Radical Mastectomy to Radical Conservation (Extreme Oncoplasty): A Revolutionary Change

Accepted Manuscript Radical Mastectomy to Radical Conservation (Extreme Oncoplasty): A Revolutionary Change Melvin J. Silverstein, MD, FACS PII:

S1072-7515(15)01674-9

DOI:

10.1016/j.jamcollsurg.2015.10.007

Reference:

ACS 8076

To appear in:

Journal of the American College of Surgeons

Received Date: 13 October 2015 Accepted Date: 19 October 2015

Please cite this article as: Silverstein MJ, Radical Mastectomy to Radical Conservation (Extreme Oncoplasty): A Revolutionary Change, Journal of the American College of Surgeons (2015), doi: 10.1016/j.jamcollsurg.2015.10.007. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Radical Mastectomy to Radical Conservation (Extreme Oncoplasty): A Revolutionary Change Melvin J Silverstein, MD, FACS1, 2

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Hoag Memorial Hospital Presbyterian, Newport Beach, CA Keck School of Medicine, Department of Surgery, University of Southern California

Disclosure Information: Nothing to disclose.

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Corresponding Author: Hoag Memorial Hospital Presbyterian Hoag Breast Center One Hoag Drive Newport Beach, CA, 92663 United States Phone 949-764-8281 Fax: 949-764-8236 [email protected]

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Presented at the American College of Surgeons 101st Annual Clinical Congress, Chicago, IL, October 2015.

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Short title: Radical Mastectomy to Extreme Oncoplasty

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Introduction After four decades of caring for patients with breast cancer, I have come to the conclusion that the combination of mastectomy, reconstruction, and radiation therapy is the least

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desirable option for local treatment. Although it may be an unavoidable approach for some

patients, for many there may be better options that yield equal survival rates but with a superior quality of life. Let me explain.

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Everyone knows the definition of radical mastectomy, a procedure, conceived and

popularized by William S. Halsted, M.D. It removes the entire breast, the underlying pectoral

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muscles, and the axillary lymph nodes, leaving behind a depression under the clavicle, prominent ribs, and a markedly deformed patient. Most younger surgeons have never performed or even observed the procedure and never will. It has virtually no role in modern breast cancer surgery. In 1971, in McCall’s Magazine, Dr. William Nolan referred to radical mastectomy as “The

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operation women fear most”. (1)

But what is radical conservation? Radical conservation is the complete opposite. It is a breast preserving procedure, so extreme that it can be used to save a breast that would normally

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require removal. Radical conservation is a breast preserving operation that uses oncoplastic surgery (a combination of oncologic principles and plastic surgical techniques) for a patient who,

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in most physicians’ opinions, requires a mastectomy. Here is a confession. I do not like the term radical conservation. The word radical

conjures up the terrible images of an ancient mutilating procedure. I used it in the title of this manuscript to contrast it with “radical” mastectomy, but I much prefer to call the technique “extreme oncoplasty”. (2) Extreme oncoplasty sounds more positive and I will use that term

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going forward. Most surgeons, regardless of age, have not performed extreme oncoplasty, have never seen a case where it was used, and probably, have never even heard the term. This manuscript will take you on a 50-year journey from 1965 to the present: from

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radical mastectomy to extreme oncoplasty, from mutilation to the opposite, to less local

recurrences, to a lower breast cancer mortality rate, to a better quality of life, to better cosmesis, to breast conservation even when mastectomy is thought to be indicated.

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Learning the Basics

I was a surgical resident from 1965-1970 at what was then the Boston City Hospital, a

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group of more than twenty aging medical buildings connected by tunnels so that it was possible not to go outside during your training, except for brief sojourns home. At that time, all three Boston medical schools provided service at Boston City Hospital, so it was an exciting and stimulating era to train there.

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During my residency, breast cancer was just breast cancer. It was all the same. It was not the nuanced disease that we appreciate today. There were different pathologic types of breast cancer, but there was only one accepted treatment: Halsted Radical Mastectomy. During my five

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years as a surgical resident, I never saw a patient with breast cancer treated any differently. When Dr. George (Barney) Crile Jr. came to Boston to give a lecture on segmental resection for

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breast cancer, I was told he was a charlatan and discouraged from attending his talk. I went anyway and his lecture began to shake my faith in Halsted’s Principles. But, when I read Dr. Bernard Fisher’s October 1970 Current Problems in Surgery entitled “The Surgical Dilemma in the Primary Therapy of Invasive Breast Cancer: A Critical Appraisal”, (3) my life changed. That paper and its radically different biologic approach to breast cancer made me want to become a surgical oncologist. Years later, in the 1990s, Dr. Fisher and I would become good friends,

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debating the treatment DCIS on the lecture circuit. Dr. Fisher trained in Dr. Ravdin’s laboratory, hence, my connection to IS Ravdin once removed. I spent the next two years as a major in the United States Army, most of it at Dewitt

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Army Hospital, Ft. Belvoir, Virginia. There were many retired military personnel and their

dependents living in that community and there were many cases of breast cancer. Virtually all the breast cancer, at that time, was clinically detected and palpable. More than 60% of these

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patients were node positive at diagnosis. Mammography was in its infancy, of poor quality, and not available to us. The only chemotherapy was 5-fluorouracil (5FU) and methotrexate and the

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patient had to be referred to Walter Reed Medical Center to get “adjuvant chemotherapy”. In spite of Dr. Fisher’s paradigm changing ideas, I continued to perform radical mastectomies at Ft. Belvoir (Figure 1). The other surgeons did the same and I was in no position to change policy. I commonly took so much skin that I could not close the defect and needed a skin graft. I never did

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less than a radical mastectomy, not once. The patients stayed in the hospital a week to 10 days, until the drains were removed. I had no real appreciation of the deformity or emotional pain I caused these women. Based on my training, I believed I was properly treating and curing breast

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cancer.

I followed military service with a three-year surgical oncology fellowship at UCLA under

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the leadership of the remarkable Dr. Donald L. Morton. I was Don’s first fellow: “Fellow Number 1”. There was no national fellowship match in 1972. At the end of my interview for fellowship, Dr. Morton looked at me and asked a simple question. “Do you want to be rich or do you want to be famous?” “Famous,” I answered without hesitating. “Then you’re hired,” he said and that was that. I spent the next three years with him at UCLA. For the first two, we did radical mastectomies. But during my third year, we began to spare the pectoralis muscles in

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selected more favorable cases. The modified radical mastectomy was becoming popular; not because there was a prospective randomized trial proving its equality, but rather because the Women’s Movement, frustrated with years of mutilation, had pressed for the change. Betty Ford

breast cancer the more mainstream subject that it is today.

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and Happy Rockefeller both had mastectomies in 1974. Their openness led the way to making

By saving the pectoral muscles, we had taken the first steps toward a less deforming and

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demoralizing treatment for breast cancer. The journey toward extreme oncoplasty had officially begun for me, but reaching it would require time, evolution, and multiple pieces of a puzzle

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coming together.

The First Piece of the Puzzle: The Van Nuys Breast Center (4, 5) Dr. Morton allowed me to assemble and run UCLA’s first multidisciplinary breast clinic (6). The staff included a radiologist, a medical, surgical, and radiation oncologist, and a nurse.

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This small team made the breast cancer experience much quicker and simpler for the patient. During my fellowship, I began to think about building an expanded multidisciplinary breast clinic to serve West Los Angeles. I visited the administrators of a number of Westside Los

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Angeles hospitals and told them of my idea for a multidisciplinary breast clinic. Their answers were generally about the same, something like: “It’s a pretty good idea, but our surgeons will eat

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you alive (or worse). The last thing they want is a young know-it-all from UCLA telling them how to manage breast cancer. They know how to manage breast cancer.” After a year of frustration, I headed 15 minutes north, over the Santa Monica Mountains

and into Van Nuys, in the middle of San Fernando Valley. A surgeon friend steered me to Valley Hospital, an old hospital with a new 230-bed tower with only about 40 in-patients and no board

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certified general surgeons routinely using the facility. So, there was no one there to offend with a new breast program. The administration provided seed money and space. No one objected. In September 1979, after a year of planning, redesigning, equipping, and painting, I

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opened a small breast center in an old building at the rear of the hospital. At that time, there was no such thing as a “Breast Center.” Local television and newspapers covered the opening, and we were immediately successful. I used part-time consultants to cover all the specialties,

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including plastic surgery, medical and radiation oncology. I was the only full-time physician. In 1982, we expanded into a newly constructed medical office building on the Valley

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Hospital campus. A group of us took out a bank loan to fund the move and develop the space. Ownership of the Van Nuys Breast Center went from the hospital to the group. All the physicians, other than the radiation oncologist, became full-time. We initially occupied 11,000 square feet but within a few years, we expanded to 15,000 square feet. At our peak, we had 12

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medical professionals and a support staff of more than 40. The Van Nuys Breast Center became internationally known as the first free-standing breast center in the United States. (4, 5) It was a model for most breast centers that came later with visitors from 40 states and 36 foreign

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countries. The Van Nuys Breast Group was not affiliated with a medical school but during its 20year tenure, the group had more than 200 publications, 2 textbooks and multiple oral

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presentations at The American Society of Clinical Oncology (ASCO). The Van Nuys Breast Center was featured on the Today Show, Good Morning America, and ABC’s 20-20. In the late 1980s, Dr. Morton and his protégé, Dr. Armando Giuliano, visited the Van Nuys Breast Center as they were designing their new breast center at St. Johns Hospital in Santa Monica. The early success of the Van Nuys Breast Center lead to the second piece of the puzzle: ductal carcinoma in situ (DCIS).

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The Second Piece of the Puzzle: Ductal Carcinoma in situ (DCIS) Initially, the Van Nuys Breast Center, had a single, outdated mammography machine. Mammograms were taken during the day and batch-read in the main hospital at night. They were

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poor quality with low contrast and minimal penetration. From 1979 through 1981, we treated an average of six patients with DCIS each year. All the lesions were clinically apparent. None were detected by mammography alone and all were treated with mastectomy.

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When we moved to the new medical office building in 1982, we started with two state-ofthe art film-screen mammography units and a full-time experienced expert breast radiologist. A

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few years later, we added a third and fourth machine. From 1983 to 1998, with our new technology, we diagnosed an average of 53 cases of DCIS each year, most of which were nonpalpable and screen-detected. Suddenly, we were inundated with a disease we knew little about.

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We continued to do mastectomies for DCIS until I had the good fortune of meeting Michael D. Lagios, M.D., a noted breast pathologist from San Francisco. He visited the Van Nuys Breast Center and taught the team a great deal about DCIS. We learned about nuclear

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grading and the limited malignant potential of low-grade lesions. We learned that many cases did not have to be treated with mastectomy. He explained that he was conducting an “Excision Only

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Trial” for small, 25 mm or less, mammographically detected DCIS locally excised with clear margins of 1 mm or more. (7, 8) He taught us about inking or color-coding all margins, serially sectioning and sequentially embedding all tissue, performing mammographic/pathologic correlation, and estimating size by three-dimensional reconstruction. Most importantly, he taught us to measure margin width, the distance of the tumor to the inked edge. Margins were important and we adopted all of Dr. Lagios’ suggestions for both DCIS and invasive cancer.

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For the next 20 years, DCIS became the most important component of my medical life. I lived and breathed it. I thought about it all the time. I had a weekly Saturday morning breakfast with a group of colleagues where we discussed life, family, and DCIS. We collected data,

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published papers, and I had the opportunity to travel the world talking about DCIS and debating its treatment. The Van Nuys Group became a leading proponent for selecting patients who could be treated with excision alone. We developed the Van Nuys DCIS Classification (9) and the Van

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Nuys Prognostic Index (10-13), an algorithm used to select patients with a low risk of local

recurrence after excision alone. The first textbook devoted solely to DCIS was published in 1997

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while we were still at the Van Nuys Breast Center. (14)

The Third Piece of the Puzzle: Partial Mastectomy for Invasive Cancer

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In 1981, the great Italian surgeon, Professor Umberto Veronesi published the Milan I Trial, a prospective randomized study comparing Halsted Radical Mastectomy with quadrant resection, axillary lymph node dissection, and radiation therapy to the ipsilateral remaining

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breast tissue for invasive breast cancer two cm or smaller. In his 1981 New England Journal landmark publication, he reported there was no difference in disease-free and overall survival, at

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five years, regardless of treatment. (15, 16) This news made the front page of the New York Times (July 2, 1981). This was the first prospective randomized trial showing that a breast preserving procedure resulted in an equal cure rate with far less deformity when compared with Halsted mastectomy.

In 1985, Bernard Fisher, M.D., Chairman of the National Adjuvant Breast and Bowel Project (NSABP) published NSABP B-06, the five-year results of a prospective randomized trial

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comparing total mastectomy and segmental mastectomy with or without breast irradiation for invasive cancer four cm or smaller. (17, 18) Distant disease-free survival and overall survival were equivalent in all three groups at

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5-years. This was the first American trial to show equality of breast conservation and mastectomy. Unfortunately, surgeons in the United States were slow to accept breast

conservation, so for much of the 1980s, mastectomy continued to be the predominant method of

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local breast cancer treatment.

At the Van Nuys Breast Center, we were early adopters of breast conservation, and it

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played a major role in our success. It quickly became our procedure of choice for patients with Stage I and II breast cancer. Women from all over Los Angeles came to the San Fernando Valley for breast conservation. Additional prospective randomized trials followed and confirmed the equality of breast conservation and mastectomy (19-23). In 1990, the National Institute of Health

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(NIH) held a Consensus Development Conference and issued a statement recommending breast conservation for the majority of women with Stage I and II breast cancer. (24, 25) The Fourth Piece of the Puzzle: Oncoplastic Breast Surgery

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The final and most important piece of the puzzle was my realization that plastic surgery could play a role in a breast conserving procedure for cancer. This was the most difficult of all

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the pieces. I was very resistant at first. Oncoplastic breast conservation requires a philosophy that, after segmental resection, the appearance of the breast is important. That concept was never part of my training. Most general surgeons, of my era, were trained to think that it was not “oncologic” to open additional surgical planes and to move or rearrange tissue during a cancer operation. The goal of the oncologic surgeon was to remove the cancer with clear margins, not to preserve breast shape and function or to worry about cosmetic results.

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During the early 1980s, it never dawned upon me to use plastic surgery as part of a breast preserving operation, in spite of the fact that I worked with plastic surgeons on a daily basis. I scrubbed and assisted on at least 100 breast reductions during the early years of the Van Nuys

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Breast Center, but I never put the two procedures, lumpectomy and reduction, together. My training led me to believe that reconstructive breast surgery after mastectomy was acceptable, if properly timed and the cancer was not too advanced. But at that point in my career, I thought that

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cosmetic breast surgery was somewhat frivolous and certainly not “oncologic.”

The turning point came in the mid 1980s when I walked into the Van Nuys Breast Center

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preoperative holding area. One of our plastic surgeons was making some unusual markings on the breasts of an elderly woman. I asked what he was doing. He called it a “batwing” reduction, saying that the markings looked like the “Batman Symbol over Gotham.” He said it was an easy, quick reduction, with less incisions than the standard approach. The nipple would be supported

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on a very broad based inferior pedicle with literally no chance of nipple necrosis. It was perfect for an older, not so healthy woman, who would physically benefit from a reduction. As I looked at it, I had that “light bulb” moment. I thought, “What if a breast cancer was right in the center of

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the batwing”? This would yield both wide margins and a good cosmetic result, something we did not always achieve with our standard segmental resection. It was a win-win concept that

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changed the focus of my career.

Putting All the Pieces Together: The Evolution of Extreme Oncoplasty For 90 years, mastectomy was essentially the only choice. In 1981 and 1985, Milan I and

NSABP-06 confirmed the equality of breast conservation compared with mastectomy. (16, 17) In 1990, an NIH Consensus Conference concluded breast conservation was equivalent and preferable to mastectomy for Stage I and II breast cancer. (25) During the next ten years, breast

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conservation was slowly accepted for invasive breast cancer and then for DCIS. Surgeons generally made an incision over the tumor, took no skin, removed a 20-30 gram segment and accepted some deformity. There was a 20-40% positive margin rate and re-excisions to clear

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margins, as a second surgical procedure, were common. This remains a problem today. The positive margin rate without shaving the cavity was recently reported as 35%. (26) Following resection of the tumor, radiation therapy was used to deal with any residual cancer and often

unchanged since breast conservation was introduced.

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added additional deformity. For many surgeons, this entire approach has remained relatively

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In the mid-1980s, oncoplastic breast conservation began at the Van Nuys Breast Center. Unbeknownst to us, oncoplastic surgery was also beginning in Europe with Werner Audretsch (27) in Dusseldoft and Krishna Clough (28) in Paris, both of whom visited the Van Nuys Breast Center and enlightened us on what they were doing. Jean Petit in Paris and Mauricio Nava in

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Milan also made major oncoplastic contributions in the early 1980s. (29, 30) In Van Nuys, we used a range of new breast conserving excisions for cancer, including: batwings, hemibatwings, crescents, round blocks, and ultimately reductions. The oncoplastic

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approach consistently yielded wider margins, less re-excisions, less radiation therapy for DCIS, and better cosmesis. (31) We removed skin over

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the tumor and reshaped the breast, trying to avoid deformity. We did this for many years for unifocal disease, five centimeters in size or smaller, in keeping with the recommendations of the NIH and the prospective randomized trials that proved the equality of breast conservation with mastectomy. (19-23)

I left Van Nuys in 1998 to become Professor of Surgery at the Keck School of Medicine, University of Southern California. At USC, I continued to perform oncoplastic breast

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conservation, expanding the oncoplastic program to include support from the Division of Plastic Surgery. I started a surgical breast fellowship in 2000 with oncoplastic surgery as the key component. The second edition of my textbook Ductal Carcinoma in Situ was published in 2002

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while I was at USC. (32)

In 2008, I moved to Hoag Memorial Hospital Presbyterian, Newport Beach, California, to become Director of its Breast Program. I was able to remain on the USC faculty and to expand

fellows, 23 of whom have rotated through Hoag.

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the USC Breast Fellowship Program to include Hoag. At this writing, we have trained 39 breast

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At Hoag, I recruited a plastic surgeon, Nirav Savalia, M.D., to the USC Faculty and together we have run the Hoag Oncoplastic Program. We developed the “split reduction” (33), a procedure that allows the removal of overlying skin when a tumor falls outside the standard Wise Pattern Reduction. With funds from The Gross Family Foundation Endowed Chair in

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Oncoplastic Surgery, we produced a video on basic oncoplastic surgery in 2010. In 2015, Dr. Savalia and I produced Silverstein and Savalia’s Advanced Oncoplastic Breast Conservation. Both of these videos were distributed worldwide at no charge. (For a free copy, contact

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vectorsurgical.com)

To better understand the contribution of breast cancer excision using a reduction

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excision, Table 1 compares our experience with 250 consecutive excisions using an ellipse over the tumor with 300 consecutive excisions using a standard Wise Pattern or split reduction. Skin over the tumor was removed in every case. The reduction excision resulted in no ink on tumor in 97% of the cases compared with

91% for excision using an ellipse. No ink on tumor is currently the accepted standard for a clear margin for invasive breast cancer. (34, 35) Only 3% of reduction excisions underwent re-

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excision and only 1% were converted to mastectomy. There were more complications for reduction excision but they were minor, consisting of a few easily treated seromas or hematomas.

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The local recurrence rate was low and similar in each group.

Finally Extreme Oncoplasty

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In 2008, at Hoag, I wondered how far we could push the oncoplastic envelope. We had been doing oncoplastic resections for unifocal Stage I and II disease for years. In addition, we

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often encountered patients with larger or multifocal/multicentric tumors who seemed technically amenable to oncoplastic resection, but there were no prospective randomized data to support breast conservation for these patients. I always believed that the relationship between the size of the breast and the span of the tumor was key. A large breast with a large tumor could easily

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accommodate a large resection. So I began an Extreme Oncoplasty Program to provide second opinions for patients who wanted to save their breast but had been told that they needed a mastectomy. Many patients sought out our program.

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Extreme oncoplasty is a breast conserving operation, using oncoplastic techniques, for a patient who, in most physicians’ opinions, requires a mastectomy. Because of the size and

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severity of the lesion, most of these patients will also need post mastectomy radiation therapy. Extreme oncoplasty can be considered, if the breast is large enough to support it, for patients with tumors larger than 50 mm, for some with multifocal or multicentric lesions, extensive DCIS or extensive intraductal component (EIC) greater than 50 mm, for patients with a previously irradiated breast with a new or recurrent cancer within that breast, and for patients with large locally advanced breast cancer with a partial or complete imaging response to neoadjuvant

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chemotherapy. (2) Patients such as these have generally not been considered acceptable candidates for breast conservation. Why would anyone want to treat these patients with breast conservation? First of all,

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some patients simply want breast conservation even when they are poor candidates and are advised against it.

The prospective randomized trials upon which breast conservation is based allowed

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tumors up to five cm. There are no prospective randomized data for larger lesions and there are not likely to be any. But what is the difference between a 48 mm cancer that qualifies and a 52

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mm cancer that does not? When breast conservation is performed for a patient who turns out to have a 55 or 60 mm cancer on final pathology, most of us will irradiate that breast if the margins are clear, and not convert to a mastectomy just because of a size larger than 50 mm. When we do that, we are doing it without the support of any Level I evidence.

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The most important reason to consider extreme oncoplasty is that breast conservation yields a better quality of life when compared with the combination of mastectomy, reconstruction, and radiation therapy, and survival is likely the same.

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Consider the quality of life with the combination of mastectomy, reconstruction and radiation therapy. For most patients, a submuscular expander will be placed at the time of

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mastectomy. This causes pain. There are drains, a foreign body, the potential of infection, and the time required for expansion. The final reconstruction requires another operation, the expander to implant exchange, or perhaps an autologous flap. If an autologous flap is used, it is a longer procedure, with additional operative risks and donor site morbidity. There may be additional operations to adjust the breast and nipple as well as tattoos for the areola. Then there is the opposite breast to consider, perhaps prophylactic mastectomy and reconstruction, or a

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reduction for symmetry. The mastectomy or mastectomies will leave insensate breast(s). The final cosmetic result will range from poor to excellent. (36-38) But my experience, from looking at more than 1000 reconstructed patients, tells me that less than 25% would be rated as excellent

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by me. Then there is the residual breast tissue needed to keep the skin and nipple, if preserved, viable. The amount of residual tissue varies, depending on how the mastectomy was done and the thickness of the flaps.

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After a mastectomy with reconstruction, most of these high-risk patients need radiation therapy. (39) Currently patients with tumors greater than five cm receive radiation therapy.

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Patients with four or more positive nodes get radiation therapy. Many radiation oncologists now treat patients with one to three positive nodes. (40) Patients with extensive lymphovascular invasion get radiation therapy, as will patients with close or involved margins following mastectomy. In other words, radiation therapy will be recommended for many patients following

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mastectomy and certainly for most patients who qualify for extreme oncoplasty. If the patient is going to be given radiation therapy following a mastectomy with reconstruction, I would generally prefer to save her breast with an acceptable cosmetic result, if it is technically possible

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and ontologically sound.

Radiation therapy is not friendly to reconstruction. (41) There is a risk of capsular

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contracture, if an implant-based reconstruction is used, or breast shrinkage, if autologous tissue is used. Radiation therapy is inconvenient from the patient’s perspective, expensive, causes some morbidity, and may interfere with the timing of chemotherapy. After a mastectomy with reconstruction, if radiation therapy is not given, 5%-10% of the

breast tissue, depending on the thickness of the flaps, are not treated, including the dermal lymphatics.

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Compare, on the other hand, breast conservation using a reduction with a simultaneous contralateral reduction for symmetry: one operation, no drains, and it looks better immediately and later. There is less pain, less expense, less hospital stay, no foreign body, and no donor site

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morbidity. The breasts are more functional and sensate. All of this results in a better body image and a happier patient. Most importantly, breast conservation with a reduction allows a patient to forget that she had breast cancer, not right away, but at some point in the future. In six months or

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a year, the patient will be getting dressed and she has two normal reduced breasts. They look good, they are sensate, and she feels like she is just a normal woman. She will be reminded of

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breast cancer only when she sees it on television or it is time for an appointment with her doctor. If she had a mastectomy, even with an excellent reconstruction, she will be reminded, on a daily basis for the rest of her life, that she had breast cancer.

Table 2 compares the 300 consecutive reductions discussed above with 105 extreme

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oncoplastic cases. For the extreme cases, the cancers are about three times the extent when compared with standard or split reduction patients with tumor 50 mm or less. The extreme specimens weighed about 70 grams more. No ink on tumor was achieved only 86% of the time

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during the first excision due to the larger size of the extreme tumors. Twelve percent of extreme patients underwent re-excision and 5% ultimately underwent mastectomy. The local recurrence

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rate for the extreme cases is slightly higher, as would be expected for patients with larger cancers. There are no long-term recurrence or survival data, at this point, for extreme patients. There was overwhelming patient satisfaction with the oncoplastic program as measured by a patient satisfaction survey.

Extreme Oncoplasty Case Example

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A 48-year old woman with multiple abnormalities detected on screening mammography is shown in Figures 2A-D. Biopsy of three suspicious areas revealed invasive lobular carcinoma in two areas and atypical ductal hyperplasia versus DCIS in the third. The disease spanned 81

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mm and was in two quadrants. Mastectomy was suggested by two surgeons but the patient sought an alternative breast conserving approach. Extreme oncoplasty was performed

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successfully. Conclusions

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We have come a long way from the Halsted Radical Mastectomy as the only procedure for breast cancer. With proper use of all currently available tools that include: screening, early detection, genetic testing, state-of-the-art chemotherapy and hormonal therapy, molecular testing, and oncoplastic surgery, we can achieve less local recurrences, less distant recurrences, a lower mortality rate from breast cancer, a better quality of life, and better cosmesis. And we can

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do all of this with a lower mastectomy rate.

It is time to accept that the appearance of the breast after breast conservation is important, that there are too many unilateral mastectomies, that there are too many bilateral mastectomies

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(42), and that prophylactic contralateral mastectomy should not be a knee jerk response nor does

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it offer any survival benefit. (42, 43) For most patients, breast conservation offers equal survival and a better quality of life when compared with mastectomy. Standard oncoplastic breast reduction should be available to all patients. (44) Combined

with radiation therapy, oncoplastic breast reduction is a better option than the combination of mastectomy, reconstruction and radiation therapy. It provides a superior quality of life with an equivalent survival rate.

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Extreme oncoplasy or radical breast conservation is a new concept. It allows breast conservation in selected patients with tumors greater than 5 cm, multifocal or multicentric disease, locally advanced tumors after partial or complete response to neoadjuvant

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chemotherapy, and in patients with recurrent or new disease after prior excision and radiation therapy. Long-term data on recurrence and survival do not currently exist for the extreme cases but are being accrued.

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Oncoplastic breast conservation is a tool that should be added to our armamentarium in the fight against breast cancer. It should be taught to all surgeons who aspire to treat patients

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with breast cancer. General surgeons who have not been trained in oncoplastic surgery should team up with a plastic surgeon so that they can offer their patients the best possible state-of-the art care. Breast surgical fellowship programs should be expanded to include extensive experience in breast oncoplastic surgery. Extreme Oncoplasty is an evolutionary leap in the progression of

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breast conservation. Some may even consider it revolutionary.

References 1.

Nolan William. The Operation women Fear Most. McCall's. 1971.

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2.

Silverstein M, Savalia N, Khan S, Ryan J. Extreme Oncoplasty: Breast Conservation for

Patients Who Need Mastectomy. Breast J. 2015;21:52-9. Fisher B. The surgical dilemma in the primary therapy of invasive breast cancer: A

critical appraisal. Current Problems in Surg. 1970;7(10):3-53. 4.

Silverstein MJ. The Van Nuys Breast Center - The First Free-Standing Multidisciplinary

Breast Center. Surg Oncol Clinics N Amer. 2000;9(2):159-75.

Silverstein MJ, Handel N, Hoffman R, et al. The Breast Center - A Multidisciplinary

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5.

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3.

Model. In: Paterson AHG LA, ed. Fundamental Problems in Breast Cancer. Boston: Martinus

6.

M AN U

Nijhoff; 1987. p. 47-58.

Silverstein MJ. The Multidisciplinary Breast Clinic: A New Approach. UCLA Cancer

Bulletin. 1973;1(1):5-6. 7.

Lagios M, Margolin F, Westdahl P, Rose N. Mammographically detected duct carcinoma

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in situ. Frequency of local recurrence following tylectomy and prognostic effect of nuclear grade on local recurrence. Cancer. 1989;63:619-24. 8.

Lagios M, Westdahl P, Margolin F, Rose M. Duct Carcinoma in situ: Relationship of

EP

extent of noninvasive disease to the frequency of occult invasion, multicentricity, lymph node metastases, and short-term treatment failures. Cancer. 1982;50:1309-14. Silverstein MJ, Poller D, Waisman J, et al. Prognostic classification of breast ductal

AC C

9.

carcinoma-in-situ. Lancet. 1995;345:1154-7. 10.

Silverstein MJ, Buchanan C. Ductal carcinoma in situ: USC/Van Nuys Prognostic Index

and the impact of margin status. The Breast. 2003;12:457-71.

19

ACCEPTED MANUSCRIPT

11.

Silverstein MJ, Epstein M, Sposto R. Predicting Local Recurrence in Patients with DCIS.

In: Silverstein MJ, Recht A, Lagios M, eds. Ductal Carcinoma in Situ of the Breast 2nd Edition. Philadelphia: Lippincott, Williams and Wilkins; 2002. Silverstein MJ, Lagios M, Craig P, et al. The Van Nuys Prognostic Index for Ductal

Carcinoma in Situ. Breast Journal. 1996;2:38-40. 13.

Silverstein MJ, Poller D, Craig P, et al. A prognostic index for ductal carcinoma in situ of

M AN U

Silverstein MJ, Lagios M, Recht A, eds. Ductal Carcinoma in Situ of the Breast. 1st ed.

Baltimore: Williams and Wilkins; 1997. 15.

SC

the breast. Cancer. 1996;77:2267-74. 14.

RI PT

12.

Veronesi U, Cascinelli N, Mariani L, et al. Twenty-year follow-up of a randomized study

comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002;347:1227-32.

Veronesi U, Saccozzi R, Del Vecchio M, et al. Comparing radical mastectomy with

TE D

16.

quadrantectomy, axillary dissection and radiotherapy in patients with small cancers of the breast. N Engl J Med 1981;305:6-10.

Fisher B, Bauer M, Margolese R, et al. Five-year results of a randomized clinical trial

EP

17.

comparing total mastectomy and lumpectomy with or without radiation therapy in the treatment

18.

AC C

of breast cancer. N Eng J Med. 1985;312:665-73. Fisher B, Jeong J, Anderson S, et al. Twenty-five year follow-up of a randomized trial

comparing radiacal mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002;347:567-75. 19.

Blichert-Toft M, Brincker H, Andersen J, et al. A Danish randomized trial comparing

breast preserving therapy with mastectomy in mammary carcinoma. Acta Oncol. 1988;27:671-5.

20

ACCEPTED MANUSCRIPT

20.

Blichert-Toft M, Rose C, Andersen J, et al. Danish randomized trial comparing breast

conservative treatment with mastectomy: six years of life table analysis. J Natl Cancer Inst Monogr. 1992;11:19-29. Lichter A, Lippman M, Danforth D, at al. Mastectomy versus breast conserving therapy

RI PT

21.

in the treatment of stage I and II carcinoma of the breast: a randomized trial at The National Cancer Institute. J Clin Oncol. 1992;10:976-82.

Van Dongen J, Bartelink H, Fentiman I, et al. Randomized clinical trial to assess the

SC

22.

value of breast-conserving therapy in stage I and II breast cancer, EORTC 10801 trial: Monogr

23.

M AN U

Natl Cancer Inst; 1992.

Sarrazin D, Le MG, Arriagada R, et al. Ten-year results of a randomized trial comparing

a conservative treatment to mastectomy in early breast cancer. Radiother Oncol. 1989;14:177-84. 24.

Lazovich DeAnn, Solomon CC, Thomas DB, et al. Breast Conservation Therapy in the

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United States following the 1990 National Institutes of Health Consensus Development Conference on the Treatment of Patients with Early Stage Invasive Breast Carcinoma. Cancer. 1999;86:628-37.

National Institutes of Health (NIH) Consensus Conference. Treatment of early breast

EP

25.

cancer. JAMA. 1991;265:391-5.

Chagpar AB, Lillelea BK, Tsangaris TN, et al. A Randomized, Controlled Trial of Cavity

AC C

26.

Shave Margins in Breast Cancer. N Engl J Med. 2015;373:503-10. 27.

Audretsch W, Rezai M, Kolotas C, et al. Tumour-specific immediate reconstruction in

breast cancer patients. Semin Plastic Surg,. 1998;11:71-99. 28.

Clough K, Lewis J, Couturaud B, et al. Oncoplastic techniques allow extensive resections

for breast conserving therapy of breast carcinomas. Ann Surg. 2003;237:26-34.

21

ACCEPTED MANUSCRIPT

29.

Grisotti A, Nava M, Arioli N, Callegari M, VZ. Post quadrantectomy reconsteruction and

local relapses. The Breast. 1997;6:315-20. 30.

Petit JY, Rigaut L, Zekri A, M. L. Poor esthetic results after conservative treatment of

RI PT

breast cancer. Technics of partial breast reconstruction Ann Chir Plast Esthet. 1989;34:103-8.

Silverstein M, Mai T, Savalia N, et al. Oncoplastic breast conservation surgery: The new

paradigm. J Surg Oncol. 2014;110(1):82-9. 32.

SC

31.

Silverstein MJ, Lagios M, Recht A, eds. Ductal Carcinoma in Situ of the Breast, Second

33.

M AN U

Edition. Philadelphia: Lippincott, Williams and Wilkins; 2002.

Silverstein MJ, Savalia N, Khan S, et al. Oncoplastic split reduction with intraoperative

radiation therapy. Ann Surg Oncol. 2015;22(10):3405-6. 34.

Moran M, Schnitt S, Giuliano A, et al. Society of Surgical OncologyeAmerican Society

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for Radiation Oncology Consensus Guideline on Margins for

Breast-Conserving Surgery With Whole-Breast Irradiation in Stages I and II Invasive Breast Cancer. Int J Radiation Oncol Biol Phys. 2014;88(3):553-64. Moran M, Schnitt S, Giuliano A, et al. Society of Surgical Oncology-American, Society

EP

35.

for Radiation Oncology consensus guideline on margins for breast-conserving surgery with

16. 36.

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whole-breast irradiation in stages I and II invasive breast cancer. Ann Surg Oncol. 2014;21:704-

Broughey J, Hoskin T, Hartmann L, et al. Impact of reconstruction and reoperation on

long-term patient-reported satisfsction after contralateral prophylactic mastectomy. Ann Surg Oncol. 2015;22:401-8.

22

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37.

Clough K, O'Donoghue J, Fitoussi A, et al. Prospective ervaluation of late cosmetic

results following breast reconstruction: I. Implant reconstruction. Plast Reconstr Surg. 2001;107:1702-9.

reconstruction. Plast Reconstr Surg. 2011;127:1417-24. 39.

Vilarino-Varela M, Chin YS, Makris A. Current indications for post-mastectomy

radiation. Int Semin Surg Oncol. 2009;6:5-6. 40.

RI PT

Craft RO, Colakoglu S, Curtis MS, et al. Patient satisfaction in unilateral and bilateral

SC

38.

Early Breast Cancer Trialists’ Collaborative Group. Effects of radiotherapy and

M AN U

differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomized trials. Lancet. 2005;366:2087-106. 41.

Moulds JEC, Berg CD. Radiation therapy and breast reconstruction. Radiation Oncol

Investigations. 1998;6(2):81-9.

Lagnado L. The Double Mastectomy Rebellion. Wall Street Journal. 2015 July 10, 2015.

43.

Kurian A, Lichtensztajn D, Keegan T, et al. Use of and Mortality After Bilateral

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42.

Mastectomy Compared With Other Surgical Treatments for Breast Cancer in California, 1998-

44.

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2011. JAMA. 2014;312(9):902-14.

Christoph A, Farhadi J, Goossens D, et al. A Position Statement on Optimizing the Role

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of Oncoplastic Breast Surgery. E Plasty. Eplasty 08/2012; 12:e40.; 2010. p. 354-60.

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Table 1. A Comparison of Elliptical Excisions With Reduction Excisions Reductions

n

250

300

Mean tumor extent, mm

22

22

Mean specimen weight, g

65

No ink on tumor, %

91

Margin ≥ 1 mm, %

79

Re-excision, %

15

Mastectomy, %

2

Complication, %

2

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Ellipses

140 97

88

2

1

3.4

2.5

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Any local recurrence, %

3

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Data

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Table 2. A Comparison of Reduction Excisions with Extreme Excisions Extreme oncoplasty tumors > 50 mm

n

300

105

Mean tumor extent, mm

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Mean specimen weight, g

140

No ink on tumor, %

97

Margin ≥ 1 mm, %

88

Re-excision, %

3

Mastectomy, %

1

229 86

67

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2.5

74

12 5

3.8

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Any local recurrence, %

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Standard/split reduction tumors ≤ 50 mm

Data

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Figure Legend

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Figure 1. A typical radical mastectomy in 1971.

Figure 2: [A] (Left) Preoperative photograph of a 48-year old with multiple

abnormalities detected on screening. (Right) Mammogram shows multicentric disease

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spanning 81 mm. Biopsy revealed two foci of invasive lobular carcinoma (ILC) and one focus of atypical ductal hyperplasia versus ductal carcinoma in situ (ADH/DCIS). [B]

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(Left) Two bracketing guide wires have been placed around each lesion for a total of 6 wires. (Right) The patient has been marked for a split reduction excision. The inner black line shows skin that will be removed over the tumors. The outer lighter yellow line shows the amount of tissue that will be removed. [C] (Left) 202 gram specimen with overlying

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skin. (Right) Specimen radiograph. Final pathology revealed two foci of invasive lobular carcinoma spanning 42 mm. Including the ADH/DCIS, the entire span was 81 mm. Closest margin was 5 mm. There were two negative sentinel lymph nodes. [D] (Left)

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Preoperative. (Right) 3 Years Postoperative and Post Radiation Therapy.

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