Ann Surg Oncol (2014) 21:3223–3230 DOI 10.1245/s10434-014-3915-z

ORIGINAL ARTICLE – BREAST ONCOLOGY

Total Skin-Sparing Mastectomy and Immediate Breast Reconstruction: An Evolution of Technique and Assessment of Outcomes Frederick Wang, MD1, Anne Warren Peled, MD1, Elisabeth Garwood, MD4, Allison Stover Fiscalini, MPH2, Hani Sbitany, MD1, Robert D. Foster, MD1, Michael Alvarado, MD2, Cheryl Ewing, MD2, E. Shelley Hwang, MD, MPH3, and Laura J. Esserman, MD, MBA5 1

Division of Plastic and Reconstructive Surgery, Department of Surgery, University of California, San Francisco, San Francisco, CA; 2Carol Franc Buck Breast Care Center, Department of Surgery, University of California, San Francisco, San Francisco, CA; 3Department of Surgery, Duke University Medical Center, Durham, NC; 4Department of Radiology and Biomedical Imaging, University of California, San Francisco, San Francisco, CA; 5Carol Franc Buck Breast Care Center, University of California, San Francisco, San Francisco, CA

ABSTRACT Background. Total skin-sparing mastectomy (TSSM) with preservation of the breast and nipple-areolar complex (NAC) skin was developed to improve aesthetic outcomes for mastectomy. Over time, indications for TSSM broadened and our technique has evolved with a series of systematic improvements. Methods. We reviewed all cases of TSSM with immediate breast reconstruction performed from 2005 to 2012. Patient comorbidities, treatment characteristics, postoperative complications, and outcomes were obtained prospectively and through medical chart review. Locoregional recurrences, distant recurrences, and patient survival were analyzed with Kaplan–Meier methods. Results. During this 8-year period, 633 patients (981 cases) underwent TSSM with median follow-up time of 29 (interquartile range 14–54) months. Immediate breast reconstruction was performed with tissue expander placement (89 %), pedicle TRAM (5 %), free flap (5 %), permanent implant (0.3 %), or latissimus flap (0.2 %). The incidences of postoperative complications decreased significantly over time. In 2012, these were down to 3.5 % for superficial nipple

Presented at the 2014 American Society of Breast Surgery Annual Meeting, Las Vegas, NV, May 2014. Ó Society of Surgical Oncology 2014 First Received: 13 April 2014; Published Online: 23 July 2014 L. J. Esserman, MD, MBA e-mail: [email protected]

necrosis, 1.0 % for complete nipple necrosis, 3.0 % for minor skin flap necrosis, 4.4 % for major skin flap necrosis, 13.3 % for infections requiring oral antibiotics, 9.9 % for infections requiring intravenous antibiotics, 3.4 % for infections requiring operative intervention, and 8.5 % for expander/ implant. Overall 5-year cumulative incidences of recurrence were 3.0 % (locoregional) and 4.2 % (distant), and there were no recurrences in the NAC skin. Conclusions. Systematic changes in our technique of TSSM and immediate breast reconstruction have decreased postoperative complications over time. Oncologic outcomes of locoregional and distal recurrences remain similar to skin-sparing mastectomy techniques.

Total skin-sparing mastectomy (TSSM) with complete preservation of the breast and nipple-areolar complex (NAC) skin and excision of nipple tissue was developed to improve aesthetic outcomes for treatment of early-stage breast cancer or for prophylactic indications.1 While there were initial concerns that preserving the NAC skin would increase locoregional recurrence rates, longer-term followup studies have demonstrated recurrence rates similar to those seen in skin-sparing mastectomy without preservation of the NAC.2–6 Our indications for TSSM have broadened since we began using this technique in 2001. Our initial criteria included women with tumors less than 2 cm in size, no clinical evidence of nipple or skin involvement, and preoperative magnetic resonance imaging (MRI) studies confirming there was no tumor within 2 cm of the nipple-

3224

areolar complex (NAC). As we gained experience, we found that routine preoperative MRI was not necessary and limited its use to cases where the tumor was close to the nipple on clinical examination or on mammography. By 2005, patients were eligible for TSSM as long as preoperative MRI demonstrated no direct tumor involvement of the NAC, even if the tumor was less than 1 cm from the NAC. Patients with clinical stage II and III disease were increasingly treated with neoadjuvant systemic therapy and restaged before mastectomy. Those who presented with initial tumor involvement of the skin but met our TSSM criteria after responding to neoadjuvant chemotherapy remained eligible for TSSM. Women with clear evidence of nipple or skin involvement at the time of mastectomy were excluded from receiving TSSM. Relative contraindications for TSSM included gigantomastia and grade III breast ptosis. Our initial experience between 2001–2004 defined the optimal technique and incisions for TSSM.1,7 We discontinued the use of free nipple grafting and NAC-crossing incisions early, and we noted an increased risk of nipple necrosis with periareolar incisions involving greater than one-third of the NAC circumference.7 All periareolar incisions performed after 2005 have incorporated less than one-third of the NAC circumference.1 In 2005, the TSSM technique was introduced to all breast surgeons at our institution, and it was quickly adopted as a standard procedure because the aesthetic outcomes were superior to prior results. Our reconstructive techniques have changed significantly over time. Before 2006, we utilized a variety of reconstructive techniques but found that patients experienced high rates of NAC and skin flap necrosis with immediate autologous reconstruction and direct-to-implant reconstruction.1,7 After realizing the benefit of gradual expansion to minimize nipple and skin flap necrosis in our early experience, we discontinued the use of immediate implant placement by 2006 and significantly reduced our use of immediate autologous reconstruction by 2007. In 2007, we began using acellular dermal matrix (ADM) to achieve complete lateral coverage of tissue expanders, and we have utilized the concept of additional prosthetic coverage with either ADM or serratus muscle since that time. In 2009, we changed our preferred drain prophylactic antibiotic from cephalexin to trimethoprim-sulfamethoxazole based on a review of the microbiology at our institution.8 We also increased the interval between completion of radiation therapy to expander-implant exchange from 3 months to 6 months for patients undergoing postmastectomy radiation therapy as an empiric strategy to reduce complications in these high-risk patients.9 This study summarizes our ongoing experience with TSSM and immediate breast reconstruction. We aim to

F. Wang et al.

assess how the systematic changes we have implemented in our reconstructive techniques have affected overall postoperative complication rates. We also determine our rates of locoregional and distant recurrences in patients who have undergone TSSM to demonstrate that this technique has become a feasible standard for mastectomy at our institution. METHODS Patient Selection We reviewed all cases of TSSM with immediate breast reconstruction that were performed from 2005 to 2012. This study was approved by the University of California, San Francisco Committee on Human Research. TSSM Technique All patients underwent TSSM with inversion of the nipple and excision of all nipple tissue at the dermal junction.7,10 TSSM incisions included inframammary, superior periareolar, lateral, and radial incisions as well as incisions incorporating prior breast surgery scars.7 Reconstructive Technique Patients underwent standard autologous and prosthetic reconstruction after TSSM. Autologous reconstructions included pedicle transverse rectus abdominis myocutaneous (TRAM) flaps, microvascular free flaps, and latissimus dorsi myocutaneous flaps. Prosthetic reconstructions included tissue expander placement and immediate implant placement. For tissue expander-implant reconstructions, postmastectomy radiation therapy was performed following completion of tissue expansion, before expanderimplant exchange.11 Classification of Comorbidities and Outcomes Patient demographics and comorbidities were collected through review of medical records. Diabetes was defined by the use of oral hypoglycemic agents or insulin. Current smoking was defined as smoking within 1 month of surgery, and former smoking was defined as a history of smoking and quitting more than 1 month before surgery. Postoperative complications were collected prospectively through regular meetings between breast surgeons, plastic surgeons, and clinic nurses. Medical records were reviewed in 2013–2014 to ensure no complications were missed. Superficial nipple necrosis was defined as NAC epidermolysis that resolved without a defect. Partial nipple necrosis was defined as necrosis leading to loss of a portion

TSSM Experience

of the NAC. Complete nipple necrosis was defined as necrosis leading to loss of the entire NAC. Minor skin flap necrosis was defined as skin flap necrosis/epidermolysis that did not require debridement. Major skin flap necrosis was defined as skin flap necrosis that required debridement. Infections were defined as breast symptoms that led to clinicians prescribing oral (PO) antibiotics or admitting patients for intravenous (IV) antibiotics. Infections requiring procedures for resolution were defined as infections requiring operative intervention. Implant loss was defined as removal of the tissue expander or implant without immediate replacement. Oncologic outcomes of tumor involvement of the nipple specimen, locoregional recurrences, and distant recurrences were collected through review of medical records. Nipple specimen involvement was determined by serial sectioning of the nipple tissue during final pathologic analysis. Locoregional recurrences were defined as subsequent diagnoses of breast cancer of the ipsilateral chest wall or locoregional lymph nodes after TSSM and negative margins were achieved on pathology. Distant recurrences were defined as subsequent diagnoses of metastatic breast cancer after TSSM was performed. Statistical Analyses The year of surgery was utilized as an instrumental variable for our ongoing change in practice. Patient comorbidities and breast-specific characteristics were compared by year of surgery and v2 analysis was used to assess for differences by year. Postoperative complications were reported by year and the trend of odds test was used to assess for the trend of change in complication rates over time. Recurrences and overall survival were analyzed with the Kaplan–Meier method. Statistical analyses were performed using Stata 13 (StataCorp LP, College Station, TX), and p values \ 0.05 were considered to be significant. RESULTS Patient Characteristics From January 2005 through December 2012, 981 TSSM procedures were performed in 633 patients (Table 1). The median follow-up time was 29 (interquartile range 14–54) months, and 122 (19 %) of patients had more than 5 years of follow-up time. The mean patient age was 47 ± 10 (range 19–76) years, and mean body mass index (BMI) was 24 ± 4 (range 15–49) kg/m2. BRCA mutations were present in 12 % of our patients. Thirty-six percent of patients received neoadjuvant chemotherapy while 19 % received adjuvant chemotherapy after mastectomy.

3225

TSSM Characteristics Of the 981 cases, 350 (36 %) were performed for prophylactic indications, 158 (16 %) were for clinical stage 0 or in situ disease, 197 (20 %) were for stage I disease, 170 (17 %) were for stage II disease, 76 (8 %) were for stage III disease, and 7 (1 %) were for stage IV disease (Table 2). There were 87 (9 %) cases that had a prior history of radiation to the breast or chest wall on the ipsilateral side, and 131 (13 %) cases underwent postmastectomy radiation therapy. Surgical Characteristics The preferred incisions were the inframammary (58 %) and superior periareolar incisions (30 %; Table 2). The remainder received radial incisions (3 %), lateral incisions (4 %), or incisions incorporating a prior breast scar (5 %). The majority of reconstructions were two-stage expanderimplant procedures (89 %), whereas the remainder of cases underwent immediate reconstruction with pedicle TRAM flaps (5 %), microvascular free flaps (5 %), immediate implant placement (0.3 %), or latissimus flaps (0.2 %). In the 877 cases of tissue expander placement, 359 (41 %) had ADM-assisted coverage laterally, whereas 296 (34 %) had serratus muscle flap coverage laterally. Postoperative Complications The overall incidence of superficial nipple necrosis was 5.0 % with a decreasing trend over the 8-year period (p = 0.004; Table 3). The overall incidence of partial nipple loss was 1.7 % with a nonsignificant trend over time (p = 0.953). The overall incidence of complete nipple loss was 2.1 % with a decreasing trend over time (p = 0.004). The incidence of minor skin flap necrosis was 5.8 % with a decreasing trend over time (p \ 0.001), whereas the incidence of major skin flap necrosis was 5.7 % with a nonsignificant decreasing trend over time (p = 0.06). The incidence of infections requiring oral antibiotics was 16 % with a decreasing trend over time (p = 0.002), and the incidence of infections requiring admission for IV antibiotics was 11.3 % with a decreasing trend over time (p = 0.015). The incidence of infections requiring procedures for resolution was 7.4 % with a decreasing trend over time (p \ 0 .001). The overall incidence of implant loss was 8.2 % with a decreasing trend over time (p = 0.019). Oncologic Outcomes Of the 626 therapeutic cases, 15 (2.4 %) nipple specimens contained in situ carcinoma, whereas 17 (2.7 %) contained invasive carcinoma on final pathology. Of the 15

0.2b 120 (19 %) 19 (15 %) 18 (19 %) 12 (14 %) 26 (25 %) 21 (22 %) 17 (21 %)

ANOVA test between groups

v2 test b

a

BMI body mass index (kg/m2)

4 (36 %) Adjuvant

3 (10 %)

0.074b 225 (36 %) 43 (33 %) 31 (33 %) 35 (41 %) 34 (32 %) 26 (27 %) 36 (44 %) 3 (27 %) Neoadjuvant

17 (55 %)

0.3b 345 (55 %) 62 (48 %) 49 (53 %) 47 (55 %) 60 (57 %) 47 (50 %) 53 (65 %) 7 (63 %) Chemotherapy

20 (65 %)

0.1b 73 (12 %) 19 (15 %) 14 (15 %) 13 (15 %) 14 (13 %) 6 (6 %) 3 (4 %) 1 (9 %) BRCA?

3 (10 %)

0.4b 174 (28 %) 44 (34 %) 26 (28 %) 20 (24 %) 26 (25 %) 25 (26 %) 26 (32 %) 1 (9 %) Former

6 (19 %)

0.9b 18 (3 %) 4 (3 %) 4 (4 %) 3 (4 %) 1 (1 %) 2 (2 %) 3 (4 %) 0 (0 %) Current

1 (3 %)

0.3b 192 (30 %) 72 (37 %) 48 (32 %) 38 (27 %) 45 (26 %) 42 (28 %) 39 (35 %) 7 (23 %) 1 (9 %) Smoking

0.5a

0.5b 17 (3 %) 4 (3 %) 4 (4 %) 0 (0 %) 4 (4 %) 4 (4 %) 1 (1 %) 0 (0 %) Diabetes

0 (0 %)

24 ± 4 24 ± 5 23 ± 4 23 ± 3 24 ± 4 24 ± 5 24 ± 4 24 ± 4 25 ± 5 BMI, kg/m (mean ± SD)

2

47 ± 10

633 130

49 ± 11 48 ± 10

93 85

47 ± 10 49 ± 10

106 95

48 ± 10 46 ± 9

82 31

Age, years (mean ± SD)

46 ± 10

11

47 ± 8

Total patients

Overall 2012 2011 2010 2009 2008 2007 2006 2005

TABLE 1 Patient characteristics, by year

0.5a

F. Wang et al. p value

3226

nipple specimens containing in situ carcinoma, 2 cases underwent resection of the nipple skin, 3 cases were treated with postmastectomy radiation alone, and ten cases did not receive additional treatment. Of the 17 nipple specimens with invasive carcinoma, ten cases underwent resection of the nipple skin, 5 cases were treated with postmastectomy radiation alone, and 2 cases did not receive any additional treatment because margins were not involved. Overall, only 12 of 626 (1.9 %) cases underwent additional resection of their NAC skin for margins. There were no locoregional recurrences in the NAC skin in cases that did not undergo additional nipple resection with a median follow-up time of 22 (interquartile range 17–37) months. Of the 601 non-stage IV therapeutic cases, 256 (43 %) had more than 3 years of follow-up time and 120 (20 %) had more than 5 years of follow-up time. The overall 5year cumulative incidence of locoregional recurrences for all non-stage IV disease was 3 %. Within the first 5 years of follow-up, there were three locoregional recurrences in stage 0 cases, 0 in stage I cases, six in stage II cases, and 5 in stage III cases. The 5-year cumulative incidence of locoregional recurrences was 3.7 % for Stage 0 disease, 0 % for stage I disease, 4.5 % for stage II disease, and 6.9 % for stage III disease (Fig. 1). The three locoregional recurrences that occurred in cases of stage 0 disease were all associated with the unusual presentation of more than 10 cm of high-grade DCIS on pathology. These cases had clear margins and recurrences occurred outside the NAC area. There were also three locoregional recurrences in stage I cases that occurred after 6 years and were not reflected in these 5-year estimates. The recurrence risk at 7 years would be overestimated, because less than 25 patients in this group remained in follow-up after 6 years at the time of the first recurrence. The overall 5-year cumulative incidence of distant recurrences in non-stage IV disease was 4.2 %. Within the first 5 years, there was one distant recurrence in stage 0 cases, 2 in stage I cases, four in stage II cases, and eight in stage III cases. The 5-year cumulative incidence of distant recurrences was 0.8 % for stage 0 disease, 1.5 % for stage I disease, 4.6 % for stage II disease, and 17.7 % for stage III disease (Fig. 1). The distant recurrence in the stage 0 case occurred simultaneously with a locoregional recurrence in a patient with more than 10 cm of high-grade DCIS on pathology. The overall 5-year survival of our TSSM cohort was 93 %. Within the first 5 years of follow-up, there was one death in stage 0 patients, 2 deaths in stage I patients, 2 deaths in stage II patients, ten deaths in stage III patients, and four deaths in stage IV patients. The 5-year survival of patients was 97 % for stage 0 disease, 98 % for stage I disease, 96 % for stage II disease, 74 % for stage III disease, and 33 % for stage IV disease (Fig. 2). There was a

4 (22 %)

2 (11 %)

2 (11 %)

0 (0 %)

II

III

IV

3 (17 %)

Postmastectomy

7 (39 %)

0 (0 %)

Pedicle TRAM flap

Free flap

Latissimus flap

0 (0 %)

0 (0 %)

ADM-assisted

Serratus

1 (3 %)

4 (13 %)

26 (84 %)

1 (2 %)

2 (4 %)

13 (27 %)

1 (2 %)

31 (65 %)

7 (15 %)

0 (0 %)

9 (19 %)

3 (6 %)

28 (58 %)

11 (23 %)

2 (4 %)

0 (0 %)

6 (13 %)

7 (15 %)

6 (13 %)

8 (17 %)

19 (40 %)

48

2006

c

b

a

Percentage relative to tissue expander cases

v2 test Incisions designed to incorporate prior breast surgery scar

TRAM flap transverse rectus abdominis myocutaneous flap

2 (100 %)

No additional coverage

TE coveragec

2 (11 %)

7 (39 %)

Immediate implant

2 (11 %)

0 (0 %)

Otherb

Reconstruction Tissue expander

0 (0 %)

Lateral

8 (44 %)

10 (56 %)

Superior Periareolar

Radial

0 (0 %)

Inframammary

TSSM incision

3 (17 %)

History

Radiation

2 (11 %)

I

6 (33 %)

18

0

Prophylactic Clinical stage

Indication

Total cases

2005

TABLE 2 Treatment characteristics, by year

0 (0 %)

45 (42 %)

61 (58 %)

0 (0 %)

6 (5 %)

8 (7 %)

0 (0 %)

106 (88 %)

6 (5 %)

10 (8 %)

0 (0 %)

15 (13 %)

89 (74 %)

22 (18 %)

10 (8 %)

1 (1 %)

9 (8 %)

21 (18 %)

28 (23 %)

23 (19 %)

38 (32 %)

120

2007

1 (1 %)

108 (79 %)

28 (20 %)

0 (0 %)

2 (1 %)

8 (5 %)

0 (0 %)

137 (93 %)

6 (4 %)

4 (3 %)

6 (4 %)

46 (31 %)

85 (58 %)

19 (13 %)

14 (10 %)

0 (0 %)

9 (6 %)

22 (15 %)

34 (23 %)

27 (18 %)

53 (36 %)

147

2008

0 (0 %)

86 (59 %)

61 (42 %)

0 (0 %)

4 (2 %)

15 (9 %)

0 (0 %)

147 (89 %)

4 (2 %)

22 (13 %)

2 (1 %)

25 (15 %)

113 (68 %)

22 (13 %)

19 (12 %)

3 (2 %)

10 (6 %)

27 (16 %)

44 (27 %)

17 (10 %)

62 (37 %)

166

2009

72 (55 %)

32 (25 %)

26 (20 %)

0 (0 %)

2 (1.5 %)

1 (0.8 %)

0 (0 %)

130 (98 %)

0 (0 %)

3 (2 %)

1 (0.8 %)

29 (22 %)

100 (75 %)

16 (12 %)

8 (6 %)

2 (2 %)

11 (8 %)

24 (18 %)

25 (19 %)

23 (17 %)

47 (35 %)

133

2010

122 (91 %)

10 (7 %)

3 (2 %)

1 (0.7 %)

8 (6 %)

1 (0.7 %)

0 (0 %)

136 (93 %)

7 (5 %)

1 (1 %)

1 (0.7 %)

60 (41 %)

77 (53 %)

16 (11 %)

13 (9 %)

0 (0 %)

11 (8 %)

32 (22 %)

17 (12 %)

29 (20 %)

55 (38 %)

146

2011

100 (53 %)

74 (39 %)

14 (7 %)

0 (0 %)

15 (7 %)

0 (0 %)

0 (0 %)

188 (93 %)

15 (7 %)

2 (1 %)

0 (0 %)

110 (54 %)

76 (37 %)

22 (11 %)

18 (9 %)

1 (0.5 %)

18 (9 %)

35 (17 %)

39 (19 %)

29 (14 %)

70 (34 %)

203

2012

296 (34 %)

359 (41 %)

221 (25 %)

2 (0.2 %)

46 (5 %)

53 (5 %)

3 (0.3 %)

877 (89 %)

45 (5 %)

42 (4 %)

29 (3 %)

296 (30 %)

568 (58 %)

131 (13 %)

87 (9 %)

7 (1 %)

76 (8 %)

170 (17 %)

197 (20 %)

158 (16 %)

350 (36 %)

981

Overall

\0.001

\0.001

\0.001

0.3

0.6

0.6

p valuea

TSSM Experience 3227

0.019 72 (8.2 %)

DISCUSSION

Trend of odds test

Percentage relative to only tissue expander or immediate implant placement b

a

PO per os (oral), IV intravenous

2 (50.0 %)

7 (21.9 %)

12 (11.3 %)

12 (8.8 %)

9 (6.1 %)

5 (3.9 %)

9 (6.7 %)

16 (8.5 %)

minimum survival of 20 months for all seven patients treated with stage IV disease.

Implant lossb

0.002

0.015 \0.001

157 (16.0 %)

111 (11.3 %) 73 (7.4 %)

27 (13.3 %) 18 (12.3 %)

12 (8.2 %) 7 (4.8 %) 8 (6.0 %) 5 (3.8 %)

10 (7.5 %) 29 (17.5 %)

21 (12.7 %) 13 (7.8 %) 25 (17.0 %) 24 (16.3 %)

37 (25.2 %) 22 (18.3 %)

14 (11.7 %) 9 (7.5 %) 4 (22.2 %) 3 (16.7 %) IV antibiotics Required procedure

7 (14.6 %) 5 (10.4 %)

4 (22.2 %) PO antibiotics

10 (20.8 %)

20 (9.9 %) 7 (3.4 %)

0.060 Infection

\0.001

56 (5.7 %)

57 (5.8 %) 6 (3.0 %)

9 (4.4 %) 4 (2.7 %)

3 (2.1 %) 2 (1.5 %)

4 (3.0 %) 17 (10.2 %)

8 (4.8 %) 12 (8.2 %)

11 (7.5 %) 5 (4.2 %)

12 (10.0 %) 9 (18.8 %) 5 (27.8 %)

2 (11.1 %)

Minor

Major

4 (8.3 %)

0.004 21 (2.1 %) 12 (1.0 %) 6 (1.4 %) 3 (0.8 %) 5 (1.8 %) 6 (4.8 %) 7 (0.8 %) 2 (4.2 %) 3 (16.7 %) Complete

Skin necrosis

0.004 49 (5 %)

17 (1.7 %) 5 (2.5 %)

7 (3.5 %) 12 (8.2 %)

1 (0.7 %) 0 (0 %)

2 (1.5 %) 2 (1.2 %)

5 (3.0 %) 3 (2.0 %)

4 (2.7 %) 10 (8.3 %)

1 (2.1 %) 0 (0 %) Partial

8 (16.7 %) 4 (22.2 %) Superficial

2 (1.7 %)

981 203 146 133 166 147 120 48 18 Nipple necrosis

Total cases

Overall 2012 2011 2010 2009 2008 2007 2006 2005

TABLE 3 Postoperative complications, by year

1.0

F. Wang et al.

p valuea

3228

Our technique of TSSM and immediate breast reconstruction has evolved through a series of targeted changes focused on reducing postoperative complications.1,7 We learned from our early experience that immediate expansion of the mastectomy pocket put patients at higher risk of NAC and skin flap necrosis.7 Complete coverage of prostheses with ADM or serratus muscle also has been shown to reduce reconstructive complications in tissue expander-implant reconstruction.12,13 In this study, we demonstrated that changes in technique over time have led to significant decreases in postoperative complications. The incidence of complete nipple necrosis in 2012 was 1.0 % and the incidence of major skin necrosis in 2012 was 4.4 %, which are similar to reports from other institutions.14,15 Even with our less selective criteria for TSSM, our oncologic outcomes remain comparable to other mastectomy techniques. The nipple parenchyma is excised in all patients at the time of TSSM, and only 5.1 % of nipple specimens in therapeutic cases were noted to have tumor involvement, which is consistent with previously published rates.2,16–18 Our overall 5-year incidence of locoregional recurrence was 3 %, and the overall 5-year cumulative incidence of distance recurrence was 4.2 %. Both of these estimates are comparable to prior reports for nipple-sparing mastectomy in the literature .19–21 We have followed 43 % of our therapeutic cases for more than 3 years, which is past the 2- to 3-year timeframe for the peak hazard of locoregional recurrences.22,23 The risk of distant recurrences in stage III disease was significantly greater than in early stage breast cancer. The overall survival of patients with early stage breast cancer was high, with greater than 95 % survival of patients at 5 years. Patients with stage III disease had a poorer overall survival of 74 % while patients with stage IV disease had the worst survival of 33 % survival at 5 years. All stage IV patients survived at least 20 months, which demonstrates that TSSM may prevent local tumor complications, even in the face of metastatic disease. A limitation of these analyses is that survival estimates may be underestimated due to right censoring and losses to follow-up. We are continuing to track our patients for these outcomes and will be able to report longer follow-up in the future. In summary, our implementation of a series of systematic targeted changes has significantly improved our postoperative complications and outcomes over time. We demonstrate that TSSM cases performed at our institution

REFERENCES

0.25

0.50

Locoregional

0

12

24

36

48

60

38 77 48 21

25 46 33 16

Followup (Months) 158 197 170 76

119 163 143 58

79 127 102 38

49 105 70 28

Distant

0.00

0.25

0.50

Number at risk Stage 0 Stage I Stage II Stage III

Recurrence

3229

0.00

Recurrence

TSSM Experience

0

Number at risk Stage 0 Stage I Stage II Stage III

12

24

36

48

60

39 77 47 20

26 46 32 14

Followup (Months) 158 197 170 76

119 163 146 59

79 126 101 36

50 105 70 28

Survival

0.00 0.25 0.50 0.75 1.00

FIG. 1 Locoregional and distant recurrences, by clinical stage. Kaplan–Meier estimates of cumulative incidence of locoregional and distant recurrences, by clinical stage. 96 9 106 mm (300 9 300 DPI)

0

Number at risk Stage 0 Stage I Stage II Stage III Stage IV

12

24

36

48

60

32 71 49 21 2

22 40 33 15 1

Followup (Months) 127 179 168 76 7

95 148 146 62 7

60 117 105 39 5

41 96 73 29 4

FIG. 2 Overall patient survival after TSSM, by clinical stage. Kaplan–Meier estimates of survival, by clinical stage. 51 9 30 mm (300 9 300 DPI)

are associated with low rates of tumor involvement of the nipple and locoregional and distant recurrences. Continuing improvements in technique and emerging data on longer-term oncologic safety support the feasibility of TSSM as a standard approach for mastectomy. DISCLOSURES Hani Sbitany, MD is a member of the speaker’s bureau for LifeCell Corporation. He did not receive any compensation or financial support for this study. The remaining authors have no financial interest in any of the products or devices mentioned in this article.

1. Warren Peled A, Foster RD, Stover AC, et al. Outcomes after total skin-sparing mastectomy and immediate reconstruction in 657 breasts. Ann Surg Oncol. 2012; 19(11):3402–9. 2. de Alcantara Filho P, Capko D, Barry JM, Morrow M, Pusic A, Sacchini VS. Nipple-sparing mastectomy for breast cancer and risk-reducing surgery: the Memorial Sloan-Kettering Cancer Center experience. Ann Surg Oncol. 2011;18(11):3117–22. 3. Jensen JA, Orringer JS, Giuliano AE. Nipple-sparing mastectomy in 99 patients with a mean follow-up of 5 years. Ann Surg Oncol. 2011;18(6):1665–70. 4. Stanec Z, Zic R, Budi S, et al. Skin and nipple-areola complex sparing mastectomy in breast cancer patients: 15-year experience. Ann Plast Surg. Dec 25 2013. 5. Munhoz AM, Aldrighi CM, Montag E, et al. Clinical outcomes following nipple-areola-sparing mastectomy with immediate implant-based breast reconstruction: a 12-year experience with an analysis of patient and breast-related factors for complications. Breast Cancer Res Treat. 2013;140:545-55. 6. Mallon P, Feron JG, Couturaud B, et al. The role of nipplesparing mastectomy in breast cancer: a comprehensive review of the literature. Plast Reconstr Surg. 2013;131(5):969–84. 7. Garwood ER, Moore D, Ewing C, et al. Total skin-sparing mastectomy: complications and local recurrence rates in 2 cohorts of patients. Ann Surg. 2009;249:26–32. 8. Mukhtar RA, Throckmorton AD, Alvarado MD, et al. Bacteriologic features of surgical site infections following breast surgery. Am J Surg. 2009;198(4):529–31. 9. Peled AW, Foster RD, Esserman LJ, Park CC, Hwang ES, Fowble B. Increasing the time to expander-implant exchange after postmastectomy radiation therapy reduces expander-implant failure. Plast Reconstr Surg. 2012;130(3):503–9. 10. Wijayanayagam A, Kumar AS, Foster RD, Esserman LJ. Optimizing the total skin-sparing mastectomy. Arch Surg. Feb 2008;143(1):38–45- discussion 45. 11. Fowble BL, Einck JP, Kim DN, et al. Role of postmastectomy radiation after neoadjuvant chemotherapy in stage II-III breast cancer. Int J Radiat Oncol Biol Phys. 2012;83(2):494–503. 12. Peled AW, Foster RD, Garwood ER, et al. The effects of acellular dermal matrix in expander-implant breast reconstruction after total skin-sparing mastectomy: results of a prospective practice improvement study. Plast Reconstr Surg. 2012;129(6):901e–8e. 13. Ward J, Cohen IK, Knaysi GA, Brown PW. Immediate breast reconstruction with tissue expansion. Plast Reconstr Surg. 1987;80(4):559–66. 14. Coopey SB, Tang R, Lei L, et al. Increasing eligibility for nipplesparing mastectomy. Ann Surg Oncol. 2013;20(10):3218–22. 15. Endara M, Chen D, Verma K, Nahabedian MY, Spear SL. Breast reconstruction following nipple-sparing mastectomy: a systematic review of the literature with pooled analysis. Plast Reconstr Surg. 2013;132(5):1043–54. 16. Sacchini V, Pinotti JA, Barros AC, et al. Nipple-sparing mastectomy for breast cancer and risk reduction: oncologic or technical problem? J Am Coll Surg. 2006;203(5):704–14. 17. Gerber B, Krause A, Reimer T, et al. Skin-sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction is an oncologically safe procedure. Ann Surg. 2003;238(1):120–7. 18. Spear SL, Willey SC, Feldman ED, et al. Nipple-sparing mastectomy for prophylactic and therapeutic indications. Plast Reconstr Surg. 2011;128:1005–14. 19. Benediktsson KP, Perbeck L. Survival in breast cancer after nipple-sparing subcutaneous mastectomy and immediate

3230 reconstruction with implants: a prospective trial with 13 years median follow-up in 216 patients. Eur J Surg Oncol. 2008;34(2):143–8. 20. Boneti C, Yuen J, Santiago C, et al. Oncologic safety of nipple skin-sparing or total skin-sparing mastectomies with immediate reconstruction. J Am Coll Surg. 2011;212(4):686–93; discussion 693–5. 21. Tokin C, Weiss A, Wang-Rodriguez J, Blair SL. Oncologic safety of skin-sparing and nipple-sparing mastectomy: a discussion and review of the literature. Int J Surg Oncol. 2012;2012:921821.

F. Wang et al. 22. Esserman LJ, Alvarado MD, Howe RJ, et al. Application of a decision analytic framework for adoption of clinical trial results: are the data regarding TARGIT-A IORT ready for prime time? Breast Cancer Res Treat. 2014;144(2):371–8. 23. Wickberg A, Holmberg L, Adami HO, Magnuson A, Villman K, Liljegren G. Sector resection with or without postoperative radiotherapy for stage I breast cancer: 20-year results of a randomized trial. J Clin Oncol. 2014;32(8):791–7.

Total skin-sparing mastectomy and immediate breast reconstruction: an evolution of technique and assessment of outcomes.

Total skin-sparing mastectomy (TSSM) with preservation of the breast and nipple-areolar complex (NAC) skin was developed to improve aesthetic outcomes...
259KB Sizes 0 Downloads 0 Views