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Background: As a consequence of effective treatment procedures, the number of long-term survivors of colorectal cancer is ever increasing. Adopting the method of a previous study on breast cancer patients, the goal of the present research was to investigate colorectal cancer patients' recollections of their illness and treatment experiences up to seven years after they have been enrolled in a randomised controlled clinical trial on the direct improvement of quality of life (RCT DIQOL)., Methods: Colorectal cancer survivors in Bavaria, Germany were mailed a questionnaire on average 78·3 months after the start of their therapy and enrolment into RCT DIQOL. The questionnaire enquired about their worst experience during the colorectal cancer episode, positive aspects of the illness, and any advice they would give to newly diagnosed patients. Patient responses were categorised by two independent raters and cross-checked by a third independent rater. Frequencies of these categories were then quantitatively analysed using descriptive statistics., Results: Of 146 remaining survivors initially enrolled in RCT DIQOL, 96 (66%) returned the questionnaire. The majority (33%) of statements regarding the worst experience was referring to "psychological distress", followed by "indigestion and discomfort during defecation" (17%), and "cancer diagnosis" (16%). Among survivors with history of a stoma, the majority (36%) regarded "stoma" as their worst experience. With 45%, "change in life priorities" has been the most frequent positive category before "support by physicians/ nurses" (25%). 43% of the survivors deemed "fighting spirit" as most important advice to overcome the disease., Conclusion: Even after many years, colorectal cancer survivors clearly remember experiences from the time of their illness. Echoing the results of the previous breast cancer survivors' study, "psychological distress", "change in life priorities" and "fighting spirit" emerged as prominent concepts. In addition, some aspects like the impact of a stoma are of specific importance for colorectal cancer survivors. These findings can be used to inform programmes to improve patient- and quality of life centred aftercare of tumour patients., Clinical Trial Information: NCT04930016, date of registration 18.06.2021., (© 2023. The Author(s).)

Purpose: The effectiveness of a pathway with quality of life (QoL) diagnosis and therapy has been already demonstrated in an earlier randomized trial (RCT) in patients with breast cancer. We refined the pathway by developing and evaluating an electronic tool for QoL assessment in routine inpatient and outpatient care., Methods: In a single-arm study, patients with breast cancer with surgical treatment in two German hospitals were enrolled. QoL (EORTC QLQ-C30, QLQ-BR23) was measured with an electronic tool after surgery and during aftercare in outpatient medical practices (3, 6, 9, 12, 18, and 24 months) so that results (QoL-profile) were available immediately. Feedback by patients and physicians was analyzed to evaluate feasibility and impact on patient-physician communication., Results: Between May 2016 and July 2018, 56 patients were enrolled. Physicians evaluated the QoL pathway as feasible. Patients whose physician regularly discussed QoL-profiles with them reported significantly more often that their specific needs were cared for (p < .001) and that their physician had found the right treatment strategy for these needs (p < .001) compared with patients whose doctor never/rarely discussed QoL-profiles. The latter significantly more often had no benefit from QoL assessments (p < .001)., Conclusion: The QoL pathway with electronic QoL assessments is feasible for inpatient and outpatient care. QoL results should be discussed directly with the patient., Clinical Trial Information: NCT04334096, date of registration 06.04.2020., (© 2021. The Author(s).)

During the last decade, the emerging field of molecular fluorescence imaging has led to the development of tumor-specific fluorescent tracers and an increase in early-phase clinical trials without having consensus on a standard methodology for evaluating an optical tracer. By combining multiple complementary state-of-the-art clinical optical imaging techniques, we propose a novel analytical framework for the clinical translation and evaluation of tumor-targeted fluorescent tracers for molecular fluorescence imaging which can be used for a range of tumor types and with different optical tracers. Here we report the implementation of this analytical framework and demonstrate the tumor-specific targeting of escalating doses of the near-infrared fluorescent tracer bevacizumab-800CW on a macroscopic and microscopic level. We subsequently demonstrate an 88% increase in the intraoperative detection rate of tumor-involved margins in primary breast cancer patients, indicating the clinical feasibility and support of future studies to evaluate the definitive clinical impact of fluorescence-guided surgery.

Although patient-reported outcomes (PROs), such as health-related quality of life, are important endpoints in randomised controlled trials (RCTs), there is little consensus about the analysis, interpretation, and reporting of these data. We did a systematic review to assess the variability, quality, and standards of PRO data analyses in advanced breast cancer RCTs. We searched PubMed for English language articles published in peer-reviewed journals between Jan 1, 2001, and Oct 30, 2017. Eligible articles were those that reported PRO results from RCTs of adult patients with advanced breast cancer receiving anti-cancer treatments with reported sample sizes of at least 50 patients-66 RCTs met the selection criteria. Only eight (12%) RCTs reported a specific PRO research hypothesis. Heterogeneity in the statistical methods used to assess PRO data was observed, with a mixture of longitudinal and cross-sectional techniques. Not all articles addressed the problem of multiple testing. Fewer than half of RCTs (28 [42%]) reported the clinical significance of their findings. 48 (73%) did not report how missing data were handled. Our systematic review shows a need to improve standards in the analysis, interpretation, and reporting of PRO data in cancer RCTs. Lack of standardisation makes it difficult to draw robust conclusions and compare findings across trials. The Setting International Standards in the Analyzing Patient-Reported Outcomes and Quality of Life Data Consortium was set up to address this need and develop recommendations on the analysis of PRO data in RCTs., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Purpose: The 70-year threshold determines whether patients are eligible or not for the breast cancer screening program in Germany. It is not known whether this age threshold also influences the choice of adjuvant treatment and ultimate outcome., Methods: 3463 patients were analyzed from the clinical cancer registry Regensburg (Germany) with primary, non-metastatic invasive breast cancer diagnosed between 2000 and 2012. The distribution of tumor biological subtypes was evaluated in breast cancer patients both in those eligible for screening (ESG, 50-69 years) and those not eligible for screening (NESG, ≥70 years). Local and systemic therapies in different subtypes as well as overall survival (OS) were analyzed., Results: 2171 patients (62.7%) pertained to the ESG and 1292 patients (37.3%) referred to the NESG. The distribution of the common subtypes Luminal A, Luminal B, HER2-like, and Basal-like was comparable in both groups. Treatment varied considerably with less systemic therapies in all subtypes in patients in the NESG. Regarding local therapies, patients in the NESG also received less surgery and less radiotherapy. As to Luminal A patients, best OS was seen in patients receiving endocrine therapy (ET) (7-year OS of 95.6%) and CHT plus ET (7-year OS of 93.1%) in the ESG. In the NESG, best OS was seen in patients receiving CHT plus ET (7-year OS of 95.2%), whereas patients receiving only ET had a 7-year OS of 73.9%., Conclusions: Despite similar tumor biology, elderly patients are undertreated regarding both systemic and local therapies compared to younger patients, leading to reduced OS.

Background: The recollections of survivors of breast cancer are an important source of information about the disease for their family, friends, and newly diagnosed patients. So far, little is known about these memories. This study investigated how accurately survivors of breast cancer remember their past quality of life (QoL) during the disease and if this memory is modified by women`s present QoL and negative affect., Material and Methods: The longitudinal population-based study included 133 survivors of breast cancer (response rate 80%). Participants were asked for their present QoL and to recall their baseline QoL (EORTC QLQ-C30, QLQ-BR23) that had been assessed about seven years ago before discharge from hospital. The dependent variable was recall bias in ten QoL dimensions. Present QoL and negative affect (PANAS) were investigated as predictor variables., Results: Overall, baseline QoL was retrospectively underrated on seven out of ten scales whereas no significant overestimation was found. In multiple linear regression analyses, controlling for confounders, a stronger underrating of QoL was significantly predicted by a lower present QoL on nine out of ten scales and by higher negative affect on six scales., Conclusions: Survivors of breast cancer tend to underestimate their past QoL during the disease when asked about seven years later. Lower present QoL and higher negative affect contribute to this recall bias. This needs to be considered when interpreting retrospectively reported QoL data. Results are discussed in relation to theory of change or stability and mood congruency theory., Competing Interests: The authors have declared that no competing interests exist.

Purpose: Adjuvant endocrine therapy (ET) is indicated in patients with steroid hormone receptor (HR)-positive breast cancer. The aim of this study was to evaluate the quality of HR determination and adjuvant endocrine treatment of breast cancer patients in a large cohort of more than 7000 women by analyzing data from a population-based regional cancer registry., Methods: Data from the Clinical Cancer Registry Regensburg (Bavaria, Germany) were analyzed. Female patients with primary, nonmetastatic invasive breast cancer who were diagnosed between 2000 and 2012 (n = 7421) were included. HR-status was available in 97.4 % (n = 7229) of the patients. This data set (n = 7229) was used for subsequent statistical analyses., Results: Since 2009, almost a complete rate of 99.6 % of analyzed HR-status was achieved. In sum, 85.8 % of the patients (n = 6199) were HR-positive, whereas 14.2 % (n = 1030) were HR-negative. Overall, 85.3 % (n = 5285) of HR-positive patients received ET either alone or in combination with chemotherapy (CHT) and/or trastuzumab. The majority of premenopausal patients received CHT plus ET (716 patients, 52.3 %). In postmenopausal patients, the most frequent systemic therapy was ET alone (2670 patients, 55.3 %). Best overall survival (OS) was found in HER2-/HR-positive patients receiving CHT plus ET plus trastuzumab (7-year OS rate of 97.2 % in premenopausal patients versus 86.9 % in postmenopausal patients). Premenopausal patients had a reduced benefit from additional CHT than postmenopausal patients. Premenopausal patients receiving only ET had a 7-year OS rate of 95.3 % compared to 92.7 % of patients receiving CHT plus ET. In contrast, postmenopausal patients treated with CHT plus ET had a 7-year OS rate of 84.0 % in comparison with those patients receiving only ET with a 7-year OS rate of 81.7 %., Conclusions: Analysis of HR in patients with early breast cancer achieved a very high quality in recent years. The vast majority of HR-positive patients received ET, and this guideline-adherent use improved OS. Inverse effects of the CHT plus ET combination in premenopausal versus postmenopausal patients and a still existing minority of patients not receiving guideline-adherent treatment should be further investigated in future studies.

The aim of the present study was to evaluate to what extent the combination of standard histopathological parameters determines the biology of breast cancer and the effect on therapy and prognosis. The Clinical Cancer Registry Regensburg (Bavaria, Germany) included n = 4,480 female patients with primary, non-metastatic (M0) invasive breast cancer diagnosed between 2000 and 2012. Immuno-histochemical analyses, i.e., estrogen receptor (ER), progesterone receptor (PR), HER2, and Ki-67 (4-IHC), defined the tumor biological subtypes Luminal A, Luminal B, HER2-like, and Basal-like. Subtype-related differences in therapies and overall survival (OS) were analyzed using multivariable statistical methods. 4344 patients (97.0 %) could be classified into the four common tumor biological subtypes. The two most frequent entities were Luminal A (48.4 %), Luminal B (24.8 %), HER2-like (17.8 %), and Basal-like subtype (9.0 %). A multivariable Cox regression model showed that the best 7-year OS was seen in Luminal A patients and that OS of Luminal B and HER2-like patients was comparable (HR = 1.59, P < 0.001 versus HR = 1.51, P = 0.03). Lowest OS was seen in patients with Basal-like tumors (HR = 2.18, P < 0.001). In conclusion, the classification of tumor biological subtypes by the ER, PR, HER2, and Ki-67 biomarkers is practical in routine clinical work. Providing that quality assurance of these markers is ensured, this classification is useful for making therapy decisions in the routine clinical management of breast cancer patients.

Background: Little is known about the subjective experience of breast cancer survivors after primary treatment. However, these experiences are important because they shape their communication about their illness in everyday life, usage and acceptance of healthcare, and expectations of new generations of patients. The present study investigated this topic by combining qualitative and quantitative methods., Methods: Breast cancer survivors in Bavaria, Germany were mailed a questionnaire up to seven years after enrolment into a randomised controlled clinical trial and start of their therapy. This enquired about their worst experiences during the breast cancer episode, positive aspects of the illness and any advice they would give to newly diagnosed patients. A category system for themes was systematically created and answers were categorised by two independent raters. Frequencies of key categories were then quantitatively analysed using descriptive statistics. In addition, local treating physicians gave their opinion on the response categories chosen by their patients., Results: 133 (80%) of 166 eligible patients who survived up to seven years returned the questionnaire. The most prominent worst experience reported by survivors was psychological distress (i.e. anxiety, uncertainty; prevalence 38%) followed by chemotherapy (25%), and cancer diagnosis (18%). Positive aspects of the illness were reported by 48% with the most frequent including change in life priorities (50%) and social support (22%). The most frequent advice survivors gave was fighting spirit (i.e. think positive, never give up; prevalence 42%). Overall, physicians' estimates of the frequency of these responses corresponded well with survivors' answers., Conclusions: Although physicians' understanding of breast cancer patients was good, psychological distress and chemotherapy-related side effects were remembered as particularly burdensome by a substantial part of survivors. On the one hand, patients' quality of life needs to be assessed repeatedly during medical follow-up to identify such specific complaints also including specific recommendations to the physician for targeted psychosocial and medical support. On the other hand the advices and positive aspects of the disease, reported by the survivors, can be used to promote positive ways of coping with the illness.

Communication between physicians and patients in everyday life is marked by a number of disruptive factors. Apart from specific interests, mistakes, and misunderstandings on both sides, there are main factors that contribute to the risk in risk communication. Using the example of mammography screening, the current work demonstrates how the meaning of test results and the informative value of measures taken to reduce risk are often misunderstood. Finally, the current work provides examples of successful risk communication.

Even though randomized controlled clinical trials demonstrated improved survival by adjuvant trastuzumab treatment of HER2-positive breast cancer patients, data on its effect in clinical routine are scarce. This study evaluated the use and efficacy of trastuzumab in routine treatment of HER2-positive breast cancer patients. Data from the clinical cancer registry Regensburg (Germany) were analyzed. The present study investigated 6,991 female patients with primary invasive breast cancer. In premenopausal HER2-positive patients a considerable increase of trastuzumab therapy was observed from 58.1% in 2006 to 90.9% in 2011, whereas in postmenopausal patients trastuzumab was rather used on a constant rate of 49.1%. Best overall survival (OS) was found in HER2/steroid hormone receptor-positive patients receiving guideline concordant treatment with trastuzumab plus chemotherapy (CHT) plus antihormone therapy (AHT) with a 7-year OS rate of 96% compared to the non-trastuzumab group with a 7-year OS rate of 92%. In multivariable analysis, HER2-positive patients treated with CHT or AHT who did not get trastuzumab, had a worse 7-year OS (65%, P = 0.006 versus 79%, P = 0.017) than the control groups. This population-based study demonstrated that guideline concordant use of adjuvant trastuzumab improves OS for HER2-positive breast cancer patients treated in routine clinical care.

The proliferation marker Ki-67 is one of the most controversially discussed parameters for treatment decisions in breast cancer patients. The purpose of this study was to evaluate the routine use and value of Ki-67 as a prognostic marker, and to analyze the associations between Ki-67 and common histopathological parameters in the routine clinical setting. Data from the clinical cancer registry Regensburg (Bavaria, Germany) were analyzed. Within the total data pool of 4,692 female patients, who had been diagnosed between 2005 and 2011, in 3,658 cases Ki-67 was routinely determined. Thus, a total of 3,658 patients with invasive breast cancer were included in the present study and used for statistical analysis. Ki-67 expression was associated with the common histopathological parameters. The strongest correlation was found between grading and Ki-67 (P < 0.001). In terms of survival analyses, Ki-67 was categorized into five categories (reference category Ki-67 ≤15 %) due to a nonlinear relationship to overall survival (OS). In multivariable analysis, Ki-67 was an independent prognostic parameter both for disease-free survival (DFS) (Ki-67 > 45 %, HR = 1.96, P = 0.001) as well as for OS (Ki-67: 26-35 %, HR = 1.71, P = 0.017; Ki-67: 36-45 %, HR = 2.05, P = 0.011; Ki-67 > 45 %, HR = 2.06, P = 0.002) independent of common clinical and histopathological factors. The 5-year DFS (OS) rate was 86.7 % (89.3 %) in patients with a Ki-67 value ≤15 % compared to 75.8 % (82.8 %) in patients with a Ki-67 value >45 %. Based on the data from a large cohort of a clinical cancer registry, it was demonstrated that Ki-67 is frequently determined in routine clinical work. Ki-67 expression is associated with common histopathological parameters, but is an additional independent prognostic parameter for DFS and OS in breast cancer patients. Future work should focus on standardization of Ki-67 assessment and specification of its role in treatment decisions.

Public health research depends on empirical information that is based on data of high quality. The aim of this study was to apply the current guidelines developed by the Technology and Methodology Platform for Networked Medical Research (TMF) for the independent assessment and enhancement of data quality. A clinical register of female breast cancer patients from two periods (N = 389 of 1996-1997 and N = 488 of 2003-2004) was used. To check the plausibility, organization, and correctness of the data quality levels, data quality indicators (DQI) were chosen, operationalized, and the variance ratios of normative-analytic-defined thresholds were calculated. Significant deviations led to data improvement, which included the commonly known source data verification (SDV). A summary data quality score was calculated before and after application of the guidelines. Eleven out of 24 DQIs were tested. Data quality systematically increased from 51.6 to 67.7%. The guidelines facilitate a systematic assessment and improvement of data quality with a reasonable use of resources. This target-oriented procedure allows for a high transparency of the available data quality, which is essential for health research.

Background: Despite thousands of papers, the value of quality of life (QoL) in curing disease remains uncertain. Until now, we lacked tools for the diagnosis and specific treatment of diseased QoL. We approached this problem stepwise by theory building, modelling, an exploratory trial and now a definitive randomised controlled trial (RCT) in breast cancer, whose results we report here., Methods: In all, 200 representative Bavarian primary breast cancer patients were recruited by five hospitals and treated by 146 care professionals. Patients were randomised to either (1) a novel care pathway including diagnosis of 'diseased' QoL (any QoL measure below 50 points) using a QoL profile and expert report sent to the patient's coordinating practitioner, who arranged QoL therapy consisting of up to five standardised treatments for specific QoL defects or (2) standard postoperative care adhering to the German national guideline for breast cancer. The primary end point was the proportion of patients in each group with diseased QoL 6 months after surgery. Patients were blinded to their allocated group., Results: At 0 and 3 months after surgery, diseased QoL was diagnosed in 70% of patients. The QoL pathway reduced rates of diseased QoL to 56% at 6 months, especially in emotion and coping, compared with 71% in controls (P=0.048). Relative risk reduction was 21% (95% confidence interval (CI): 0-37), absolute risk reduction 15% (95% CI: 0.3-29), number needed to treat (NNT)=7 (95% CI: 3-37). When QoL therapy finished after successful treatment, diseased QoL often returned again, indicating good responsiveness of the QoL pathway., Conclusion: A three-component outcome system including clinician-derived objective, patient-reported subjective end points and qualitative analysis of clinical relevance was developed in the last 10 years for cancer as a complex intervention. A separate QoL pathway was implemented for the diagnosis and treatment of diseased QoL and its effectiveness tested in a community-based, pragmatic, definitive RCT. While the pathway was active, it was effective with an NNT of 7.

Introduction: The goal of the 2008 updated guideline: early detection of breast cancer in Germany is to support physicians as well as healthy and affected women in the decision-making process involved in the diagnostic chain for the early detection of breast cancer by providing them with evidence- and consensus-based recommendations. The updated guideline replaces the guideline issued in 2003., Materials and Methods: The guideline forms the basis for developing an effective and efficient national early breast cancer detection program that meets the standards set by the Council of Europe and WHO for cancer control programs. The guideline presents the current, evidence- and consensus-based state of scientific knowledge in a multidisciplinary approach for the entire diagnostic chain, consisting of history taking and risk consultation, information on health behavior, clinical breast examination, diagnostic imaging, image-guided percutaneous tissue-acquisition techniques, open surgical excisional biopsy and pathomorphological tissue evaluation. The guideline recommends a set of quality indicators to assure resource availability, performance quality and outcomes enhancing total quality management for early breast cancer diagnosis., Conclusion: Currently, early detection of breast cancer offers the most promising possibility to optimize the diagnosis and treatment of breast cancer and, as a result, reduce breast cancer mortality and improve health related quality of life in women.

A system for quality-of-life diagnosis and therapy (QoL system) was implemented for breast cancer patients. The system fulfilled the criteria for complex interventions (Medical Research Council). Following theory and modeling, this study contains the exploratory trial as a next step before the randomised clinical trial (RCT) answering three questions: (1) Are there differences between implementation sample and general population? (2) Which amount and type of disagreement exist between patient and coordinating practitioners (CPs) in assessed global QoL? (3) Are there empirical reasons for a cutoff of 50 points discriminating between healthy and diseased QoL? Implementation was successful: 74% of CPs worked along the care pathway. However, CPs showed preferences for selecting patients with lower age and UICC prognostic staging. Patients and CPs disagreed considerably in values of global QoL, despite education in QoL assessment by outreach visits, opinion leaders and CME: Zero values of QoL were only expressed by patients. Finally, the cutoff of 50 points was supported by the relationship between QoL in single items and global QoL: no patients with values above 50 dropped global QoL below 50, but values below 50 and especially at 0 points in single items, induced a dramatic fall of global QoL down to below 50. The exploratory trial was important for defining the complex intervention in the definitive RCT: control for age and prognostic stage grading, support for a QoL unit combining patient's and CP's assessment of QoL and support for the 50-point cutoff criterion between healthy and diseased QoL.

The updated 2008 German Guideline for Early Detection of Breast Cancer provides evidence-based and consensus-based recommendations of the knowledge gained by the German Society for Surgery and the German Society of Plastic, Aesthetic, and Reconstructive Surgeons together with 29 professional societies, associations, and nonmedical organizations. The guideline is meant to assist physicians, healthy women, and patients in medical decisions with recommendations regarding the diagnostic chain in early detection of breast cancer. In addition to these recommendations, the guideline also includes descriptions of quality assurance for resources, procedures, outcomes, and evaluation using a set of quality indicators. It updates the previous version from 2003. The guideline's recommendations are presented. They are described in detail in the full publication (in German) Geburtsh Frauenh 2008; 68:251-261. The long version of the Guideline, methods report, and evidence report are available on the internet at www.awmf-leitlinien.de (reg. no. 077/001) with free access.

Background and Aims: A system for quality of life (QoL) diagnosis and therapy in breast cancer patients was developed according to the Medical Research Council (MRC) framework of complex interventions. Along MRC's five phases in the continuum of evidence, the present paper deals with phase I: modeling (i.e., delineating the conceptual, methodological, and logistic requirements)., Basic Elements: Theoretical background is a new conceptualization of QoL that provides a rational basis to diagnose "diseased" QoL. A care pathway as the central part of modeling is composed of the following interrelated structural elements: patients (n = 170), clinicians (n = 10), experts in a quality of life unit (n = 5), coordinating practitioners (n = 38), local opinion leaders (n = 12), and professional therapists for QoL enhancing therapies (n = 75). Networking of these structural elements was achieved by clinical algorithm. In the clinical center, the patient and doctor delivered a questionnaire (EORTC) and health status report. The QoL unit transformed it into a profile and experts' report. The coordinating practitioner transformed the latter into a decision on QoL therapy and the care pathway ended with the professional therapists. Implementation of this system used a multifaceted strategy including educational outreach visits, local opinion leaders, and quality circles., Conclusion: The suffering cancer patient is the main focus of this QoL diagnosis and therapy system. It will have to pass the rigorous test of a definitive randomized trial.

Objectives: Improvements in the life expectancy of women with breast cancer raise important questions how to improve quality of life (QoL) for women sustaining complications and side effects of cancer treatment. The presented study examined the prevalence of arm morbidity in a cohort of primary breast cancer patients over time as a result of the extent of axillary lymph node dissection. Of particular interest is the question of using a recognized QoL assessment instrument at defined assessment points as an endpoint criteria of oncological treatment., Methods: A prospective, population-based, longitudinal cohort study of patients with primary breast cancer was performed (n = 389). QoL data (EORTC QLQ C30 + BR23) and clinical data were assessed at designated time points. Primary endpoint of this analysis was patient reported arm morbidity assessed with the three-idem scale in the BR 23 (swelling, moving, pain)., Results: 20% of the patients evidenced considerable impairments in arm functioning. Arm morbidity was significantly related to the number of lymph nodes dissected (P < 0.002 entire cohort, P < 0.001 lymph node negatives) and was independent of age, stage of the disease, kind of breast surgery and radiation treatment. Early impairments in arm functioning (below 50 score values) assessed within 6 months after axillary surgery was a good predictor for late arm morbidity at 12 months RR 11.5 (CI 95% 4.7-28.4), 24 months RR 6.0 (CI95% 2.8-13.3) and 36 months RR 3.8 (CI 95% 1.8-7.9)., Conclusions: Arm morbidity after axillary surgery is a severe and chronic condition affecting many breast cancer patients. The recognized QoL assessment instrument depict patients with severe impairments in arm functioning after axillary lymph node dissection and predict late arm morbidity. To increase patients' quality of life it thus may serve as a valid assessment tool for screening, allowing early referral for treatment and monitoring.

Background: The project conducted at the Tumour Centre in Regensburg aims to integrate quality of life (QL) diagnostics with the therapy of breast cancer patients and to evaluate the efficacy of QL diagnostics in the context of a randomized clinical trial., Methods: The Regensburg Tumour Centre provides the infrastructure of the present project (telemedicine, project groups, quality circle). The treatment of breast cancer patients is based on the recent national breast cancer therapy guideline, including assorted QL-enhancing therapy options such as pain therapy, physiotherapy and lymphatic drainage, psychotherapy, social counselling and rehabilitation, nutrition and sports. During an implementation phase a new method of QL diagnostics has been developed. Five experts with varying professional background use the individual patient's QL profile and clinical and socio-demographic information in order to generate a QL report including a treatment recommendation. The study is designed as a two- arm randomized clinical trial with one test group (communication of the QL findings to the co-ordinating physician) and a control group (no communication). Patients with newly diagnosed breast cancer who are treated in the study region by one of the co-ordinating doctors will be included in this randomized study. At designated points in time QL assessments (EORTC QLQ-C30 plus BR23) will be conducted over a 12-months period., Expected Results: We expect that patients in the test group will experience a lower amount of QL deficits at the end of the study period (M = 1, SD = 2) than patients in the control group (M = 2, SD = 2). The statistical confirmation of this expected effect requires a total sample size of N = 200 (n = 100 vs. n = 100, alpha = 5% [two-tailed], beta = 10%)., Conclusions: This is the first study to evaluate a new form of QL diagnostics in the complexity of a real patient care environment, and it promises to make the inclusion of the quality of life concept into the current breast cancer treatment guideline more tangible.

The aim of this evidence-, consensus- and outcome-based good clinical practice guideline is to help physicians, and women in making appropriate healthcare decisions about the early detection of breast cancer. The principle of early detection of breast cancer comprises the detection and diagnosis of pre-malignant breast tumours (UICC stage 0, carcinoma in situ) with a possible cancer risk reduction and the detection and diagnosis of breast cancer at an early stage (UICC stage 1) with a scientifically proven 90% chance of cure. By establishing a nation-wide comprehensive quality assurance program for the early detection of breast cancer this guideline lays the foundation for a timely reduction of breast cancer mortality and achievement of cure with less impairment of patient's quality of life. It would appear that this guideline makes major improvements in women's healthcare feasible.

Systematically developed, evidence- and consensus-based guidelines are important tools for improving health care services. The effectiveness of a guideline does not only relate to its methodological quality but also to the implementation strategy used. The following paper describes the systematic development of a strategy for implementing and evaluating the guideline "Early Detection of Breast Cancer in Germany" as part of a national project. A multi-faceted systematic implementation strategy has been developed addressing existing barriers and building on projects that have recently been introduced in Germany to improve the early detection and management of breast cancer. The aim is to induce behavioural changes in women as healthcare recipients and physicians as healthcare providers, both involved in the medical decision-making process within the scope of the guideline. Furthermore, it supports organisational changes to assure compliance with the guideline by means of quality assurance and quality management. To ensure evaluation of the implementation process a set of quality indicators have been identified for the baseline assessment of structures, provider performance and outcomes. Both the effectiveness of the implementation process and the effectiveness of the guideline itself will be measured by using the same set of indicators for reevaluation within a pre-defined time interval of 18 months. The quasi-experimental design of this uncontrolled before and after implementation study outlined in the present paper allows the assessment of clinically relevant changes using quality indicators that measure the effectiveness of the guideline on a national level.

Background: The present analysis focuses on the long term psychological reactions to early stage breast cancer. Two hypotheses were formulated. The first hypothesis draws a direct link between tumour size/survival chances and Quality of life (QoL): The better the survival chances, the better QoL ('biological danger model'). The second hypothesis assumes that localized early breast cancer has excellent prognosis (> 90% five year survival rate), and that therefore QoL differences between various forms of early breast cancer should be minimal ('medico-pragmatic model')., Patients and Methods: In a defined rural area with 252.000 inhabitants (small-area-analysis), a total of n = 389 patients with primary breast cancer were recruited. For the present analysis we selected a subgroup (n = 269) from the cohort by tumour size (pTis, pT1a,b, pT1c, and pT2). QoL scores for global quality of life, emotional functioning and future perspective were computed according to the EORTC manual and compared to age-matched norm data of the German population., Results: A total of 690 QoL questionnaires were obtained from n = 269 patients with comparable completion rates within the four subgroups (pTis, pT1a,b, pT1c, and pT2). For all four groups and in all scores there were improvements over time. Generally, pTis always scored highest, pT2 always lowest, the other two groups in between. After one year pTis patients had higher mean scores in global quality of life than the norm. In contrast, pT1a,b were considerably lower than the norm and the difference between these two was 17.2 score points. It seems that the small difference (3.5%) in five year survival chances between pTis and T1 a,b tumours transforms into marked differences regarding quality of life, thus supporting a biological danger model of the survival/QoL relationship., Conclusions: Our results show that physicians have to realise although their early breast cancer patients have excellent survival chances, psychological distress is present. From a clinical perspective we would recommend that early stage breast cancer patients, and especially patients with occult, pT1a,b tumours be informed about their excellent prognosis. In addition, cognitive therapy might help patients stop worrying about their cancer., (Copyright 2004 Birkhäuser Verlag, Basel)

Background and Objectives: Breast-conserving surgery requires excision of all gross tumor and subsequent radiation therapy. It is generally accepted that the presence of microscopically positive margins requires reexcision. The goal of this study was to identify characteristics that distinguish breast biopsy specimens with positive margins that when reexcised are free from residual tumor. This population of patients may benefit from breast irradiation only, without the need for another surgical procedure., Methods: One hundred and fifteen of 395 cancer-proven biopsies had positive surgical margins and were treated with reexcision or mastectomy. Sixty-seven of these were negative for residual tumor and 48 were positive for residual tumor. Evaluation for tumor type, tumor size, grade, presence of vascular invasion, volume of the biopsy specimen, true positivity and the number of positive margins, multifocality of the tumor, and type of anesthesia was done by univariate and multivariate analysis., Results: Univariate and multivariate analysis revealed that factors associated with a positive reexcision included margin status, method of detection, histologic appearance, and type of anesthesia used., Conclusion: These results suggest that small, clinically detectable unifocal tumors could be treated without the need for a further excision. Eradication of microscopic residual tumor could be done by irradiation only, sparing the patient an additional surgical procedure.

Aims: Axillary node dissection for breast cancer is important for staging and its prognostic value. Sentinel nodes are defined as the first nodes into which the primary cancer drains. This study investigates whether identification, removal and pathological examination of these nodes indicates whether the completion of axillary lymphadenectomy is required., Methods: Using a vital dye injected at the primary tumour site, we were able to identify sentinel nodes in 96 out of 98 women examined., Results: An average number of 2.7 +/- 1.2 nodes per patient were identified as sentinel nodes. In 83% of cases there was a correlation between the involvement of the sentinel nodes and the rest of the axillary nodes. In 14% of patients the sentinel nodes were the only nodes involved with tumour. In three cases the sentinel nodes were negative, but other axillary nodes were tumour-positive., Conclusion: The major problem in routine application of this method to the decision to perform axillary lymph node dissection (ALND) is the time needed for pathological identification of lymph node involvement by tumor.

Background: Efforts directed at early detection of breast cancer have resulted in an increased incidence of nonpalpable mammographic lesions that warrant excisional biopsy. The most common localization method is by use of the hook wire technique, or needle localization biopsy. Although much has been written about the localization technique, the impact of the method of anesthesia on the accuracy of the biopsy and especially on the completeness of the excision has not been clarified., Patients and Methods: We studied 450 needle localization breast biopsies to determine whether the type of anesthesia (local versus general) influenced the accuracy and completeness of the biopsy. We compared 153 biopsies performed under local anesthesia to 297 done under general anesthesia., Results: The use of local versus general anesthesia did not affect accuracy; however, it did determine the inability to achieve clean margins (27.6% versus 7.3%, respectively, P <0.02). It was more difficult to excise completely specimens located deeper than 3 cm in the breast, when the localizing needle travelled more than 3 cm, and when the lesions were of the microcalcification mammographic pattern., Conclusions: For lesions mammographically suspicious for malignancy, mainly those located deeper than 3 cm, general anesthesia is preferred.

Breast self examination (BSE) is recommended for the early detection of breast cancer in the European Code against Cancer. Evidence from North America suggests that there is reasonable public awareness of its importance, but compliance with regular BSE is reported by only a minority of young women. Attitudes to and practice of BSE has rarely been studied outside North America. In the present study, attitudes to BSE were evaluated by questionnaire in a sample of 16,486 students aged 17-30 from 20 European countries. Frequency of BSE practice was reported by the 9,181 women in the sample. Information on public recommendations concerning BSE was obtained from cancer organizations in each country. The data were collected as part of the European Health Behaviour Survey, an international study on health beliefs and health behaviour. The results showed that BSE was recommended in 16 countries and 'breast awareness' in two, while two countries did not recommend self-examination. 54% of women reported as never having practiced BSE. Regular practice (monthly) was reported by only 8% of the sample, with another 36% reporting occasional BSE. Significant differences emerged between centres in different countries ranging from 6% to 15% reporting regular BSE. Attitude towards BSE was a significant predictor of BSE practice within each centre and across all centres combined. Attitudes towards BSE were significantly less positive in the two centres from countries without BSE recommendations than in the others, but levels of practice were similar.(ABSTRACT TRUNCATED AT 250 WORDS)

Adenoid cystic carcinoma of the breast is a rare neoplasm that usually has a benign biological behavior. A patient who was operated upon for removal of this tumor developed metastases to the lungs and brain 12 years after mastectomy. This is probably the first report in the literature of brain metastasis from adenoid cystic carcinoma of the breast. Radiological and histological evidence of both primary breast tumor and the metastasis to the brain are presented.