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Rates of reoperation after breast-conserving surgery remain high

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February 17, 2016

Use of breast-conserving surgery has decreased among younger women with early-stage breast cancer, according to the results of a population-based study.

However, nearly one-quarter of women required reoperation within 90 days of surgery, results showed.

E. Shelley Hwang, MD, MPH

E. Shelley Hwang, MD, MPH

Although breast-conserving surgery offers a conservative surgical option for women, some women will have surgical margins that are not tumor free and require additional surgery.

“From a policy perspective, rates of repeated lumpectomy might be considered a measure of quality,” Art Sedrakyan, MD, PhD, professor of healthcare policy and research in cardiothoracic surgery at Weill Cornell Medicine, and colleagues wrote. “However, major concerns remain that injudicious quality measures will lead to surgical decisions to perform larger lumpectomies than needed, to ignore pathologic margin or to recommend mastectomy instead of breast conservation surgery to avoid being penalized for the reoperation rate.”

Sedrakyan and colleagues sought to determine the rates of reoperation, procedure choice and surgeon experience on the odds of reoperation within 90 days of initial breast-conserving surgery.

Thus, they conducted a population-based survey of women undergoing breast-conserving surgery in New York State between January 2003 and December 2013. Data were collected from mandatory reporting databases, which included all hospitals and ambulatory surgery centers in the state.

The rate of reoperation within 90 days of breast-conserving surgery served as the primary endpoint.

The study included data from 89,448 women (mean age, 61.7±13.7 years) aged 20 years or older. Forty-two percent of women were aged 65 years or older. The majority (90.5%) received outpatient surgery.

The number of women aged 20 to 49 years who underwent breast-conserving surgery significantly declined in year 2013 compared with 2003 (n = 1,146 vs. 1,960; P < .001 for trend).

The use of breast-conserving surgery varied between years 2013 and 2003 among women aged 50 to 64 years (n = 3,068 vs. 2,899) and 65 years or older (n = 3,644 vs. 3,270).

The mean overall rate of 90-day reoperation was 30.9% (n = 27,010). Reoperation rates decreased from 39.5% (n = 6,630 of 16,805) in the years 2003 to 2004 to 23.1% (n = 5,148 of 22,286) between 2011 and 2013.

The highest rate of reoperation occurred among women aged 20 years to 49 years (37.7%; n = 6,990), whereas the lowest rate occurred among women aged 65 years or older (26.3%; n = 9,656; P < .001 for trend).

The incidence of breast-conserving surgery as a subsequent procedure increased over time, from 63.9% (n = 4,237 of 6,630) between 2003 and 2004 to 82.7% (n = 4,258 of 5,148) between 2011 and 2013 (P < .001 for trend).

Among the 19,466 women who underwent breast-conserving surgery as a second procedure, 12.5% (n = 2,429) required a third operation, representing 2.7% of the overall study population.

The researchers observed that reoperation rates varied significantly by surgeon experience, with 90-day reoperation rates ranging from 0% to 100%.

Low-volume surgeons (< 14 cases per year) had an unadjusted reoperation rate of 35.2%, compared with 29.6% among middle-volume surgeons (14-33 cases per year) and 27.5% among high-volume surgeons (≥ 34 cases per year).

Using high-volume surgeons as the reference, adjusted analyses indicated women appeared more likely to undergo reoperation if their initial surgery was with a low-volume surgeon (OR = 1.49; 95% CI, 1.19-1.87) or middle-volume surgeons (OR = 1.2; 95% CI, 0.93-1.56).

The researchers acknowledged several study limitations, including their lack of information on tumor size, grade or staging. Further, the study did not measure cancer recurrence or patient satisfaction, nor did it ascertain breast or surgical oncology fellowship training among practitioners.

“After developing guidelines, quality metrics need to be developed and studies need to assess the effect of guidelines on rates of reoperations after breast-conserving surgery," Sedrakyan and colleagues wrote.

Comprehensive re-excision guidelines are needed for women undergoing breast-conserving surgery, Uttara Nag, MD, surgical resident at Duke University Medical Center, and E. Shelley Hwang, MD, MPH, professor of surgery at Duke University School of Medicine, wrote in an accompanying editorial.

“Establishing a rational, evidence-based approach to re-excision … has the potential to provide substantial national cost savings by eliminating re-excisions for close but negative margins,” Nag and Hwang wrote. “As these guidelines for margin status are widely adopted, identification of persistent outliers to these guidelines and assessment of the effect of this practice change on surgical outcomes and value of care for early-stage breast cancer should remain important goals.” – by Cameron Kelsall

Disclosure: Sedrakyan reports funding from the FDA to establish the MDEpiNet Science and Infrastructure Center. One study researcher reports employment with the MDEpiNet Science and Infrastructure Center. The other researchers, Nag and Hwang report no relevant financial disclosures.

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PERSPECTIVE
Anees B. Chagpar, MD, MPH, FACS

Anees B. Chagpar, MD, MPH, FACS

These data confirm what we already know: Roughly 30% of patients require reoperation after a partial mastectomy. When we look at this in an objective way, surgeons may be surprised by that number, but it has been consistently found in a number of other studies.

The primary question is, how do we reduce reoperation rates without compromising patient outcomes?

My colleagues and I published the results of a randomized, controlled trial of cavity-shaved margins last year in The New England Journal of Medicine. This is a very simple technique that involves taking a little bit more tissue around the cavity during breast-conserving surgery. We found that this reduced our re-excision rate at Yale by half, from 20% to 10%.

Surgeons around the country are looking for ways to reduce re-excision rates. The best way to do that is to do a better surgery the first time around.

Reference: Chagpar AB, et al. N Engl J Med. 2015;doi:10.1056/NEJMoa1504473.


Anees B. Chagpar, MD, MPH, FACS
Yale School of Medicine

Disclosure: Chagpar reports no relevant financial disclosures.


PERSPECTIVE

This study by Isaacs and colleagues evaluated over 89,000 women undergoing breast-conserving surgery (BCS) to evaluate the rate of reoperations within 90 days of the initial BCS procedure. This study demonstrates one of the main limitations BCS — the potential need for re-excision to achieve negative margins that helps avoid local recurrence.

The researchers, like others before, note that about 25% of women who undergo BCS will require a second surgery to re-excise positive margin(s); however, these rates are steadily decreasing. These rates are owed in part to better patient selection, more experience with BCS, and as a result of the consensus provided by the Society of Surgical Oncology and the American Society for Radiation Oncology that provides a definition of adequate margins as “no tumor on ink” — meaning a negative margin requires no additional surgery.

The researchers also note better outcomes with higher-volume surgeons. It is not surprising that the researchers found up to a 50% higher rate of re-excision for low-volume surgeons; however, other studies showed no significant difference.

We have seen, as this study recognizes, an increase in the number of younger women who desire mastectomy over BCS. Some of the reasons for this are increased genetic testing and more access to reconstruction. As the researchers recognize, one of the major limitations of this study is that it does not account for patient satisfaction or cancer recurrence, which plays a tremendously important role in the surgeon–patient discussions and recommended therapy.

BCS is a safe, proven treatment for many women with breast cancer. This study reinforces that there needs to be a clear discussion between the surgeon and patient regarding the expectations and possible need for re-excision(s). The decision to proceed with breast conservation compared with mastectomy is a personal choice, and an informed discussion between the surgeon and patient should take place to discuss the advantages and potential limitations of each therapy. 


Salvatore M. Nardello, DO
Fox Chase Cancer Center

Disclosure: Nardello reports no relevant financial disclosures.