-
The New England Journal of Medicine Aug 2002In 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... (Clinical Trial)
Clinical Trial Comparative Study Randomized Controlled Trial
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.
Topics: Breast Neoplasms; Combined Modality Therapy; Disease-Free Survival; Female; Follow-Up Studies; Humans; Incidence; Lymphatic Metastasis; Mastectomy, Radical; Mastectomy, Simple; Neoplasm Recurrence, Local; Randomized Controlled Trials as Topic; Survival Analysis
PubMed: 12192016
DOI: 10.1056/NEJMoa020128 -
The Lancet. Oncology Oct 2010Sentinel-lymph-node (SLN) surgery was designed to minimise the side-effects of lymph-node surgery but still offer outcomes equivalent to axillary-lymph-node dissection... (Comparative Study)
Comparative Study Randomized Controlled Trial
Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically node-negative patients with breast cancer: overall survival findings from the NSABP B-32 randomised phase 3 trial.
BACKGROUND
Sentinel-lymph-node (SLN) surgery was designed to minimise the side-effects of lymph-node surgery but still offer outcomes equivalent to axillary-lymph-node dissection (ALND). The aims of National Surgical Adjuvant Breast and Bowel Project (NSABP) trial B-32 were to establish whether SLN resection in patients with breast cancer achieves the same survival and regional control as ALND, but with fewer side-effects.
METHODS
NSABP B-32 was a randomised controlled phase 3 trial done at 80 centres in Canada and the USA between May 1, 1999, and Feb 29, 2004. Women with invasive breast cancer were randomly assigned to either SLN resection plus ALND (group 1) or to SLN resection alone with ALND only if the SLNs were positive (group 2). Random assignment was done at the NSABP Biostatistical Center (Pittsburgh, PA, USA) with a biased coin minimisation approach in an allocation ratio of 1:1. Stratification variables were age at entry (≤ 49 years, ≥ 50 years), clinical tumour size (≤ 2·0 cm, 2·1-4·0 cm, ≥ 4·1 cm), and surgical plan (lumpectomy, mastectomy). SLN resection was done with a blue dye and radioactive tracer. Outcome analyses were done in patients who were assessed as having pathologically negative sentinel nodes and for whom follow-up data were available. The primary endpoint was overall survival. Analyses were done on an intention-to-treat basis. All deaths, irrespective of cause, were included. The mean time on study for the SLN-negative patients with follow-up information was 95·6 months (range 70·1-126·7). This study is registered with ClinicalTrials.gov, number NCT00003830.
FINDINGS
5611 women were randomly assigned to the treatment groups, 3989 had pathologically negative SLN. 309 deaths were reported in the 3986 SLN-negative patients with follow-up information: 140 of 1975 patients in group 1 and 169 of 2011 in group 2. Log-rank comparison of overall survival in groups 1 and 2 yielded an unadjusted hazard ratio (HR) of 1·20 (95% CI 0·96-1·50; p=0·12). 8-year Kaplan-Meier estimates for overall survival were 91·8% (95% CI 90·4-93·3) in group 1 and 90·3% (88·8-91·8) in group 2. Treatment comparisons for disease-free survival yielded an unadjusted HR of 1·05 (95% CI 0·90-1·22; p=0·54). 8-year Kaplan-Meier estimates for disease-free survival were 82·4% (80·5-84·4) in group 1 and 81·5% (79·6-83·4) in group 2. There were eight regional-node recurrences as first events in group 1 and 14 in group 2 (p=0·22). Patients are continuing follow-up for longer-term assessment of survival and regional control. The most common adverse events were allergic reactions, mostly related to the administration of the blue dye.
INTERPRETATION
Overall survival, disease-free survival, and regional control were statistically equivalent between groups. When the SLN is negative, SLN surgery alone with no further ALND is an appropriate, safe, and effective therapy for breast cancer patients with clinically negative lymph nodes.
FUNDING
US Public Health Service, National Cancer Institute, and Department of Health and Human Services.
Topics: Axilla; Breast Neoplasms; Canada; Chemotherapy, Adjuvant; Coloring Agents; Disease-Free Survival; Female; Humans; Kaplan-Meier Estimate; Lymph Node Excision; Lymphatic Metastasis; Mastectomy, Modified Radical; Mastectomy, Segmental; Middle Aged; Neoplasm Recurrence, Local; Proportional Hazards Models; Radiopharmaceuticals; Radiotherapy, Adjuvant; Risk Assessment; Risk Factors; Rosaniline Dyes; Sentinel Lymph Node Biopsy; Technetium Tc 99m Sulfur Colloid; Time Factors; Treatment Outcome; United States
PubMed: 20863759
DOI: 10.1016/S1470-2045(10)70207-2 -
The New England Journal of Medicine Oct 2002In 1976, we initiated a randomized trial to determine whether lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of... (Comparative Study)
Comparative Study
BACKGROUND
In 1976, we initiated a randomized trial to determine whether lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer.
METHODS
A total of 1851 women for whom follow-up data were available and nodal status was known underwent randomly assigned treatment consisting of total mastectomy, lumpectomy alone, or lumpectomy and breast irradiation. Kaplan-Meier and cumulative-incidence estimates of the outcome were obtained.
RESULTS
The cumulative incidence of recurrent tumor in the ipsilateral breast was 14.3 percent in the women who underwent lumpectomy and breast irradiation, as compared with 39.2 percent in the women who underwent lumpectomy without irradiation (P<0.001). No significant differences were observed among the three groups of women with respect to disease-free survival, distant-disease-free survival, or overall survival. The hazard ratio for death among the women who underwent lumpectomy alone, as compared with those who underwent total mastectomy, was 1.05 (95 percent confidence interval, 0.90 to 1.23; P=0.51). The hazard ratio for death among the women who underwent lumpectomy followed by breast irradiation, as compared with those who underwent total mastectomy, was 0.97 (95 percent confidence interval, 0.83 to 1.14; P=0.74). Among the lumpectomy-treated women whose surgical specimens had tumor-free margins, the hazard ratio for death among the women who underwent postoperative breast irradiation, as compared with those who did not, was 0.91 (95 percent confidence interval, 0.77 to 1.06; P=0.23). Radiation therapy was associated with a marginally significant decrease in deaths due to breast cancer. This decrease was partially offset by an increase in deaths from other causes.
CONCLUSIONS
Lumpectomy followed by breast irradiation continues to be appropriate therapy for women with breast cancer, provided that the margins of resected specimens are free of tumor and an acceptable cosmetic result can be obtained.
Topics: Breast Neoplasms; Combined Modality Therapy; Disease-Free Survival; Female; Follow-Up Studies; Humans; Incidence; Mastectomy, Radical; Mastectomy, Segmental; Neoplasm Invasiveness; Neoplasm Recurrence, Local; Neoplasms, Second Primary; Randomized Controlled Trials as Topic; Survival Analysis
PubMed: 12393820
DOI: 10.1056/NEJMoa022152 -
Chirurgia (Bucharest, Romania : 1990) 2014The present paper is a presentation of our technique of axillopexy, used after the excision of the axillary lymph nodes in 29 cases of breast cancer patients. We have...
The present paper is a presentation of our technique of axillopexy, used after the excision of the axillary lymph nodes in 29 cases of breast cancer patients. We have used this technique after Madden modified radical mastectomy or after quadrantectomy for tumors in the external quadrants of the mammary gland. We have studied and compared with a 30 case control group, the duration of the lymphorrhagia the moment of removing the drains, the presence absence of other local complications. We have also measured the time until the beginning of the oncological postoperative therapy. Every one of the aspects we have studied was improved in the axillopexy group.
Topics: Axilla; Breast Neoplasms; Case-Control Studies; Drainage; Female; Humans; Lymph Node Excision; Mastectomy, Modified Radical; Mastectomy, Segmental; Romania; Treatment Outcome
PubMed: 25149619
DOI: No ID Found -
The New England Journal of Medicine Oct 2002We conducted 20 years of follow-up of women enrolled in a randomized trial to compare the efficacy of radical (Halsted) mastectomy with that of breast-conserving surgery. (Comparative Study)
Comparative Study
BACKGROUND
We conducted 20 years of follow-up of women enrolled in a randomized trial to compare the efficacy of radical (Halsted) mastectomy with that of breast-conserving surgery.
METHODS
From 1973 to 1980, 701 women with breast cancers measuring no more than 2 cm in diameter were randomly assigned to undergo radical mastectomy (349 patients) or breast-conserving surgery (quadrantectomy) followed by radiotherapy to the ipsilateral mammary tissue (352 patients). After 1976, patients in both groups who had positive axillary nodes also received adjuvant chemotherapy with cyclophosphamide, methotrexate, and fluorouracil.
RESULTS
Thirty women in the group that underwent breast-conserving therapy had a recurrence of tumor in the same breast, whereas eight women in the radical-mastectomy group had local recurrences (P<0.001). The crude cumulative incidence of these events was 8.8 percent and 2.3 percent, respectively, after 20 years. In contrast, there was no significant difference between the two groups in the rates of contralateral-breast carcinomas, distant metastases, or second primary cancers. After a median follow-up of 20 years, the rate of death from all causes was 41.7 percent in the group that underwent breast-conserving surgery and 41.2 percent in the radical-mastectomy group (P=1.0). The respective rates of death from breast cancer were 26.1 percent and 24.3 percent (P=0.8).
CONCLUSIONS
The long-term survival rate among women who undergo breast-conserving surgery is the same as that among women who undergo radical mastectomy. Breast-conserving surgery is therefore the treatment of choice for women with relatively small breast cancers.
Topics: Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Combined Modality Therapy; Female; Follow-Up Studies; Humans; Incidence; Mastectomy, Radical; Mastectomy, Segmental; Neoplasm Metastasis; Neoplasm Recurrence, Local; Neoplasms, Second Primary; Randomized Controlled Trials as Topic; Survival Rate
PubMed: 12393819
DOI: 10.1056/NEJMoa020989 -
Drug Design, Development and Therapy 2023This study evaluated the effect of a combined infusion of dexmedetomidine and esketamine on the quality of recovery in patients undergoing modified radical mastectomy. (Randomized Controlled Trial)
Randomized Controlled Trial
Effect of Dexmedetomidine and Two Different Doses of Esketamine Combined Infusion on the Quality of Recovery in Patients Undergoing Modified Radical Mastectomy for Breast Cancer - A Randomised Controlled Study.
PURPOSE
This study evaluated the effect of a combined infusion of dexmedetomidine and esketamine on the quality of recovery in patients undergoing modified radical mastectomy.
METHODS
A total of 135 patients were randomly divided into three groups: dexmedetomidine group (group D) received dexmedetomidine (0.5 µg/kg loading, 0.4 µg/kg/h infusion), dexmedetomidine plus low-dose esketamine group (group DE) received dexmedetomidine (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and esketamine (0.5 mg/kg loading, 2 µg/kg/min infusion), dexmedetomidine plus high-dose esketamine group (group DE) received dexmedetomidine (0.5 µg/kg loading, 0.4 µg/kg/h infusion) and esketamine (0.5 mg/kg loading, 4 µg/kg/min infusion). The primary outcome was the overall quality of recovery-15 (QoR-15) scores at 1 day after surgery. The secondary endpoints were total QoR-15 scores at 3 days after surgery, propofol and remifentanil requirement, awaking and extubation time, postoperative visual analogue scale (VAS) pain scores, rescue analgesic, nausea and vomiting, bradycardia, excessive sedation, nightmares, and agitation.
RESULTS
The overall QoR-15 scores were much higher in groups DE and DE than in groups D 1 and D 3 days after surgery ( < 0.05). VAS pain scores at 6, 12, 24 h postoperatively, propofol and remifentanil requirements were significantly lower in groups DE and DE than in group D ( < 0.05). Compared with group D, awaking time, extubation time, and post-anesthesia care unit (PACU) stay were significantly prolonged in groups DE and DE ( < 0.05) and were much longer in group DE than in group DE ( < 0.05). The proportion of postoperative rescue analgesics and bradycardia was higher and the incidence of excessive sedation was lower in group D than in groups DE and DE ( < 0.05).
CONCLUSION
Dexmedetomidine plus esketamine partly improved postoperative recovery quality and decreased the incidence of bradycardia but prolonged awaking time, extubation time, and PACU stay, especially dexmedetomidine plus 4 µg/kg/min esketamine.
Topics: Humans; Female; Breast Neoplasms; Mastectomy, Modified Radical; Dexmedetomidine; Bradycardia; Propofol; Remifentanil; Mastectomy; Pain
PubMed: 37664451
DOI: 10.2147/DDDT.S422896 -
Journal of Medicine and Life 2016Surgical treatment of breast cancer has been marked by a constant evolution since the Halsted radical mastectomy described in the late 19th century has become the... (Review)
Review
Surgical treatment of breast cancer has been marked by a constant evolution since the Halsted radical mastectomy described in the late 19th century has become the current standard Madden radical mastectomy, a breast surgery that involves the ablation of tissue with the axillary lymphatic preserving both pectoral muscles. The purpose of this paper was to present the stages that have marked the evolution of this intervention and to provide an overview of the way breast cancer has been understood and treated in the last century.
Topics: Axilla; Breast Neoplasms; Female; Humans; Lymphedema; Mastectomy, Radical; Postoperative Complications
PubMed: 27453752
DOI: No ID Found -
Gland Surgery Jun 2018Breast surgeries for cancer and tumors were first described approximately 3,000 years ago, and since that time the standard of management has changed dramatically. From... (Review)
Review
Breast surgeries for cancer and tumors were first described approximately 3,000 years ago, and since that time the standard of management has changed dramatically. From Egyptian papyri to Hippocratic theory, from Galen's dissections to Halsted's radical mastectomy, and from sentinel lymph node mapping to the development of nipple-sparing mastectomies, this review starts at the beginning and highlights breakthroughs and innovation in technique and medicine that have fundamentally changed the way breast cancer is managed. The progression depicted in this review acts as a proxy to the management of other complex diseases. Breast cancer was initially managed with operative extirpation alone, but now requires a multidisciplinary team across various surgical, medical, psychological, and social specialties in order to produce the best outcomes for our patients.
PubMed: 29998080
DOI: 10.21037/gs.2017.09.07 -
Drug Design, Development and Therapy 2022This study aims to investigate the effects of the different doses of esketamine on postoperative quality of recovery in patients undergoing modified radical mastectomy. (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of the Different Doses of Esketamine on Postoperative Quality of Recovery in Patients Undergoing Modified Radical Mastectomy: A Randomized, Double-Blind, Controlled Trial.
PURPOSE
This study aims to investigate the effects of the different doses of esketamine on postoperative quality of recovery in patients undergoing modified radical mastectomy.
METHODS
Ninety-nine female patients were randomly allocated to three groups: the low-dose esketamine group (group E) (0.5 mg/kg loading, 2 µg/kg/h infusion), the high-dose esketamine group (group E) (0.5 mg/kg loading, 4 µg/kg/h infusion), the control group (group C) (received normal saline). The primary outcome was the quality of recovery-15 (QoR-15) scores on postoperative day 1 (POD1) and days 3 (POD3). The secondary outcomes were the sleep quality scores on POD1, bispectral index (BIS) value at 10, 30, and 60 min after operation, numeric rating scale (NRS) pain scores within 24 h after surgery, nausea, vomiting, drowsiness, nightmare, and intraoperative awareness.
RESULTS
The total QoR-15 scores were higher in group E and group E than in group C on POD1 and POD3 (<0.05). The sleep quality scores on POD1 and BIS value at 10, 30, and 60 min after operation were higher in group E and group E than in group C (<0.05). The NRS pain scores at 2, 4 and 6 h after surgery in group E and at 2, 4, 6, 12 and 24 h after surgery in group E were lower than in group C (<0.05). The NRS pain scores at 6, 12 and 24 h after surgery in group E were lower than in group E (<0.05). The incidence of drowsiness was higher in group E and group E than in group C (<0.05).
CONCLUSION
Esketamine infusion improved to some extent the quality of recovery on POD1 and POD3 in patients undergoing modified radical mastectomy, especially 4 µg/kg/h esketamine was better, but the BIS value and incidence of drowsiness were significantly increased.
Topics: Humans; Female; Mastectomy, Modified Radical; Breast Neoplasms; Mastectomy; Pain, Postoperative; Double-Blind Method
PubMed: 36561309
DOI: 10.2147/DDDT.S392784