Effect of Immediate Implant-Based Breast Reconstruction After Mastectomy With and Without Acellular Dermal Matrix Among Women With Breast Cancer: A Randomized Clinical Trial.

Importance: The use of acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) is established practice. Existing evidence validating ADMs proposed advantages, including improved cosmetics and more single-stage IBBRs, is lacking. Objective: To evaluate whether IBBR with ADM results in fewer reoperations and increased health-related quality of life (HRQoL) compared with conventional IBBR without ADM. Design, Setting, and Participants: This was an open-label, multicenter, randomized clinical trial of women with primary breast cancer who planned for mastectomy and immediate IBBR, with a 2-year follow-up for all participants. Participants were enrolled at 5 breast cancer units in Sweden and the United Kingdom between 2014 and May 2017. Exclusion criteria included previous radiotherapy and neo-adjuvant chemotherapy. Data were analyzed until August 2017. Interventions: Participants were allocated to immediate IBBR with or without ADM. Main Outcomes and Measures: The primary trial end point was number of reoperations at 2 years. HRQoL, a secondary end point, was measured as patient-reported outcome measures using 3 instruments from the European Organization for Research and Treatment of Cancer Quality of life Questionnaire. Results: From start of enrollment on April 24, 2014, to close of trial on May 10, 2017, a total of 135 women were enrolled (mean [SD] age, 50.4 [9.5] years); 64 were assigned to have an IBBR procedure with ADM and 65 to the control group who had IBBR without ADM. There was no statistically significant difference between groups for the primary outcome. Of 129 patients analyzed at 2-year follow-up, 44 of 64 (69%) had at least 1 surgical event in the ADM group vs 43 of 65 (66%) in the control group. In the ADM group, 31 patients (48%) had at least 1 reoperation on the ipsilateral side vs 35 (54%) in the control group. The overall number of reoperations on the ipsilateral side were 42 and 43 respectively. Within the follow-up time of 24 months, 9 patients (14%) in the ADM group had the implant removed compared with 7 (11%) in the control group. We found no significant mean differences in postoperative patient-reported HRQoL domains, including perception of body image (mean difference, 3; 99% CI, -11 to 17; P = .57) and satisfaction with cosmetic outcome (mean difference, 8; 99% CI, -6 to 20; P = .11). Conclusions and Relevance: Immediate IBBR with ADM did not yield fewer reoperations compared with conventional IBBR without ADM, nor was IBBR with ADM superior in terms of HRQoL or patient-reported cosmetic outcomes. Patients treated for breast cancer contemplating ADM-supported IBBR should be informed about the lack of evidence validating ADM's suggested benefits. Trial Registration: ClinicalTrials.gov Identifier: NCT02061527.

Surgical Management of Hereditary Breast Cancer.

The identification that breast cancer is hereditary was first described in the nineteenth century. With the identification of the BRCA1 and BRCA 2 breast/ovarian cancer susceptibility genes in the mid-1990s and the introduction of genetic testing, significant advancements have been made in tailoring surveillance, guiding decisions on medical or surgical risk reduction and cancer treatments for genetic variant carriers. This review discusses various medical and surgical management options for hereditary breast cancers.

Anesthesia Related to Breast Cancer Recurrence and Chronic Pain: A Review of Current Research.

Patients with breast cancer often require several procedures requiring anesthesia, such as central venous catheter placements, mastectomies, lymph node dissections, and reconstructive surgeries. Recent research findings have suggested there may be a reduced risk of cancer recurrence and chronic pain with specific anesthetic techniques. Regional techniques, total intravenous anesthetics, and select adjuncts have been reviewed to identify their role in breast cancer recurrence and chronic pain. A review of the pathophysiology as it pertains to volatile anesthetics, propofol as a total intravenous anesthetic, paravertebral nerve blocks, dexmedetomidine, and ketorolac, as well as the role each of these plays in the prevention of chronic pain and cancer recurrence is provided. Current research and recommendations for practice are presented in the context of providing anesthesia to mitigate chronic pain and cancer recurrence in patients with breast cancer.

Oncoplastic breast surgery: A guide to good practice.

Oncoplastic Breast Surgery has become standard of care in the management of Breast Cancer patients. These guidelines written by an Expert Advisory Group; convened by the Association of Breast Surgery (ABS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS), are designed to provide all members of the breast cancer multidisciplinary team (MDT) with guidance on the best breast surgical oncoplastic and reconstructive practice at each stage of a patient's journey, based on current evidence. It is hoped they will also be of benefit to the wide range of professionals and service commissioners who are involved in this area of clinical practice.

Fibromatosis of the breast: a 10-year multi-institutional experience and review of the literature.

BACKGROUND: Breast fibromatosis is a rare clinical entity, but poses significant diagnostic and therapeutic challenges. In light of recent changes in management practices, the aim was to review our institutional experience of breast fibromatosis and provide a review of current available literature on such management. METHODS: A search of pathological databases within two tertiary institutions for all patients diagnosed with fibromatosis of the breast over a 10-year period (2007-2016) was performed. Clinicopathological characteristics and modes of treatment were recorded for each patient. Concurrently a comprehensive literature search was performed and studies relating to breast fibromatosis and its management were identified and reviewed. RESULTS: Sixteen patients were identified. Median age at diagnosis was 42 (range 21-70) and all patients were diagnosed with core biopsy. The most useful imaging modality in diagnosis was ultrasonography and magnetic resonance imaging. 13/16 were treated surgically whilst 3/16 were treated using a watch-and-wait approach. 6/13 (46%) required re-excision of margins and 2/13 (15%) had recurrence after surgery. On review of the literature, there is no dedicated guideline in place for the management of breast fibromatosis. Currently a 'watch and wait' approach is favoured over surgical intervention due to high levels of recurrence and associated surgical morbidity. All cases should be discussed at a sarcoma multidisciplinary team meeting and tyrosine kinase inhibitors should be considered in advanced cases. CONCLUSIONS: Breast fibromatosis is rare but affects young patients. Active surveillance is now favoured over surgical resection due to high recurrence rates and extensive morbidity. Dedicated guidelines are required to ensure best outcomes.

The Impact of the COVID-19 Pandemic on Surgical Management of Breast Cancer: Global Trends and Future Perspectives.

INTRODUCTION: The rapid spread of COVID-19 across the globe is forcing surgical oncologists to change their daily practice. We sought to evaluate how breast surgeons are adapting their surgical activity to limit viral spread and spare hospital resources. METHODS: A panel of 12 breast surgeons from the most affected regions of the world convened a virtual meeting on April 7, 2020, to discuss the changes in their local surgical practice during the COVID-19 pandemic. Similarly, a Web-based poll based was created to evaluate changes in surgical practice among breast surgeons from several countries. RESULTS: The virtual meeting showed that distinct countries and regions were experiencing different phases of the pandemic. Surgical priority was given to patients with aggressive disease not candidate for primary systemic therapy, those with progressive disease under neoadjuvant systemic therapy, and patients who have finished neoadjuvant therapy. One hundred breast surgeons filled out the poll. The trend showed reductions in operating room schedules, indications for surgery, and consultations, with an increasingly restrictive approach to elective surgery with worsening of the pandemic. CONCLUSION: The COVID-19 emergency should not compromise treatment of a potentially lethal disease such as breast cancer. Our results reveal that physicians are instinctively reluctant to abandon conventional standards of care when possible. However, as the situation deteriorates, alternative strategies of de-escalation are being adopted. IMPLICATIONS FOR PRACTICE: This study aimed to characterize how the COVID-19 pandemic is affecting breast cancer surgery and which strategies are being adopted to cope with the situation.

Contemporary Multi-Institutional Cohort of 550 Cases of Phyllodes Tumors (2007-2017) Demonstrates a Need for More Individualized Margin Guidelines.

PURPOSE: Phyllodes tumors (PTs) are rare breast neoplasms, which have little granular data on margins. Current guidelines recommend ≥ 1 cm margins; however, recent data suggest narrower margins are sufficient, and for benign PT, a negative margin may not be necessary. METHODS: We performed an 11-institution contemporary (2007-2017) review of PT practices. Demographics, surgical, and histopathologic data were captured. Logistic regression was used to estimate the association of select covariates with local recurrence (LR). RESULTS: Of 550 PT patients, the majority underwent excisional biopsy (55.3%, n = 302/546) or lumpectomy (wide excision) (38.5%, n = 210/546). Median tumor size was 30 mm, 68.9% (n = 379) were benign, 19.6% (n = 108) borderline, and 10.5% (n = 58) malignant. Surgical margins were positive in 42% (n = 231) and negative in 57.3% (n = 311). A second operation was performed in 38.0% (n = 209) of the total cohort, including 51 patients with an initial negative margin (82.4% with < 2 mm), and 157 with an initial positive margin, with residual disease only found in six (2.9%). Notably, 32.0% (n = 74) of those with an initial positive margin did not undergo a second operation, among whom only 2.7% (n = 2) recurred. Recurrence occurred in 3.3% (n = 18) of the total cohort (n = 15 LR, n = 3 distant), at median follow-up of 36.7 months. LR (all PT grades) was not reduced with wider negative margin width (≥ 2 mm v < 2 mm: odds ratio [OR] = 0.39; 95% CI, 0.07 to 2.10; P = .27) or final margin status (positive v negative: OR = 0.96; 95% CI, 0.26 to 3.52; P = .96). CONCLUSION: In current practice, many patients are managed outside of current guidelines. For the entire cohort, a wider margin width was not associated with a reduced risk of LR. We do not recommend re-excision of a negative margin for benign PT, regardless of margin width, as a progressively wider surgical margin is unlikely to reduce LR.

Quality indicators for the diagnosis and surgical management of breast cancer in South Africa.

INTRODUCTION: Quality indicators (QIs) for breast cancer care have been developed and applied in high-income countries and contributed to improved quality of care and patient outcomes over time. MATERIALS AND METHODS: A modified Delphi process was used to derive expert consensus. Potential QIs were rated by a panel of 17 breast cancer experts from various subspecialties and across South African provinces. Each QI was rated according to importance to measure, scientific acceptability and feasibility. Scoring ranged from 1 (no agreement) to 5 (strong agreement). Inclusion thresholds were set a priori at mean ratings ≥4 with a coefficient variation of ≥25%. Levels of evidence were determined for each indicator. RESULTS: The literature review identified 790 potential QIs. After categorisation and removal of duplicates, 52 remained for panel review. There was strong consensus for 47 which were merged to 30 QIs by exclusion of similar indicators and indicator grouping. The final set included eight QIs with level I or II evidence and two QIs with level III evidence which were deemed "mandatory" due to clinical priority and impact on care. The remaining QIs with lower-level evidence were grouped as eight "recommended" QIs (regarded as standard of care) and twelve "optional" QIs (not regarded as standard of care). CONCLUSION: A regional set of QIs was developed to facilitate standardised treatment and auditing of surgical care for breast cancer patients in South Africa. Routine monitoring of the ten mandatory QIs, which were selected to have the most substantial impact on patient outcome, is proposed.

Influence of adherence with guideline-driven recommendations on survival in women operated for breast cancer: Real-life evidence from Italy.

BACKGROUND: A set of indicators to assess the quality of care for women operated for breast cancer was developed by an expert working group of the Italian Health Ministry in order to compare the Italian regions. A study to validate these indicators through their relationship with survival was carried out. METHODS: The 16,753 women who were residents in three Italian regions (Lombardy, Emilia-Romagna and Lazio) and hospitalized for breast cancer surgery during 2011 entered the cohort and were followed until 2016. Adherence to selected recommendations (i.e., surgery timeliness, medical therapy timeliness, appropriateness of complementary radiotherapy and mammographic follow-up) was assessed. Multivariable proportional hazards models were fitted to estimate hazard ratios for the association between adherence with recommendations and the risk of all-cause mortality. RESULTS: Adherence to recommendations was 53% for medical therapy timeliness, 73% for appropriateness of mammographic follow-up, 74% for surgery timeliness and 82% for appropriateness of complementary radiotherapy. Risk reductions of 26%, 62% and 56% were observed for adherence to recommendations on medical therapy timeliness, appropriateness of complementary radiotherapy and mammographic follow-up, respectively. There was no evidence that mortality was affected by surgery timeliness. CONCLUSIONS: Clinical benefits are expected from improvements in adherence to the considered recommendations. Close control of women operated for breast cancer through medical care timeliness and appropriateness of radiotherapy and mammographic monitoring must be considered the cornerstone of national guidance, national audits, and quality improvement incentive schemes.

Unexpected Obstruction of a Parker Flex-Tip Endotracheal Tube Caused by Outward Bending of Its Tip: A Case Report.

We report a case of Parker Flex-Tip endotracheal tube obstruction caused by its tip bending outward against the tube lumen. The Parker Flex-Tip tube tip is designed to bend inward to prevent damage to airway structures during intubation. However, when its tip is bent outward, the tube aperture is distorted, shifts against the tracheal wall, and is occluded. Moreover, the cross-sectional area of the openings on the side of the endotracheal tube, the "Murphy's eyes" which are ellipses, decrease because the openings are pulled parallel to their long axis. Outward bending of the tip can obstruct the tube.

Beyond the speed of SOUND.

Much anticipation awaits the results of the SOUND trial, (Gentilini and Veronesi in Breast 21:678-681, 2012) which may prove the futility of performing sentinel node biopsy (SNB) in low-risk breast cancer patients. However, do we really not know the answer to the questions that the SOUND trial poses already? Consideration must be taken of the very much overlooked trials predating the sentinel node era, which risk stratified patients according to the absence of palpable lymphadenopathy and without dependence upon ultrasound imaging (clinically negative axilla). This automatically selects a low-risk group of patients for axillary disease (low axillary burden) and the relevance of these critical trials is discussed.

A Roundtable Discussion of the Breast Cancer Therapy Expert Group (BCTEG): Clinical Developments and Practice Guidance on Human Epidermal Growth Factor Receptor 2 (HER2)-positive Breast Cancer.

Expression of human epidermal growth factor receptor 2 (HER2) in breast cancer defines a subset of patients (∼15%-20%) who are candidates for anti-HER2 therapies, most notably, trastuzumab, pertuzumab, antibody drug conjugates (eg, T-DM1), and tyrosine kinase inhibitor (TKI) drugs (eg, lapatinib and neratinib), all of which have dramatically changed the prognosis for this aggressive subtype of breast cancer. A roundtable meeting of the Breast Cancer Therapy Expert Group (BCTEG) was convened in March 2018 in an effort to discuss and clarify, from the perspective of the practicing community oncologist, recent developments in the diagnosis and treatment of HER2-positive (HER2+) breast cancer. Members of the group selected 4 key topics for discussion prior to the meeting, including diagnosis of HER2+ disease, and its treatment in the neoadjuvant, adjuvant, and metastatic settings. Approved testing methods, such as immunohistochemistry and fluorescence in situ hybridization, are used to demonstrate overexpression and/or amplification of HER2 in breast tumors, and established clinical guidelines are used to appropriately define treatment plans for patients with HER2+ disease. The panel acknowledges a range of treatment options now available for treatment of HER2+ breast cancer in the neoadjuvant, adjuvant, and advanced/metastatic settings, although it is noted that many controversies remain, including the optimal sequence of therapies, the most appropriate treatment(s) for subsets of patients with HER2+ disease (eg, hormone receptor-negative or -positive/HER2+), and uncertainties surrounding the diagnosis and definition of HER2+ disease. The current report summarizes the discussion of the BCTEG panel on this topic.

Case-Based Review and Clinical Guidance on the Use of Genomic Assays for Early-Stage Breast Cancer: Breast Cancer Therapy Expert Group (BCTEG).

In addition to classical clinicopathologic factors, such as hormone receptor positivity, human epidermal growth factor receptor 2 (HER2) status, and tumor size, grade, and lymph node status, a number of commercially available genomic tests may be used to help inform treatment decisions for early breast cancer patients. Although these tests improve our understanding of breast cancer and help to individualize treatment decisions, clinicians face challenges when deciding on the most appropriate test to order, and the advantages, if any, of one test over another. The Breast Cancer Therapy Expert Group (BCTEG) recently convened a roundtable meeting to discuss issues surrounding the use of genomic testing in early breast cancer, with the goal of providing practical guidance on the use of these tests by the community oncologist, for whom breast cancer may be only one of many tumor types they treat. The group recognizes that genomic testing can provide important prognostic (eg, risk for recurrence), and in some cases predictive, information (eg, benefit of chemotherapy, or extended adjuvant endocrine therapy), which can be used to help guide treatment decisions in breast cancer. The available tests differ in the types of information they provide, and in the patient populations and clinical trials that were conducted to validate them. We summarize the discussion of the BCTEG on this topic, and we also consider several patient cases and clinical scenarios in which genomic testing may, or may not, be useful to guide treatment decisions for the practicing community oncologist.

TP53 Mutations and Outcomes in Breast Cancer: Reading beyond the Headlines.

TP53 is the most frequently mutated gene in breast cancer, but its role in survival is confounded by different studies concluding that TP53 mutations are associated with negative, neutral, or positive outcomes. Closer examination showed that many studies were limited by factors such as imprecise methods to detect TP53 mutations and small cohorts that combined patients treated with drugs having very different mechanisms of action. When only studies of patients receiving the same treatment(s) were compared, they tended to agree. These analyses reveal a role for TP53 in response to different treatments as complex as its different biological activities. We discuss studies that have assessed the role of TP53 mutations in breast cancer treatment and limitations in interpreting reported results.

Timing between Breast Reconstruction and Oncologic Mastectomy-One Center Experience.

Background and objectives: Breast cancer is the most common cancer in women. The immunohistochemical profile, but also the stage of the tumor determines the therapeutic management, which varies from conservative surgery to mastectomy associated with chemotherapy, hormonal and biological therapy and/or radiotherapy. Mastectomy remains one of the most radical surgical intervention for women, having great consequences on quality of life, which can be improved by realizing immediate or delayed breast reconstruction. The objective of the study was to evaluate the period of time between the mastectomy and the breast reconstruction. Material and methods: We performed a retrospective study on 57 female patients admitted to the Plastic Surgery Department of the Clinical Emergency Hospital "Prof. Dr. Agrippa Ionescu", Bucharest, Romania. All the patients underwent immediate or delayed breast reconstruction after mastectomy for confirmed breast cancer. Descriptive data analysis was realized with evaluation of type of breast reconstruction considering the staging of the tumor, the invaded lymph nodes, and the necessity of adjuvant chemoradiotherapy. Moreover, the median period between mastectomy and reconstruction was evaluated. Results: The immediate breast reconstruction was performed in patients with stage I, in patients with stage II, delayed reconstruction was performed after minimum six months, and the patients with stage III had the breast reconstructed with free flap (50%), 8-43 months post-mastectomy. Radiotherapy determines the type of breast reconstruction, in most of the cases the latissimus dorsi flap was used with implant (22.6%). Conclusions: Breast reconstruction is an important step in increasing the quality of life for women who underwent mastectomy after breast cancer. The proper timing for breast reconstruction must be settled by a team formed by the patient, the plastic surgeon, and the oncologist.

Management of Male Breast Cancer: ASCO Guideline.

PURPOSE: To develop recommendations concerning the management of male breast cancer. METHODS: ASCO convened an Expert Panel to develop recommendations based on a systematic review and a formal consensus process. RESULTS: Twenty-six descriptive reports or observational studies met eligibility criteria and formed the evidentiary basis for the recommendations. RECOMMENDATIONS: Many of the management approaches used for men with breast cancer are like those used for women. Men with hormone receptor-positive breast cancer who are candidates for adjuvant endocrine therapy should be offered tamoxifen for an initial duration of five years; those with a contraindication to tamoxifen may be offered a gonadotropin-releasing hormone agonist/antagonist plus aromatase inhibitor. Men who have completed five years of tamoxifen, have tolerated therapy, and still have a high risk of recurrence may be offered an additional five years of therapy. Men with early-stage disease should not be treated with bone-modifying agents to prevent recurrence, but could still receive these agents to prevent or treat osteoporosis. Men with advanced or metastatic disease should be offered endocrine therapy as first-line therapy, except in cases of visceral crisis or rapidly progressive disease. Targeted systemic therapy may be used to treat advanced or metastatic cancer using the same indications and combinations offered to women. Ipsilateral annual mammogram should be offered to men with a history of breast cancer treated with lumpectomy regardless of genetic predisposition; contralateral annual mammogram may be offered to men with a history of breast cancer and a genetic predisposing mutation. Breast magnetic resonance imaging is not recommended routinely. Genetic counseling and germline genetic testing of cancer predisposition genes should be offered to all men with breast cancer.

Consensus Statement on Robotic Mastectomy-Expert Panel From International Endoscopic and Robotic Breast Surgery Symposium (IERBS) 2019.

OBJECTIVES: To achieve a consensus statement on robotic mastectomy. BACKGROUND: Robotic-assisted surgery has gained much attention especially the results of few case series reporting on the technical feasibility, safety and early oncologic outcomes of robotic-assisted mastectomy in a few centers worldwide. The aim of this consensus statement was to develop and provide standardized guidelines on robotic mastectomy based on consensus statement by a panel of experts from indications to outcome measures and indicators, thereby providing a valuable guide for breast surgeons worldwide. METHODOLOGY: An internationally representative expert panel of 10 surgeons was invited to participate in the generation of a consensus statement. 52 statements were created in 6 domains: indications, contraindications, technical considerations, patient counseling, outcome measures and indicators, training and learning curve assessment. Experts were asked to vote if they agree, disagree or of the opinion that the statement should be rephrased. Two electronic rounds via online survey of iterative rating and feedback were anonymously completed, followed by a final round of in-person meeting during the inaugural International Endoscopic and Robotic Breast Surgery Symposium 2019 from May 24 to 25, 2019. Consensus was reached when there was at least 80% agreement on each statement. RESULTS: A total of 53 statements with at least 80% agreement were generated after 3 rounds of voting; 21 statements from first round of voting, 20 statements from second round of voting and 12 statements from the final round of in-person meeting. All experts agreed that the consensus statement served as expert recommendations but not mandatory for a successful and safe practice of robotic mastectomy. CONCLUSION: Robotic mastectomy is a promising technique and could well be the future of minimally invasive breast surgery whereas proving to be safe and feasible. The first consensus statement on robotic mastectomy from an international panel of experts serves as an extremely important milestone and provides recommendations for breast surgeons keen to embark on this technique.

Pediatric Malignant Phyllodes Tumors of the Breast: Characteristics and Outcomes Based on the Surveillance Epidemiology and End Results Database.

BACKGROUND: Malignant phyllodes tumors of the breast are uncommon in women and rare in children. This study aimed to assess the differences in survival among five specific pathologic groups of breast malignancies and the differences between pediatric and adult breast phyllodes malignancy. MATERIALS AND METHODS: Using the Surveillance, Epidemiology, and End Results database, we collected data on 270 pediatric (aged ≤21 y) female breast malignant tumor patients and 2773 female malignant phyllodes tumor patients between 1976 and 2015. We evaluated survival differences among younger patients with breast malignancy and compared the pediatric and adult groups based on characteristics, treatment patterns, and survival months. Finally, we identified the risk and protective factors for breast phyllodes cases using a multivariable Cox analysis. RESULTS: We collected and analyzed 270 malignant breast cancer patients aged ≤21 y and 2773 malignant phyllodes tumor patients. Pediatric patients with malignant phyllodes tumors (22.2%, n = 60) exhibited better overall survival (OS; log-rank, P = 0.012) and cancer-specific survival (CSS; log-rank, P = 0.005) among the younger patients with malignant breast tumors. Furthermore, pediatric patients with malignant phyllodes tumors showed better OS (log-rank, P = 0.004), and similar CSS (log-rank, P = 0.105), compared with older patients. After adjustments for potential confounding factors, age >21 y, Black race, tumor size of >100 mm, high grade, wider invasion, positive nodal status, larger scope surgery, and no surgery were found to be associated with worse OS. All these factors, except for race, were found to be independent risk factors for CSS. CONCLUSIONS: The prognosis of malignant phyllodes tumors in children is better than that of adults. Appropriate surgical scope and risk of overtreatment should be considered when treating pediatric malignant phyllodes tumor patients.