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The Yale Journal of Biology and Medicine Sep 2023: To evaluate the comparative effectiveness of treatments, a randomized clinical trial remains the gold standard but can be challenged by a high cost, a limited sample... (Randomized Controlled Trial)
Randomized Controlled Trial
: To evaluate the comparative effectiveness of treatments, a randomized clinical trial remains the gold standard but can be challenged by a high cost, a limited sample size, an inability to fully reflect the real world, and feasibility concerns. The objective is to showcase a big data approach that takes advantage of large electronic medical record (EMR) data to emulate clinical trials. To overcome the limitations of regression analysis, a deep learning-based analysis pipeline was developed. : Lumpectomy (breast-conserving surgery) and mastectomy are the two most commonly used surgical procedures for early-stage female breast cancer patients. An emulation trial was designed using the Surveillance, Epidemiology, and End Results (SEER)-Medicare data to evaluate their relative effectiveness in overall survival. The analysis pipeline consisted of a propensity score step, a weighted survival analysis step, and a bootstrap inference step. : A total of 65,997 subjects were enrolled in the emulated trial, with 50,704 and 15,293 in the lumpectomy and mastectomy arms, respectively. The two surgery procedures had comparable effects in terms of overall survival (survival year change = 0.08, 95% confidence interval (CI): -0.08, 0.25) for the elderly SEER-Medicare early-stage female breast cancer patients. : This study demonstrated the power of "mining large EMR data + deep learning-based analysis," and the proposed analysis strategy and technique can be potentially broadly applicable. It provided convincing evidence of the comparative effectiveness of lumpectomy and mastectomy.
Topics: Aged; Female; Humans; Big Data; Breast Neoplasms; Deep Learning; Mastectomy; Mastectomy, Segmental; Medicare; United States; Comparative Effectiveness Research
PubMed: 37781001
DOI: 10.59249/IAJU7580 -
Three-Dimensional Surface Analysis for Preoperative Prediction of Breast Volume: A Validation Study.Plastic and Reconstructive Surgery Dec 2023Few studies have examined whether preoperative three-dimensional surface imaging can accurately predict breast volume. Reliably predicting breast volume preoperatively...
BACKGROUND
Few studies have examined whether preoperative three-dimensional surface imaging can accurately predict breast volume. Reliably predicting breast volume preoperatively can assist with breast reconstruction planning, patient education, and perioperative risk stratification.
METHODS
The authors conducted a review of patients who underwent mastectomy from 2020 to 2021 and included all patients who had preoperative VECTRA XT three-dimensional imaging. VECTRA Analysis Module (VAM) and VECTRA Body Sculptor (VBS) were used for volumetric analysis using standard anatomical breast borders. Breast weights were obtained intraoperatively. Predictive accuracy was defined as VAM estimates ±10% of mastectomy specimen weight or ±100 g of mastectomy weight.
RESULTS
The study included 179 patients (266 breasts). There was no significant difference ( P = 0.22) between mean mastectomy weight of 620.8 ± 360.3 g and mean VAM estimate of 609.5 ± 361.9 g. Mean VBS estimate was 498.9 ± 337.6 g, which differed from mean mastectomy weight ( P < 0.001). When defining predictive accuracy as ±100 g, 58.7% of VAM and 44.4% of VBS estimates were accurate. Body mass index, body surface area, and ptosis grade significantly affected VAM and VBS breast volume predictions.
CONCLUSIONS
VAM is more accurate at predicting mastectomy weight than VBS, likely because of VAM's analysis of surface topography rather than discrete surface landmarks. Discrepancies between VECTRA estimates and mastectomy weight were likely attributable to differences between surgical mastectomy borders and breast borders used in volumetric analysis. Surgeons should consider the physical characteristics of patients when using three-dimensional imaging.
CLINICAL QUESTION/LEVEL OF EVIDENCE
Diagnostic, I.
Topics: Female; Humans; Breast; Breast Neoplasms; Imaging, Three-Dimensional; Mammaplasty; Mastectomy
PubMed: 36995175
DOI: 10.1097/PRS.0000000000010473 -
Asia-Pacific Journal of Clinical... Aug 2023The Victorian Tumour Summits are an initiative of the Victorian Integrated Cancer Services to engage clinicians and consumers in identifying unwarranted variations in...
AIM
The Victorian Tumour Summits are an initiative of the Victorian Integrated Cancer Services to engage clinicians and consumers in identifying unwarranted variations in cancer care across the state. From the analysis presented at the Victorian Breast Tumour Summit in 2021, this study provides a state-wide overview of epidemiology and surgical care of breast cancer in Victoria to outline any variations in care across the state, and limitations in data reporting, which impacts the understanding of breast cancer burden and service planning.
METHODS
A retrospective analysis of Victorian breast cancer patients diagnosed between 2016 and 2018 was performed using a linked data set provided by the Department of Health. The linked data sources include Victorian Cancer Registry, Victorian Admitted Episodes Dataset and Victorian Radiotherapy Minimum Data Set, from which patient demographic details, tumor characteristics and treatment records were extracted. Pearson's chi-squared test was used to determine the statistical significance of relationships between various categorical parameters. Variables including demographics, types of surgery (breast-conserving vs. mastectomy), rates of neoadjuvant chemotherapy, and time to surgery were examined.
RESULTS
One thousand nine hundred thirty-seven patients with ductal carcinoma in situ and 13,375 patients with invasive breast cancer (IBC) were included. Of 11,351 patients with stages I-III IBC (85%, N = 13,375) 66% underwent breast-conserving surgery (BCS), and 31% underwent mastectomy. The ratio of mastectomy to BCS increased with increasing disease stage. Neoadjuvant chemotherapy was utilized in 11% of early IBC patients who were surgically treated. Eighty-three percent of patients undergoing upfront breast surgery were treated within 5 weeks of diagnosis, with a significant difference in the median time to surgery between public and private sectors. Breast reconstruction was performed in 37% of mastectomy patients, of whom 83% underwent immediate breast reconstruction, and 17% underwent delayed breast reconstruction.
CONCLUSIONS
Victorian breast cancer data show a high quality of surgical care coordination. Significant gaps in our data warrant future improvements in the Victorian breast cancer notification system and access to pharmaceutical data for an enhanced understanding of the breast cancer treatment pathways and care delivery.
Topics: Humans; Female; Breast Neoplasms; Mastectomy; Retrospective Studies; Mastectomy, Segmental; Mammaplasty
PubMed: 36373172
DOI: 10.1111/ajco.13884 -
Annals of Surgery Nov 2023To compare long-term quality of life (QOL) outcomes in breast cancer survivors who received breast-conserving surgery with radiotherapy (BCS+RT) with those who received...
OBJECTIVE
To compare long-term quality of life (QOL) outcomes in breast cancer survivors who received breast-conserving surgery with radiotherapy (BCS+RT) with those who received a mastectomy and reconstructive surgery (Mast+Recon) without radiotherapy and identify other important factors.
BACKGROUND
The long-term differences in patient-reported QOL outcomes following BCS+RT and Mast+Recon are not well understood.
METHODS
We identified patients from the Texas Cancer Registry with stage 0-II breast cancer diagnosed in 2009-2014 after BCS+RT or Mast+Recon without radiotherapy. Sampling was stratified by age and race and ethnicity. A paper survey was sent to 4800 patients which included validated BREAST-Q and PROMIS modules. Multivariable linear regression models were implemented for each outcome. Minimal clinically important difference for BREAST-Q and PROMIS modules, respectively, was 4 points and 2 points.
RESULTS
Of 1215 respondents (25.3% response rate), 631 received BCS+RT and 584 received Mast+Recon. The median interval from diagnosis to survey completion was 9 years. In adjusted analysis, Mast+Recon was associated with worse BREAST-Q psychosocial well-being (effect size: -3.80, P =0.04) and sexual well-being (effect size: -5.41, P =0.02), but better PROMIS physical function (effect size: 0.54, P =0.03) and similar BREAST-Q satisfaction with breasts, physical well-being, and PROMIS upper extremity function ( P >0.05) compared with BCS+RT. Only the difference in sexual well-being reached clinical significance. Older (≥65) patients receiving BCS+RT and younger (<50) patients receiving autologous Mast+Recon typically reported higher QOL scores. Receipt of chemotherapy was associated with detriments to multiple QOL domains.
CONCLUSIONS
Patients who underwent Mast+Recon reported worse long-term sexual well-being compared with BCS+RT. Older patients derived a greater benefit from BCS+RT, while younger patients derived a greater benefit from Mast+Recon. These data inform preference-sensitive decision-making for women with early-stage breast cancer.
Topics: Female; Humans; Mastectomy; Mastectomy, Segmental; Breast Neoplasms; Quality of Life; Radiotherapy, Adjuvant; Patient Reported Outcome Measures
PubMed: 37232937
DOI: 10.1097/SLA.0000000000005920 -
BMC Women's Health Nov 2023In the competitive health care environment, patient satisfaction and quality of life (QoL) have become the subject of interest to evaluate the efficacy of therapeutic...
BACKGROUND
In the competitive health care environment, patient satisfaction and quality of life (QoL) have become the subject of interest to evaluate the efficacy of therapeutic interventions as we experience improved breast cancer survival in modern times. The knowledge of the long-term effects of surgery on the QoL in breast cancer patients is currently limited in the Asian setting. The purpose of this longitudinal study is to evaluate the QoL of early-stage breast cancer patients undergoing mastectomy and breast-conserving surgery (BCS).
METHODS
In this prospective cohort study, the QoL of 208 patients who underwent mastectomy and the BCS treatment were assessed, using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire. The questionnaire was administered at the baseline, 6 and 12 months following diagnosis. One-way ANCOVA was used for statistical analysis.
RESULTS
A total of 208 female survivors of Stage 0-II breast cancer were included, among them 47.1% underwent BCS and 52.9% underwent mastectomy. Older (63.3%), Chinese women (63.6%), and patients with primary education (71.7%) were more likely to undergo mastectomy. At baseline, no significant differences were observed for QoL in both treatment groups. At 6 months, patients who underwent BCS had better social functioning scales( P = 0.006) and worse symptom scales for dyspnoea (P = 0.031), compared to mastectomy patients. One year after diagnosis, the role functioning score of the mastectomy group was significantly higher than the BCS group, specifically among patients who had undergone chemotherapy (P = 0.034).
CONCLUSION
Patients who underwent BCS had better social functioning and worse dyspnoea symptoms compared to patients undergoing mastectomy at six months. During one year, there were only significant improvements in the role functioning among the mastectomy groups compared to the BCS groups. After further stratification, only mastectomy patients who received chemotherapy exhibited improved role functioning compared to patients those who did not undergo chemotherapy. Providing social and physical support postoperatively and monitoring patients for cancer worry, or other symptoms in the long-term survivorship period would be important to ensure optimal QoL.
Topics: Female; Humans; Mastectomy; Breast Neoplasms; Mastectomy, Segmental; Quality of Life; Longitudinal Studies; Cancer Survivors; Prospective Studies; Malaysia; Survivors; Surveys and Questionnaires; Dyspnea
PubMed: 37974118
DOI: 10.1186/s12905-023-02738-w -
Current Oncology (Toronto, Ont.) Feb 2024The role of postmastectomy radiotherapy and regional nodal irradiation after radical mastectomy is defined in high-risk patients with locally advanced tumors, positive... (Review)
Review
The role of postmastectomy radiotherapy and regional nodal irradiation after radical mastectomy is defined in high-risk patients with locally advanced tumors, positive margins, and unfavorable biology. The benefit of postmastectomy radiotherapy in intermediate-risk patients (T3N0 tumors) remains a matter of controversy. It has been demonstrated that radiotherapy after breast-conserving surgery lowers the locoregional recurrence rate compared with surgery alone and improves the overall survival rate. In patients with four or more positive lymph nodes or extracapsular extension, regional lymph node irradiation is indicated regardless of the surgery type (breast-conserving surgery or mastectomy). Despite the consensus that patients with more than three positive lymph nodes should be treated with radiotherapy, there is controversy regarding the recommendations for patients with one to three involved lymph nodes. In patients with N0 disease with negative findings on axillary surgery, there is a trend to administer regional lymph node irradiation in patients with a high risk of recurrence. In patients treated with neoadjuvant systemic therapy and mastectomy, adjuvant radiotherapy should be administered in cases of clinical stage III and/or ≥ypN1. In patients treated with neoadjuvant systemic therapy and breast-conserving surgery, postoperative radiotherapy is indicated irrespective of pathological response.
Topics: Humans; Female; Breast Neoplasms; Mastectomy; Radiotherapy, Adjuvant; Neoplasm Recurrence, Local; Mastectomy, Segmental
PubMed: 38534923
DOI: 10.3390/curroncol31030090 -
JAMA Surgery Mar 2024Robotic-assisted nipple-sparing mastectomies with multiport robots have been described in the US since 2015; however, significant hurdles to multiport robotic surgery...
IMPORTANCE
Robotic-assisted nipple-sparing mastectomies with multiport robots have been described in the US since 2015; however, significant hurdles to multiport robotic surgery exist in breast surgery.
OBJECTIVE
To demonstrate that the single-port da Vinci SP (Intuitive Surgical) robotic system is feasible in patients undergoing robotic nipple-sparing mastectomy (rNSM).
DESIGN, SETTING, AND PARTICIPANTS
An initial case series of 20 patients at a large university hospital underwent bilateral single-port robotic nipple-sparing mastectomies (SPrNSM) with tissue expander reconstruction from February 1, 2020, through January 4, 2023. Participants included women who met surgical criteria for nipple-sparing mastectomies, per standard of care.
INTERVENTION
Surgery using a single-port robot and the surgical technique of the authors.
MAIN OUTCOMES AND MEASURES
Age, indication, body mass index, breast size, operative time, conversion to open surgery, systemic complications, postoperative skin necrosis, and reported skin and nipple areolar complex (NAC) sensation.
RESULTS
Twenty women aged 29 to 63 years (median, 40 years) underwent bilateral SPrNSM. Eleven patients completed prophylactic surgery due to a high risk for breast cancer (more than 20% lifetime risk) and 9 patients had breast cancer. Breast size ranged from A through D cup with median B cup and a body mass index range of 19.7 through 27.8 (median 24.4). The total duration of the procedure from incision to skin closure for both sides ranged from 205 minutes to 351 minutes (median, 277). The median robotic time for bilateral SPrNSM was 116 minutes and varied by cup size (A cup, 95 minutes; B cup, 140 minutes; C cup, 118 minutes; D cup, 114 minutes) with no inflection point in learning curve. No cases were converted to open and no immediate complications, such as hematoma, positive margins, or recurrence, were seen. In the first 10 patients prior to routine sensation testing, 20 resected breasts had measurable NAC sensation at a range from 4 to 36 months post-index resection (65%). In the second 10 patients of the cohort, measurable NAC was preserved in 13 of 20 resected breasts 2 weeks following the index operation (65%).
CONCLUSION AND RELEVANCE
In this case series, SPrNSM with immediate reconstruction was feasible and performed safely by an experienced breast surgeon with limited previous robotic training. Further studies confirming the preliminary data demonstrating improved NAC and skin sensation following SPrNSM are warranted.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT05245812.
Topics: Humans; Female; Mastectomy; Robotics; Robotic Surgical Procedures; Breast Neoplasms; Nipples; Feasibility Studies
PubMed: 38231502
DOI: 10.1001/jamasurg.2023.6999 -
Plastic and Reconstructive Surgery Feb 2024Nipple-sparing mastectomy is commonly performed for breast cancer treatment or prevention. The authors present one of the largest breast reconstruction series in the...
BACKGROUND
Nipple-sparing mastectomy is commonly performed for breast cancer treatment or prevention. The authors present one of the largest breast reconstruction series in the literature.
METHODS
A single-institution retrospective review was conducted from 2007 to 2019.
RESULTS
The authors' query identified 3035 implant-based breast reconstructions after nipple-sparing mastectomy, including 2043 direct-to-implant and 992 tissue expander-to-implant reconstructions. The overall major complication rate was 9.15%, and the nipple necrosis rate was 1.20%. Therapeutic mastectomy was associated with higher overall complications and explantations compared with prophylactic mastectomy ( P < 0.01). In comparisons of unilateral and bilateral procedures, bilateral mastectomy had an increased risk for complications (OR, 1.46; 95% CI, 0.997 to 2.145; P = 0.05). Tissue-expander reconstructions had higher rates of nipple necrosis (1.9% versus 0.88%; P = 0.015), infection (4.2% versus 2.8%; P = 0.04), and explantation (5.1% versus 3.5%; P = 0.04) compared with direct-to-implant reconstruction. When assessing plane of reconstruction, the authors found similar rates of complications between subpectoral dual-plane and prepectoral reconstruction. There was no difference in complications between reconstruction with acellular dermal matrix or mesh compared with total or partial muscle coverage without acellular dermal matrix/mesh (OR, 0.749; 95% CI, 0.404 to 1.391; P = 0.361). Multivariable regression analysis revealed preoperative radiotherapy (OR, 2.465; 95% CI, 1.579 to 3.848; P < 0.001), smoking (OR, 2.53; 95% CI, 1.581 to 4.054; P < 0.001), and a periareolar incision (OR, 3.657; 95% CI, 2.276 to 5.875; P < 0.001) to be the strongest predictors of complications and nipple necrosis ( P < 0.05).
CONCLUSIONS
Nipple-sparing mastectomy and immediate breast reconstruction has a low rate of complications. In this series, radiation therapy, smoking, and incision choice predicted overall complications and nipple necrosis, whereas direct-to-implant reconstruction and acellular dermal matrix or mesh did not increase risk.
CLINICAL QUESTION/LEVEL OF EVIDENCE
Therapeutic, III.
Topics: Humans; Female; Mastectomy; Breast Neoplasms; Breast Implants; Nipples; Mammaplasty; Retrospective Studies; Necrosis
PubMed: 37141449
DOI: 10.1097/PRS.0000000000010616 -
Annals of Surgical Oncology Oct 2023The rate of contralateral prophylactic mastectomy (CPM) continues to rise despite no improvement in survival, an increased risk of surgical complications, and negative...
BACKGROUND
The rate of contralateral prophylactic mastectomy (CPM) continues to rise despite no improvement in survival, an increased risk of surgical complications, and negative effects on quality of life. This study explored the experiences of the partners of women who undergo CPM.
METHODS
This study was part of an investigation into the factors motivating women with early-stage unilateral breast cancer and low genetic risk to opt for contralateral prophylactic mastectomy (CPM). Participating women were asked for permission to invite their partners to take part in interviews. In-depth interviews with partners were conducted using a semi-structured topic guide. A thematic analysis of the data was performed RESULTS: Of 35 partners, all men, 15 agreed to be interviewed. Most perceived their role to be strong and logical. Some hoped their wives would choose a bilateral mastectomy. All felt strongly that the final decision was up to their partners. The partners often framed the decision for CPM as one of life or death. Thus, any aesthetic effects were unimportant by comparison. The male partners had difficulty grasping the physical and emotional changes inherent in mastectomy, which made communicating about sexuality and intimacy very challenging for the couples. In the early recovery period, some noted the stress of managing home life.
CONCLUSIONS
The experiences of the male partners provide insight into how couples navigate complex treatment decision-making, both together and separately. There may be a benefit to including partners in pre- and post-surgical counseling to mitigate miscommunication regarding the expected oncologic and emotional outcomes related to CPM.
Topics: Male; Female; Humans; Mastectomy; Breast Neoplasms; Prophylactic Mastectomy; Quality of Life; Decision Making
PubMed: 37573282
DOI: 10.1245/s10434-023-14022-0 -
Computers in Biology and Medicine Oct 2023Breast cancer is the most commonly diagnosed cancer type worldwide. Given high survivorship, increased focus has been placed on long-term treatment outcomes and patient...
Breast cancer is the most commonly diagnosed cancer type worldwide. Given high survivorship, increased focus has been placed on long-term treatment outcomes and patient quality of life. While breast-conserving surgery (BCS) is the preferred treatment strategy for early-stage breast cancer, anticipated healing and breast deformation (cosmetic) outcomes weigh heavily on surgeon and patient selection between BCS and more aggressive mastectomy procedures. Unfortunately, surgical outcomes following BCS are difficult to predict, owing to the complexity of the tissue repair process and significant patient-to-patient variability. To overcome this challenge, we developed a predictive computational mechanobiological model that simulates breast healing and deformation following BCS. The coupled biochemical-biomechanical model incorporates multi-scale cell and tissue mechanics, including collagen deposition and remodeling, collagen-dependent cell migration and contractility, and tissue plastic deformation. Available human clinical data evaluating cavity contraction and histopathological data from an experimental porcine lumpectomy study were used for model calibration. The computational model was successfully fit to data by optimizing biochemical and mechanobiological parameters through Gaussian process surrogates. The calibrated model was then applied to define key mechanobiological parameters and relationships influencing healing and breast deformation outcomes. Variability in patient characteristics including cavity-to-breast volume percentage and breast composition were further evaluated to determine effects on cavity contraction and breast cosmetic outcomes, with simulation outcomes aligning well with previously reported human studies. The proposed model has the potential to assist surgeons and their patients in developing and discussing individualized treatment plans that lead to more satisfying post-surgical outcomes and improved quality of life.
Topics: Humans; Animals; Swine; Female; Mastectomy, Segmental; Mastectomy; Breast Neoplasms; Quality of Life; Collagen
PubMed: 37647782
DOI: 10.1016/j.compbiomed.2023.107342