Health care professionals overestimate the risk for locoregional recurrences after breast cancer treatment depending on their specialty.

PURPOSE: For the implementation of personalised surveillance, it is important to create more awareness among HCPs with regard to the risk for locoregional recurrences (LRRs). The aim of this study is to evaluate the current awareness and estimations of individual risks for LRRs after completion of primary treatment for breast cancer among health care professionals (HCPs) in the Netherlands, without using any prediction tools. METHODS: A cross-sectional survey was performed among 60 HCPs working in breast cancer care in seven Dutch hospitals and 25 general practitioners (GPs). The survey consisted of eleven realistic surgically treated breast cancer cases. HCPs were asked to estimate the 5-year risk for LRRs for each case, which was compared to the estimations by the INFLUENCE-nomogram using one-sample Wilcoxon tests. Differences in estimations between HCPs with different specialities were determined using Kruskal-Wallis tests and Dunn tests. RESULTS: HCPs tended to structurally overestimate the 5-year risk for LRR on each case. Average overestimations ranged from 4.8 to 26.1%. Groups of HCPs with varying specialities differed significantly in risk estimations. GPs tended to overestimate the risk for LRRs on average the most (15.0%) and medical oncologists had the lowest average overestimation (2.7%). CONCLUSIONS: It is important to create more awareness of the risk for LRRs, which is a pre-requisite for the implementation of personalised surveillance after breast cancer. Besides education for HCPs, the use of prediction models such as the INFLUENCE-nomogram can support in estimating an objective estimate of each individual patient's risk.

Trends on Axillary Surgery in Nondistant Metastatic Breast Cancer Patients Treated Between 2011 and 2015: A Dutch Population-based Study in the ACOSOG-Z0011 and AMAROS Era.

OBJECTIVES: To evaluate patterns of care in axillary surgery for Dutch clinical T1-4N0M0 (cT1-4N0M0) breast cancer patients and to assess the effect of the American College for Surgeons Oncology Group (ACOSOG)-Z0011 and After Mapping of the Axilla: Radiotherapy Or Surgery (AMAROS) trial on axillary surgery patterns in Dutch cT1-2N0M0 sentinel node positive breast cancer patients. BACKGROUND: Since publication of the ACOSOG-Z0011 and AMAROS trial, omitting a completion axillary lymph node dissection (cALND) in sentinel node positive breast cancer patients is proposed in selected patients. METHODS: Data were obtained from the nationwide Nationaal Borstkanker Overleg Nederland breast cancer audit. Descriptive analyses were used to demonstrate trends in axillary surgery. Multivariable logistic regression analyses were used to identify factors associated with the omission of cALND in cT1-2N0M0 sentinel node-positive breast cancer patients. RESULTS: Between 2011 and 2015 in cT1-4N0M0 breast cancer patients, the use of sentinel lymph node biopsy as definitive axillary staging increased from 72% to 93%, and (c)ALND as definitive axillary staging decreased from 24% to 6% (P < 0.001). The use of cALND decreased from 75% to 17% in cT1-2N0 sentinel node-positive patients (P < 0.001). Earlier year of diagnosis, lower age, primary mastectomy, invasive lobular subtype, increasing tumor grade, and treatment in a nonteaching hospital were associated with a lower probability of omitting cALND (P < 0.001). CONCLUSIONS: This study shows a trend towards less extensive axillary surgery in Dutch cT1-T4N0M0 breast cancer patients; illustrated by an overall increase of sentinel lymph node biopsy and decrease in cALND. Despite this trend, particularly noticed in cT1-2N0 sentinel node-positive patients after publication of the ACOSOG-Z0011 and AMAROS trial, variations in patterns of care in axillary surgery are still present.

Clinical auditing as an instrument for quality improvement in breast cancer care in the Netherlands: The national NABON Breast Cancer Audit.

BACKGROUND: In 2011, the NABON Breast Cancer Audit (NBCA) was instituted as a nation-wide audit to address quality of breast cancer care and guideline adherence in the Netherlands. The development of the NBCA and the results of 4 years of auditing are described. METHODS: Clinical and pathological characteristics of patients diagnosed with invasive breast cancer or in situ carcinoma (DCIS) and information regarding diagnosis and treatment are collected in all hospitals (n = 92) in the Netherlands. Thirty-two quality indicators measuring care structure, processes and outcomes were evaluated over time and compared between hospitals. RESULTS: The NBCA contains data of 56,927 patients (7,649 DCIS and 49,073 invasive cancers). Patients being discussed in pre- and post-operative multidisciplinary team meetings improved (2011: 83% and 91%; 2014: 98% and 99%, respectively) over the years. Tumour margin positivity rates after breast-conserving surgery for invasive cancer requiring re-operation were consistently low (∼5%). Other indicators, for example, the use of an MRI-scan prior to surgery or immediate breast reconstruction following mastectomy showed considerable hospital variation. CONCLUSIONS: Results shown an overall high quality of breast cancer care in all hospitals in the Netherlands. For most quality indicators improvement was seen over time, while some indicators showed yet unexplained variation. J. Surg. Oncol. 2017;115:243-249. © 2016 Wiley Periodicals, Inc.

Total pancreatectomy for primary pancreatic neoplasms: renaissance of an unpopular operation.

OBJECTIVE: To assess the long-term survival and quality of life in total pancreatectomies and to identify risk factors for perioperative morbidity and mortality. BACKGROUND: Total pancreatectomy may be required in locally advanced or centrally located pancreatic neoplasms to achieve complete tumor clearance, but available data on short- and long-term results are limited. METHODS: A total of 434 consecutive total pancreatectomies for primary pancreatic or periampullary tumors were performed between October 2001 and September 2012 at the authors' institution and were prospectively documented and analyzed. Long-term outcome was assessed using Kaplan-Meier and quality of life analysis (EORTC-QLQ-C30 and PAN26). Uni- and multivariate analysis was performed to identify perioperative risk factors and predictors for long-term survival. RESULTS: Extended total pancreatectomies were performed in 54% of cases, with arterial and portal vein resections in 15% and 32%, respectively. Overall 30-day and in-hospital mortality rates were 3.7% and 7.8%, respectively. High blood loss, long operative time, and arterial resections were independently associated with increased perioperative mortality (P ≤ 0.018). In malignant disease, median and 5-year survival were good for standard total pancreatectomies (28.6 months and 24.3%, respectively) and were significantly impaired after vascular resections (P < 0.001). Poor tumor grading, high American Joint Commission on Cancer tumor stage, age more than 70 years, and an R1 resection were independent prognostic parameters. Long-term global quality of life was comparable with a matched healthy control group. CONCLUSIONS: Standard total pancreatectomy, if needed, is associated with good long-term outcome in pancreatic cancer. Marked surgical morbidity and impaired survival associated with vascular resections reflect the invasiveness of extended total pancreatectomies and the underlying advanced malignant disease.

Toward International Harmonization of Breast Implant Registries: International Collaboration of Breast Registry Activities Global Common Data Set.

BACKGROUND: The Poly Implant Prothèse incident and breast implant-associated anaplastic large cell lymphoma have pointed to the need for uniform registries for breast implants as key features to monitoring the outcomes of breast implant surgeries internationally. The purpose of this study was to identify and harmonize common data elements collected by breast implant registries across the International Collaboration of Breast Registry Activities (ICOBRA) global consortium. METHODS: The authors convened an international group of surgeons, consumers, nurses, registry experts, and regulators to review the data points. A modified Delphi approach was applied, to rate the importance of each point on a six-point Likert scale. RESULTS: Data points from six national breast implant registries were divided into categories: clinical, implant-related, patient-reported findings; operation details and implanting technique details; patient characteristics; unique device identifiers; unique patient identifiers; and clinical demographics. A total of 52 data points collected by over 33 percent of national registries were identified. After five rounds, 34 data points formed the final set with agreed definitions. The group recognized the critical importance of additional elements that are currently not uniformly collected (e.g., patient-reported outcomes and long-term data) and set out the process for the dynamic global set updates driven by evidence gaps. CONCLUSIONS: The authors defined internationally agreed on common data elements and definitions used in breast implant registries. This collaboration will allow data sets to be combined, enabling an effective global early warning system of implant-related problems and further work on data sets.

Breast conserving therapy after neoadjuvant chemotherapy; data from the Dutch Breast Cancer Audit.

INTRODUCTION: NAC has led to an increase in breast conserving surgery (BCS) worldwide. This study aims to analyse trends in the use of neoadjuvant chemotherapy (NAC) and the impact on surgical outcomes. METHODS: We reviewed all records of cT1-4N0-3M0 breast cancer patients diagnosed between July 2011 and June 2016 who have been registered in the Dutch National Breast Cancer Audit (NBCA) (N = 57.177). The surgical outcomes of 'BCS after NAC' were compared with 'primary BCS', using a multivariable logistic regression model. RESULTS: Between 2011 and 2016, the use of NAC increased from 9% to 18% and 'BCS after NAC' (N = 4170) increased from 43% to 57%. We observed an involved invasive margin rate (IMR) of 6,7% and a re-excision rate of 6,6%. As compared to 'primary BCS', the IMR of 'BCS after NAC' is higher for cT1 (12,3% versus 8,3%; p < 0.005), equal for cT2 (14% versus 14%; p = 0.046) and lower for cT3 breast cancer (28,3% versus 31%; p < 0.005). Prognostic factors associated with IMR for both 'primary BCS' as for 'BCS after NAC' are: lobular invasive breast cancer and a hormone receptor positive receptor status (all p < 0,005). CONCLUSION: The use of NAC and the incidence of 'BCS after NAC' increased exponentially in time for all stages of invasive breast cancer in the Netherlands. This nationwide data confirms that 'BCS after NAC' compared to 'primary BCS' leads to equal surgical outcomes for cT2 and improved surgical outcomes for cT3 breast cancer. These promising results encourage current developments towards de-escalation of surgical treatment.

The Dutch Breast Implant Registry: Registration of Breast Implant-Associated Anaplastic Large Cell Lymphoma-A Proof of Concept.

BACKGROUND: The Dutch Breast Implant Registry (DBIR) was established in April of 2015 and currently contains information on 38,000 implants in 18,000 women. As a clinical registry, it evaluates the quality of breast implant surgery, including adverse events such as breast implant-associated (BIA) anaplastic large cell lymphoma (ALCL). To examine the efficacy of the DBIR, the capture rate of BIA-ALCL was compared to the registration of BIA-ALCL in the Dutch Nationwide Network and Registry of Histo- and Cytopathology (PALGA) as a gold standard, in combination with matching these databases to obtain complementary information. METHODS: All BIA-ALCL patients diagnosed and registered in The Netherlands in 2016 and 2017 were identified separately in the PALGA and DBIR databases. In addition, both databases were matched using indirect key identifiers. Pathologic information from the PALGA and clinical and device characteristics from the DBIR were obtained for all patients. RESULTS: Matching of both databases gave a capture rate of BIA-ALCL in the DBIR of 100 percent (n = 6) in 2016 and 70 percent (n = 7) in 2017. In total, 17 patients were identified in the PALGA, of which 14 patients were also identified in the DBIR; three patients were not registered; and 10 patients were registered false-positive. Of all confirmed patients, symptoms, staging results, treatment, and implant information were registered. CONCLUSIONS: Currently, the DBIR contains 2 full registration years and captures most of the BIA-ALCL patients despite overestimation. Therefore, pathology confirmation remains essential. By matching these databases, complementary clinical and implant information could be retrieved, establishing the DBIR as an essential postmarketing surveillance system for health risk assessments.

High risk device registries: Global value, costs, and sustainable funding.

BACKGROUND: Well-designed implant registries have been shown to be a worthwhile investment, from both a health and economic perspective. However, many registries do not attain desirable capture rates or lack sufficient funding, potentially leading to premature termination. This study aims to provide information about rarely discussed, yet pivotal topics regarding the long-term survival of implant registries, focusing on costs, funding models, and the role of stakeholders. METHODS: Worldwide, relatively recently developed breast device (BD) registries were compared to long-standing, orthopaedic (OD) and cardiovascular device (CD) registries. A standardised questionnaire was sent to the registries' designated representatives with key positions, discussing start-up costs, costs of maintenance, value of investment, governance, stakeholders, funding, and sustainability. RESULTS: Thirteen registries were included, originating from nine countries (seven BD registries, five OD registries, one CD registry). In general, start-up costs were comparable, and younger registries were more expensive to maintain. Numerous stakeholders showed interest in registry outcomes. However, only 50% of the registries reported a sustainable funding structure. CONCLUSION: This study provides a global perspective on implantable device registries. All registries provided important information, serving three unique purposes by evaluating the quality of healthcare provided, the quality of all registered devices, and processing recall information. Yet, only half of the registries were certain of sustainable funding, and thus their future existence. It is of utmost importance to bring this to the attention of all parties involved.