General Principles of Mastectomy: From Halsted Radical Mastectomy and Modified Radical Mastectomy to Total (Simple) Mastectomy


Development of the Radical Mastectomy—Historical Aspects

The Halsted radical mastectomy, published by William Stewart Halsted in his 1894 seminal report “The result of operations for the cure of cancer of the breast,” transformed that era of breast cancer treatment. The operation embodied the concept of complete en bloc resection of the breast with the pectoralis major and minor muscles, and the regional lymphatics. The Halstedian approach was largely directed at preventing local or regional recurrences for a disease considered to be principally of locoregional concern. Halsted’s synthesis of the techniques of his predecessors in surgery and pathology allowed him to achieve unprecedented success in the absence of therapeutic adjuncts such as irradiation or chemotherapy. The techniques now known as the Halsted radical mastectomy and the modified radical mastectomy are an evolution of these methods, which used varying degrees of breast extirpation and lymphatic dissection ( Table 30.1 ). The en bloc technique described by Halsted, although published simultaneously by Meyer, allowed a reduction in the local recurrence rate to 6% from rates as high as 51% to 82% for renowned European surgeons of the era ( Table 30.2 ).

Table 30.1
Historical Development of Modified Radical Mastectomy
Study Year Surgery
Moore a 1867 Segmental breast resection, selective axillary dissection
Volkmann b 1875 Total breast extirpation, with removal of pectoralis major fascia, preservation of pectoralis major muscle
Gross c 1880 Total mastectomy and complete axillary dissection
Banks d 1882 Modified radical mastectomy, with pectoralis preservation
Sprengel e 1882 Total mastectomy and selective axillary dissection
Kuster f 1883 Total mastectomy and routine axillary dissection
Halsted g 1894 Radical mastectomy
Meyer h 1894 Radical mastectomy
Murphy i 1912 Radical mastectomy, modified by pectoralis preservation
McWhirter j 1948 Modified radical mastectomy with radiotherapy
Patey k 1948 Modified radical mastectomy with resection of pectoralis minor
Madden l 1965 Modified radical mastectomy with pectoralis preservation

a Data from Moore CH. On the influence of inadequate operations on the theory of cancer. R Med Chir Soc Lond . 1867;1:244.

b Data from Volkmann R. Geschwülste der mamma (36 Fälle) Beitrage zur Chirurgie. Leipsig . 1895:310.

c Data from Gross SW. A Practical Treatment of Tumors of The Mammary Gland Embracing Their Histology, Pathology, Diagnosis and Treatment. New York: Appleton; 1880.

d Data from Banks WM. On free removal of mammary cancer with extirpation of the axillary glands as a necessary accompaniment. BMJ . 1882;2:1138.

e Data from Sprengel O. Mittheilungen über die in den Jahren 1874 bis 1878 aur der Volkmann's chen Klinik operativ behandelten 131 Falle von Brust-carcinom. Archir F Klin Chir. 1882;27:805.

f Data from Küster E. Zur Behandlung des brustkrebses verhandlungen der deutschen gesellschaft für Chirurgie. Leipsig; 1883:288.

g Data from Halsted.

h Data from Meyer.

i Data from Murphy.

j Data from McWhirter.

k Data from Patey and Dyson and Patey.

l Data from Madden et al. and Madden.

Table 30.2
Chronology of the Mastectomy for Treatment of Breast Cancer With Expectant (Average) 3-Year “Cure Rates”
Modified from Cooper WA. The history of the radical mastectomy. In Hoeber PB, ed. Annals of Medical History . Vol. 3. New York: Paul B Hoeber; 1941.
Type of Operation Study Year No. of Cases 3-Year Cures (%)
Simple mastectomy Winiwarter (Billroth) a 1867–1875 4.7
Average 4.7
Complete mastectomy and axillary dissection in most cases Oldekop b 1850–1878 229 11.7
Dietrich (Lucke) c 1872–1890 148 16.2
Horner d 1881–1893 144 19.4
Poulsen e 1870–1888 110 20
Banks f 1877 46 20
Schmid (Kuster) g 1871–1885 21.5
Average 18.1
Complete (total) mastectomy, axillary dissection, removal of pectoral fascia and greater or lesser amounts of pectoral muscle Sprengel (Volkmann) h 1874–1878 200 11
Schmidt i 1877–1886 112 18.8
Rotter j 30 20
Mahler k 1887–1897 150 21
Joerss l 1885–1893 98 28.5
Average 19.9
Modern radical mastectomy Halsted m 1889–1894 76 45
Halsted n 1907 232 38.3
Hutchison o 1910–1933 39.4
Average 40.9

a Data from Winiwarter V (Billroth). Beiträge zur statistik d. carcinome . Stuttgart: Gedruckt bei L. Schumacher; 1878.

b Data from Oldekop J. Statistiche Zusammenstellung von 250 Fällen von Mamma-Carcinom. Arch F Klin Chir . 1879;24:536.

c Data from Dietrich G (Lucke). Beitrag zur Statistik des Mammacarcinom. Duch Z F Chir . 1892;33:471.

d Data from Horner F. Ueber die Endresultate von 172 operierten Fällen maligner Tumoren der weiblichen Brust. Beitr Z Klin Chir . 1894;12:619.

e Data from Poulsen K. Die Geschwülste der Mamma. Arch F Klin Chir . 1891;42:593.

f Data from Banks M. A plea for the more free removal of cancerous growths. Liverpool Manchester Surg Rep . 1878;192.

g Data from Schmid H (Kuster). Zur statistik der mammacarcinome und deren heilung. Dtsch Z F Chir . 1887;26:139.

h Data from Sprengel O (Volkmann). 131 Fälle von Brust-Carcinom. Arch F Klin Chir . 1882;27:805.

i Data from Schmidt GB. Die Geschwülste der Brustdrüse. Beitr Z Klin Chir . 1889;4:40.

j Data from Rotter J. Günstigere Dauererfolge durch eine verbesserte operative Behandlung der Mammakarzinome. Berl Klin Wochenschr . 1896;33:69.

k Data from Mahler F. Ueber die in der Heidelberger Klinik 1887–1897 behandelten Fälle von Carcinoma Mammae. Beitr Z Klin Chir . 1900;26:681.

l Data from Joerss K. Ueber die beutige Prognose der Exstirpatio mammae carcinomatosae. Dtsch Z F Chir . 1897;44:101.

m Data from Halsted.

n Data from Halsted.

o Data from Hutchison RG. Radiation therapy in carcinoma of the breast. Surg Gynecol Obstet . 1936;62:653. (Collected figures.)

The initial clinical experience by Halsted suggested the pectoralis minor muscle was transected only for technical expediency during the axillary dissection and was thereafter reapproximated to close the posterior superior axillary space. Soon after, however, Halsted advocated Meyer’s concept of the routine resection of both pectoralis muscles en bloc with the breast tissue and all levels (I–III) of axillary lymph nodes. This method, once advocated by both Halsted and Meyer, became the state-of-the-art operative procedure for several decades in treating cancer of the breast.

In its final procedural form, the technique of the radical mastectomy espoused by Halsted embodied the following principles:

  • Wide excision of the skin, covering the defect with Thiersch grafts

  • Routine removal of both pectoral muscles

  • Routine axillary dissection (levels I–III)

  • Removal of all tissues en bloc, with wide resection as possible on all sides of the growth

  • Routine sacrifice of the long thoracic nerve and the thoracodorsal nerve, artery, and vein

To attribute the development of the modern operation to a single individual would discredit the remarkable contributions of Halsted’s predecessors in surgery and pathology who extended the operation because of the clinical observations noted in the natural history of breast cancer. The work of these leaders of medical science enabled Halsted to complete the evolution of the radical mastectomy in the late 19th century. Again, the raison d’être of the procedure was locoregional control of disease.

Modified Radical Mastectomy

In contrast to the Halsted radical mastectomy, the modified radical mastectomy defines a surgery of complete breast removal, with the inclusion of the tumor, overlying skin, and axillary lymphatics, coupled with preservation of the pectoralis major muscle for better cosmesis of the chest wall and improved arm function. At the turn of the 20th century, both American and British surgeons began adopting more conservative procedures. By 1912, Murphy had abandoned the Halsted radical mastectomy in favor of preserving both pectoral muscles. This practice was based on the experiences of Bryant of London, who acknowledged only one case of recurrent breast carcinoma in the pectoral muscles in patients followed over a 40-year clinical review period. This paradigm shift was noted in widely acclaimed reports of the modified radical mastectomy by McWhirter, Patey and Dyson, and Patey. In 1979, the National Institutes of Health Consensus Development Conference on the treatment of breast cancer stated that the modified radical mastectomy was the standard of treatment for women with stages I and II breast cancer during that period of time. By 1981, only 3% of patients received radical mastectomy, and 73% underwent modified radical mastectomy.

Support for limiting the level of axillary dissection was demonstrated by Madden and colleagues using the Auchincloss technique, which questioned the need to completely dissect the axillary contents. Auchincloss found that the apical nodes (level III) should be removed if clinically involved because of the high rate of recurrence if these nodes were found to be positive and not subsequently removed. However, if these level III nodes were clinically negative, complete axillary dissection was unnecessary because mastectomy with excision of levels I and II in addition to pectoralis preservation had control and survival rates identical with more radical approaches. Furthermore, if Rotter’s nodes were not involved, clearance of these interpectoral nodes was found to be unnecessary. This trend toward less invasive procedures led to the reduction in morbidity associated with the radical mastectomy.

Retrospective and Prospective Studies of the Modified Radical Mastectomy

Multiple retrospective clinical studies were conducted to evaluate survival outcomes after modified radical mastectomy and are summarized in Tables 30.3 to 30.5 . These series clearly demonstrated that survival rates decreased as the tumor size increased and lymph node metastases became evident. In these nonrandomized, retrospective studies, there appeared to be no survival benefit obtained by a complete axillary dissection to include level III nodes or removal of the pectoralis minor muscle (Patey vs. Auchincloss-Madden techniques). Recovery of axillary lymph nodes was also shown to be equivalent between the classic radical mastectomy and the modified radical mastectomy.

Table 30.3
Results of Retrospective Clinical Trials of Patients Treated With Modified Radical Mastectomy Alone a
Study Location/Affiliation Technique No. of Patients Disease Stage Absolute Survival (%)
5-year 10-year
Handley Thackray, 1969 b United Kingdom Patey 77 I 75 61
58 II 57 25
Delarue, 1969 c,d Toronto Madden 75 I 61.8
25 II 51.4
Madden, 1972 e,f New York City Madden 94 I 81.6 63
II 32.4 17
Robinson, 1976 g Mayo Clinic Madden 280 I 81
II 54
Meyer, 1978 h Rockford, Illinois Madden 175 I–III 74 43
Baker, 1979 d,i Johns Hopkins University Patey 91 I 90
22 II 72
31 III 45
Leis, 1980 j,k New York Medical College Patey 397 I 72.2
333 II 40.2
Nemoto, 1980 d,l American College of Surgeons Mixed 8906 I 65.1
7832 II 35.1
Hermann, 1985 d,m Cleveland Clinic Madden 358 I 73 56
211 II 55 28

a Includes some patients treated with radical mastectomy with equivalent results.

b Data from Handley RS, Thackray AC. Conservative radical mastectomy (Patey’s operation). Ann Surg . 1969;170:880.

c Data from Delarue NC, Anderson WD, Starr J. Modified radical mastectomy in the individualized treatment of breast carcinoma. Surg Gynecol Obstet . 1969;129:79.

d TNM classification.

e Data from Madden et al.

f Manchester classification.

g Data from Robinson GN, van Heerden JA, Payne WS, et al. The primary surgical treatment of carcinoma of the breast: a changing trend toward modified radical mastectomy. Mayo Clin Proc. 1976;51:433–442.

h Data from Meyer et al.

i Data from Baker et al.

j Data from Leis HP Jr. Modified radical mastectomy: definition and role in breast cancer surgery. Int Surg . 1980;65:211.

k Columbia Clinical Classification.

l Data from Nemoto T, Vana J, Bedwani RN, et al. Management and survival of female breast cancer: Results of a national survey by the American College of Surgeons. Cancer . 1980;45:2917.

m Data from Hermann RE et al.

Table 30.4
Five- and 10-Year Survival Rates as a Function of Axillary Nodal Status After Modified Radical Mastectomy
Study and Year Clinic or Study Group No. of Patients Survival Rate for Patients with Negative Nodes Survival Rate by Number of Positive Nodes
Any 1–3 ≥4
5-year 10-year 5-year 10-year 5-year 10-year 5-year 10-year
Handley and Thackray, 1969 a United Kingdom 135 75 57 61 25 NA NA NA NA
Madden, 1972 b New York City 94 82 63 32 17 NA NA NA NA
Robinson, 1976 c Mayo Clinic 339 80 g (93) 48 g (55) 61 g (72) 37 g (42)
Nemoto, 1980 d American College of Surgeons 24,136 71.8 40.4 63.1–58.8 h 51.9–22.2 h
Hermann, 1985 e Cleveland Clinic 564 78 62 55 28 66 41 47 25
Martin, 1986 f Mayo Clinic 208 87 74 56 NA NA NA NA
NA , Not available.

a Data from Handley RS, Thackray AC. Conservative radical mastectomy (Patey’s operation). Ann Surg . 1969;170:880.

b Data from Madden et al.

c Data from Robinson GN, van Heerden JA, Payne WS, et al. The primary surgical treatment of carcinoma of the breast: a changing trend toward modified radical mastectomy. Mayo Clin Proc . 1976;51:433–442.

d Data from Nemoto T, Vana J, Bedwani RN, et al. Management and survival of female breast cancer: results of a national survey by the American College of Surgeons. Cancer . 1980;45:2917.

e Data from Hermann et al.

f Data from Martin JK et al. Is modified radical mastectomy really equivalent to radical mastectomy in treatment of carcinoma of the breast? Cancer . 1986;57:510.

g Determinate survival.

h Range inclusive of number of positive nodes.

Table 30.5
Local and Regional 5- and 10-Year Recurrence Rates of Various Sites in Retrospective Studies After Modified Radical Mastectomy
Study and Year Clinic or Study Group No. of Patients Disease Stage Site (%)
Chest Wall Scar or Operative Field Axilla
Delarue, 1969 a Toronto General g (Canada) 43 I 0 0
32 II 12.5
25 III 15
Madden, 1972 b New York City h 94 I–III 10 0
Handley, 1976 c United Kingdom h 77 A i 10 1.8
58 B 22.6 0.1
8 C 63.6 9.1
Baker, 1979 d Johns Hopkins g 91 I 13.2 1.1
22 II 9.1 4.5
31 III 22.6 22.6
Leis, 1980 e New York Medical College h 116 0 0 0
397 I 5 0.08
333 II 13.8 0.08
Crowe, 1991 f Case Western 917 LN– 6.5 2.7
475 LN+ 9 8.4
Staging is TNM unless otherwise noted.
LN– , Lymph node negative; LN+ , lymph node positive.

a Data from Delarue NC, Anderson WD, Starr J. Modified radical mastectomy in the individualized treatment of breast carcinoma. Surg Gynecol Obstet . 1979;129:79.

b Data from Madden et al.

c Data from Handley.

d Data from Baker et al.

e Data from Leis HP Jr. Modified radical mastectomy: definition and role in breast cancer surgery. Int Surg . 1980;65:211.

f Data from Crowe JP, Gordon NH, Antunez AR, et al. Local-regional breast cancer recurrence following mastectomy. Arch Surg . 1991;126:429–432.

g Five-year recurrence rates.

h Ten-year recurrence rates.

i Columbia Clinical Classification.

Baker and associates of Johns Hopkins University compared the results of modified radical mastectomy with radical mastectomy in the treatment of operable breast cancer. For 205 patients with stage I cancer, 60 with stage II disease, and 67 with stage III disease (based on the tumor, node, metastasis [TNM] system), there were no statistically significant differences in 5-year survival when both procedures were compared. Furthermore, no statistically significant differences in incidence of locoregional recurrence were evident in patients with stages I and II disease. In contrast, individuals with stage III disease treated with modified radical mastectomy had a statistically significant ( P = 0.002) higher incidence of locoregional recurrence (chest wall and axilla) compared with patients treated with radical mastectomy. The authors concluded that modified radical mastectomy was the treatment of choice in patients with stage I and II disease. For patients with stage III disease, the radical mastectomy provided a greater probability of locoregional control of disease but did not improve survival.

During the 1970s, two prospective randomized trials by Turner in Manchester, England, and by Maddox at the University of Alabama, Birmingham, compared the Halsted radical mastectomy with the modified radical mastectomy. The study by Turner and colleagues consisted of 534 patients with T 1 or T 2 (N 0 or N 1 ) carcinoma of the breast and demonstrated that, after a median follow-up of 5 years, there was no significant difference in disease-free survival, overall survival, or locoregional control rates between the surgery types ( Table 30.6 ).

Table 30.6
Manchester Trial Results: Overall Survival, Disease-Free Survival, and Local and Distant Disease-Free Survival Rates (%) for Radical and Modified Radical Mastectomy According to Clinical and Pathologic Stage at Entry
From Turner L, Swindell R, Bell WG, et al. Radical versus modified radical mastectomy for breast cancer. Ann R Coll Surg Engl . 1981;63:239–243.
No. of Patients Followed Up Overall Survival (5-year) Disease-Free Local Recurrence (5-year) a Disease-Free of Distant Metastases (5-year) a Overall Disease-Free Survival (5-year) a
All Cases
Radical 278 70 75 63 58
Modified 256 70 79 63 58
Clinical Stage I
Pathologic Stage I
Radical 119 80 85 79 69
Modified 108 79 90 79 71
Pathologic Stage II
Radical 52 57 57 52 39
Modified 49 62 74 62 57
Clinical Stage II
Pathologic Stage I
Radical 41 85 91 79 79
Modified 38 78 88 71 70
Pathologic Stage II
Radical 64 55 59 47 38
Modified 59 55 56 45 30

a Figures indicate the percentages of patients not experiencing each event regardless of any other outcome.

The study by Maddox and associates compared modified radical mastectomy with radical mastectomy in 311 patients with stage I to III breast cancers. Patients with positive lymph nodes were randomized to receive chemotherapy. The results of this study demonstrated no significant difference in the 5-year disease-free survival rates but did show a significant decrease in local recurrence rates after the radical mastectomy ( Table 30.7 ). A trend toward improved overall survival after radical mastectomy versus modified radical mastectomy was evident after 5 years (84% vs. 76%, respectively) and became more evident after 10 years (74% vs. 65%, respectively). Although there was no significant difference in the overall survival rates between the procedures in patients with smaller cancers, the survival rate for patients with T 2 or T 3 tumors was significantly improved after radical mastectomy.

Table 30.7
University of Alabama Prospective Randomized Trial to Compare the Halsted Radical Mastectomy With the Modified Radical Mastectomy: Local Recurrence Rates of the Two Techniques
Modified from Maddox WA, Carpenter JT Jr, Laws HL, et al. A randomized prospective trial of radical (Halstead) mastectomy versus radical modified mastectomy in 311 breast cancer patients. Ann Surg . 1983;198:207-212; and Maddox WA, Carpenter JT Jr, Laws HL, et al. Does radical mastectomy still have a place in the treatment of primary operable breast cancer? Arch Surg . 1987;122:1317–1320.
Disease Stage Modified Radical Mastectomy Halsted Radical Mastectomy
No. of Patients % Local Recurrence No. of Patients % Local Recurrence
5-year 10-year 5-year 10-year
n % n % n % n %
I 43 13.8 4 9.3 NA NA 37 11.9 2 5.4 NA NA
II 112 36 8 7.1 NA NA 83 26.7 3 3.6 NA NA
III 20 6.4 4 20 a NA NA 16 5.1 1 6.3 a NA NA
Total 175 56.2 16 9.1 b 20 11.4 c 136 43.7 6 4.4 b 8 5.8 c
NA , Not available.

a P = nonsignificant.

b P = 0.09.

c P = 0.04.

Subsequent prospective trials performed in the 1980s and 1990s also observed no significant difference in survival between the Halsted radical mastectomy and the modified radical mastectomy. The study performed by Morimoto at the University of Tokushima, Japan, compared modified radical mastectomy with radical mastectomy in patients with stage II disease who received postoperative chemotherapy. The results showed no significant difference in 5-year survival, overall survival, or local recurrence between the two groups.

A prospective 25-year follow-up in 193 patients with operable breast cancer who were treated with Patey’s modified radical mastectomy was reported by Staunton and associates at St. Bartholomew’s Hospital, London. Of those patients, 66% had stage I disease, 24% stage II, and 9% stage III. A total of 42% received endocrine therapy and 9% received chemotherapy. Six percent of patients received radiation as part of their initial treatment. The 5-, 10-, and 15-year survival rates for clinical stage I breast cancer (T 1 /T 2 N 0 ) were 90%, 79%, and 74%; for stage II (T 1 /T 2 N 1 ), 81%, 64%, and 60%; and for stage III (T 3 N 0 /N 1 ), 78%, 70%, and 0%, respectively. The isolated local recurrence rate was 5%. Symptomatic lymphedema occurred in 2% of patients, and half of those patients had adjuvant radiation treatment. Given the excellent results in controlling the disease, rapidity in achieving the therapeutic and staging goals, and minimal morbidity, the authors concluded that modified radical mastectomy continued to be a good choice for treating patients with primary operable breast cancer.

Total (Simple) Mastectomy

The term total mastectomy is synonymous with simple mastectomy . This procedure represents further modification of the modified radical mastectomy preserving not only the pectoral muscles, but also the axillary lymph nodes. The rationale for this modification is based on the hypothesis that breast cancer is a systemic disease and that biological rather than anatomic factors are responsible for metastatic dissemination. Accordingly, the total mastectomy was designed to treat local disease in the breast and omit regional nodal dissection because the latter had no influence on survival and resulted in significant surgical morbidity.

Several studies comparing radical procedures with total mastectomy with or without postoperative radiation therapy have been conducted. Eight retrospective studies showed no significant differences in survival after 5 years but indicated a trend toward improved 10-year survival after radiation therapy ( Table 30.8 ). These retrospective studies spanned three decades and used a variety of techniques and surgeons, making rigorous statistical comparisons difficult. However, it appeared evident that the survival rates achieved with total mastectomy with or without irradiation were comparable to those obtained with radical mastectomy.

Table 30.8
Survival Results of Retrospective Clinical Trials for Simple (Total) Mastectomy With or Without Radiotherapy
Study and Year Clinic or Study Group Absolute Survival (%)
No. of Patients Disease Stage 5-year 10-year
−RT +RT −RT +RT
Williams et al., 1953 St. Bartholomew (United Kingdom) 110 I 77 67 33 40
45 II 35 21
Smith and Meyer, 1959 Rockford, Illinois 97 I and II 54 32
Shimkin et al., 1961 Rockford, Illinois 103 I and II 51 31
Devitt 1962 Ottawa (Canada) 119 I 68 45
30 II 56 47
Den Besten and Ziffren, 1965 University of Iowa 133 I 55.7
95 II 33.7
Kyle et al., 1976 Cancer Research Campaign (United Kingdom) 1152 I a 78 79
1116 II 71 76
Meyer et al., 1978 Rockford, Illinois 252 I and II 69 40
Hermann et al., 1985 Cleveland Clinic 355 I 78 60
47 II 53 37
RT , Radiotherapy.

a Manchester Staging Classification.

There has been recent increase in rates of mastectomy across the United States in patients with early-stage breast cancer, and reasons are likely multifactorial. For patients with early-stage breast cancer, this may be partially due to the increased availability of reconstruction as a result of the Women’s Health and Cancer Rights Act, mandating insurance coverage of postmastectomy reconstruction. Furthermore, availability of genetic testing increasingly identifies women with BRCA mutations who may benefit from risk-reducing bilateral mastectomy. With regards to limited axillary surgery, axillary lymph node staging with sentinel lymph node biopsy and nodal irradiation laid the groundwork for this paradigm shift. The option of omitting nodal dissection in those with a clinically node-negative axilla with proven negative sentinel lymph nodes (SLNs) has been extended to patients who have limited metastatic disease in the SLNs. Similarly, there has been a trend toward omission of axillary lymph node dissection (ALND) in those who have pathologically proven metastasis and are converted to node-negative disease by neoadjuvant chemotherapy (NACT).

The American College of Surgeons Oncology Group (ACOSOG) Z0011 study demonstrated that, among patients treated with lumpectomy with one to two positive SLNs and treated with postoperative whole breast radiation, there was no difference in overall and disease-free survival rates between groups of patients with and without ALND. In patients undergoing mastectomy with limited nodal metastasis in the SLNs, the AMAROS trial supports avoiding ALND and receipt of axillary nodal irradiation.

The SLN biopsy technique has been shown to be effective in axillary staging after NACT. In clinically node-negative patients, SLN identification rates and false-negative rates (FNRs) are similar to those in patients who undergo upfront surgery, and this practice is now accepted as standard of care. In patients with biopsy-proven node-positive disease at initial presentation, the ACOSOG Z1071 study showed that 41% of patients with N1 disease were converted to node-negative after NACT with an overall FNR of 12.6%, decreasing to 9.1% when three or more SLNs were removed. This suggests that node-positive patients traditionally treated by ALND could now have SLN biopsy for axillary nodal staging after chemotherapy in conjunction with total mastectomy.

Parallel to the increasing use of total mastectomy in treating invasive breast cancer, a growing use of total mastectomy has also been observed in patients with ductal carcinoma in situ (DCIS). Using the National Cancer Database (NCDB), Rutter and colleagues demonstrated a decreased use of mastectomy rates in treating DCIS from 1998 (36%) to 2004 (28%) before rising again through 2011 (33%). It is well known that DCIS is associated with an excellent survival outcome after either breast-conserving treatment or mastectomy. Current studies evaluating the natural history of DCIS suggest that there is no survival benefit of surgical therapy for low-grade DCIS, and omission of surgery with use of primary endocrine therapy alone as treatment for DCIS is being studied. It remains to be seen how this finding will impact surgical decision-making.

Prospective Trials of Total (Simple) Mastectomy With and Without Irradiation

The trend toward more conservative surgery led to prospective randomized clinical trials to study total mastectomy with or without radiation therapy in the treatment of breast cancer. The Groote Schur trial in South Africa compared total mastectomy with radical mastectomy without irradiation in 96 patients with stage I and II breast cancer. This trial was terminated after only 3 years because of the high recurrence rate in the total mastectomy group. Axillary lymph node and skin flap recurrences were seen in 9.8% and 13.7% of patients, respectively, leading to the conclusion that total mastectomy without irradiation should be avoided.

Several subsequent studies generally supported a decrease in local recurrence with radiation therapy with no impact on survival. The Copenhagen trial evaluated 666 patients with a 25-year follow-up. This study showed that overall survival rates were identical between study groups at 5 years (60%), 10 years (40%), and 25 years (28%). Recurrence-free survival at 25 years was 58% for radical mastectomy and 45% for total mastectomy with irradiation in women with stage I disease; however, this was not statistically significant. The 25-year survival rates for patients with and without lymph node metastasis were 20% and 60%, respectively, demonstrating that nodal status has a strong prognostic value for long-term survival.

The Edinburgh trial compared total mastectomy with postoperative radiotherapy to radical mastectomy in 490 patients. In contrast to the Copenhagen study, this trial demonstrated improved 12-year survival rates in patients with stage I disease in the radical mastectomy group ( Fig. 30.1 ). A significant difference was also seen in the axillary recurrence rates in the total mastectomy group versus the radical mastectomy group (12% vs. 3%). As a result of these differences in recurrence rates based on nodal status, more prospective clinical trials were initiated comparing total mastectomy with lymph node dissection and subsequent radiation therapy versus radical mastectomy and radiation therapy if lymph node involvement was detected. These results also showed no difference in overall survival between those having total mastectomy and irradiation versus radical mastectomy; however, recurrence rates tended to be lower with the more radical procedure.

Fig. 30.1, Crude survival rates for cases according to international stage of the disease and treatment option. RM I , Radical mastectomy for stage I; SM III , simple (total) mastectomy plus radiotherapy for stage III, and so forth.

To determine whether radiation therapy in patients with histologically proven nodal metastases would be as effective as axillary clearance, Forrest and colleagues conducted a randomized trial to study 417 patients who had mastectomy and four-node axillary sampling or full axillary clearance. Those who had positive nodes by sampling received radiation therapy. Patients with positive nodes received cyclophosphamide, methotrexate, and fluorouracil (CMF) or oophorectomy if they were premenopausal; tamoxifen was given to postmenopausal women and premenopausal women with negative nodes. The incidence of distant metastasis and the 12-year overall survival rates were the same in both groups. Although the radiation reduced chest wall recurrences in node-positive patients compared with patients with axillary clearance, the latter group showed slightly fewer axillary recurrences (5.4% vs. 3%). Adjuvant systemic treatment reduced locoregional recurrences in node-positive women in both groups. Several studies demonstrated similar findings showing that the addition of radiation therapy after total mastectomy did not affect the survival but reduced the recurrence rates at the chest wall and nodal basins.

The trials of the National Surgical Adjuvant Breast and Bowel Project (NSABP) cooperative group have played a key role in determining the surgical management for patients with breast cancer. Protocol NSABP-B-04 was developed in the 1970s and compared total mastectomy with and without axillary irradiation versus radical mastectomy. A total of 1655 patients were evaluated at an average follow-up of 11 years and again at 25 years. Of these patients, 1079 patients with clinically negative axillary nodes were randomized to undergo radical mastectomy, total mastectomy with nodal irradiation, or total mastectomy alone. An additional 586 patients with clinically node-positive disease were randomized to receive radical mastectomy or total mastectomy with nodal irradiation. The study showed no difference in disease-free survival between these groups for patients with clinically negative lymph nodes and no difference in distant and locoregional recurrence-free survival between total mastectomy with irradiation versus radical mastectomy in patients with clinically positive lymph nodes. In those node-negative patients who had local recurrence, the rate was lowest after total mastectomy with irradiation. This trial also demonstrated that results after 5 years accurately predicted the outcome at 10 years.

These studies predated routine use of systemic therapy and with recent advancements in systemic treatment based on biologic subtype coupled with SLN biopsy and selective use of radiation therapy, local recurrence rates after total mastectomy are significantly lower. Furthermore, studies also showed that there are no differences in local recurrence with further refinements in mastectomy technique (skin-sparing mastectomy [SSM]) or in disease-free survival.

Breast Cancer Treatment in the United States

Trends and Patterns of Care, 1971 to 1984

The American College of Surgeons (ACS) conducted two surveys for the treatment of breast carcinoma in the United States: a long-term survey in 1976 and a short-term survey in 1981. The National Survey outlined an important transition in curative surgical procedures used by US surgeons from the Halsted radical mastectomy to the modified radical mastectomy techniques. The 1981 short-term survey confirmed that most patients receiving treatment underwent a modified radical mastectomy rather than a radical mastectomy (77% vs. 3%). The results of the short-term survey also confirmed an increase in the proportion of patients being treated with partial mastectomy, largely attributed to the seminal contribution of clinical trials conducted by Fisher and coworkers in association with the NSABP investigators.

In the 1976 long-term survey, 60.6% of patients were treated by surgery alone, compared with 58.8% in the 1981 short-term analysis ( Table 30.9 ). The use of surgery plus irradiation (with or without chemotherapy) decreased from 19.8% to 16.6%, and the use of chemotherapy (with or without irradiation) with operation increased from 16.4% to 22.7% during this 5-year period. The change was limited to patients with regional and distant disease, and there was no significant change in the use of other treatment modalities between the long- and short-term surveys. For both analyses, 82% to 84% of patients in the localized disease stage were treated with surgery alone. For both surveys, the use of operative therapy as a sole modality decreased with advancing stage of disease, and the proportion of patients treated with surgery alone was similar in both surveys ( Table 30.9 ). Furthermore, operation plus irradiation was used more often than operation plus chemotherapy in the treatment of patients with cancer diagnosed as localized or regional. For patients with advanced-stage disease, irradiation, chemotherapy, or endocrine therapy, alone or in combination, was used more often (42.1% long-term and 38.7% short-term).

Table 30.9
Type of Treatment and Stage Distribution of Patients with Carcinoma of the Breast
From Wilson RE, Donegan WL, Mettlin C, et al. The 1982 national survey of carcinoma of the breast in the United States by the American College of Surgeons. Surg Gynecol Obstet . 1984;159:309–318.
Operation Clinical Stage Regional to:
Localized Axillary Nodes With or Without Adjacent Tissue Adjacent Tissue Only Distant Total
n % n % n % n % n %
Long-Term Survey (1976)
Surgical treatment only 11,592 84.4 3395 35.8 454 53.9 261 14.1 15,702 60.6
Surgical treatment and radiation 1275 9.3 2289 24.2 148 17.6 165 8.9 3877 15
Surgical treatment and chemotherapy 460 3.4 2284 24.1 57 6.8 215 11.6 3016 11.6
Surgical treatment and hormone therapy 75 0.5 132 1.4 12 1.4 103 5.6 322 1.2
Surgical treatment, radiation, and chemotherapy 154 1.1 911 9.6 34 4 142 7.7 1241 4.8
Surgical treatment and others a 52 0.4 264 2.8 14 1.7 184 10 514 2
Others a 120 0.9 198 2.1 123 14.6 778 42.1 1219 4.7
Total 13,728 100 9473 100 842 100 1848 100 25,891 100
Short-Term Survey (1981)
Surgical treatment only 8065 82.2 2444 35 285 53.5 140 11.2 10,934 58.8
Surgical treatment and radiation 1035 10.6 731 10.4 94 17.6 56 4.5 1916 10.3
Surgical treatment and chemotherapy 355 3.6 2444 35 44 8.3 209 16.7 3052 16.4
Surgical treatment and hormone therapy 78 0.8 179 2.6 8 1.5 96 7.7 361 1.9
Surgical treatment, radiation, and chemotherapy 88 0.9 857 12.3 37 6.9 181 14.4 1163 6.3
Surgical treatment and others a 27 0.3 140 2 12 2.3 87 6.9 266 1.4
Others a 162 1.6 192 2.7 53 9.9 485 38.7 892 4.8
Total 9810 100 6987 100 533 100 1254 100 18,584 100

a Radiation, chemotherapy, or both, and radiation, hormone therapy, or both.

You're Reading a Preview

Become a Clinical Tree membership for Full access and enjoy Unlimited articles

Become membership

If you are a member. Log in here