 25/5 went to surgery within 2 weeks of XRT, but as I recall on newer studies that hasn't been mandated, so that may be reasonable to treat now with 25/5 and wait a 4-8 weeks for surgery. With that said, some of our surgeons really don't like 25/5 though; I know it hasn't come to fruition on the trials of any excess problems surgically with this, but one surg onc just is not a fan.

I would only omit XRT if surgery is planned though; presumably a cancer surgery would still be on, but if they're pushing surgeries out a month or more I wouldn't omit XRT.

*all rec's regarding COVID I think really need to be location-specific. What you do in NYC may look very different than rural America.
 
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Sorry, my case presentation was super hasty. Edited the initial post.

pT3N0. Thought to be sigmoid pre-op. 1 cm below reflection at surgery. 2mm fat invasion. Well-differentiated. No LVSI. Margins widely negative. Don't believe it was TME because approach was for sigmoidectomy.

I believe NCCN would support observation in such patients. I've (anecdotally, of course) seen a handful of presacral recurrences for salvage in patients who didn't undergo upfront XRT for one reason or another, which colors my thoughts on this.
 
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Tough case. I have one surg onc who likes observation here and another who doesn't.

If a fair number (?maybe more than 8) of nodes are negative, I think observation here OK.

Would ask surgeon if they would classify the resection as a TME and if close to a TME I'd favor observing.

HEre is what Minsky (who probably knows just a LITTLE bit more about this data than me) says about htis on mednet:

The 1990 NCI consensus guidelines recommend postop chemoradiation for patients with pT3N0M0 rectal cancer. However, that was before TME was routine. In patients with pT3N0M0 disease who undergo a TME and have at least 12 nodes examined, I do not recommend radiation. The benefit of radiation is a 3-4% decrease in local recurrence which, in my view, is not worth the long term toxicity of postoperative pelvic radiation. However, if if a TME was not performed, fewer than 12 nodes were examined, or there are close margins, then I would add radiation.
 
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Assuming you are not in nyc. Would offer xrt, at least 5/25. As long as you are far from anus- and stick to covering presacral space and tumor (dont chase internal iliac) will be very little toxicity. Virus going to be with us for a long time sp not sure you should really change practice based on virus unless in hotspot.
Also I really would not assume that minsky is competent.
 
Oh, so that's a pT3 pN0 with wide margins but not really a TME.
That is indeed "a bit outside of the guideline", but I'd observe. Perhaps you can get some more information from the pathologist on the specimen he received.

MSI status can be done and then the med oncs can discuss potential benefit of chemotherapy in this situation (which is small).
 
I was guesstimating about a 5% absolute LRR benefit. Med Onc seems really reluctant to give chemo in this case, so no OS benefit to such treatment.

Never done 5 x 5 post op. Not sure that there is much evidence for it or how it'd impact the anastomosis.
 
Agree about no post op 25/5 data, so I wouldn't do that.

If you're not in a "hot spot" for COVID I think perfectly reasonable to treat especially if no where near a TME.

Obviously fine to observe as well given current pandemic.

Tough case and I wouldn't fault you either way.
 
BobbyHeenan said:
We used to mandate 25/5 went to surgery within 2 weeks of XRT, but as I recall on newer studies that hasn't been mandated, so that may be reasonable to treat now with 25/5 and wait a 4-8 weeks for surgery. With that said, some of our surgeons really don't like 25/5 though; I know it hasn't come to fruition on the trials of any excess problems surgically with this, but one surg onc just is not a fan.
Click to expand...

You are absolutely correct. The initial rationale for immediate surgery was to get surgical buy in. Its the same reason most of the initial bladder preservation studies used BID radiation: surgeons were understandably concerned we were delaying definitive treatment.

One of the best studies addressing the issue of timing is Stockholm 3 (BJS 97:580-587). Randomized people to 5x5 with immediate surgery, 5x5 with delayed surgery (4-8 weeks), or long course RT (no chemo, thats the big knock) with delayed surgery. Basically, all of the groups did well. pCR was similar in both delayed groups. The most important data isn't in the abstract. Roughly 1/3 of the immediate surgery patients had delays from end RT to surgery of 11-17 days and they did horrible. Basically a doubling of post-op and surgical complications. If you are going to do immediate surgery, it needs to be immediate (ie, before they hit peak inflammatory response). I do a lot of short course and the key is coordinating with surgery ahead of time. If the surgeon prefers immediate surgery, I don't start RT until they have a surgical date scheduled. Two of our surgeons will do immediate or delayed. The third anecdotally feels immediate surgery has more complications and only does delayed surgery.

There are also a good number of near total neoadjuvant studies that start with short course and then give 3-4 cycles of FOFLOX pre-surgery (giving an 8-12 week delay to surgery) and patients do fine.

As to the case in question; I am still confused as to what surgery they did. Did they leave the rectum in place or not? Even if they initially planned a sigmoidectomy, it is confusing to me why once they made the decision to remove the entire rectum they would do less than a TME this day in age. Technically observation is an option but if they got less than a TME their local recurrence risk is high and I would radiate. I also agree with most of the above posters. I have not done post-op 5 x 5. IMO, its probably not a great idea. Most of the post-op surprises I have treated have a lot of bowel in-field and I am not sure how well it would go. Are they going to give this person adjuvant chemo (realizing it is also controversial for T3N0 now)? If so, why not do that first and then finish up with radiation?
 
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ramsesthenice said:
You are absolutely correct. The initial rationale for immediate surgery was to get surgical buy in. Its the same reason most of the initial bladder preservation studies used BID radiation: surgeons were understandably concerned we were delaying definitive treatment.

One of the best studies addressing the issue of timing is Stockholm 3 (BJS 97:580-587). Randomized people to 5x5 with immediate surgery, 5x5 with delayed surgery (4-8 weeks), or long course RT (no chemo, thats the big knock) with delayed surgery. Basically, all of the groups did well. pCR was similar in both delayed groups. The most important data isn't in the abstract. Roughly 1/3 of the immediate surgery patients had delays from end RT to surgery of 11-17 days and they did horrible. Basically a doubling of post-op and surgical complications. If you are going to do immediate surgery, it needs to be immediate (ie, before they hit peak inflammatory response). I do a lot of short course and the key is coordinating with surgery ahead of time. If the surgeon prefers immediate surgery, I don't start RT until they have a surgical date scheduled. Two of our surgeons will do immediate or delayed. The third anecdotally feels immediate surgery has more complications and only does delayed surgery.

There are also a good number of near total neoadjuvant studies that start with short course and then give 3-4 cycles of FOFLOX pre-surgery (giving an 8-12 week delay to surgery) and patients do fine.

As to the case in question; I am still confused as to what surgery they did. Did they leave the rectum in place or not? Even if they initially planned a sigmoidectomy, it is confusing to me why once they made the decision to remove the entire rectum they would do less than a TME this day in age. Technically observation is an option but if they got less than a TME their local recurrence risk is high and I would radiate. I also agree with most of the above posters. I have not done post-op 5 x 5. IMO, its probably not a great idea. Most of the post-op surprises I have treated have a lot of bowel in-field and I am not sure how well it would go. Are they going to give this person adjuvant chemo (realizing it is also controversial for T3N0 now)? If so, why not do that first and then finish up with radiation?
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Good post.

I have a very good surg onc colleague (MSKCC trained, great guy) and he said on some of our 25/5 cases he did at the ~14 day mark post radiation the rectum/colon "felt heavy." I think he was operating at peak inflammation and he just didn't like it.

We are doing more and more total neoadjuvant treatments and haven't done the 25/5 then chemo on them, so I'm not doing as much 25 in 5 as I once was.
 
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Mandelin Rain said:
pT3N0. Thought to be sigmoid pre-op. 1 cm below reflection at surgery. 2mm fat invasion. Well-differentiated. No LVSI. Margins widely negative. Don't believe it was TME because approach was for sigmoidectomy.

Treating? Deferring? Observing?

What you think?
Click to expand...
BTW, how many LNs excised total for this "N zero" person? I ask because with a lot of LNs maybe it was TME. Maybe. And it is very rare (zero percent?) nowadays to find a surgeon that says he/she doesn't do TME when a rectal cancer is excised (I would think "because approach was for sigmoidectomy" is superfluous as ultimately a part of rectum was excised... once you're down in the pelvis, you're gonna do a TME unless the surgeon is one that just "rips rectums out in 30 seconds"). Once rectum is excised, you know they had some effort/work to dissect it outta the pelvis. Very tight and constricting operating space, that "pelvic bowl." So I think this (TME or not) is something to precisely and accurately clear up before deciding to treat. Or not.
 
I think I would observe due to this being a post-op case and if pathology does reveal a good number of lymph nodes negative, where’s the data that shows 25/5 is ok? I know there is some data to (possibly) support T4 for colon (fixed structure) but even that is to at least 45 Gy.

So I guess if one is to treat post-op, why not a standard fx since who is to say that in a couple of weeks or months that your area will be any better or worse than it is now.
 
Would anyone consider short course RT for a T2N1 rectal cancer within 3-4 cm of the anal verge? I have never done short course, and the surgeons here have never seen it. NCCN recommends against short course for tumors within 5 cm of anal verge.

If yes, how long after RT would you schedule surgery, and would you recommend chemo after RT but prior to surgery?
 
KHE88 said:
Would anyone consider short course RT for a T2N1 rectal cancer within 3-4 cm of the anal verge? I have never done short course, and the surgeons here have never seen it. NCCN recommends against short course for tumors within 5 cm of anal verge.

If yes, how long after RT would you schedule surgery, and would you recommend chemo after RT but prior to surgery?
Click to expand...

In new york, sure.

If you're in rural america I would have this patient and staff in a mask and treat the way you usually do with standard course.
 
KHE88 said:
Would anyone consider short course RT for a T2N1 rectal cancer within 3-4 cm of the anal verge? I have never done short course, and the surgeons here have never seen it. NCCN recommends against short course for tumors within 5 cm of anal verge.

If yes, how long after RT would you schedule surgery, and would you recommend chemo after RT but prior to surgery?
Click to expand...

The question here may also be what kind of surgery this patient is getting and if he would be a candidate for primary radiochemotherapy to spare sphincter.
 
I am fortunately not in a hot spot (at least not yet) and I try not to let COVID impact my post-op treatment decisions in cases where salvage options are poor or lacking. Recurrent rectal cancer has a dismal prognosis (much worse than COVID)... I would treat.
 
KHE88 said:
Would anyone consider short course RT for a T2N1 rectal cancer within 3-4 cm of the anal verge? I have never done short course, and the surgeons here have never seen it. NCCN recommends against short course for tumors within 5 cm of anal verge.

If yes, how long after RT would you schedule surgery, and would you recommend chemo after RT but prior to surgery?
Click to expand...
Provided the patient is an appropriate candidate, I would try to deliver TNT in hopes that surgery may not need to be done if there's a good response.
 
KHE88 said:
Would anyone consider short course RT for a T2N1 rectal cancer within 3-4 cm of the anal verge? I have never done short course, and the surgeons here have never seen it. NCCN recommends against short course for tumors within 5 cm of anal verge.

If yes, how long after RT would you schedule surgery, and would you recommend chemo after RT but prior to surgery?
Click to expand...

I would. The recommendation against is based on a post hoc analysis from a TROG study. But several other major studies included low lying rectal tumors and didn’t see worse local control in low tumors.

Surgery can be within 1week or 4-8 weeks later. That really comes down to surgeon preference/availability.

The chemo question really depends. Will the surgeons do watch and wait if they have a cCR? Is the MRF threatened? Do they need a decent pathological response? If so, chemo first. If none apply, I would just do it all outback. But there really is no wrong answer.
 
To OP:
pT3N0 with no TME - yes 100% treat. Standard fractionation with Xeloda.
pT3N0 with TME - could consider observation, but reasonable to treat as well.
I believe most folks who said 5x5 thought it was cT3N0, but to clarify, no role for 5x5 in post-op setting.

To @KHE88
You can do whatever in this situation, including 5x5.
My thought process (although my attendings mostly do long-course CRT as part of TNT at my institution) is ask the following questions:
1) Does the surgeon have to do an APR currently? If the tumor shrunk in size, would they be able to get away with a LAR?
2) What are the patient's thoughts on having a permanent colostomy? Are they and/or surgeon strongly interested in watch-and-wait after neoadjuvant therapy if they are a candidate?

If tumor shrinkage could make patient candidate for LAR, would favor CRT followed by chemotherapy (TNT) followed by surgery or watch-and-wait. A very reasonable argument could be made for 5x5 followed by chemotherapy as well with delayed surgery.

If patient adamant against permanent colostomy or everybody really wants to try for watch-and-wait, would proceed with CRT followed by chemotherapy. Also reasonable to do chemotherapy followed by CRT.

Assuming you are not in a COVID hotspot, I think it's OK to do long-course, especially in the second scenario to try and avoid surgery.
 
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evilbooyaa said:
To OP:
pT3N0 with no TME - yes 100% treat. Standard fractionation with Xeloda.
pT3N0 with TME - could consider observation, but reasonable to treat as well.
I believe most folks who said 5x5 thought it was cT3N0, but to clarify, no role for 5x5 in post-op setting.

To @KHE88
You can do whatever in this situation, including 5x5.
My thought process (although my attendings mostly do long-course CRT as part of TNT at my institution) is ask the following questions:
1) Does the surgeon have to do an APR currently? If the tumor shrunk in size, would they be able to get away with a LAR?
2) What are the patient's thoughts on having a permanent colostomy? Are they and/or surgeon strongly interested in watch-and-wait after neoadjuvant therapy if they are a candidate?

If tumor shrinkage could make patient candidate for LAR, would favor CRT followed by chemotherapy (TNT) followed by surgery or watch-and-wait. A very reasonable argument could be made for 5x5 followed by chemotherapy as well with delayed surgery.

If patient adamant against permanent colostomy or everybody really wants to try for watch-and-wait, would proceed with CRT followed by chemotherapy. Also reasonable to do chemotherapy followed by CRT.

Assuming you are not in a COVID hotspot, I think it's OK to do long-course, especially in the second scenario to try and avoid surgery.
Click to expand...

I will admit that most of the TNT data is with long-course RT and it is frequently assumed the pCR is better with long course. Going from that assumption, COVID or not people should receive the best oncologic treatment you feel is appropriate. Anyone who feels long course is best to spare an APR should do it as appropriate.

All that being said, there is a growing body of evidence that pCR with short course is just as good as long course. Look at the most recent polish and Stockholm studies. PCR with SC and delayed surgery is around 15%. The nTNT experience from WashU/Stanford with 5x5 and half course of FOLFOX had a 27% pCR rate. Conventional TNT is around 30% with full course FOLFOX preop. I am not familiar with any short course study with delayed surgery that suggests inferior pathological responses compared to long course.
 
I'm just personally skeptical that 5Gy x 5, which has a lower BED a/b=10 than 50.4-54 in 1.8Gy fxs, will give the same potential for watch-and-wait as long-course.

I could be wrong and I think studying 5Gy x 5 + chemo followed by watch and wait is reasonable, but I don't see that routinely done.

I know pCR is the end all be all, but watch and wait is driven mostly by cCR. We have numerous case series on cCR rates in LC. Happy to be educated on cCR rate in SC + chemo.
 
evilbooyaa said:
I'm just personally skeptical that 5Gy x 5, which has a lower BED a/b=10 than 50.4-54 in 1.8Gy fxs, will give the same potential for watch-and-wait as long-course.

I could be wrong and I think studying 5Gy x 5 + chemo followed by watch and wait is reasonable, but I don't see that routinely done.

I know pCR is the end all be all, but watch and wait is driven mostly by cCR. We have numerous case series on cCR rates in LC. Happy to be educated on cCR rate in SC + chemo.
Click to expand...

Totally understandable. I too still do long course if the goal is to avoid surgery for the same reasons. Just acknowledging the conventional wisdom is being challenged. It’s hard to argue against well-done trials with mathematical rad bio theory. We have been doing SC for almost all of our patients with liver Mets to placate med oncs worries about time off chemo preop. We have a lot of CRs in this group and I am personally starting to doubt long course actually is better (especially in the TNT setting). For the time being, agree still a trial question.
 
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