Thursday, March 12, 2009

Breast Cancer and MRI

Finally some news on the use (or overuse) or MRI in breast cancer. The COMICE trial was a large, multicenter, randomized controlled trial from the UK that assessed the utility of MRI in the pre-operative work-up of breast cancer. The results basically demonstrated no significant benefit in terms of survival nor did it lead to a reduced need for re-operation in breast conservation therapy.

According to Dr. Monica Morrow (the Tom Brady of breast oncology):
MRI finds two to three times more disease in observed rates of local recurrence in patients selected (for breast conserving surgery)without MRI. This results in increased mastectomy rate for questionable patient benefit. To date neither short term surgical outcomes nor long term local control or contralateral breast cancer rates are impoved with MRI.

Essentially, MRI does not improve surgical outcomes, leads to a higher rate of unnecessary mastectomy, and is extremely expensive (about $1600 a pop, out of pocket). Seems like a slam dunk---time to start getting away from routine pre-operative MRI's for breast cancer.

I had a patient recently who had had a mammogram which showed multiple concerning areas of pleomorphic calcifications diffusely throughout the breast. I sent her for stereotactic needle biopsy of all the spots but the radiologist called and said he wanted to get an MRI first. I was in the middle of something, so I hastily agreed, assuming he had a good enough reason. Well the MRI showed... multiple suspicious areas of pleomorphic calcifications. All the subsequent core biopsies were positive for DCIS. She ended up getting a mastectomy. In retrospect, the MRI added absolutely nothing to the case. We knew she had multicentric/multifocal disease based on mammography alone. The MRI simply (expensively) confirmed what we already knew. It was wasteful, delayed defintive surgery, and just added more stress and cost to an already charged situation.

There are situations where MRI could potentially be useful (to help resolve discordances betwen conventional imaging and physical exam, to assess response to neoadjuvant chemotherapy, inflammatory breast cancer, patients with positive axillary lymph nodes and occult primary breast cancers, some patients with hereditary breast cancer syndromes) but at this point in time there is not nearly enough evidence to support its routine use in most patients with breast cancer...


Anonymous said...

I agree Buckeye, nothing beats LAYING HANDS ON THE PATIENT!!!! And no radiation concerns or need to remove nipple rings... Is there really such a thing as a "Breast Fellowship???" one of the local Surgeons claimed he did one, but maybe he just went to Hooters alot...

Anonymous said...

I so agree wtih this.
Just had a patient with biopsy proven small (6mm)infiltrating ductal carcinoma. Negative mammo on the other side. Wanted to go to the "breast center". They got MRI, showed something on the other side (ultrasound negative), biopsy was negative.

How much do you think that added to her overall care? (other than big dollars)

Anonymous said...

I wish "somebody" would come down with a standard about this.

When I get online with my bc friends I feel positively under-cared for when they start slinging their MRI's around.

This gal had one, that gal gets one every year because her original cancer wasn't detected with a mammo, gals who might have lobular need them.

And don't get me started on the digital mammogram. There is a LOT of one-upsmanship among survivors and apparently the radiology community is happy to oblige.

Dr.T said...

There has been lots of "news on the use of MRI in breast cancer" during the last 20 years.

MRI is definitely a lot more sensitive in finding breast cancer than is mammography. In women with dene breasts (65% of women) up to 70% of malignancies discovered on a mammogram can be seen, in retrospect, on last year's study.

The sensitivity of MRI in detecting breast cancer is consistently found to be in the 95-97% area, although specificity varies widely in different studies, from 37-96%.

Until this COMICE trial all the evidence produced so far has shown a definite benefit in doing presurgical MRI to stage disease:

1. In a study of 64 patients with biopsy-proven or presumed breast cancer, Orel et al identified 13 patients (20%) with mammographically occult multi-focal or diffuse disease.
2. In a study of 463 patients and 548 histopathologically correlated lesions, Fischer and colleagues concluded that MRI may reveal occult multifocal, multicentric, or contralateral breast cancer and may result in therapy changes. MRI alone depicted multifocality in 30 patients, multicentricity in 24 patients, and additional contralateral carcinomas in 15 patients.The therapeutic approach was changed in 66 patients (14.3%) because MRI revealed more extensive disease than was noted using conventional imaging techniques along with clinical examination.
3. Harms and associates found additional cancers in 11 (37%) of 30 patients and suggested that MRI could be used to stage candidates for breast-conserving therapy, to more effectively plan lumpectomy, and to reduce repeat excision surgery.

As for the COMICE trial, I looked everywhere for a copy of this paper so that I could evaluate what they actually did, and what they define as "early" breast cancer. Personally, I have found that studies published primarily in The Lancet need to be carefully scrutinized; however, in any event, given the large body of established research that is extant I would reserve judgment until this paper is avaialable for everyone to closely read and extrapolate to how we currently stage newly diagnosed breast cancer.

Orac said...

"As for the COMICE trial, I looked everywhere for a copy of this paper so that I could evaluate what they actually did, and what they define as "early" breast cancer. Personally, I have found that studies published primarily in The Lancet need to be carefully scrutinized; however, in any event, given the large body of established research that is extant I would reserve judgment until this paper is avaialable for everyone to closely read and extrapolate to how we currently stage newly diagnosed breast cancer."

Oh, please. It's not as though the COMICE trial was the first to report no benefit to routine use of preoperative MRI. There was an ASCO talk last year that showed no benefit, and there have been other retrospective studies. The COMICE trial is important because it's the first prospective trial to look at the question--and its results agree with a lot of the retrospective data. As for where the COMICE trial was first reported, its results were first reported at the San Antonio Breast Cancer Symposium in December.

The bottom line is that, with not that many exceptions, routine preoperative MRI does not help patients with breast cancer, and it's a heck of a lot more expensive.

I had the pleasure of seeing Monica Morrow debate a radiologist about the utility of routine preoperative MRIs for breast cancer at the Society of Surgical Oncology Meeting three weeks ago. Dr. Morrow basically wiped the floor with the radiologist. The radiologist used anecdotes and case reports, while Dr. Morrow used an encyclopedic knowledge of the medical literature. It was, in fact, embarrassing to watch. I felt sorry for the poor radiologist.

Dr.T said...

Nice anecdote regarding Dr. Morrow. You sound a little hostile, Orac, but I have found the opponents of breast MRI to be so -- I'm interested in why that is so.

In any event, I still haven't seen the COMICE trial and I have some questions about the news clippings that refer to it.

Although other studies have not been prospective, per se, they have evaluated significant numbers of patients with breast cancer prior to surgery with MRI to determine the frequency that this procedure altered the approach; one such study is here: AJR Am J Roentgenol. 2004 Oct;183(4):1149-57

The COMICE trial blurbs claim that only 6% of the time, MRI actually changed the surgical approach and that is "not significant."

I guess my question is, who makes the decision for an informed patient not to have the BMRI with even a 6% chance that it will change the approach or affect longevity?

I guess once we spend billions on cost effectiveness research the government can make that decision for us.

Jeffrey Parks MD FACS said...

Thanks for the input Orac. DrT: the evidence simply isn't there to support routine MRI. The 6% who had management changed often had it changed unnecessarily; i.e., patient undergoing mastectomy (which turns out to be unnecessary) based on MRI results. The 6% has nothing to do with longevity or survival; just change in management. Read the paper yourself.

JMC said...

I disagree with much of what is said here. The COMICE trial has not published any conclusions except that the preoperative breast MRI did not change sixth-month reoperation rates.

It is VERY CLEAR in the literature that preoperative MRI changes the surgical plan in 20-30% of patients if all-comers with breast cancer are scanned. What is not yet clear is the long-term consequences of using MRI - in other words - does it change survival or recurrence rates? The only two papers that really address this are Solin in 2008 and Fisher in 2004. They disagree as to the long-term effects of MRI, but if you read the papers closely, the one saying MRI doesn't change outcomes did not include all patients in their study group. They only included those who were already worked up and shown to be good condidates for BCT. Then they RETROSPECTIVELY looked at who had MRIs and who didn't. But if you think about it, all the people who had MRIs and were shown not to be candidates for BCT would have already been removed from the study group! No wonder they got the results that they did.

I still think preoperative breast MRI is going to become routine except for the obviously localized breast cancer in a woman with fatty breasts.

I also agree that the anti-breast MRI folks are quite hostile.

Dr Kathy health forum said...

The sensitivity of MRI in detecting breast cancer is consistently found to be in the 95-97% area, although specificity varies widely in different studies, from 37-96%.

It's ture!

Anonymous said...

I am a dedicated board certified breast radiogist. I think breast MRI is an incredible adjunctive tool. Time will play out how and when to use it in the screening and diagnosis of breast cancer. At our breast center we have seen numerous cases where preoperative MRI has enabled both the patient and surgeon to make better decisions in advance of surgery. Several patients have had one surgery instead of two. Future studies will better guide us on how and when to use this technology. I do, believe, however, it is here to stay.

I am not sure why so many surgeons are opposed to using this incredible technology, if used correctly, in the right patients. Reminds me of the battle I had 10 to fifteen years ago, getting local surgeons to do core biopsies first, surgery second. There was tremendous resistance. Core biposy is less invasive, less costly and accurate. Yet, I understand in a recent article by Silverstein that 40% of diagnositic biopsies in this country are still surgical. Core biopsy is becoming the standard of care and should have been a decade ago!
MRI has a place in the staging and preoperative evaluation of breast cancer. We'll all have to put our heads together for the when and where. MRI is far more sensitive than the mammogram, fact. Wouldn't most surgeons want to have all the facts before operating?? I have discussions with my surgeons about the long term significance of occult disease with conventional imaging. I have asked them, "Does it make sense to operate on the disease we can see and not the disease we can't see ( with conventional imaging ). If you are not going to operate on the disease you can't see, why operate on the disease you can see? Just doesn't made sense to me. Ultimately, MRI will find a place in the evaluation of breast cancer and hopefully be cost effective, reducing recurrence rates and the number of surgeries needed to successfully treat people.

I will leave with this example. A local physician in her 40's presented with a palpable abn. Her breast tissue was extremely dense. Her primary or index lesion was mammographically occult, but could be seen by ultrasound. No additional lesions were initially seen by ultrasound. Lumpectomy was planned. The patient did get an MRI, but the surgeon took the patient to the OR the day after the MRI, before the MRI was read. After finding out second hand the patient was in the OR, I literally RAN to find out if she had an MRI. Yes, she had an MRI the day before. This patient had five separate lesions in her involved breast, three of which were deep and in a different quadrant from the index lesion. Their deep location made them difficult to see by ultrasound. These additinal lesions were not visible mammographically. No one will argue this patient needed a mastectomy. I called the sugeon immediately. The patient had already had a lumpectomy for the index lesion.
I am on the front lines of this disease. I see alot of breast cancer. I also see MRI making a signicant contribution. I anxiously await more studies and more debate. Till then, at our center, we try to use this technology judiciously, in those patients whom we suspect will most benefit.
I find the hostile debate between some radiologists and some surgeons to be disappointing. We need to be working on this together. We have accepted a high false postive biopsy rate with mammograhy and ultrasound for years. Except for cost, why would MRI be any different? We have allowed a HUGE percentage of women to go to the OR for diagnostic surgical biopsies and benign disease for years, at a HUGE economic cost. So why now all the uproar about increasing access to a non invasive exam that has a sensitivity of greater the 95%?
I am all for using MRI in the right patients, the right clinical setting. But to dismiss it as an amazing and incredibly useful tool in some women is premature.

Anonymous said...

I would love to debate with Kellie. I don't believe surgeons like kellie really understand the benefits and limitations of all three imaging modalities. Would Kellie go to surgery with a 6 mm invasive lesion, dense breasts and no MRI? We already do additional biopsies on suspect lesions detected by mammography and ultrasound, prior to going to surgery. We do this to determine extent of disease and to exclude multifocal and multicentric disease. Many of these biopsies are negative. Why would it matter if we had a suspect lesion on MRI biopsied pre operatively to prove it was negative. MRI's postive predictive value in high risk patients is significant. False postives with mammography and ultrasound are an accepted limitation of both those modalities. Yes, pre operative evaluation MRI will add additional delays and economic burden to some patients, BUT will allow us to better treat others.
In time, we will all better understand when and how to use this technology.
Finally, the cost issue. In your last statement you seemed preoccupied with cost. Yes, unfortunately for your patient, cost was added for a false positive. This is a limitation of any imaging technology, including MRI, mammo and ultrasound. I suspect this patient did gain from the MRI. I am assuming her contralateral breast was negative.
MRI has an amazing negative predictive value, 99% in some studies.
Not to change the subject, but if look at cost and burden, look at diagnostic surgical biopsies. How much of an economic burden do negative diagostic surgical biopses add to overall health care costs?? My understanding is 40% of diagnostic biopsies in this country are still surgical!! Why? Core biopsy has been available since the early to mid 90's. Think of all the unecessary surgeries that are being done in this country. Just food for thought.

Anonymous said...

As a patient in the eye of this storm, it's all very disconcerting.

Clustered calcifications seen on mammo, biopsy confirmed DCIS, 11:00 position, grade 3 (or maybe it was 2-3).

This was followed by the MRI or not MRI debate, with 2 out of the 3 surgeons I consulted advocating FOR an MRI. (Hey, after the first 2 disagreed, I needed a tiebreaker!)

The MRI revealed another, larger, suspicious area, 6:00 position, biopsy confirmed DCIS w/no evidence of calcs, grade 2-3.

Mastectomy is now recommended, so yes, I've been upgraded and no, I'm not happy about that. My surgeon feels that while he could try two lumpectomies he probably wouldn't get clean margins, and even if he succeeded I'd be unhappy with the cosmetic result (and I have large breasts).

My argument for excision of the first known area (w/calcs) only and radiation for the second (exactly what would have happened if I'd never had the MRI) was a non-starter.

So, what am I to think? That had I not had the MRI, I'd either be having multiple surgeries due to lack of clean margins OR if I got lucky and the margins were clear, that I'd be sitting on a "recurrence" waiting to happen?

Re false positives: Well, sure, but what about false positives on mammo? After all, when I had the original stereotactic biopsy the standard line was "don't worry too much, 80% of the time it turns out to be benign." Isn't that a false positive rate of 80%?

All of this leads me to think the controversy is REALLY about the cost & availability of MRI guided biopsy.

Cynthia said...

You know I had Cervical Cancer when I found out I was Pregnat and the Dr's said keep the child or abort I kepted my son , Then with all the complications I had a complete Hysterectomy which includes ovaries cervix and the Uterus, and that was one at a time , Then I had adhension so they had to go in for that then appendix but between all this I had cyrotherapy several times, then I had lumps on my breast which was fibrostic but then I took the Braca test 1 & 2 and the results were false / positive with chance of 95% of having Breast cancer hold and behold I had a lump they biopsied it in several areas right and left breast -then they caught it stage I, I decided to have a Mastectomy complete bilateral-becuase I was not going to take a chance . Let me give the Dr.s a Damn hint I had cervica ca age 22 then Breast ca age 29-30 . Dr's looked at me like Damn how could this be. Well I tell yah How I have a strong Hx of my family having it My mother had Breast Ca age 18 when she was living in New York then Came to Chicago to the Better Hospital, then Grandmother and Uncle and 4 aunts, My family has a very strong hx. not only that it skip several generation and hit me. strong I am now 35 years old and still going through test liver has spots I am not a drinker, had all test pet scan mri ct, evry frakin test out there and Im tired when in the hell is the Government going to do something about this . Like people like me that cant afford worthless test that should not be ordered like a Mri, If it shows on a ct scan w/and w-out die and ultrasound why in the hell do I need a 2000 k test.? Dr's sometimes try to make out money from the ill - so my advice to every one that has big concerns about cervical and breast ca get all the read out and certain test only made for these test so you wont go broke in the long run. Ask for a first second and third opinion and go to the best Dr's that only specialize on that. Also get the BRaca test that is a very important test. make sure you know your family hx . and talk with the Dr's. write everything down and if they are too busy to sit down and talk to you and they look busy dont go with him/her. Go with a Dr who truly cares for peoples feeling and health. That is what Dr's are lacking off. as for me I am still going through this ......but I look at my child 12 years old and he keeps me alive.