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Clinical Genetics Aug 2021Improper medical use of variant of uncertain significance (VUS) remains a concern in hereditary cancer genetic testing. The goal of this study was to assess the... (Meta-Analysis)
Meta-Analysis
Improper medical use of variant of uncertain significance (VUS) remains a concern in hereditary cancer genetic testing. The goal of this study was to assess the association between pathogenic and likely pathogenic (P/LP), VUS, and benign and likely benign (B/LB) genetic test results and cancer-related surgical and screening management. Systematic searches of Medline, Embase, EBSCO CINAHL Plus, and PsycINFO were conducted from 1946 to August 26, 2020. Eligible studies included individuals with cancer genetic test result and surgical or screening management outcomes. We reviewed 885 abstracts and 22 studies that reported relevant surgical and screening outcomes were included. Meta-analysis revealed significantly higher surgical rates among individuals with P/LP than among those with VUS for therapeutic mastectomy with contralateral prophylactic mastectomy (OR = 7.35, 95% CI, 4.14-13.64), prophylactic mastectomy (OR = 3.05, 95% CI, 1.5-6.19), and oophorectomy (OR = 6.46, 95% CI, 3.64-11.44). There were no significant differences in therapeutic mastectomy, or breast conservation or lumpectomy rates between individuals with P/LP and VUS, or in any outcomes between patients with VUS and B/LB. Studies evaluating screening outcomes were limited, and results were conflicting. Comprehensive analysis do not indicate that a significant number of individuals with VUS results undergo inappropriate clinical management.
Topics: BRCA1 Protein; BRCA2 Protein; Breast Neoplasms; Female; Genetic Predisposition to Disease; Genetic Testing; Humans; Middle Aged; Ovarian Neoplasms; Ovariectomy; Prophylactic Mastectomy; Prophylactic Surgical Procedures
PubMed: 33843052
DOI: 10.1111/cge.13966 -
Cureus Sep 2020Gastric cancer is the third-most fatal cancer in the world. Though over the years, we saw patients mostly with intestinal type accounting for the highest mortality... (Review)
Review
Gastric cancer is the third-most fatal cancer in the world. Though over the years, we saw patients mostly with intestinal type accounting for the highest mortality rate, the recent rise of the diffuse form with germline E-cadherin (CDH1) mutations has added a whole new level of interest to study in detail about the association between CDH1 and diffuse gastric cancer (DGC). This introduced a set guideline formulated by Internal Gastric Cancer Linkage Consortium (IGCLC) for patients with family history of diffuse gastric cancer and invasive lobular breast cancer (ILBC). The analysis of this link was also important to set proper management protocol for patients who were CDH1 mutation carriers which now involves genetic counselling, endoscopic surveillance and screening and prophylactic total gastrectomy (PTG). The study was conducted in accordance to the 'PRISMA guidelines for reporting systematic review and meta-analysis'. Peer-reviewed studies were included from the PubMed database and relevant articles were selected to be included in the study. Appropriate inclusion/exclusion criteria with free full text English articles were applied while selecting the articles. A total of 10 studies on review with different study populations showed that of the 42 patients who were diagnosed with diffuse gastric cancer, 88% of them showed a positive germline E-cadherin gene mutation and 100% of the CDH1 mutation carriers showed microscopic changes of signet ring cell adenocarcinoma of the stomach. The beneficial effects of PTG with better survival rates and low mortality rates has outweighed other treatment modalities. Laparoscopic approach has proved to be more useful and a safer approach for gastrectomy surgeries with better post-operative management. The need for prophylactic mastectomy is also increased in the recent times and thus this requires a new set of guidelines for ILBC patients with hereditary diffuse gastric cancer (HDGC) syndrome.
PubMed: 33062523
DOI: 10.7759/cureus.10406 -
The Cochrane Database of Systematic... May 2016Breast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by... (Review)
Review
BACKGROUND
Breast cancer is the most common cancer in women worldwide, and is a leading cause of cancer death among women. Prophylactic or curative mastectomy is often followed by breast reconstruction for which there are several surgical approaches that use breast implants with which surgeons can restore the natural feel, size and shape of the breast.
OBJECTIVES
To assess the effects of different types of breast implants on capsular contracture, surgical short- and long-term complications, postoperative satisfaction level and quality of life in women who have undergone reconstructive breast surgery after mastectomy.
SEARCH METHODS
We searched the Cochrane Breast Cancer Group's Specialised Register on 20 July 2015, MEDLINE (1985 to 20 July 2015), EMBASE (1985 to 20 July 2015) and the Cochrane Central Register of Controlled Trials (CENTRAL; Issue 8, 2015). We also searched the World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) and ClinicalTrials.gov on 16 July 2015.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs that compared different types of breast implants for reconstructive surgery. We considered the following types of intervention: implant envelope surfaces - texturised versus smooth; implant filler material - silicone versus saline, PVP-Hydrogel versus saline; implant shape - anatomical versus round; implant volume - variable versus fixed; brands - different implant manufacturing companies and implant generation (fifth versus previous generations).
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed methodological quality and extracted data. We used standard Cochrane methodological procedures. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.
MAIN RESULTS
Five RCTs with 202 participants met the inclusion criteria. The women participants were typically in their 50s, and the majority of them (about 82%) received reconstructive surgery following breast cancer, while the others had reconstructive surgery after prophylactic mastectomy. The studies were heterogenous in terms of implant comparisons, which prevented us from pooling the data.The studies were judged as being at an unclear risk of bias for most risk of bias items owing to poor quality of reporting in the trial publications. Three of the five RCTs were judged to be at high risk of attrition bias, and one at high risk of detection bias.Textured silicone versus smooth silicone implants: textured implants were associated with worse outcomes when compared to smooth implants (capsular contracture: risk ratio (RR) 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence; reintervention: RR 0.82, 95% CI 0.14 to 4.71; 1 study, 20 participants; very low quality evidence). No results in this comparison were statistically significant.Silicone versus saline implants: saline-filled implants performed better than silicone-filled implants for some outcomes; specifically, they produced less severe capsular contracture (RR 3.25, 95% CI 1.24 to 8.51; 1 study, 60 participants; very low quality evidence) and increased patient satisfaction (RR 0.60, 95% CI 0.41 to 0.88; 1 study, 58 participants; very low quality evidence). However reintervention was significantly more frequent in the saline-filled implant group than in the silicone-filled group (OR 0.08, 95% CI 0.01 to 0.43; 1 study, 60 participants; very low quality evidence).Poly(N-vinyl-2-pyrrolidone) hydrogel-filled (PVP-hydrogel) versus saline-filled implants: PVP-hydrogel-filled implants were associated with worse outcomes when compared to saline-filled implants (capsular contracture: RR 3.50, 95% CI 0.83 to 14.83; 1 study, 40 participants; very low quality evidence; short-term complications: RR 2.10, 95% CI 0.21 to 21.39; 1 study, 41 participants; very low quality evidence).Anatomical versus round implants: anatomical implants were associated with worse outcomes than round implants (capsular contracture: RR 2.00, 95% CI 0.20 to 20.15; 1 study, 36 participants; very low quality evidence; short-term complications: RR 2.00, 95% CI 0.42 to 9.58; 1 study, 36 participants; very low quality evidence; reintervention: RR 1.50, 95% CI 0.51 to 4.43; 1 study, 36 participants; very low quality evidence). No results in this comparison were statistically significant.Variable-volume versus fixed-volume implants: data about one-stage reconstruction using variable-volume implants were compared with data about fixed-volume implants positioned during the second surgical procedure of two-stage reconstructions. Fixed-volume implant reconstructions were possibly associated with a greater number of women reporting that their reconstruction corresponded with expected results (RR 0.25, 95% CI 0.10 to 0.62; 1 study, 40 participants; very low quality evidence) and fewer reinterventions (RR 7.00, 95% CI 1.82 to 26.89; 1 study, 40 participants; very low quality evidence) when compared to variable-volume implants. A higher patient satisfaction level (rated from 1 to 6, with 1 being very bad and 6 being very good) was found with the fixed-volume implants for overall aesthetic result (mean difference (MD) -1.10, 95% CI -1.59 to -0.61; 1 study, 40 participants; very low quality evidence).There were no studies that examined the effects of recent (fifth) generation silicone implants versus previous generations or different implant manufacturing companies.
AUTHORS' CONCLUSIONS
Despite the central role of breast reconstruction in women with breast cancer, the best implants to use in reconstructive surgery have been studied rarely in the context of RCTs. Furthermore the quality of these studies and the overall evidence they provide is largely unsatisfactory. Some of our results can be interpreted as early evidence of potentially large differences between different surgical approaches, which should be confirmed in new high-quality RCTs that include a larger number of women. These days - even after a few million women have had breasts reconstructed - surgeons cannot inform women about the risks and complications of different implant-based breast reconstructive options on the basis of results derived from RCTs.
Topics: Breast Implants; Breast Neoplasms; Female; Humans; Hydrogels; Mammaplasty; Mastectomy; Middle Aged; Patient Satisfaction; Prophylactic Surgical Procedures; Prosthesis Failure; Randomized Controlled Trials as Topic; Silicone Gels; Sodium Chloride
PubMed: 27182693
DOI: 10.1002/14651858.CD010895.pub2 -
Current Oncology (Toronto, Ont.) Mar 2023Female pathogenic variant carriers have an increased lifetime risk for breast and ovarian cancer. Cancer-unaffected women who are newly diagnosed with this pathogenic... (Review)
Review
Female pathogenic variant carriers have an increased lifetime risk for breast and ovarian cancer. Cancer-unaffected women who are newly diagnosed with this pathogenic variant may experience psychological distress because of imminent health threat. No comprehensible review on psychological morbidity in cancer-unaffected pathogenic variant carriers is currently available. This review aims to give an overview about all available the studies in which psychological outcomes have been assessed in cancer-unaffected pathogenic variant carriers, whether as a primary outcome or secondary measurement. A systematic search across four databases (Web of Science, PubMed, ScienceDirect, and EBSCO) was conducted. Studies had to report on cancer-unaffected pathogenic variant carriers (exclusively or separately) and use a validated measure of psychological morbidity to be eligible. Measures were only included if they were used in at least three studies. The final review consisted of 45 studies from 13 countries. Distress measures, including anxiety and cancer worry, were most often assessed. Most studies found a peak of distress immediately after genetic test result disclosure, with a subsequent decline over the following months. Only some studies found elevated distress in carriers compared to non-carriers in longer follow-ups. Depression was frequently investigated but largely not found to be of clinical significance. Quality of life seemed to be largely unaffected by a positive genetic test result, although there was some evidence that younger women, especially, were less satisfied with their role functioning in life. Body image has been infrequently assessed so far, but the evidence suggested that there may be a decrease in body image after genetic test result disclosure that may decrease further for women who opt for a prophylactic mastectomy. Across all the outcomes, various versions of instruments were used, often limiting the comparability among the studies. Hence, future research should consider using frequently used instruments, as outlined by this review. Finally, while many studies included cancer-unaffected carriers, they were often not reported on separately, which made it difficult to draw specific conclusions about this population.
Topics: Female; Humans; BRCA1 Protein; Quality of Life; Breast Neoplasms; BRCA2 Protein; Mastectomy
PubMed: 37185387
DOI: 10.3390/curroncol30040274 -
The Patient Jul 2022The aims of this review were (i) to evaluate whether patient-reported outcome measures used in clinical studies for assessing sensation after mastectomy and breast...
AIMS
The aims of this review were (i) to evaluate whether patient-reported outcome measures used in clinical studies for assessing sensation after mastectomy and breast reconstruction are suitable for this purpose, and (ii) to explore whether any measures used for assessing sensation after non-oncologic breast surgery are worth modifying for use in post-mastectomy patients.
METHODS
PRISMA guidelines were followed (PROSPERO number CRD42020178066). We searched six databases for studies of oncologic (i.e., therapeutic, prophylactic, and reconstructive) and non-oncologic breast surgery (e.g., breast reduction) in which sensation was assessed with a patient-reported outcome measure. From the selected studies, we extracted eligible measures, evaluated their fitness for purpose, and summarized the content of sensation-specific items.
RESULTS
Of 6728 articles identified, we selected 135 studies that used 124 eligible patient-reported outcome measures. For 97% of these measures, details regarding development and measurement properties were unavailable. Four (3%) validated measures-the Sensory Disturbances subscale of the Breast Cancer Sequelae Cause Scales, the Discomfort subscale of the Breast Sensation Assessment Scale (BSAS), Didier et al.'s questionnaire for "Assessment of the patients' satisfaction with cosmetic results, physical and emotional impact of mastectomy", and the Breast Specific Pain subscale of the Breast Cancer Treatment Outcomes Scale (BCTOS)-each contain at least one item pertaining to breast sensation, but target different concepts of interest. In total, the measures feature 215 sensation-specific items, most of which concern symptom severity (97%) as opposed to impact on daily functioning (3%).
CONCLUSION
Patient-reported outcome measures used in clinical studies for assessing sensation after mastectomy and breast reconstruction are unsuitable for this purpose: they are either non-validated or non-specific. We failed to identify any measures for use in non-oncologic breast surgery populations worth modifying. To collect meaningful, patient-relevant data regarding sensation after mastectomy, it is pertinent that future clinical trials adopt psychometrically robust, specific patient-reported outcome measures.
Topics: Breast Neoplasms; Female; Humans; Mammaplasty; Mastectomy; Patient Reported Outcome Measures; Patient Satisfaction; Quality of Life; Sensation
PubMed: 35040096
DOI: 10.1007/s40271-021-00565-5 -
Plastic and Reconstructive Surgery.... May 2024Breast reconstruction is a standard procedure in postmastectomy plastic surgery. The necessity of routine histological examinations for mastectomy scars during delayed...
BACKGROUND
Breast reconstruction is a standard procedure in postmastectomy plastic surgery. The necessity of routine histological examinations for mastectomy scars during delayed reconstruction remains a topic of debate. We evaluated the need for histological examination of scars during delayed breast reconstruction.
METHODS
We conducted a systematic review using PubMed, TDnet, and Cochrane Central in August 2023. Inclusion criteria involved delayed breast reconstruction with histological scar analysis and malignancy reporting. Exclusion criteria encompassed noncancerous breast diseases, prophylactic mastectomies, articles lacking relevant information, case reports, technique descriptions, and reviews. We independently assessed articles. Differences in recurrence rates were determined using a Z-test for proportions. A linear regression model explored the relationship between reconstruction timing and pathological results. The number needed to treat was calculated based on the literature. The Wilcoxon test was used to compare mean reconstruction times and postreconstruction follow-up between groups.
RESULTS
Our analysis covered 11 retrospective observational studies published between 2003 and 2018, including 3754 mastectomy scars. The malignancy recurrence rate was 0.19%, consistent with previous reports, with a number needed to treat of 144.93-188.68 patients. The timing of breast reconstruction postmastectomy averaged 19.9 months, without statistically significant association between reconstruction timing and recurrence rates. Postreconstruction follow-up periods ranged from 60 to 87 months. The postreconstruction adverse outcomes ratio was 2.21%.
CONCLUSIONS
Assessing the necessity of histological examination in breast reconstruction is complex. Based on the literature and this study, we do not recommend routine histological examination of mastectomy scars during delayed reconstruction. A selective approach based on risk factors may be beneficial, warranting further research.
PubMed: 38798931
DOI: 10.1097/GOX.0000000000005847 -
Cancer Epidemiology, Biomarkers &... Dec 2004Women who are carriers of BRCA gene mutations have an elevated lifetime risk of developing breast or ovarian cancer. Although a number of risk-reducing options are... (Review)
Review
OBJECTIVE
Women who are carriers of BRCA gene mutations have an elevated lifetime risk of developing breast or ovarian cancer. Although a number of risk-reducing options are currently available to mutation carriers, uncertainty exists in terms of their efficacy. A systematic review of the literature was conducted to describe the utilization of screening and preventive surgery among unaffected mutation carriers in the face of uncertainty.
METHODS
MEDLINE, PubMed, and CANCERLIT, English-only computerized literature searches were done to identify articles pertaining to decisions made by unaffected BRCA mutation carriers to reduce risk of breast and ovarian cancer. Studies were required to include information on choices taken by at-risk women following disclosure of a positive BRCA test.
RESULTS
Only seven studies (5 American and 2 Dutch studies) were identified. The proportion of mutation carriers who chose preventive surgery over screening varied widely across the studies, ranging from 0% to 54% for prophylactic mastectomy and from 13% to 53% for prophylactic oophorectomy. Furthermore, a significant minority of women who chose surveillance failed to comply with the recommended schedule.
CONCLUSION
There is considerable variability within and between countries in risk reduction strategies utilized by healthy mutation carriers. This variability may relate to differences in (1) population characteristics; (2) recommendations for follow-up care of unaffected carriers; (3) prevailing values towards body integrity, femininity, and preventive surgery; and (4) health care funding systems. Future research needs to provide further insight into factors influencing women's decisions to adopt various risk reduction strategies.
Topics: Breast Neoplasms; DNA Mutational Analysis; Decision Making; Female; Genes, BRCA1; Genes, BRCA2; Genetic Predisposition to Disease; Genetic Testing; Humans; Ovarian Neoplasms; Ovariectomy; Patient Compliance; Risk Factors
PubMed: 15598752
DOI: No ID Found -
JAMA Surgery Aug 2020Overtreatment of early-stage breast cancer results in increased morbidity and cost without improving survival. Major surgical organizations participating in the Choosing...
IMPORTANCE
Overtreatment of early-stage breast cancer results in increased morbidity and cost without improving survival. Major surgical organizations participating in the Choosing Wisely campaign identified 4 breast cancer operations as low value: (1) axillary lymph node dissection for limited nodal disease in patients receiving lumpectomy and radiation, (2) re-excision for close but negative lumpectomy margins for invasive cancer, (3) contralateral prophylactic mastectomy in patients at average risk with unilateral cancer, and (4) sentinel lymph node biopsy in women 70 years or older with hormone receptor-positive cancer.
OBJECTIVE
To evaluate the extent to which these procedures have been deimplemented, determine the implications of decreased use, and recognize possible barriers and facilitators to deimplementation.
EVIDENCE REVIEW
A systematic review of published literature on use trends in breast surgery was performed in accordance with PRISMA guidelines. The Ovid, Embase, Cumulative Index to Nursing and Allied Health Literature, and Cochrane databases were searched for original research with relevance to the Choosing Wisely recommendations of interest. Eligible studies were examined for data about use, and any patient-level, clinician-level, or system-level factors associated with use.
FINDINGS
Concordant with recommendations, national rates of axillary lymph node dissection for patients with limited nodal disease have decreased by approximately 50% (from 44% in 2011 to 30% to 34% in 2012 and 25% to 28% in 2013), and national rates of lumpectomy margin re-excision have decreased by nearly 40% (from 16% to 34% before to 14% to 18% after publication of a consensus statement). Conversely, national rates of contralateral prophylactic mastectomy continue to rise each year, accounting for up to 30% of all mastectomies for breast cancer (range in all mastectomy cases: 2010-2012, 28%-30%; 1998, <2%), and rates of sentinel lymph node biopsy in women 70 years or older with low-risk breast cancer are persistently greater than 80% (range, 80%-88%). Factors associated with high rates of contralateral prophylactic mastectomy use are younger age, white race, increased socioeconomic status, and the availability of breast reconstruction; limited data exist on factors associated with high rates of sentinel lymph node biopsy in women 70 years or older. Successful deimplementation of axillary lymph node dissection and lumpectomy margin re-excision were associated with decreased costs and improved patient-centered outcomes.
CONCLUSIONS AND RELEVANCE
This review demonstrates variable deimplementation of 4 low-value surgical procedures in patients with breast cancer. Addressing specific patient-level, clinician-level, and system-level barriers to deimplementation is necessary to encourage shared decision-making and reduce overtreatment.
Topics: Breast Neoplasms; Clinical Decision-Making; Female; Humans; Mastectomy; Practice Guidelines as Topic; Procedures and Techniques Utilization; Value-Based Health Insurance
PubMed: 32492121
DOI: 10.1001/jamasurg.2020.0322 -
Genetics in Medicine : Official Journal... Oct 2018To review the evidence for the effectiveness and cost-effectiveness of cancer risk management interventions for BRCA carriers.
PURPOSE
To review the evidence for the effectiveness and cost-effectiveness of cancer risk management interventions for BRCA carriers.
METHODS
Comparative effectiveness and cost-effectiveness analyses were identified by searching scientific and health economic databases. Eligible studies modeled the impact of a cancer risk management intervention in BRCA carriers on life expectancy (LE), cancer incidence, or quality-adjusted life years (QALYs), with or without costs.
RESULTS
Twenty-six economic evaluations and eight comparative effectiveness analyses were included. Combined risk-reducing salpingo-oophorectomy and prophylactic mastectomy resulted in the greatest LE and was cost-effective in most analyses. Despite leading to increased LE and QALYs, combined mammography and breast magnetic resonance imaging (MRI) was less likely to be cost-effective than either mammography or MRI alone, particularly for women over 50 and BRCA2 carriers. Variation in patient compliance to risk management interventions was incorporated in 11/34 studies with the remaining analyses assuming 100% adherence.
CONCLUSION
Prophylactic surgery and intensive breast screening are effective and cost-effective in models of BRCA carrier risk management. Findings were based predominantly on assuming perfect adherence to recommendations without assessment of the health-care resource use and costs related to engaging patients and maximizing compliance, meaning the real-world impact on clinical outcomes and resource use remains unclear.
Topics: BRCA1 Protein; BRCA2 Protein; Breast Neoplasms; Cost-Benefit Analysis; Female; Humans; Mass Screening; Risk Management
PubMed: 29323669
DOI: 10.1038/gim.2017.255 -
Plastic and Reconstructive Surgery May 2021Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a significant public health concern for women with breast implants. The increase in incidence...
BACKGROUND
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a significant public health concern for women with breast implants. The increase in incidence rates underscores the need for improved methods for risk reduction and risk management. The purpose of this study was to perform a systematic review to assess surgical risk reduction techniques and analyze communication/informed consent practices in patients with textured implants.
METHODS
A systematic review of the literature was conducted in PubMed (legacy), Embase (Embase.com), and Scopus with four search strategies including key terms centered around breast reconstruction and BIA-ALCL.
RESULTS
A total of 571 articles were identified, of which 276 were included in the final review after duplicates were removed. After review, no articles were determined to fit the inclusion criteria of demonstrating data-driven evidence of BIA-ALCL risk reduction through surgical measures, demonstrating a significant lack of data on risk reduction for BIA-ALCL.
CONCLUSIONS
Risk management for BIA-ALCL is an evolving area requiring additional investigation. Although removal of textured devices in asymptomatic patients is not currently recommended by the Food and Drug Administration, variability in estimates of risk has led many patients to electively replace these implants in an effort to decrease their risk of developing BIA-ALCL. To date, however, there is no evidence supporting the concept that replacing textured implants with smooth implants reduces risk for this disease. This information should be used to aid in the informed consent process for patients presenting to discuss management of textured breast implants.
Topics: Asymptomatic Diseases; Breast Implants; Breast Neoplasms; Decision Making, Shared; Device Removal; Elective Surgical Procedures; Esthetics; Female; Humans; Incidence; Informed Consent; Lymphoma, Large-Cell, Anaplastic; Mammaplasty; Mastectomy; Population Surveillance; Postoperative Complications; Prophylactic Mastectomy; Risk; Risk Management; Risk Reduction Behavior; Surface Properties
PubMed: 33890875
DOI: 10.1097/PRS.0000000000008040