Has your breast surgeon just stopped sampling the axilla in cStage I if the patient is over 70?

[Mandelin Rain]

And if so, how do you counsel these patients? I've been discussing the results of CALGB 9343 with the caveat that the study population had axillary sampling. I tell them, they are unlikely to have nodal involvement and that those numbers are likely good estimates but not perfect. But this is a difficult distinction for patients to have to process.

I'm not really sure why this suddenly became okay to do in the absence of contraindication, but it's been an issue for me lately.

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[evilbooyaa]

And if so, how do you counsel these patients? I've been discussing the results of CALGB 9343 with the caveat that the study population had axillary sampling. I tell them, they are unlikely to have nodal involvement and that those numbers are likely good estimates but not perfect. But this is a difficult distinction for patients to have to process.

I'm not really sure why this suddenly became okay to do in the absence of contraindication, but it's been an issue for me lately.

No SLNB on invasive cancer in that population (not on DCIS)?
OK - so read CALGB 9343. Really sneaky that they just only use criteria of ALND for axillary staging. No mention of SLNB at all.

Wait - I take it back:

These findings suggest that axillary evaluation (by means of dissection or sentinel-node biopsy) has little value in women 70 years of age or older who are receiving tamoxifen for clinical stage I, estrogen-receptor–positive breast cancer (an exception would be women for whom chemotherapy is being considered on the basis of the axillary status).

I think it's a bit of a stretch to equate ALND and SLNB.

I guess there isn't 0 evidence to support it, but the paper is saying that women over 70 never have pathological upstaging of their breast cancer at time of surgery?

 

[Mandelin Rain]

No SLNB on invasive cancer in that population (not on DCIS)? What's the rationale?

Desire to minimize anesthesia time, surgical recovery/morbidity, and lymphedema risk. It's been a whole thing and the subject of numerous "uncomfortable" tumor boards... but... they keep coming.

 

[evilbooyaa]

Desire to minimize anesthesia time, surgical recovery/morbidity, and lymphedema risk. It's been a whole thing and the subject of numerous "uncomfortable" tumor boards... but... they keep coming.

I get #1. Surgical morbidity? What's the morbidity and recovery time on a SLNB? Same question to risk of lymphedema on SLNB alone?

Edited my previous post with some additional thoughts as well.

 

[seper]

I just treat axilla on everybody if not sampled.

 

[BobbyHeenan]

The majority of patients on CALGB did NOT get axillary dissection. 63-64% of patients had no dissection. See table 1.

http://www.nejm.org/doi/pdf/10.1056/NEJMoa040587

So I think it's reasonable to still use that data to counsel patients that have not had a dissection or SLNB. I agree with comments above though, that I think a SLNB should be attempted on the vast vast majority of patients in this era - even those over 70.

The axillary management is one criticism of that trial, but one I find more applicable is tamoxifen compliance. I can't recall the exact numbers, but on-study patients appeared to have excellent compliance of tamoxifen greater than that seen in routine practice reported in other studies.

One "test" I had a breast attending do in residency that I've adopted is if the patient is undecided about what to do sometimes I suggest starting AI quickly after surgery and then seeing her back in ~4 weeks. If she's miserable or non compliant I push hard for XRT then, because I know she won't make it on the AI. THen I think the magnitude of XRT benefit is much greater.

 

[Mandelin Rain]

I just treat axilla on everybody if not sampled.

The typical lady I've been seeing is 80-84 years old with a 1 cm, Grade 1, ER+, invasive ductal resected with 5 mm margin. No axillary sampling. These are ladies, I'd ordinarily (if negative SLNBx) push toward observation, and I guess I haven't tried to dissuade them from that if they wish to proceed that way. Based on no SLNBx, you'd default to steep tangents to cover axilla? Would you mention observation at all?

 

[BobbyHeenan]

The typical lady I've been seeing is 80-84 years old with a 1 cm, Grade 1, ER+, invasive ductal resected with 5 mm margin. No axillary sampling. These are ladies, I'd ordinarily (if negative SLNBx) push toward observation, and I guess I haven't tried to dissuade them from that if they wish to proceed that way. Based on no SLNBx, you'd default to steep tangents to cover axilla? Would you mention observation at all?

Even without axillary dissection I'd observe this lady after a 1 month trial of AI. If I treated I'd do high tangents, 42.56 Gy in 16 fractions with no boost.

I wouldn't fault anyone for treating, but I don't think the lack of axillary nodes changes much here (most on CALBG didn't have axillary sampling) unless that have LVSI or higher grade disease. I'd still politely ask surgeons to start doing SLNB's here (sounds like you've done that), but it is what it is...

 

[medgator]

.

One "test" I had a breast attending do in residency that I've adopted is if the patient is undecided about what to do sometimes I suggest starting AI quickly after surgery and then seeing her back in ~4 weeks. If she's miserable or non compliant I push hard for XRT then, because I know she won't make it on the AI. THen I think the magnitude of XRT benefit is much greater.

Pretty much what I do, but I usually see them a little further out before the 4 month cutoff from surgery where most people would no longer offer xrt.

Interesting thread. Didn't realize people were skipping it altogether. In our community, only recently have the surgeons started switching to slnb only in the Z11 population. Don't see them skipping it altogether any time soon

 

[Reaganite]

Have started noticing this from a high volume, well respected surg onc in my community. Have heard him cite mskcc nomograms and tells me he prefers I just xrt axilla if pt is at sufficient risk. Less busy guys slnb everyone in part for the extra reimbursement (or so I hear).

 

[seper]

I've seen maybe 5 patients like that in total, and treated either high tangents or axillary AP/PA matched to tangents.
No subset of invasive stage I breast Ca exists, where risk of nodes < 15%, am I wrong?

The typical lady I've been seeing is 80-84 years old with a 1 cm, Grade 1, ER+, invasive ductal resected with 5 mm margin. No axillary sampling. These are ladies, I'd ordinarily (if negative SLNBx) push toward observation, and I guess I haven't tried to dissuade them from that if they wish to proceed that way. Based on no SLNBx, you'd default to steep tangents to cover axilla? Would you mention observation at all?

 

[BobbyHeenan]

No subset of invasive stage I breast Ca exists, where risk of nodes < 15%, am I wrong?

This is true from a purely pathologic standpoint, but is it clinically relevant if those nodes never cause failure?

As noted in CALGB, 60+% of patients never had the axilla even sampled, so presumably there are a fair number of patients that would have had pathologically involved lymph nodes that were not treated with radiation, yet failure rates there were very low. May be the tamoxifen is keeping them at bay, or maybe it's just such low grade disease it's not going to progress?

One thing I see when patients are worked up at more rural centers is they fail to do a thorough axillary ultrasound. Just make sure if no nodes are being taken in this patient population that the radiologist does a thorough axillary ultrasound and dictates the results as well. I've heard a few "oh yeah, we definitely looked at the axilla, I just must not have commented on it" when I've called to inquire about this when it comes up.

 

[Mandelin Rain]

Have started noticing this from a high volume, well respected surg onc in my community. Have heard him cite mskcc nomograms and tells me he prefers I just xrt axilla if pt is at sufficient risk. Less busy guys slnb everyone in part for the extra reimbursement (or so I hear).

It's tough to get less than 10% on the nomogram in my experience. Not sure I ever have.

 

[evilbooyaa]

They say in the paper the rate of ALND was about 1/3. Where is the discussion on percentage of patients who got a SLNB? Breast surgeons were willing to completely forego ALL axillary sampling (which was not the question the trial was specifically asking) in this patient population?

The methods go much more in-depth on their initial publication:
http://www.nejm.org/doi/full/10.1056/NEJMoa040587

They were powered to detect a difference in loco-regional recurrence, which they saw (albeit clinically small). They weren't powered to detect differences in the things they say are negative.

Per my first post - they discuss in the discussion that axillary dissection is not necessary, and I agree with them, but then extrapolate that to SLNB is not necessary. Don't necessarily agree with that.

 

[BobbyHeenan]

They say in the paper the rate of ALND was about 1/3. Where is the discussion on percentage of patients who got a SLNB? Breast surgeons were willing to completely forego ALL axillary sampling (which was not the question the trial was specifically asking) in this patient population?

The methods go much more in-depth on their initial publication:
http://www.nejm.org/doi/full/10.1056/NEJMoa040587

They were powered to detect a difference in loco-regional recurrence, which they saw (albeit clinically small). They weren't powered to detect differences in the things they say are negative.

Per my first post - they discuss in the discussion that axillary dissection is not necessary, and I agree with them, but then extrapolate that to SLNB is not necessary. Don't necessarily agree with that.

It's my understanding that SLNBs were not done in the trial. You either had axillary dissection or no sampling of lymph nodes. In the methods section it mentions that axillary dissection was "allowed but was discouraged" on trial though. Someone please correct me if wrong.

The NSABP SLNB trial (SLNB vs. SLNB plus axillary dissection) B-32 enrolled from 1999-2004. CALGB over 70 trial enrolled from 1994-1999. So I don't think SLNB was being done regularly during the time of the CALGB trial.

I agree though that I think it's a stretch to say that no pathologic node sampling needs to be done in this population since SLNB has become so standard now and is generally very well tolerated. My surg oncs too though recently have done a minority of cases with lumpectomy alone with no SLNB in elderly patients like others in the thread are commenting.

 

[Burt Radnolds]

It is also my understanding that SLNbx was not part of this study and it was clinical staging or ALND. In CALGB, they basically said that clinical staging of the axilla was appropriate in most cases. Therefore you could omit surgical axillary staging, which happened to be ALND at the time, and most people did just fine. Why can't you apply the same principles to omitting SLNbx? Seems like a perfectly rational application of the data at hand. Sure, there is less morbidity with SLNbx vs ALND, but it doesn't mean you have to do it now. Most women I see with early stage breast cancer have 90% of their postoperative pain, range of motion issues, paresthesias, etc from their sentinel node biopsy site so its not morbidity free.

In general, I would prefer to have the information provided by the SLNbx in most cases, but I don't get worked up if I don't have it. Granted, only in the appropriate setting, like the CALGB population.

 

[evilbooyaa]

It's my understanding that SLNBs were not done in the trial. You either had axillary dissection or no sampling of lymph nodes. In the methods section it mentions that axillary dissection was "allowed but was discouraged" on trial though. Someone please correct me if wrong.

The NSABP SLNB trial (SLNB vs. SLNB plus axillary dissection) B-32 enrolled from 1999-2004. CALGB over 70 trial enrolled from 1994-1999. So I don't think SLNB was being done regularly during the time of the CALGB trial.

I agree though that I think it's a stretch to say that no pathologic node sampling needs to be done in this population since SLNB has become so standard now and is generally very well tolerated. My surg oncs too though recently have done a minority of cases with lumpectomy alone with no SLNB in elderly patients like others in the thread are commenting.

Good points. Didn't think about when SLNB became a thing.

I guess I'm slowly warming up to the thought in this very specific patient population (cT1 cN0, meaning axilla has been evaluated with ultrasound at least, over 70, ER+).
I always worry about data being 'extrapolated' as an excuse to do things outside of standard of care, but that shouldn't make me value the trial by itself less I suppose.

 

[mavrik13]

Saw an 82F with the same scenario today. Lumpectomy under done under local. pT1c (1.9cm) Offered AI +/- RT, and patient was leaning towards no RT, but wanted a trial of AI for a few weeks before committing.

Not sure if you've seen this from ASCO Choosing Wisely, but they extrapolate from CALGB 9343 and recommend against SLNB in women over 70 with ER+. There was a lot of discussion from local surgeons when this was published, but I don't recall what they decided as a group. http://www.choosingwisely.org/clini...de-biopsy-in-node-negative-women-70-and-over/

 

[seper]

Ha. This is not based on data.

 

[evilbooyaa]

Saw an 82F with the same scenario today. Lumpectomy under done under local. pT1c (1.9cm) Offered AI +/- RT, and patient was leaning towards no RT, but wanted a trial of AI for a few weeks before committing.

Not sure if you've seen this from ASCO Choosing Wisely, but they extrapolate from CALGB 9343 and recommend against SLNB in women over 70 with ER+. There was a lot of discussion from local surgeons when this was published, but I don't recall what they decided as a group. http://www.choosingwisely.org/clini...de-biopsy-in-node-negative-women-70-and-over/

I mean, as long as they get radiation, then whatever, don't stage the axilla. Not sure where their statement is coming from (would appreciate it if they actually cited the study, and no CALGB 9343 does not count).

 

[Palex80]

I mean, as long as they get radiation, then whatever, don't stage the axilla. Not sure where their statement is coming from (would appreciate it if they actually cited the study, and no CALGB 9343 does not count).

Well the question is "what" radiation you are going to deliver? Would you electively treat the axilla in a cN0 75 year old without axillary surgical staging?
And if yes, maybe it's time we start talking about what levels one should treat then...

 

[evilbooyaa]

Well the question is "what" radiation you are going to deliver? Would you electively treat the axilla in a cN0 75 year old without axillary surgical staging?
And if yes, maybe it's time we start talking about what levels one should treat then...

Levels 1 and 2 as they weren't dissected would likely be enough to control any theoretical microscopic disease. Can be covered with standard tangent fields, wouldn't do SCV FWIW.

 

[Palex80]

Levels 1 and 2 as they weren't dissected would likely be enough to control any theoretical microscopic disease. Can be covered with standard tangent fields, wouldn't do SCV FWIW.

I agree.

One could even advocate to skip level 2. I have seldom seen sentinel nodes in level 2.

 

[BobbyHeenan]

I mean, as long as they get radiation, then whatever, don't stage the axilla. Not sure where their statement is coming from (would appreciate it if they actually cited the study, and no CALGB 9343 does not count).

I'll play Devil's advocate here....

From CALGB 9343 you have an n of 115 patients that did not have their axilla staged and did not have radiation. See table 1.

In that cohort of patients you have only 2 axillary failures.

So though the trial did not ask the question of yes/no SLNB for this patient cohort, you at minimum have data for a fairly large series of patients that are well documented prospectively that never had their axilla sampled and did not have radiation and you have a 1.7% axillary failure rate.

====

I agree that I still think SLNB is a good idea in the vast majority of patients, but I don't get too worked up about an 80 year old with a grade 1, no LVSI tumor that didn't have a SLNB. I really don't take that into account much when discussing the role of radiation with this kind of patient. If I do treat I just do tangents.

 

[seper]

I want to just say that 45 Gy to axilla AP/PA is very well tolerated.

 

[evilbooyaa]

I'll play Devil's advocate here....

From CALGB 9343 you have an n of 115 patients that did not have their axilla staged and did not have radiation. See table 1.

In that cohort of patients you have only 2 axillary failures.

So though the trial did not ask the question of yes/no SLNB for this patient cohort, you at minimum have data for a fairly large series of patients that are well documented prospectively that never had their axilla sampled and did not have radiation and you have a 1.7% axillary failure rate.

====

I agree that I still think SLNB is a good idea in the vast majority of patients, but I don't get too worked up about an 80 year old with a grade 1, no LVSI tumor that didn't have a SLNB. I really don't take that into account much when discussing the role of radiation with this kind of patient. If I do treat I just do tangents.

Yeah I mean I guess. Maybe that is the wave of the future. Stop sampling Axillary LN and stop RT after lumpectomy in the older population, and then see how far surgeons can push that age down while still maintaining clinical outcomes.

One thing that could happen as a result of this is that patients will be miscategorized as low risk (say without axillary US pre-op, or +LVSI, close margins, or whatever) and not even sent to a Rad Onc for discussion of radiation. I would prefer that all these patients at least meet with a Rad Onc to discuss that 'yes, there is a benefit to RT, but the chance of recurrence without it is still quite low. Are you comfortable with a 95% chance to not have it come back or do you want to push that to 99%?'

Patients will hear 'you don't need RT' from the breast surgeon and think that outcomes are completely equal. Then an extra 4% of the population (a big absolute number) will have recurrence.

I guess this is my rambling rant that if I'm discussing surgery as a serious option, I want them to at least meet with a surgeon unless they flat out tell me they are absolutely not having surgery, while surgeons always 'feel comfortable' (per discussion in tumor boards) discussing risks, benefits, and side effects of radiation to patients on the fence. And then it's some case that shouldn't have gotten surgery (like multi-nodal N2 lung or bilateral neck nodes in p16+ oropharynx) that then shows up for adjuvant treatment, and now needs trimodality.

 

[medgator]

Yeah I mean I guess. Maybe that is the wave of the future. Stop sampling Axillary LN and stop RT after lumpectomy in the older population, and then see how far surgeons can push that age down while still maintaining clinical outcomes.

One thing that could happen as a result of this is that patients will be miscategorized as low risk (say without axillary US pre-op, or +LVSI, close margins, or whatever) and not even sent to a Rad Onc for discussion of radiation. I would prefer that all these patients at least meet with a Rad Onc to discuss that 'yes, there is a benefit to RT, but the chance of recurrence without it is still quite low. Are you comfortable with a 95% chance to not have it come back or do you want to push that to 99%?'

Patients will hear 'you don't need RT' from the breast surgeon and think that outcomes are completely equal. Then an extra 4% of the population (a big absolute number) will have recurrence.

I guess this is my rambling rant that if I'm discussing surgery as a serious option, I want them to at least meet with a surgeon unless they flat out tell me they are absolutely not having surgery, while surgeons always 'feel comfortable' (per discussion in tumor boards) discussing risks, benefits, and side effects of radiation to patients on the fence. And then it's some case that shouldn't have gotten surgery (like multi-nodal N2 lung or bilateral neck nodes in p16+ oropharynx) that then shows up for adjuvant treatment, and now needs trimodality.

Yup, ditto for prostate ca. Also med oncs like to give radiation opinions quite often I've noticed (not the newer trained ones,, usually the old school ones)

 

[BobbyHeenan]

Agree fully with you guys (re: I as the rad onc want to have the XRT discussion with the patient). I really don't like other people going "over the risks and benefits of radiation and they declined" like I see with urology and occaisionally med onc.

I'm spoiled in that 99% of the breast patients I see come through a multi disciplinary clinic at our cancer center, so I'm seeing them prior to surgery as well...but that's not the case everywhere I know.

Remember too that the final results of CALGB did show a statitistically significant local control benefit. I don't think the authors of the trial or the surgeons or the rad oncs need to interpret that trial as "no one needs radiation because no survival benefit or only small magnitude of local control benefit." I think that's between the RAD ONC and the patient in a formal consult.

 

[medgator]

Remember too that the final results of CALGB did show a statitistically significant local control benefit. I don't think the authors of the trial or the surgeons or the rad oncs need to interpret that trial as "no one needs radiation because no survival benefit or only small magnitude of local control benefit." I think that's between the RAD ONC and the patient in a formal consult.

Correct, that fact is lost upon many med oncs and surgeons who like to talk about the rec in the nccn guidelines without referring to the actual study that forms the basis for said guideline.

 

[Winged Scapula]

Who are these breast surgeons and how are they getting patients to decline axillary sampling?

Maybe we grow them old here, but 70 is young; data/no data, even the 90 year olds want SLNBx. I tell them they don't need it and yet, they still want it. Med onc wants it too.

As far as morbidity and operative time, perhaps for some its significantly increased but for most it isn't/shouldn't be.

 

[medgator]

Maybe we grow them old here, but 70 is young; data/no data, even the 90 year olds want SLNBx.

Totally agree, same in FL. I go over the calgb study with my 70-75 y/o but I tell them I'd get treated in their shoes if they are otherwise healthy with 15-20 year life expectancy. It's easy now with 3 weeks of hypofractionation.

 

[Winged Scapula]

Totally agree, same in FL. I go over the calgb study with my 70-75 y/o but I tell them I'd get treated in their shoes if they are otherwise healthy with 15-20 year life expectancy. It's easy now with 3 weeks of hypofractionation.

When you practice in "God's waiting room", things are different.

 

[Palex80]

The whole situation is going to get even more complicated when partial breast irradiation becomes more widespread. These patients are excellent candidates for PBI, since most of the recurrent tumors tend to grow locally.
Certainly omitting axillary staging and treatment is going to lead to a couple more events per 100 patients, but most of the patients that fail without any radiation at all, fail locally.

Single shot electron or orthovoltage treatment intraoperatively are probably going to happen alot more often in the future and I also aspect several brachytherapy options like the SAVI-device to become more popular.

 

[medgator]

The whole situation is going to get even more complicated when partial breast irradiation becomes more widespread. These patients are excellent candidates for PBI, since most of the recurrent tumors tend to grow locally.
Certainly omitting axillary staging and treatment is going to lead to a couple more events per 100 patients, but most of the patients that fail without any radiation at all, fail locally.

Single shot electron or orthovoltage treatment intraoperatively are probably going to happen alot more often in the future and I also aspect several brachytherapy options like the SAVI-device to become more popular.

I don't know if pbi will continue to remain popular in the era of 3 week hypofractionated whole breast treatment

 

[Palex80]

I don't know if pbi will continue to remain popular in the era of 3 week hypofractionated whole breast treatment

Single-shot intraoperative PBI is great in my opinion.

Other than that, the IMPORT-LOW trial from the UK seems to demonstrate that PBI using EBRT may be the way to go forward.
http://www.ecco-org.eu/Global/News/...east-may-not-be-needed-in-early-breast-cancer
http://www.ecco-org.eu/Events/EBCC10/Abstract-search?abstractid=25356

 

[medgator]

Single-shot intraoperative PBI is great in my opinion.

Yeah prob once we get enough data, I still think the hypofx data is stronger though