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Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation.

BACKGROUND: In women with breast cancer, the role of radical mastectomy, as compared with less extensive surgery, has been a matter of debate. We report 25-year findings of a randomized trial initiated in 1971 to determine whether less extensive surgery with or without radiation therapy was as effective as the Halsted radical mastectomy. METHODS: A total of 1079 women with clinically negative axillary nodes underwent radical mastectomy, total mastectomy without axillary dissection but with postoperative irradiation, or total mastectomy plus axillary dissection only if their nodes became positive. A total of 586 women with clinically positive axillary nodes either underwent radical mastectomy or underwent total mastectomy without axillary dissection but with postoperative irradiation. Kaplan-Meier and cumulative-incidence estimates of outcome were obtained. RESULTS: No significant differences were observed among the three groups of women with negative nodes or between the two groups of women with positive nodes with respect to disease-free survival, relapse-free survival, distant-disease-free survival, or overall survival. Among women with negative nodes, the hazard ratio for death among those who were treated with total mastectomy and radiation as compared with those who underwent radical mastectomy was 1.08 (95 percent confidence interval, 0.91 to 1.28; P=0.38), and the hazard ratio for death among those who had total mastectomy without radiation as compared with those who underwent radical mastectomy was 1.03 (95 percent confidence interval, 0.87 to 1.23; P=0.72). Among women with positive nodes, the hazard ratio for death among those who underwent total mastectomy and radiation as compared with those who underwent radical mastectomy was 1.06 (95 percent confidence interval, 0.89 to 1.27; P=0.49). CONCLUSIONS: The findings validate earlier results showing no advantage from radical mastectomy. Although differences of a few percentage points cannot be excluded, the findings fail to show a significant survival advantage from removing occult positive nodes at the time of initial surgery or from radiation therapy.

Breast Neoplasms↗

A comparative study of subcutaneous mastectomy with radical mastectomy.

The purpose of this study was to compare the results of 133 cases (131 patients) of subcutaneous mastectomy with axillary dissection between 1983 and 1999 and 910 cases of radical mastectomy during the same period. The median follow-up period of the subcutaneous mastectomy group and the radical mastectomy group were 66 months and 81 months, respectively. The age at operation was significantly (p<0.01) younger in the subcutaneous mastectomy group than in the radical mastectomy group and the clinical stage was significantly (p<0.01) earlier. Lymph node metastasis was significantly (p<0.01) higher in the radical mastectomy than in the subcutaneous mastectomy group. There was no difference in ER status between the two groups. There was local recurrence in 5 (3.8%) members of the subcutaneous mastectomy group and in 12 (1.3%) members of the radical mastectomy group. There was no difference in disease-free survival and overall survival between the two groups. Divided into two subgroups by lymph node status, there was no difference in disease-free survival and overall survival between the two groups. Local recurrence occurred more frequently (p<0.05) in the subcutaneous mastectomy group, however, than in the radical mastectomy group when no lymph node metastasis was found. Multivariate analysis using the Cox hazard model showed that operation method and lymph node status were independent prognostic factors for local recurrence, whereas, lymph node status and ER status were independent prognostic factors of disease-free survival. In conclusion, subcutaneous mastectomy presents a risk factor for local recurrence, but the survival rate of the subcutaneous mastectomy group is as favourable as the radical mastectomy group.

Adult↗

Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer.

In 1976 we began a randomized trial to evaluate breast conservation by a segmental mastectomy in the treatment of Stage I and II breast tumors less than or equal to 4 cm in size. The operation removes only sufficient tissue to ensure that margins of resected specimens are free of tumor. Women were randomly assigned to total mastectomy, segmental mastectomy alone, or segmental mastectomy followed by breast irradiation. All patients had axillary dissections, and patients with positive nodes received chemotherapy. Life-table estimates based on data from 1843 women indicated that treatment by segmental mastectomy, with or without breast irradiation, resulted in disease-free, distant-disease-free, and overall survival at five years that was no worse than that after total breast removal. In fact, disease-free survival after segmental mastectomy plus radiation was better than disease-free survival after total mastectomy (P = 0.04), and overall survival after segmental mastectomy, with or without radiation, was better than overall survival after total mastectomy (P = 0.07, and 0.06, respectively). A total of 92.3 per cent of women treated with radiation remained free of breast tumor at five years, as compared with 72.1 per cent of those receiving no radiation (P less than 0.001). Among patients with positive nodes 97.9 per cent of women treated with radiation and 63.8 per cent of those receiving no radiation remained tumor-free (P less than 0.001), although both groups received chemotherapy. We conclude that segmental mastectomy, followed by breast irradiation in all patients and adjuvant chemotherapy in women with positive nodes, is appropriate therapy for Stage I and II breast tumors less than or equal to 4 cm, provided that margins of resected specimens are free of tumor.

Breast Neoplasms↗

A comparison of modified radical mastectomy to radical mastectomy in the treatment of operable breast cancer.

This study compares the results of modified radical mastectomy (144 cases) to radical mastectomy (188 cases) in the treatment of operable breast cancer. Two hundred five patients had Stage I breast cancer, 60 had Stage II disease and 67 had Stage III disease (TNM System). There was no statistically significant difference in five year survival when the results of a radical mastectomy were compared to a modified radical mastectomy at any stage of disease. There was no statistically significant difference in the incidence of local recurrence in patients with Stage I and Stage II disease when the results of a radical mastectomy were compared to modified radical mastectomy. Those patients with Stage III disease who were treated by a modified radical mastectomy had a statistically significant higher incidence of local recurrence (chest wall and axilla) in comparison to patients treated by radical mastectomy. We have concluded that a modified radical mastectomy is the treatment of choice in patients with Stage I and Stage II diseases. In patients with Stage III disease, a radical mastectomy provides a better chance of local control of the disease but offers no increased chance of survival.

Breast Neoplasms↗

Immediate breast reconstruction following mastectomy is as safe as mastectomy alone.

We evaluated wound complications and potential risk factors after mastectomy with immediate breast reconstruction and compared them with similar data after modified radical mastectomy. The incidences of infection, seroma, hematoma, and epidermolysis were compared among 395 patients (305 with modified radical mastectomies and 90 with mastectomy with immediate breast reconstruction) from Virginia Mason Medical Center, Seattle, Wash, between 1983 and 1989. Obesity, age (60 years or older), smoking, antibiotics, and wound drainage were examined as possible risk factors. There were more wound complications in the modified radical mastectomy group (48% vs 31%), and specifically, more seromas (30% vs 13%). In the modified radical mastectomy group, age of 60 years or older was associated with seroma and infection, drainage greater than 30 mL per day (at time of drain removal) with seroma, and smoking with epidermolysis. In the mastectomy with immediate breast reconstruction group, obesity was associated with seroma and epidermolysis. We conclude that mastectomy with immediate breast reconstruction appears to be as safe as modified radical mastectomy alone with respect to wound complications.

Age Factors↗

[Radical mastectomy and modified radical mastectomy in the treatment of breast cancer. Indications and results].

We studied first the long term results in a series of 1 139 immediately operable breast cancers, treated by a protocol which gave an important role to extended radical mastectomy (radical mastectomy with internal mammary node dissection). No difference in survival was noted according to the surgical procedure used, and the extended mastectomy does not seem to have demonstrated its superiority. Its value could be judged in a more rigorous manner thanks to the results of an international therapeutic trial, comparing radical mastectomy with extended radical mastectomy. Results were improved by the extended procedure in only one sub-group of patients, whose tumours was located in central or inner quadrants, T1 or T2, with positive axillary nodes: these patients represents 13 per cent of patients with immediately operable tumors. Taking these results into account a new protocol has been adopted at the Institut Gustave-Roussy: T1 cancers will be the object of a therapeutic trial between conservative treatment and modified radical mastectomy. T2 (internal or central) cancers, with axillary nodal involvement will be treated by extended radical mastectomy. T2 tumors (external) and all T3 tumors will be treated by a modified radical mastectomy.

Breast Neoplasms↗

Mastectomy with axillary clearance versus mastectomy without it. Late results of a trial in which patients had no adjuvant chemo-, radio- or endocrine therapy.

OBJECTIVE: Long-term outcome of comparison of mastectomy with axillary clearance to mastectomy without it. DESIGN: Second analysis of a terminated prospective randomised trial. SETTING: The Breast Clinic, Groote Schuur Hospital, Cape Town. PATIENTS: Ninety-five women aged under 76 years with stages 1 and 2 (T1-2 NO-1 MO) breast cancer. INTERVENTIONS: Radical mastectomy (mastectomy and formal axillary dissection with pectoral muscle excision) or simple mastectomy (mastectomy without axillary dissection if nodes were not clinically palpable, or local excision of the nodes if they were). OUTCOME MEASURES: Loco-regional recurrence and survival. RESULTS: Whereas initial analysis at 40 months had showed more axillary recurrences (P = 0.056) in the simple mastectomy group (leading to the termination of the trial), this difference has disappeared at 10 years (P = 0.113). There was no difference in rate of recurrence at all other sites, time to recurrence, or survival rates at 40 months or at 10 or 25 years. CONCLUSIONS: Full axillary clearance offered no better long-term loco-regional control or survival. Early analysis and marginally significant differences in axillary recurrence prompted premature termination of this trial.

Adult↗

Glandular excision in total glandular mastectomy and modified radical mastectomy: a comparison.

Total glandular mastectomy and modified radical mastectomy were compared for the amount of breast tissue remaining after surgery. Multiple biopsies were taken from the anterior chest walls of women following total glandular mastectomy (N = 27) and modified radical mastectomy (N = 28) to try to detect any residual glandular tissue. Regardless of procedure performed, breast tissue was identified histologically in 5 percent of all biopsy specimens (159 and 161, respectively). One of every five operative fields was shown to have glandular elements in at least one of the biopsy sites; the positive biopsies did not form a discernible pattern. The residual breast tissue in each of these patients averaged less than 1 gm. On the basis of this study, modified radical mastectomy and total glandular mastectomy appear to be equally effective in removing most of the breast.

Biopsy↗

Effect of mastectomy versus mastectomy plus adjuvant ovariectomy on prolactin response to TRH in breast cancer.

The endocrine effects of ovariectomy need to be further investigated. The present study was carried out to evaluate the influence of the adjuvant ovariectomy on the mastectomy-induced changes in PRL response to TRH in breast cancer. The study included 34 patients with locally limited breast carcinoma, 18 of whom were treated with radical mastectomy, whereas the other 16 underwent mastectomy plus adjuvant ovariectomy. PRL secretion in response to TRH (200 mcg I.V. as bolus) was evaluated one day before and 7 days after surgery. In patients treated with mastectomy only, PRL increase after TRH was significantly higher after surgery than before. On the contrary, no difference was seen in patients treated with mastectomy plus ovariectomy. This study shows that the adjuvant ovariectomy may block the increase in PRL response to TRH induced by mastectomy in breast cancer.

Adult↗

Radical mastectomy versus radical mastectomy plus internal mammary dissection. Five-year results of an international cooperative study.

From 1963 to 1968, the international group collected 1580 cases of breast cancer, randomized into two therapeutic groups: radical mastectomy and extended mastectomy. The data were processed on the UNIVAC 1107 computer of the I.N.S.E.R.M. Computing Center. No significant difference was observed between the two groups in the overall five-year survival rate. However, a more detailed analysis, according to certain prognostic features, showed that extended mastectomy improved the results in one subgroup: cancers of inner or medial quadrants, axillary N+. Within this group the difference was highly significant for a smaller subgroup (190 patients) including only tumors T1 and T2. In conclusion, there is no indication for extended mastectomy in any cancers of the outer quadrants or in those of the inner or medial quadrants without axillary involvement. A limited indication for extended mastectomy may be provisionally retained for T1 and T2 cancers of the inner or medial quadrants with axillary involvement.

Breast Neoplasms↗

Local and distant recurrence rates in skin-sparing mastectomies compared with non-skin-sparing mastectomies.

BACKGROUND: Skin-sparing mastectomies (SSMs) are being used more frequently to treat many cases of breast cancer. This type of surgery maximizes breast skin preservation and facilitates immediate reconstruction, resulting in a superior cosmetic appearance after mastectomy and a more satisfied patient. Although SSMs are becoming more common, there are few data regarding the local and distant recurrence rates. METHODS: A total of 231 patients treated with mastectomies from 1990 to 1998 were studied, including 77 SSM and 154 non-skin-sparing (NSSM) mastectomy patients. RESULTS: The local recurrence rates for SSM and NSSM were 3.90% (3 of 77 patients) and 3.25% (5 of 154 patients), respectively. The local recurrence-free survival at 5 years was 95.3% for SSM patients and 95.2% for NSSM patients (P = .28). The distant recurrence rates of SSM and NSSM were 3.9% (3 of 77 patients) and 3.9% (6 of 154 patients), respectively. The distant recurrence-free actuarial survival at 5 years was 90.2% for SSM patients and 92% for NSSM patients (P = .07). CONCLUSIONS: Mastectomies using the skin-sparing technique do not appear to result in any increase in local or distant recurrence and improve aesthetic results of the immediate reconstruction.

Adult↗

Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation.

In 1971 we began a randomized trial to compare alternative local and regional treatments of breast cancer, all of which employ breast removal. Life-table estimates were obtained for 1665 women enrolled in the study for a mean of 126 months. There were no significant differences among three groups of patients with clinically negative axillary nodes, with respect to disease-free survival, distant-disease--free survival, or overall survival (about 57 per cent) at 10 years. The patients were treated by radical mastectomy, total ("simple") mastectomy without axillary dissection but with regional irradiation, or total mastectomy without irradiation plus axillary dissection only if nodes were subsequently positive. Similarly, no differences were observed between patients with clinically positive nodes treated by radical mastectomy or by total mastectomy without axillary dissection but with regional irradiation. Survival at 10 years was about 38 per cent in both groups. Our findings indicate that the location of a breast tumor does not influence the prognosis and that irradiation of internal mammary nodes in patients with inner-quadrant lesions does not improve survival. The data also demonstrate that the results obtained at five years accurately predict the outcome at 10 years. We conclude that the variations of local and regional treatment used in this study are not important in determining survival of patients with breast cancer.

Breast Neoplasms↗

Body image, self-concept, and self-esteem in women who had a mastectomy and either wore an external breast prosthesis or had breast reconstruction and women who had not experienced mastectomy.

The perceptions of three groups of women regarding their body image, self-concept, total self-image, and self-esteem were compared. The groups included 64 women who had mastectomies and wore external breast prostheses, 31 women who had mastectomies and underwent breast reconstruction, and a control group of 78 women who had not experienced mastectomy. The body image, total self-image, and self-esteem mean scores indicated that the prosthesis and reconstruction groups had more positive feelings regarding their bodies than did the control group. There were no significant differences in self-concept among the three groups. These findings challenge a common assumption that mastectomy automatically results in psychiatric morbidity caused by an altered body image and suggest that health professionals should not make assumptions about how a woman will psychologically respond to mastectomy.

Body Image↗

A randomized prospective trial of radical (Halsted) mastectomy versus modified radical mastectomy in 311 breast cancer patients.

This study reports the results of a prospectively randomized trial for treatment of carcinoma of the breast comparing standard (Halsted) radical mastectomy to a modified radical mastectomy. Three hundred eleven patients with primary operable carcinoma of the breast were entered in a surgical and adjunctive chemotherapy trial in Alabama between 1975 and 1978. A total of 91 surgeons participated (all Diplomats of the American Board of Surgery and Members of the American College of Surgeons). All operative reports, pathology and therapy were reviewed by referees. Histologically node positive patients were randomized after operation to receive melphalan or C.M.F.(cytoxan, methotrexate, and 5-FU) for 1 year. After a median follow-up of 5.5 years, there was no significant difference in disease-free survival or in overall survival between the two groups. There was a trend toward improved 5-year survival rates in the radical mastectomy group compared to the modified radical mastectomy group (84% vs. 76%, p = 0.14). There was also an increased incidence of local wound recurrence in those patients receiving modified radical mastectomy, but the differences were not statistically significant (p = 0.09). Longer follow-up will be necessary to evaluate these results more fully.

Breast Neoplasms↗

The nipple-sparing mastectomy: early results of a feasibility study of a new application of perioperative radiotherapy (ELIOT) in the treatment of breast cancer when mastectomy is indicated.

BACKGROUND: Breast cancer surgery has become less and less mutilating, however a mastectomy is required in the case of multicentric, large tumors or recurrences after conservative treatment. The removal of the nipple areola complex during the mastectomy dramatically increases the feeling of mutilation. To reduce this negative psychological impact, in cancers located outside of the central area of the breast, we propose a new type of nipple-sparing mastectomy associated with intraoperative electron beam radiotherapy (ELIOT) delivered on the region of the areola. The nipple-sparing mastectomy is performed leaving 5 mm of glandular tissue behind the nipple areola complex to preserve its blood supply. The reconstruction is immediately performed with a prosthesis or an autologous flap. PATIENTS AND METHODS: Twenty-five patients were included in the study; two of them had a bilateral nipple-sparing mastectomy. RESULTS: Pathological examinations demonstrated the presence of 19 infiltrating carcinomas and 8 ductal carcinoma in situ. Two patients had a superficial skin areolar slough followed by spontaneous healing. One necrosis of the areola occurred due to extensive retroareolar dissection. In the early follow-up, the color of the areola was preserved. All patients except one expressed their satisfaction of having kept their areola. CONCLUSIONS: These preliminary results are encouraging but they require further studies to evaluate the long-term results, the local recurrence rate and the psychological impact.

Adult↗

Five-year results of a randomized clinical trial comparing modified radical mastectomy and extended radical mastectomy for stage II breast cancer.

A controlled cooperative study was carried out to assess the value of modified radical mastectomy for patients with stage II breast cancer. The data was analyzed from 11 institutions in the Shikoku District participating in a prospective clinical trial in which patients were randomly assigned either to a modified radical mastectomy group or an extended radical mastectomy group. These two groups of patients were similar to each other in terms of such background factors as age distribution, menopausal status, TNM classification, tumor size, location of the primary tumor, axillary nodal involvement, histological type, and estrogen receptor status. The median follow-up times in the modified and extended radical mastectomy groups were 4.7 and 4.5 years, respectively. The cumulative curves indicated no difference between the two groups in either disease-free survival or overall survival. The survival rates were classified according to the presence or absence of axillary nodal metastases. However, no significant difference was found between the two groups. These findings thus suggest that the routine removal of the grossly uninvolved major pectoral muscle and parasternal lymph nodes is not necessary in patients with stage II breast cancer.

Adenocarcinoma↗

One-stage simple mastectomy with immediate reconstruction for high-risk patients. An improved technique: the biologic basis for ductal-glandular mastectomy.

The heterogeneity of human breast carcinoma appears to be a cumulative interrelationship of genetic and environmental factors that may be identifiable with a high risk for carcinogenesis. Until breast cancer prevention is realized, one-stage total ductal-glandular mastectomy with immediate reconstruction may be offered as an alternative to simple mastectomy for women at high risk for developing cancer. This technique affords the complete extirpation of breast tissue at a deep plane with flaps that are identical in thickness to those elevated in classic mastectomies for invasive cancer. Breast reconstruction with submuscular prostheses in a one-stage procedure gives an aesthetically acceptable result. The role of ductal-glandular mastectomy as prophylaxis for invasive carcinoma warrants future prospective trials.

Adult↗