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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 -
Asian Pacific Journal of Cancer... Jun 2023Breast cancer is the most prevalent from of cancer among women worldwide and leading cause of death. Breast cancer can be treated surgically, systemically (with hormonal... (Randomized Controlled Trial)
Randomized Controlled Trial
Effectiveness of Scapular Strengthening Exercises on Shoulder Dysfunction for Pain and Functional Disability after Modified Radical Mastectomy: A Controlled Clinical Trial.
BACKGROUND
Breast cancer is the most prevalent from of cancer among women worldwide and leading cause of death. Breast cancer can be treated surgically, systemically (with hormonal therapy, chemotherapy) or with radiotherapy. Through the years, breast cancers management evolved towards conservation surgery. A surgical remove of partial or complete breast tissue, surrounding tissues, and nearby lymph nodes is called mastectomy. In Modified Radical Mastectomy, there is removal of entire breast tissue and lymph nodes. Treatment of modified radical mastectomy may lead to side effects such as shoulder pain, restricted shoulder mobility and anatomical and biomechanical changes of the shoulder, and also reduce functional disability.
METHOD
Eighty six participants were included in this study. Two groups, each of 43 were made, Group A (control group) was given conventional exercises and Group B (study group) was given scapular strengthening exercises with conventional exercises. Outcome measures - Shoulder Pain And Functional Disability, Shoulder range of motion were assessed both pre and post-test.
RESULT
Group B had lower pain intensity (77.116 ± 5.798vs 82.837 ± 3.860) and functional disability (70.326 ± 5.281 vs 77.791± 5.102) and higher shoulder flexion (167.98 ± 8.230 vs 107.05 ±8.018), abduction (156.91 ± 8.230 vs 107.63 ±8.230) and external rotation (62.372 ± 7.007 vs 41.907 ±6.771) range of motion than Group A.
CONCLUSION
The current study concluded that, scapular strengthening exercises along with conventional treatment proved beneficial and effective rather than only conventional treatment on shoulder dysfunction for pain and functional disability after modified radical mastectomy.
Topics: Humans; Female; Shoulder; Shoulder Pain; Mastectomy, Modified Radical; Breast Neoplasms; Mastectomy; Exercise Therapy
PubMed: 37378941
DOI: 10.31557/APJCP.2023.24.6.2099 -
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 -
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 -
Cureus Jul 2017Breast cancer is a socially relevant group of malignant conditions of the mammary gland, affecting both males and females. Most commonly the surgical approach of choice... (Review)
Review
Breast cancer is a socially relevant group of malignant conditions of the mammary gland, affecting both males and females. Most commonly the surgical approach of choice is a modified radical mastectomy (MRM), due to it allowing for both the removal of the main tumor mass and adjacent glandular tissue, which are suspected of infiltration and multifocality of the process, and a sentinel axillary lymph node removal. Most common post-surgical complications following MRM are the formation of a hematoma, the infection of the surgical wound and the formation of a seroma. These post-surgical complications can, at least in part, be attributed to the drainage of the surgical wound. However, the lack of modern and official guidelines provides an ample scope for innovation, but also leads to a need for a randomized comparison of the results. We compared different approaches to wound drainage after MRM, reviewed based on the armamentarium, number of drains, location, type of drainage system, timing of drain removal and no drainage alternatives. Currently, based on the general results, scientific and comparative discussions, seemingly the most affordable methodology with the best patient outcome, with regards to hospital stay and post-operative complications, is the placement of one medial to lateral (pectoro-axillary) drain with low negative pressure. Ideally, the drain should be removed on the second or third postoperative day or when the amount of drained fluid in the last 24 hours reaches below 50 milliliters.
PubMed: 28929038
DOI: 10.7759/cureus.1454 -
Annals of Surgical Oncology Aug 2023Modified radical mastectomy (MRM) still is largely performed in inpatient settings. This study sought to determine the value (expenditures and complications) of...
BACKGROUND
Modified radical mastectomy (MRM) still is largely performed in inpatient settings. This study sought to determine the value (expenditures and complications) of ambulatory MRM.
METHODS
Health Care Utilization Project (HCUP) state databases from 2016 were queried for patients who underwent MRM. The study examined rates of 30-day readmission for surgical-site infection (SSI) or hematoma, charges by index care setting, and predictors of 30-day readmission.
RESULTS
Overall, 8090 patients underwent MRM: 5113 (63 %) inpatient and 2977 (37 %) ambulatory patients. Compared with the patients who underwent inpatient MRM, those who underwent ambulatory MRM were older (61 vs. 59 years), more often white (66 % vs. 57 %), in the lowest income quartile (28 % vs. 21 %), insured by Medicare (43 % vs. 33 %) and residents in a small metro area (6 % vs. 4 %) (all p < 0.01). Of the 5113 patients treated as inpatients, 126 (2.5 %) were readmitted, whereas 50 (1.7 %) of the ambulatory patients were readmitted (p = 0.02). The adjusted charge for inpatient MRM without readmission was $113,878 (range, $107,355-120,402) compared with $94,463 (range, $86,021-102,907) for ambulatory MRM, and the charge for inpatient MRM requiring readmission was $159,355 (range, $147,142-171,568) compared with $139,940 (range, $125,808-154,073) for ambulatory MRM (all p < 0.01). This difference remained significant after adjustment for hospital length of stay. Adjusted logistic regression showed that the ambulatory setting was protective for readmission (odds ratio, 0.49; 95 % confidence interval, 0.35-0.70; p < 0.01).
CONCLUSIONS
The analyses suggest that ambulatory MRM is both safe and less expensive. The findings advocate that MRM, a last holdout of inpatient care within breast surgical oncology, can be transitioned to the ambulatory setting for appropriate patients.
Topics: Humans; Aged; United States; Female; Mastectomy, Modified Radical; Breast Neoplasms; Mastectomy; Medicare; Hospitalization; Patient Readmission; Retrospective Studies; Ambulatory Surgical Procedures
PubMed: 37166742
DOI: 10.1245/s10434-023-13588-z