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1.
Arch Gynecol Obstet ; 2020 Jan 27.
Artigo em Inglês | MEDLINE | ID: mdl-31989290

RESUMO

PURPOSE: This study aims to answer the questions where breast cancer patients in Germany receive follow-up care (with what types of doctors) and what are the long-term problems and treatment regrets of breast cancer patients. METHODS: In the prospective multicenter cohort study BRENDA II ("Breast Cancer under Evidence-Based Guidelines"), 456 patients with primary breast cancer were sampled consecutively over a period of 4 years (2009-2012) and contacted again 5 years after surgery. Long-term problems were elicited on a 4-point Likert scale ranging from 0 ('not at all') to 3 ('very much'). RESULTS: 82% of the patients receive follow-up (FU) at the private practice gynecologist. In 22%, the initial treating hospital is involved in the FU, and in 20% the general practitioner does this (multiple answers possible). Long-term problems attributed to the treatment were most often related to endocrine therapy (mean 1.29) and to chemotherapy (mean 0.94). Most of the patients were happy to have had radiotherapy (95%). For chemotherapy, endocrine therapy, and antibody therapy, the satisfaction for the treatment decision was 87%, 87%, and 84% respectively. Among patients who reported they regretted having undergone a recommended treatment, it was most often for endocrine therapy (5%) and chemotherapy (4%). CONCLUSION: In Germany, different specialists are involved in the patients' FU care for BC. The detection of long-term problems due to BC treatment is an essential part of FU care.

2.
PLoS One ; 14(7): e0218434, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31283775

RESUMO

BACKGROUND: In this study based on the BRENDA data, we investigated the impact of endocrine ± chemotherapy for luminal A, nodal positive breast cancer on recurrence free (RFS) and overall survival (OS). In addition, we analysed if tumor size of luminal A breast cancer influences survival in patients with the same number of positive lymph nodes. METHODS: In this retrospective multi-centre cohort study data of 1376 nodal-positive patients with primary diagnosis of luminal A breast cancer during 2001-2008 were analysed. The results were stratified by therapy and adjusted by age, tumor size and number of affected lymph nodes. RESULTS: In our study population, patients had a good to excellent prognosis (5-year RFS: 91% and tumorspecific 5-year OS 96.5%). There was no significant difference in RFS stratified by patients with only endocrine therapy and with endocrine plus chemo-therapy. Patients with 1-3 affected lymph nodes had no significant differences in OS treated only with endocrine therapy or with endocrine plus chemotherapy, independent of tumor size. Patients with large tumors and more than 3 affected lymph nodes had a significant worse survival as compared to the small tumors. However, despite the worse prognosis of those, adjuvant chemotherapy failed in order to improve RFS. CONCLUSIONS: According to our data, nodal positive patients with luminal A breast cancer have, if any, a limited benefit of adjuvant chemotherapy. Tumor size and nodal status seem to be of prognostic value in terms of survival, however both tumor size as well as nodal status were not predictive for a benefit of adjuvant chemotherapy.

3.
Dtsch Med Wochenschr ; 144(14): 990-996, 2019 07.
Artigo em Alemão | MEDLINE | ID: mdl-31096279

RESUMO

The AWMF and its medical societies perceive an increasing dominance of economic targets in the hospital health care sector, leading to impairment of patient care. While resource use in health care should be appropriate, efficient and fairly allocated, "economization" creates a burdensome situation for physicians, nurses and other health care professionals.The AMWF and the medical societies studied causes and developed measures for a scientific, patient-centred and resource-conscious medical care. Disincentives due to the remuneration system, number and equipment of hospitals resp. specialist departments and their basic funding need to be overcome. Proposed actions relate to the patient-doctor-level, the management level of hospitals and the level of planning and financing hospitals including compensation of hospital care. To place patients and their health in the forefront again, joint efforts of all stakeholders in health care are needed.


Assuntos
Economia Hospitalar , Administração Hospitalar , Assistência Centrada no Paciente/economia , Sociedades Médicas/organização & administração , Humanos
4.
Breast J ; 25(3): 386-392, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30945393

RESUMO

BACKGROUND: This study examined the association between cognitive impairment and guideline adherence for application of chemotherapy in older patients with breast cancer. PATIENTS AND METHODS: In the prospective multicenter cohort study BRENDA II, patients aged ≥65 years with primary breast cancer were sampled over a period of 4 years (2009-2012). A multiprofessional team (tumor board) discussed recommendation for adjuvant chemotherapy according to the German S3 guideline. Cognitive impairment was screened by the clock-drawing test (CDT) prior to adjuvant treatment. RESULTS: Two hundred and sixty-three patients were included in the study and CDT data were available for 193 patients. Thirty-one percent of the patients had cognitive impairment with different degree of severity. In high-risk patients (n = 61) tumor board recommendation in favor of chemotherapy was 90% and in intermediate-risk patients (n = 170) 27%. Not receiving recommendation for chemotherapy in spite of guideline recommendation was more frequent in patients with cognitive impairment (67%) vs patients without cognitive impairment (46%) with P = 0.02 (OR 2.4, 95% confidence interval (CI) 1.2-4.9). Age, education, migration background and comorbidities were not associated with chemotherapy recommendation by the tumor board among cognitively impaired patients. Once the tumor board had recommended chemotherapy, application of chemotherapy was similar in both groups of patients with or without cognitive impairment. CONCLUSION: Almost one third of older patients with breast cancer are affected by cognitive impairment prior to adjuvant treatment. In these patients, cognitive impairment was associated with tumor board decision against chemotherapy in spite of a positive guideline recommendation.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/psicologia , Disfunção Cognitiva/etiologia , Fidelidade a Diretrizes , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/complicações , Quimioterapia Adjuvante , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Prospectivos
5.
BMC Cancer ; 19(1): 90, 2019 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-30658597

RESUMO

BACKGROUND: The decision making process for axillary dissection has changed in recent years for patients with early breast cancer and positive sentinel lymph nodes (LN). The question now arises, what is the optimal surgical treatment for patients with positive axillary LN (pN+). This article tries to answer the following questions: (1) Is there a survival benefit for breast cancer patients with 3 or more positive LN (pN3+) and with more than 10 removed LN? (2) Is there a survival benefit for high risk breast cancer patients (triple negative or Her2 + breast cancer) and with 3 or more positive LN (pN3+) with more than 10 removed LN? (3) In pN + patients is the prognostic value of the lymph node ratio (LNR) of pN+/pN removed impaired if 10 or less LN are removed? METHODS: A retrospective database analysis of the multi center cohort database BRENDA (breast cancer under evidence based guidelines) with data from 9625 patients from 17 breast centers was carried out. Guideline adherence was defined by the 2008 German National consensus guidelines. RESULTS: 2992 out of 9625 patients had histological confirmed positive lymph nodes. The most important factors for survival were intrinsic sub types, tumor size and guideline adherent chemo- and hormonal treatment (and age at diagnosis for overall survival (OAS)). Uni-and multivariable analyses for recurrence free survival (RFS) and OAS showed no significant survival benefit when removing more than 10 lymph nodes even for high-risk patients. The mean and median of LNR were significantly higher in the pN+ patients with ≤10 excised LN compared to patients with > 10 excised LN. LNR was in both, uni-and multivariable, analysis a highly significant prognostic factor for RFS and OAS in both subgroups of pN + patients with less respective more than 10 excised LN. Multivariable COX regression analysis was adjusted by age, tumor size, intrinsic sub types and guideline adherent adjuvant systemic therapy. CONCLUSION: The removal of more than 10 LN did not result in a significant survival benefit even in high risk pN + breast cancer patients.


Assuntos
Axila , Neoplasias da Mama/cirurgia , Mama/cirurgia , Excisão de Linfonodo/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Mama/metabolismo , Mama/patologia , Neoplasias da Mama/metabolismo , Neoplasias da Mama/patologia , Intervalo Livre de Doença , Feminino , Humanos , Excisão de Linfonodo/estatística & dados numéricos , Pessoa de Meia-Idade , Análise Multivariada , Receptor ErbB-2/metabolismo , Estudos Retrospectivos , Fatores de Risco
6.
Geburtshilfe Frauenheilkd ; 78(11): 1056-1088, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30581198

RESUMO

Purpose The aim of this official guideline coordinated and published by the German Society for Gynecology and Obstetrics (DGGG) and the German Cancer Society (DKG) was to optimize the screening, diagnosis, therapy and follow-up care of breast cancer. Method The process of updating the S3 guideline published in 2012 was based on the adaptation of identified source guidelines. They were combined with reviews of evidence compiled using PICO (Patients/Interventions/Control/Outcome) questions and with the results of a systematic search of literature databases followed by the selection and evaluation of the identified literature. The interdisciplinary working groups took the identified materials as their starting point and used them to develop suggestions for recommendations and statements, which were then modified and graded in a structured consensus process procedure. Recommendations Part 2 of this short version of the guideline presents recommendations for the therapy of primary, recurrent and metastatic breast cancer. Loco-regional therapies are de-escalated in the current guideline. In addition to reducing the safety margins for surgical procedures, the guideline also recommends reducing the radicality of axillary surgery. The choice and extent of systemic therapy depends on the respective tumor biology. New substances are becoming available, particularly to treat metastatic breast cancer.

7.
Geburtshilfe Frauenheilkd ; 78(10): 927-948, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30369626

RESUMO

Purpose The aim of this official guideline coordinated and published by the German Society for Gynecology and Obstetrics (DGGG) and the German Cancer Society (DKG) was to optimize the screening, diagnosis, therapy and follow-up care of breast cancer. Methods The process of updating the S3 guideline dating from 2012 was based on the adaptation of identified source guidelines which were combined with reviews of evidence compiled using PICO (Patients/Interventions/Control/Outcome) questions and the results of a systematic search of literature databases and the selection and evaluation of the identified literature. The interdisciplinary working groups took the identified materials as their starting point to develop recommendations and statements which were modified and graded in a structured consensus procedure. Recommendations Part 1 of this short version of the guideline presents recommendations for the screening, diagnosis and follow-up care of breast cancer. The importance of mammography for screening is confirmed in this updated version of the guideline and forms the basis for all screening. In addition to the conventional methods used to diagnose breast cancer, computed tomography (CT) is recommended for staging in women with a higher risk of recurrence. The follow-up concept includes suggested intervals between physical, ultrasound and mammography examinations, additional high-tech diagnostic procedures, and the determination of tumor markers for the evaluation of metastatic disease.

8.
Dtsch Arztebl Int ; 115(18): 316-323, 2018 05 04.
Artigo em Inglês | MEDLINE | ID: mdl-29807560

RESUMO

BACKGROUND: Breast cancer is the most common cancer in women. The German S3 guideline of 2012 has now been updated to take account of advances in the early detection, diagnostic evaluation, treatment, and follow-up care of this disease. METHODS: The updating process was based on the adaptation of identified source guidelines and on reviews of the scientific evidence. A systematic search in multiple literature databases was carried out, and the full texts of the selected articles were evaluated. Suggested recommendations were then proposed by interdisciplinary working groups and modified and graded in a nominal consensus procedure. RESULTS: The value of mammographic screening is confirmed in the updated guideline. As for the diagnostic evaluation of breast cancer, computed tomography is recommended for staging in patients with a high risk of recurrence, in addition to conventional methods. As for surgical treatment, the evidence supporting locoregional surgery for primary breast cancer now affords an opportunity for de-escalation: complete resection yields the best outcome, but a safety margin of several millimeters is not necessary. Axillary dissection is no longer recommended except in certain defined situations. Radiotherapeutic approaches consist of hypofractionated applications. Adjuvant systemic therapy is indicated for patients in certain high-risk situations defined by a constellation of factors including tumor grade, patient age, node status, Ki-67 antigen expression, hormone receptor status, and human epidermal growth factor receptor 2 (HER2) status. All patients with hormone receptor-positive breast cancer should receive endocrine therapy. The indication for chemotherapy and/or anti-HER2 therapy should be determined in consideration of the expected benefit and side effects. CONCLUSION: Consistent implementation of the recommendations in the newly updated guideline can help lessen morbidity and mortality from breast cancer. The actual extent to which breast cancer guidelines are implemented should be a topic of future research.


Assuntos
Assistência ao Convalescente/métodos , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/terapia , Programas de Rastreamento/métodos , Assistência ao Convalescente/normas , Idoso , Biópsia por Agulha/métodos , Neoplasias da Mama/epidemiologia , Tratamento Farmacológico/métodos , Tratamento Farmacológico/normas , Feminino , Alemanha/epidemiologia , Guias como Assunto , Humanos , Mamografia , Programas de Rastreamento/normas , Pessoa de Meia-Idade , Enfermagem Oncológica/métodos , Radiografia/métodos , Radiografia/normas , Procedimentos Cirúrgicos Operatórios/métodos , Procedimentos Cirúrgicos Operatórios/normas , Tomografia Computadorizada por Raios X/métodos
9.
Breast ; 40: 54-59, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29698925

RESUMO

OBJECTIVES: Certified multi-disciplinary breast cancer centres (CBCs) have been established worldwide. Development of CBCs, guideline-adherent systemic therapy and surgical management should now show an impact on outcomes. This analysis aimed to investigate whether guideline adherence (GA) rates, relapse-free survival (RFS) and overall survival (OS) have significantly improved at CBCs compared to the pre-certification period. MATERIALS AND METHODS: 8323 patients with primary breast cancer were treated in 17 German CBCs, which had been certified between 2003 and 2007 [2003 (n = 1), 2004 (n = 6), 2005 (n = 3), 2006 (n = 6) and 2007 (n = 1)]. 3544 patients (42.6%) were treated before certification and 4779 patients (57.4%) after certification. RESULTS AND CONCLUSION: A highly significant (p < 0.001) difference in 100%-GA was found between the various hospitals before certification (min 25.0%; max 54.6%). In 2008, when all participating hospitals were certified, the GA rate was 61.8% (min 39.5%, max 74.4%) and 69.2% (min 45.9%, max 86.4%) for patients <75 y (n = 6675). The difference between pre-certification 100%-GA (46.9%) and post-certification (57.2%) was highly significant (p < 0.001). RFS and OS were both significantly better after certification compared to the pre-certification period (RFS: HR = 0.79; 95% CI: 0.68-0.92; p = 0.003; OS: HR = 0.75; 95% CI: 0.65-0.85; p < 0.001). 5-year RFS (OS) of patients <75 y was 89.6% (85.4%) pre-certification and 91.4% (89.5%) post-certification. Since improvement in GA and outcomes correlated as well, GA remains a highly significant prognostic factor for RFS and OS regardless of NPI, intrinsic subtype and adjuvant systemic therapy. This suggests that the certification process is strongly associated with improvements in outcome.


Assuntos
Instituições de Assistência Ambulatorial/normas , Protocolos Antineoplásicos/normas , Neoplasias da Mama/mortalidade , Fidelidade a Diretrizes/estatística & dados numéricos , Melhoria de Qualidade/estatística & dados numéricos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/terapia , Certificação , Intervalo Livre de Doença , Feminino , Alemanha , Humanos , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/mortalidade , Resultado do Tratamento , Adulto Jovem
10.
J Geriatr Oncol ; 9(2): 163-169, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29055624

RESUMO

OBJECTIVES: To determine predictive/prognostic factors for patients with metastatic breast cancer (MBC) receiving first-line monochemotherapy using biomarker analysis and geriatric assessment (GA). MATERIALS AND METHODS: Karnofsky Performance Status (KPS) and GA as clinical parameters, and prognostic inflammatory and nutritional index (PINI), and Glasgow prognostic score (GPS) as biomarkers were analyzed for association with clinical outcome within the randomized phase III PEg-LIposomal Doxorubicin vs. CApecitabin iN MBC (PELICAN) trial of first-line pegylated liposomal doxorubicin (PLD) or capecitabine. RESULTS: Of 210 patients, 38% were >65years old. GA (n=152) classified 74% as fit, 10% as compromised, and 16% as frail. Biomarkers showed no age dependency. In multivariate analysis (n=70) KPS, GA, cumulative illness rating scale-geriatrics (CIRS-G), and GPS were significantly associated with time to progression, and KPS, CIRS-G, and instrumental activities of daily living (IADL) from GA, and PINI showed a significant correlation with overall survival. CONCLUSION: GA evaluation was feasible. KPS significantly correlated with efficacy outcomes. Items of a GA and biomarkers of inflammation and nutrition may have prognostic significance in patients with MBC.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Capecitabina/efeitos adversos , Doxorrubicina/análogos & derivados , Avaliação Geriátrica/métodos , Fatores Etários , Idoso , Biomarcadores/sangue , Progressão da Doença , Doxorrubicina/efeitos adversos , Feminino , Fragilidade/diagnóstico , Humanos , Avaliação de Estado de Karnofsky , Pessoa de Meia-Idade , Polietilenoglicóis/efeitos adversos , Resultado do Tratamento
11.
Breast J ; 24(4): 480-486, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29265572

RESUMO

The Z0011 trial has fundamentally changed axillary management in breast cancer patients. However, some important questions remain, like the role of extracapsular nodal extension (ENE) in positive sentinel nodes and the need for further axillary treatment. In this retrospective cohort study, we reviewed and analyzed data from 342 clinically node negative (cN0) breast cancer patients with a positive sentinel node and subsequent axillary lymph node dissection (ALND) from the BRENDA data base. The 104 (30.4%) ENE positive patients had a significantly higher proportion of ≥3 positive axillary lymph nodes (65.0%) compared to ENE negative patients with a positive sentinel node (21.4%). Likewise, ENE positive patients had significantly more often lymph node metastasis size >2 mm (96.2%) than ENE negative patients (72.7%). T1 status was observed significantly more often in ENE negative patients (53.2%) than in ENE positive patients (24.0%). While ENE was linked to worse overall survival in univariate analysis, this effect disappeared when adjusting for nodal status, age, and comorbidities in multivariate analysis. ENE of the sentinel node is an important predictor for nonsentinel lymph node involvement. We suggest that ENE influences survival only via a higher number of positive nodes - one of the most predictive parameters for survival outcome in breast cancer.


Assuntos
Neoplasias da Mama/patologia , Metástase Linfática/patologia , Biópsia de Linfonodo Sentinela , Linfonodo Sentinela/patologia , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/mortalidade , Feminino , Humanos , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Estudos Retrospectivos , Linfonodo Sentinela/cirurgia , Análise de Sobrevida
12.
Breast J ; 24(2): 120-127, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-28685896

RESUMO

In the treatment of breast cancer, decisions on adjuvant treatment reflect individual patient characteristics like age and comorbidity. This study assessed the association between adherence to guidelines for adjuvant treatment and survival while taking into account age at diagnosis and comorbidities. We collected the Charlson comorbidity index at baseline for 2179 women treated for primary breast cancer from 1992 to 2008 who participated in a German retrospective multicenter cohort study. We assessed subsequent adjuvant therapy guideline adherence and survival in relation to baseline comorbidities. Guidelines for adjuvant chemotherapy and radiotherapy were more often violated in patients with higher Charlson score. Patients with higher Charlson scores received chemotherapy and radiotherapy less often and had higher rates of mastectomy. Irrespective of comorbidity (Charlson score 0, 1-2, ≥3), patients with 100% guideline-adherent adjuvant treatment showed better overall and disease-free survival (DFS) compared to patients with guideline violations (GVs). Controlling for age, comorbidity and tumor characteristics, the hazard ratio for at least one GV was 1.65 (95% confidence interval [CI]: 1.33-2.07) for overall survival and 1.84 (95% CI: 1.53-2.22) for DFS. Guideline-adherent treatment was significantly less frequent in comorbid patients, although guideline adherence was strongly associated with improved survival, irrespective of severity, and number of comorbid diseases.


Assuntos
Neoplasias da Mama/mortalidade , Fidelidade a Diretrizes/estatística & dados numéricos , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/terapia , Quimioterapia Adjuvante , Comorbidade , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Taxa de Sobrevida
13.
Z Evid Fortbild Qual Gesundhwes ; 129: 3-11, 2017 Dec.
Artigo em Alemão | MEDLINE | ID: mdl-29157559

RESUMO

The question of how to improve healthcare quality and the need for patient empowerment and shared decision-making has been the subject of political and scientific debate for years. In addition to various quality initiatives, "top lists" summarizing selected recommendations to increase awareness of overuse, spread by means of public campaigns, has become popular on the international level - known as the "Choosing Wisely" initiative. However, the trustworthiness of "top lists", their impact on patient-relevant outcomes, their role in and integration into the context of the various pre-existing approaches to improve healthcare quality and the effects of neglecting under- and misuse are not clear. On the other hand, "top lists" may provide new opportunities to improve awareness and dissemination of carefully selected recommendations based on high-quality guidelines. Therefore, the Association of Scientific Medical Societies in Germany (AWMF) has established an ad hoc commission to design a system-specific initiative. The commission has the task to clarify goals, methods of development and concepts for implementation and evaluation, to address concerns and to build upon specific existing resources - e. g., the established quality management system for guidelines in Germany. The key goals defined by the commission include the systematization of the dialogue between healthcare practitioners and patients and the promotion of ethically founded decision-making as an answer to an increasing economic orientation of the healthcare system. To ensure the methodological quality of specific recommendations, the commission has developed a manual. To the best of our knowledge, this manual is the first detailed method paper aiming to guide developers of "Choosing Wisely" recommendations. More than 20 German medical scientific societies have already addressed the subject of "top lists".


Assuntos
Assistência à Saúde/normas , Qualidade da Assistência à Saúde , Tomada de Decisões , Alemanha , Humanos , Sociedades Médicas , Sociedades Científicas
14.
J Cancer Res Clin Oncol ; 143(9): 1823-1831, 2017 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28439713

RESUMO

PURPOSE: Sentinel lymph node (SLN) biopsy has replaced axillary lymph node dissection (ALND) for the staging of clinically node-negative breast cancer patients (BCP), demonstrating equivalent survival to ALND while resulting in reduced morbidity. ALND has remained the standard of care for the majority of BCP with clinical axillary metastases or metastases found on SLN biopsy. More recently, it is debated whether ALND could be avoided not only in SLN-negative BCP but also in selected SLN-positive disease or even in all patients. This analysis of pN+ BCP shows the impact of the number of excised lymph nodes on RFS and OAS adjusted by age, tumor size, intrinsic subtypes and adjuvant systemic therapy. METHODS: In this retrospective, multicenter cohort study, we investigated data from 2992 pN+ primary BCP recruited from 17 participating certified breast cancer centers in Germany between 2001 and 2008 within the BRENDA study group. RESULTS: The median number of excised lymph nodes was 17. The number of excised lymph nodes was neither significant for RFS (p = 0.085) nor for OAS (p = 0.285). Adjustments were made for age, tumor size and intrinsic subtypes. The most important significant parameters for RFS were intrinsic subtypes (p < 0.001) and tumor size (p < 0.001) and for OAS age (p < 0.001) and intrinsic subtypes (p < 0.001). There were no significant differences in RFS and OAS in any subgroup stratified by the number of excised lymph nodes. Only for T3/T4 tumors, there is a very small significant advantage of ALND for RFS but not for OAS. After adjusting in addition by guideline adherence of adjuvant systemic therapy (AST), intrinsic subtypes and guideline-adherent AST are the most important significant (p < 0.001) parameters for RFS and OAS. CONCLUSIONS: The number of excised lymph nodes of pN+ BCP neither correlates with RFS nor with OAS. Survival of pN+ BCP is primarily determined by the biology and the guideline-adherent AST based on the corresponding intrinsic subtypes. These results support the omission of a radical ALND at least for pN+ patients scheduled for breast-conserving surgery (not mastectomy), provided they receive whole breast irradiation and guideline-adherent AST.


Assuntos
Neoplasias da Mama/patologia , Excisão de Linfonodo/mortalidade , Metástase Linfática/patologia , Biópsia de Linfonodo Sentinela/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/mortalidade , Neoplasias da Mama/cirurgia , Estudos de Coortes , Intervalo Livre de Doença , Feminino , Humanos , Excisão de Linfonodo/métodos , Metástase Linfática/diagnóstico , Pessoa de Meia-Idade , Estudos Retrospectivos , Biópsia de Linfonodo Sentinela/métodos
15.
Oncology ; 92(6): 317-324, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28334705

RESUMO

OBJECTIVE: To identify subgroups of patients with pT1 pN0 breast cancer (BC) who might not profit from adjuvant systemic therapy (AST). METHODS: Data of 3,774 pT1 pN0 BC patients from 17 certified BC centres within the BRENDA study group were collected between 1992 and 2008 and retrospectively analysed. Uni- and multivariate analyses were performed using Kaplan-Meier methods and Cox regression models. RESULTS: 279 (7.4%) of the pT1 pN0 BC patients were T1a, 944 (25.0%) were T1b and 2,551 (67.6%) were T1c. There was no significant difference (p > 0.1) in recurrence-free survival (RFS)/overall survival (OAS) between patients with pT1a, pT1b, and T1c. Patients receiving any type of AST had a better outcome compared to women without AST after adjusting for age, tumour size, and intrinsic subtypes (RFS: p < 0.001; OAS: p < 0.001). AST was the most important prognostic parameter for RFS followed by intrinsic subtypes and age. CONCLUSION: Patients with pT1 pN0 BC profit from AST independently of molecular subtypes, tumour size, age or comorbidity, with 5-year RFS of more than 95%. The correct definition of subgroups of patients who do not need AST is still an open question.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Adulto , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/administração & dosagem , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Quimioterapia Adjuvante/efeitos adversos , Esquema de Medicação , Feminino , Alemanha/epidemiologia , Humanos , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Guias de Prática Clínica como Assunto , Prognóstico , Modelos de Riscos Proporcionais , Receptor ErbB-2 , Estudos Retrospectivos , Medição de Risco , Adulto Jovem
16.
Breast Cancer ; 24(2): 281-287, 2017 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-27193566

RESUMO

BACKGROUND: We analysed factors that might influence patients' and physicians' decisions against the initiation of guideline adherent adjuvant endocrine therapy (ET). METHODS: In a prospective multi-centre study, including four certified breast cancer centres in Germany, patients with primary breast cancer were included from 2009 to 2012. Patients completed a questionnaire prior to surgery, adjuvant therapy, and 6 months after adjuvant therapy. This questionnaire assessed health-related quality of life (QoL), psychiatric co-morbidity, demographic characteristics, and the intensity of fear for ET. Guideline adherence was classified based on an algorithm derived from international guidelines. The tumour board's (TB) decisions against or for ET was documented. The TB was blinded regarding the guideline results. RESULTS: In 666 patients, adjuvant ET was indicated according to the guideline recommendations. The TB decided in 92.3 % (n = 615) of those that adjuvant ET was indicated. TB's decision against ET was associated with the younger age of patients (OR = 0.5; 95 % CI 0.3-0.9) and poor QoL (OR = 1.7; 95 % CI 1.0-2.8). In 93 patients, ET was not indicated according to the guidelines, and the TB decided in 84 of those not to prescribe ET. The TB decided in 93.4 % of the cases according to the guidelines. Of the patients, where the TB prescribed ET, 5 % (n = 31) decided against ET. This decision was associated with fear of ET (OR = 2.2; 95 % CI 1.0-5.2) and higher age (OR 9; 95 % CI 1.0-48.1). Psychiatric co-morbidity (OR = 1.8; 95 % CI 0.7-4.2), poor QoL (OR = 0.4; 95 % CI 0.2-1.2), and education (OR = 1.2; 95 % CI 0.5-2.6) were not associated with the decision. DISCUSSION: Guideline adherent implementation of adjuvant ET is high. Physicians' decision against ET is mainly associated with patients' younger age and poor quality of life, whereas patients' decision, once the TB decided to initiate ET and if ET is indicated by guidelines, is associated with higher age and fear of ET.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Quimioterapia Adjuvante/psicologia , Fidelidade a Diretrizes , Relações Médico-Paciente , Adulto , Idoso , Tomada de Decisões , Feminino , Alemanha , Humanos , Estudos Prospectivos , Qualidade de Vida , Estresse Psicológico , Inquéritos e Questionários
17.
Breast Cancer Res Treat ; 161(1): 63-72, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27798749

RESUMO

PURPOSE: The PELICAN trial evaluates for the first time efficacy and safety of pegylated liposomal doxorubicin (PLD) versus capecitabine as first-line treatment of metastatic breast cancer (MBC). METHODS: This randomized, phase III, open-label, multicenter trial enrolled first-line MBC patients who were ineligible for endocrine or trastuzumab therapy. Cumulative adjuvant anthracyclines of 360 mg/m2 doxorubicin or equivalent were allowed. Left ventricular ejection fraction of >50 % was required. Patients received PLD 50 mg/m2 every 28 days or capecitabine 1250 mg/m2 twice daily for 14 days every 21 days. The primary endpoint was time-to-disease progression (TTP). RESULTS: 210 patients were randomized (n = 105, PLD and n = 105, capecitabine). Adjuvant anthracyclines were given to 37 % (PLD) and 36 % (capecitabine) of patients. No significant difference was observed in TTP [HR = 1.21 (95 % confidence interval, 0.838-1.750)]. Median TTP was 6.0 months for both PLD and capecitabine. Comparing patients with or without prior anthracyclines, no significant difference in TTP was observed in the PLD arm (log-rank P = 0.64). For PLD versus capecitabine, respectively, overall survival (median, 23.3 months vs. 26.8 months) and time-to-treatment failure (median, 4.6 months vs. 3.7 months) were not statistically significantly different. Compared to PLD, patients on capecitabine experienced more serious adverse events (P = 0.015) and more cardiac events among patients who had prior anthracycline exposure (18 vs. 8 %; P = 0.31). CONCLUSION: Both PLD and capecitabine are effective first-line agents for MBC.


Assuntos
Antimetabólitos Antineoplásicos/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Capecitabina/uso terapêutico , Doxorrubicina/análogos & derivados , Adulto , Idoso , Idoso de 80 Anos ou mais , Antimetabólitos Antineoplásicos/administração & dosagem , Antimetabólitos Antineoplásicos/efeitos adversos , Neoplasias da Mama/mortalidade , Capecitabina/administração & dosagem , Capecitabina/efeitos adversos , Progressão da Doença , Doxorrubicina/administração & dosagem , Doxorrubicina/efeitos adversos , Doxorrubicina/uso terapêutico , Feminino , Humanos , Pessoa de Meia-Idade , Metástase Neoplásica , Estadiamento de Neoplasias , Polietilenoglicóis/administração & dosagem , Polietilenoglicóis/efeitos adversos , Polietilenoglicóis/uso terapêutico , Qualidade de Vida , Fatores de Risco , Análise de Sobrevida , Resultado do Tratamento , Adulto Jovem
18.
Breast ; 31: 66-75, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27816834

RESUMO

PURPOSE: Visceral metastasis of breast cancer (BC) is an alarming development and correlates with poor median overall survival. The purpose of this retrospective study is to examine the risk factors for developing visceral metastasis by considering tumor biology and patient characteristics. METHODS: Using the BRENDA database, the risk factors such as histological and intrinsic subtypes of BC, age at primary diagnosis, grading, nodal status, tumor size and year of primary diagnosis were examined in univariate and multivariate analysis. Categorical variables were compared by using χ2 tests. Furthermore, multivariate Cox proportional hazards regression models, Kaplan-Meier product-limit method and log-rank test were applied. The results of two tree-building algorithms, "exhausted CHAID" (Chi-squared Automatic Interaction Detector) and CART (Classification and Regression Trees) were verified with further multivariate analysis, radial basis function networks (RBF-net), feedforward multilayer perceptron networks (MLP) and logistic regression. RESULTS: In a patient collective of 886 metastasized patients, 56.9% had developed visceral metastases and 27.1% visceral-only metastases. The different histological and intrinsic subtypes of BC and the grading correlate significantly with the visceral-only metastasis behavior, whereas the age at primary diagnosis, the nodal status, the tumor size and the year of the primary diagnosis had no influence. Patients with ductal/other BC, LuminalB/HER2, TNBC, HER2 overexpressing subtype and grade 3 had an increased risk for the development of visceral-only metastasis. CONCLUSIONS: Intrinsic and histological subtypes as well as the grading of BC affected significantly the visceral metastasis behavior.


Assuntos
Neoplasias da Mama/patologia , Carcinoma Ductal de Mama/secundário , Neoplasias Hepáticas/secundário , Neoplasias Pulmonares/secundário , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/química , Distribuição de Qui-Quadrado , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos Logísticos , Pessoa de Meia-Idade , Análise Multivariada , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Fatores de Risco , Adulto Jovem
19.
Arch Gynecol Obstet ; 295(1): 211-223, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27832352

RESUMO

PURPOSE: The development of metastases is the most aggressive attribute of breast cancer. In this retrospective multicenter study, we evaluated if and how the different pathological breast cancer subtypes influence the spreading of tumor cells, the development of metastasis and the survival of breast cancer patients. METHODS: This retrospective German multicenter study is based on the BRENDA collective including 9625 breast cancer patients treated in the adjuvant setting. We used the χ 2 tests for the analysis of the categorical variables between groups of patients with different sites of metastasis. Survival distributions and median survival times were estimated using the Kaplan-Meier product-limit method. The log-rank test was applied to compare survival rates. The Cox proportional hazards model was used to estimate the hazard ratio and confidence intervals. RESULTS: 886 women developed metastases during a time interval of 53 months after primary diagnosis. Luminal A tumor patients were more likely to get bone metastases than lung, liver or CNS metastases. Patients with a triple-negative subtype were, however, the least affected by metastasis in the skeleton. They were most likely to develop visceral metastases. Location, numbers of metastases herein and the subtype influenced the overall survival (OAS). Altogether, the best OAS was found in patients with the luminal A subtype, the worst in patients with the triple-negative subtype. CONCLUSIONS: Knowledge of the typical metastatic pattern of the subtypes of breast cancer will help to personalize therapeutic options and follow-up examinations of cancer patients.


Assuntos
Neoplasias Ósseas/secundário , Neoplasias da Mama/patologia , Feminino , Humanos , Estimativa de Kaplan-Meier , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Taxa de Sobrevida
20.
PLoS One ; 11(12): e0168730, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27992550

RESUMO

BACKGROUND: Luminal A breast cancers respond well to anti-hormonal therapy (HT), are associated with a generally favorable prognosis and constitute the majority of breast cancer subtypes. HT is the mainstay of treatment of these patients, accompanied by an acceptable profile of side effects, whereas the added benefit of chemotherapy (CHT), including anthracycline and taxane-based programs, is less clear-cut and has undergone a process of critical revision. METHODS: In the framework of the BRENDA collective, we analyzed the benefits of CHT compared to HT in 4570 luminal A patients (pts) with primary diagnosis between 2001 and 2008. The results were adjusted by nodal status, age, tumor size and grading. RESULTS: There has been a progressive reduction in the use of CHT in luminal A patients during the last decade. Neither univariate nor multivariate analyses showed any statistically significant differences in relapse free survival (RFS) with the addition of CHT to adjuvant HT, independent of the nodal status, age, tumor size or grading. Even for patients with more than 3 affected lymph nodes, there was no significant difference (univariate: p = 0.865; HR 0.94; 95% CI: 0.46-1.93; multivariate: p = 0.812; HR 0.92; 95% CI: 0.45-1.88). CONCLUSIONS: The addition of CHT to HT provides minimal or no clinical benefit at all to patients with luminal A breast cancer, independent of the RFS-risk. Consequently, risk estimation cannot be the initial step in the decisional process. These findings-that are in line with several publications-should encourage the critical evaluation of applying adjuvant CHT to patients with luminal A breast cancer.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/mortalidade , Adulto , Idoso , Idoso de 80 Anos ou mais , Quimioterapia Adjuvante/métodos , Intervalo Livre de Doença , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxa de Sobrevida
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