When the results of the American College of Surgeons Oncology Group Phase III Z001 study came out last year, researchers at the University of Michigan were just finishing their own study on the viability of building a pathology lab in their ambulatory surgical center to do frozen-section intraoperative assessments of tumor margins and lymph nodes during lumpectomies. But then the widely heralded ACOSOG report showed that axillary lymph node dissection (ALND) does not improve survival in breast cancer patients with limited nodal disease.
If breast surgeons were going to be doing fewer ALNDs, would a pathology lab in an outpatient center still make sense?
It turns out that an intraoperative pathology consultation service at a free-standing ambulatory surgical center was still economically feasible, as reported in the July issue of The American Journal of Surgery (2012;20:66–77). Further, in the short time the pathology service has been available, the rate of re-excisions at the university has dropped from 26 to nine percent.
“We found that even if you take into account the Z0011 findings, it still greatly reduces costs for the patient, improves quality of life, and decreases the cost of care,” said first author Michael S. Sabel, MD, Associate Professor of Surgery at the University of Michigan Comprehensive Cancer Center.
He explained that not many lumpectomy cases have intraoperative margin assessment done in the hospital setting now because of the costs involved, because surgeons are concerned about the extra time needed, and because most breast cancer surgery has moved from major universities to outpatient surgicenters.
“More cases are done at surgicenters, and very few of those have pathology on premises,” he noted in a telephone interview. And most centers won't build a new surgicenter with a pathology section in it because specimens are just going to be sent back to the main hospital.
This means that many women, thinking their tumor has been removed, will be told to return for a second operation. “The literature shows that at most institutions 30 to 40 percent of patients are returning to the OR after a lumpectomy in order to get clearance of close or involved margins if they are not doing intraoperative margin analysis, whether the surgery is done at the main hospital or a surgicenter. We dropped that significantly.”
He noted that this study is not the first to show that intraoperative margin analysis can significantly reduce reoperation rates for patients, but the difference is that prior studies were conducted at large institutions.
“We have shown that it can be done at a surgical center—that it is efficient, cost efficient for the patient, and greatly improves quality of care,” he said.
Sabel admitted that reducing the number of procedures in the surgicenter also puts financial pressure on the institution—“We get paid for operations, so this is sort of ironic, that we can greatly reduce the cost of care but we are spending money to lose money.”
He said he believes that intraoperative margin assessment should be standard of care for breast cancer surgery, but part of the motivation must come from third-party payers. “You have to incentivize this. We are saving a lot of money for third-party payers and doing a lot to improve patient quality of care and quality of life — there should be an incentive for that.”
He noted that multiple studies show that cosmetic results are worse after re-excisions for involved tumor margins. And the mastectomy rate is a bit higher, he said, if the patient worries about the possibility of a second re-excision, and says just do a mastectomy.
Waiting for an intraoperative assessment adds time in the operating room, Sabel said, but in fact the impact is time-neutral considering the time not spent on re-excision procedures.
In the study, patient data were collected for the eight months before the establishment of a pathology laboratory in the surgicenter, when intraoperative pathology consultation was not available, and the eight months after when it was performed routinely.
The average number of surgeries per patient decreased from 1.5 to 1.23, and the number of patients requiring one surgery increased from 59 percent to 80 percent.
The percentage of re-excisions decreased from 26 to nine percent, and frozen sections allowed 93 percent of node-positive patients to avoid a second surgery for axillary lymph node dissection.
Further, a cost analysis showed savings between $400 and $600 per breast cancer patient, even when accounting for fewer axillary lymph node dissections based on the ACOSOG Z0011 data.
The study was an intent-to-treat analysis because patients operated on in the main hospital because of concomitant conditions such as heart disease or anesthetic risk were left in the count, he said, adding that outcomes would have been even better if those had been left out.
‘A Good Start’
A spokesperson for the American Society of Breast Surgeons applauded the Michigan researchers for making surgeons aware of their options—in this case doing intraoperative margin and lymph node assessments in an outpatient ambulatory setting.
“It doesn't sound like that big a deal, but the majority of our breast surgeries are outpatient, lumpectomy and sentinel node, and in some cases even a mastectomy might even be outpatient, so it would be nice to offer the patient the option of having her surgery in an outpatient facility,” said Deanna J. Attai, MD, a member of the Society's Board of Directors and Chair of its communications committee.
Attai, a surgeon in private practice at the Center for Breast Care, Inc. in Burbank, California, said she performs surgery in a tertiary care center and few in an ambulatory care center, but the main reason not to perform lumpectomies has been the lack of pathology.
“This is something that I could potentially take to our outpatient surgery center and say ‘it can be done, can you figure out a way this could happen here?,’” she said.
She noted that she performs surgery mostly in a tertiary care center and few in an ambulatory care center, mainly because of the lack of pathology in the ambulatory center.
“This opens the door to let people start thinking there are alternatives to where we do our surgery,” she said. “It's a good start.”
Attai said she was impressed that the researchers were able to show that an ambulatory surgicenter pathology service could be cost effective and that the re-excision rate could be reduced. “A hospital is not the most efficient place to be doing outpatient surgery, so anything that can be done to keep the standard of care in an ambulatory care center is positive,” she said.
Attai said the researchers' concerns about the impact of ACOSOG Z0011 were important, and that this has led her to perform some breast surgeries in ambulatory centers now that pathology is not routine.
“This is something physicians can potentially take to their ambulatory centers and pathologists and see if they can start developing this,” she said. “Re-excisions will still be necessary, but when the re-excision rate in some places is 50 percent, we can certainly do a lot better than that.”