RESUMO
BACKGROUND AND PURPOSE: In the BOOG 2013-08 trial (NCT02271828), cT1-2N0 breast cancer patients were randomized between breast conserving surgery with or without sentinel lymph node biopsy (SLNB) followed by whole breast radiotherapy (WBRT). While awaiting primary endpoint results (axillary recurrence rate), this study aims to perform a quality assurance analysis on protocol adherence and (incidental) axillary radiation therapy (RT) dose. MATERIALS AND METHODS: Patients were enrolled between 2015 and 2022. Data on prescribed RT and (in 25% of included patients) planning target volumes (PTV) parameters were recorded for axillary levels I-IV and compared between treatment arms. Multivariable linear regression analysis was performed to determine prognostic variables for incidental axillary RT dose. RESULTS: 1,439/1,461 included patients (98.5%) were treated according to protocol and 87 patients (5.9%) received regional RT (SLNB 10.9%, no-SLNB 1.5 %). In 326 patients included in the subgroup analysis, the mean incidental PTV dose at axilla level I was 59.5% of the prescribed breast RT dose. In 5 patients (1.5%) the mean PTV dose at level I was ≥95% of the prescribed breast dose. No statistically or clinically significant differences regarding incidental axillary RT dose were found between treatment arms. Tumour bed boost (yes/no) was associated with a higher incidental mean dose in level I (R2 = 0.035, F(6, 263) = 1.532, p 0.168). CONCLUSION: The results indicate that RT-protocol adherence was high, and that incidental axillary RT dose was low in the BOOG 2013-08 trial. Potential differences between treatmentarms regarding the primary endpoint can thus not be attributed to different axillary radiation doses.
Assuntos
Neoplasias da Mama , Excisão de Linfonodo , Humanos , Feminino , Excisão de Linfonodo/métodos , Mastectomia Segmentar , Metástase Linfática/patologia , Biópsia de Linfonodo Sentinela/métodos , Neoplasias da Mama/radioterapia , Neoplasias da Mama/cirurgia , Neoplasias da Mama/patologia , Axila/patologia , Linfonodos/patologiaRESUMO
INTRODUCTION: Implant loss following breast reconstruction is a devastating complication, which should be prevented as much as possible. This study aimed to validate a previously developed multicenter risk model for implant loss after implant-based breast reconstructions, using national data from the Dutch Breast Implant Registry (DBIR). METHODS: The validation cohort consisted of patients who underwent a mastectomy followed by either a direct-to-implant (DTI) or two-stage breast reconstruction between September 2017 and January 2021 registered in the DBIR. Reconstructions with an autologous adjunctive and patients with missing data on the risk factors extracted from the multicenter risk model (obesity, smoking, nipple preserving procedure, DTI reconstruction) were excluded. The primary outcome was implant loss. The predicted probability of implant loss was calculated using beta regression coefficients extracted from the multicenter risk model and compared to the observed probability. RESULTS: The validation cohort consisted of 3769 reconstructions and implant loss occurred after 307 reconstructions (8.1%). Although the observed implant loss rate increased when the risk factors accumulated, the predicted and observed probabilities of implant loss did not match. Of the four risk factors in the multicenter risk model, only obesity and smoking were significantly associated to implant loss. CONCLUSION: The multicenter risk model could not be validated using nationwide data of the DBIR and is therefore not accurate in Dutch practice. In the future, the risk model should be improved by including other factors to provide a validated tool for the preoperative risk assessment of implant loss.
Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama , Mamoplastia , Humanos , Feminino , Mastectomia/efeitos adversos , Mastectomia/métodos , Neoplasias da Mama/complicações , Mamoplastia/métodos , Implante Mamário/efeitos adversos , Implante Mamário/métodos , Implantes de Mama/efeitos adversos , Obesidade/complicações , Estudos Retrospectivos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Resultado do TratamentoRESUMO
INTRODUCTION: This study aimed to evaluate complication rates, patient satisfaction, and cosmetic outcomes after oncoplastic breast-conserving surgery (OPS). Furthermore, outcome differences between volume displacement and volume replacement techniques and the effect of postoperative complications on outcomes were evaluated. METHODS: This was a prospective single-center study addressing patients who underwent OPS from 2017 to 2020. The BREAST-Q was used to measure patient satisfaction, and cosmetic outcomes were assessed by patient self-evaluation and panel evaluation based on medical photographs. RESULTS: A total of 75 patients were included. The overall complication rate was 18.7%, of which 4% required invasive interventions. Median BREAST-Q scores ranged from 56 to 100 and cosmetic outcomes were scored good to excellent in 60-86%. No differences in complications were observed between volume replacement and volume displacement techniques. Following volume displacement techniques, patients-reported higher BREAST-Q scores for the domain "physical well-being of the chest" and lower cosmetic outcomes scores for "mammary symmetry." Patients with complications scored significantly lower on several domains of the BREAST-Q and in various cosmetic outcome categories. CONCLUSION: In this cohort, an overall complication rate of 18.7% was observed. Patients were generally satisfied, and most cosmetic outcomes were good to excellent. Volume displacement or replacement techniques were performed for different indications and generally showed comparable results. Expected differences in physical discomfort and symmetry between both techniques were observed. In addition, the occurrence of complications resulted in lower patient satisfaction and cosmetic outcomes. These findings emphasize the importance of thorough preoperative counselling.
Assuntos
Neoplasias da Mama , Mamoplastia , Humanos , Feminino , Satisfação do Paciente , Mamoplastia/efeitos adversos , Mamoplastia/métodos , Estudos Prospectivos , Mastectomia , Mastectomia Segmentar/efeitos adversos , Mastectomia Segmentar/métodos , Neoplasias da Mama/cirurgiaRESUMO
INTRODUCTION AND OBJECTIVES: To evaluate the migration of 99mTc-tilmanocept from the injection site (IS) as well as the uptake in sentinel nodes (SNs) and non-SNs for lymphatic mapping in patients with breast cancer and melanoma, scheduled for SN biopsy after interstitial tracer administration. MATERIALS AND METHODS: For 29 primary tumours in 28 patients (mean age: 62y, range: 45-81y) scheduled for SN biopsy planar images were acquired 10 and 120min after administration of 74MBq 99mTc-tilmanocept, in order to evaluate lymphatic drainage as well as uptake ratios between injection site (IS), SN and non-SN. SPECT-CT was performed immediately after delayed planar images to enable anatomical lymph node localization. RESULTS: SNs were visualized in all patients (100%) with drainage to 34 basins. Uptake in non-SNs was perceived in 16 basins (47%). Number of SNs was concordant between early and delayed images in all basins excepting five (86%). In 24 patients tracer migrated to one lymph node basin (LNB), in three to 2 and in one to 4. When IS was included (N=29) on image, IS/SN ratio could be measured per LNB. The IS/SN ratio at 2h compared to 15min decreased with an average of 66% (range: 15-96%). SN/non-SN 2h ratio in LNBs with visible non-SNs averaged 6.6 (range: 2.3-15.6). In 9 patients with two SNs SN1/SN2 ratio averaged 1.9 on delayed images. At histopathology, SNs were found to be tumour positive in 7 basins (20%). CONCLUSION: 99mTc-tilmanocept appears to meet the requirements for improved SN imaging in breast cancer and melanoma on the basis of early and persistent SN visualization frequently accompanied by no or markedly less non-SN uptake. This is associated to rapid migration from the injection site together with increasing SN uptake and retention as expressed by decreasing IS/SN and persistently high SN/non-SN ratios. Further head-to-head comparison of 99mTc-tilmanocept with standard SN radiotracers in larger series of patients is necessary.
Assuntos
Neoplasias da Mama/diagnóstico por imagem , Dextranos/farmacocinética , Mananas/farmacocinética , Melanoma/diagnóstico por imagem , Compostos Radiofarmacêuticos/farmacocinética , Linfonodo Sentinela/diagnóstico por imagem , Neoplasias Cutâneas/diagnóstico por imagem , Pentetato de Tecnécio Tc 99m/análogos & derivados , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/patologia , Dextranos/administração & dosagem , Feminino , Humanos , Linfonodos/diagnóstico por imagem , Masculino , Mananas/administração & dosagem , Melanoma/patologia , Pessoa de Meia-Idade , Compostos Radiofarmacêuticos/administração & dosagem , Linfonodo Sentinela/metabolismo , Biópsia de Linfonodo Sentinela , Tomografia Computadorizada com Tomografia Computadorizada de Emissão de Fóton Único , Neoplasias Cutâneas/patologia , Pentetato de Tecnécio Tc 99m/administração & dosagem , Pentetato de Tecnécio Tc 99m/farmacocinética , Fatores de TempoRESUMO
Over the last decades, technological developments in the field of radiology have resulted in a widespread use of imaging for personalising medicine in oncology, including patients with a sarcoma. New scanner hardware, imaging protocols, image reconstruction algorithms, radiotracers, and contrast media, enabled the assessment of the physical and biological properties of tumours associated with response to treatment. In this context, medical imaging has the potential to select sarcoma patients who do not benefit from (neo-)adjuvant treatment and facilitate treatment adaptation. Due to the biological heterogeneity in sarcomas, the challenge at hand is to acquire a practicable set of imaging features for specific sarcoma subtypes, allowing response assessment. This review provides a comprehensive overview of available clinical data on imaging-based response monitoring in sarcoma patients and future research directions. Eventually, it is expected that imaging-based response monitoring will help to achieve successful modification of (neo)adjuvant treatments and improve clinical care for these patients.
Assuntos
Imagem Multimodal , Planejamento de Assistência ao Paciente , Medicina de Precisão , Sarcoma/diagnóstico por imagem , Sarcoma/terapia , Biomarcadores , Proliferação de Células , Fibroblastos/patologia , Glucose/metabolismo , Humanos , Hipóxia/patologia , Terapia Neoadjuvante , Metástase Neoplásica , Sarcoma/irrigação sanguínea , Sarcoma/patologiaRESUMO
PURPOSE: To assess the feasibility of using freehand Single Photon Emission Computed Tomography (freehandSPECT) for the identification of technetium-99m-hydroxydiphosphonate (99mTc-HDP) positive bone lesions and to evaluate the possibility of using these imaging data-sets for augmented- and virtual-reality based navigation approaches. MATERIAL AND METHODS: In 20 consecutive patients referred for scintigraphy with 99mTc-HDP, 21 three-dimensional freehandSPECT-images were generated using a handheld gamma camera. Concordance of the two different data sets was ranked. Furthermore, feasibility of segmenting the hotspot of tracer accumulation for navigation purposes was assessed. RESULTS: In 86% of the cases freehandSPECT images showed good concordance with the corresponding part of the scintigraphic images. In lesions with a signal to background ratio (SBR) >1.36, freehandSPECT provided an automatically segmented reference point for navigation purposes. In 14% of the cases (average SBR 1.82, range 1.0-3.4) freehandSPECT images showed intermediate concordance due to difficult anatomical area or negative bone scintigraphy and could not be used as navigation targets. CONCLUSION: In this pilot study, in 86% of the cases freehandSPECT demonstrated good concordance with traditional scintigraphy. A lesion with a SBR of 1.36 or more was suitable for navigation. These high-quality freehandSPECT images supported the future exploration navigation strategies, e.g. guided needle biopsies.
Assuntos
Biópsia por Agulha/métodos , Doenças Ósseas/diagnóstico por imagem , Câmaras gama , Biópsia Guiada por Imagem/métodos , Medronato de Tecnécio Tc 99m/análogos & derivados , Tomografia Computadorizada de Emissão de Fóton Único/métodos , Doenças Ósseas/patologia , Neoplasias Ósseas/diagnóstico por imagem , Neoplasias Ósseas/secundário , Método Duplo-Cego , Desenho de Equipamento , Humanos , Biópsia Guiada por Imagem/instrumentação , Especificidade de Órgãos , Imagens de Fantasmas , Projetos Piloto , Compostos Radiofarmacêuticos/farmacocinética , Software , Medronato de Tecnécio Tc 99m/farmacocinética , Tomografia Computadorizada de Emissão de Fóton Único/instrumentação , Imagem Corporal TotalRESUMO
PURPOSE: Hybrid image-guided surgery technologies such as combined radio- and fluorescence-guidance are increasingly gaining interest, but their added value still needs to be proven. In order to evaluate if and how fluorescence-guidance can help realize improvements beyond the current state-of-the-art in sentinel node (SN) biopsy procedures, use of the hybrid tracer indocyanine green (ICG)-99mTc-nancolloid was evaluated in a large cohort of patients. PATIENTS AND METHODS: A prospective trial was conducted (n = 501 procedures) in a heterogeneous cohort of 495 patients with different malignancies (skin malignancies, oral cavity cancer, penile cancer, prostate cancer and vulva cancer). After injection of ICG-99mTc-nanocolloid, SNs were preoperatively identified based on lymphoscintigraphy and SPECT/CT. Intraoperatively, SNs were pursued via gamma tracing, visual identification (blue dye) and/or near-infrared fluorescence imaging during either open surgical procedures (head and neck, penile, vulvar cancer and melanoma) or robot assisted laparoscopic surgery (prostate cancer). As the patients acted as their own control, use of hybrid guidance could be compared to conventional radioguidance and the use of blue dye (n = 300). This was based on reported surgical complications, overall survival, LN recurrence free survival, and false negative rates (FNR). RESULTS: A total of 1,327 SN-related hotspots were identified on 501 preoperative SPECT/CT scans. Intraoperatively, a total number of 1,643 SNs were identified based on the combination of gamma-tracing (>98%) and fluorescence-guidance (>95%). In patients wherein blue dye was used (n = 300) fluorescence-based SN detection was superior over visual blue dye-based detection (22-78%). No adverse effects related to the use of the hybrid tracer or the fluorescence-guidance procedure were found and outcome values were not negatively influenced. CONCLUSION: With ICG-99mTc-nanocolloid, the SN biopsy procedure has become more accurate and independent of the use of blue dye. With that, the procedure has evolved to be universal for different malignancies and anatomical locations.
Assuntos
Período Pré-Operatório , Biópsia de Linfonodo Sentinela/métodos , Humanos , Período IntraoperatórioRESUMO
BACKGROUND: Studies showed that axillary lymph node dissection can be safely omitted in presence of positive sentinel lymph node(s) in breast cancer patients treated with breast conserving therapy. Since the outcome of the sentinel lymph node biopsy has no clinical consequence, the value of the procedure itself is being questioned. The aim of the BOOG 2013-08 trial is to investigate whether the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients treated with breast conserving therapy. METHODS: The BOOG 2013-08 is a Dutch prospective non-inferiority randomized multicentre trial. Women with pathologically confirmed clinically node negative T1-2 invasive breast cancer undergoing breast conserving therapy will be randomized for sentinel lymph node biopsy versus no sentinel lymph node biopsy. Endpoints include regional recurrence after 5 (primary endpoint) and 10 years of follow-up, distant-disease free and overall survival, quality of life, morbidity and cost-effectiveness. Previous data indicate a 5-year regional recurrence free survival rate of 99% for the control arm and 96% for the study arm. In combination with a non-inferiority limit of 5% and probability of 0.8, this result in a sample size of 1.644 patients including a lost to follow-up rate of 10%. Primary and secondary endpoints will be reported after 5 and 10 years of follow-up. DISCUSSION: If the sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy, this study will cost-effectively lead to a decreased axillary morbidity rate and thereby improved quality of life with non-inferior regional control, distant-disease free survival and overall survival. TRIAL REGISTRATION: The BOOG 2013-08 study is registered in ClinicalTrials.gov since October 20, 2014, Identifier: NCT02271828. https://clinicaltrials.gov/ct2/show/NCT02271828.
Assuntos
Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Mastectomia Segmentar , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Feminino , Seguimentos , Humanos , Metástase Linfática , Mastectomia Segmentar/efeitos adversos , Mastectomia Segmentar/métodos , Recidiva Local de Neoplasia , Estadiamento de Neoplasias , Países Baixos , Qualidade de Vida , Retratamento , Linfonodo Sentinela/patologia , Biópsia de Linfonodo Sentinela , Resultado do Tratamento , Conduta ExpectanteRESUMO
BACKGROUND: Soft tissue tumours of the abdominal wall account for approximately 10% of all soft tissue tumours. Tumours at this site comprise a heterogeneous group of pathologies with distinct clinical behaviours and responses to treatment. The management of these tumours has largely been extrapolated from studies of soft tissue tumours at other sites. This review aims to summarise the existing data relating to abdominal wall tumours and suggest principles for managing soft tissue tumours at this site. METHODS: Relevant articles were retrieved from a comprehensive literature search using the PubMed database. Key words included abdominal wall, soft tissue tumours, surgery, radiotherapy and chemotherapy. No restrictions on publication date were used. RESULTS: The most common pathologies presenting in the abdominal wall are desmoid tumours, soft-tissue sarcoma and dermatofibrosarcoma protuberans (DFSP). Desmoid tumours should be managed with an initial period of observation, with surgery reserved for progressive lesions. Surgery should be the primary treatment for soft-tissue sarcomas and DFSP, with radiotherapy reserved for large-high grade tumours and preferentially given pre-operatively. CONCLUSIONS: Abdominal wall tumours are rare and should be managed in centres with experience in the management of soft tissue tumours. Management should be tailored to the biological behaviour of specific pathologies.
Assuntos
Parede Abdominal , Dermatofibrossarcoma/terapia , Fibromatose Abdominal/terapia , Sarcoma/terapia , Neoplasias de Tecidos Moles/terapia , Dermatofibrossarcoma/diagnóstico , Dermatofibrossarcoma/epidemiologia , Dermatofibrossarcoma/patologia , Fibromatose Abdominal/diagnóstico , Fibromatose Abdominal/epidemiologia , Fibromatose Abdominal/patologia , Humanos , Estadiamento de Neoplasias , Procedimentos de Cirurgia Plástica , Sarcoma/diagnóstico , Sarcoma/epidemiologia , Sarcoma/patologia , Neoplasias de Tecidos Moles/diagnóstico , Neoplasias de Tecidos Moles/epidemiologia , Neoplasias de Tecidos Moles/patologiaRESUMO
OBJECTIVES: Accurate tumour localisation is essential for breast-conserving surgery of non-palpable tumours. Current localisation technologies are associated with disadvantages such as logistical challenges and migration issues (wire guided localisation) or legislative complexities and high administrative burden (radioactive localisation). We present MAgnetic MArker LOCalisation (MaMaLoc), a novel technology that aims to overcome these disadvantages using a magnetic marker and a magnetic detection probe. This feasibility study reports on the first experience with this new technology for breast cancer localisation. MATERIALS AND METHODS: Fifteen patients with unifocal, non-palpable breast cancer were recruited. They received concurrent placement of the magnetic marker in addition to a radioactive iodine seed, which is standard of care in our clinic. In a subset of five patients, migration of the magnetic marker was studied. During surgery, a magnetic probe and gammaprobe were alternately used to localise the markers and guide surgery. The primary outcome parameter was successful transcutaneous identification of the magnetic marker. Additionally, data on radiologist and surgeon satisfaction were collected. RESULTS: Magnetic marker placement was successful in all cases. Radiologists could easily adapt to the technology in the clinical workflow. Migration of the magnetic marker was negligible. The primary endpoint of the study was met with an identification rate of 100%. Both radiologists and surgeons reflected that the technology was intuitive to use and that it was comparable to radioactive iodine seed localisation. CONCLUSION: Magnetic marker localisation for non-palpable breast cancer is feasible and safe, and may be a viable non-radioactive alternative to current localisation technologies.
Assuntos
Neoplasias da Mama/diagnóstico , Marcadores Fiduciais , Radioisótopos do Iodo , Imãs , Compostos Radiofarmacêuticos , Adulto , Neoplasias da Mama/patologia , Estudos de Viabilidade , Feminino , Humanos , PalpaçãoRESUMO
BACKGROUND: Worldwide, sentinel node biopsy (SNB) is the recommended staging procedure for stage I/II melanoma. Most melanoma guidelines recommend re-excision plus SNB as soon as possible after primary excision. To date, there is no evidence to support this timeframe. AIM: To determine melanoma specific survival (MSS) for time intervals between excisional biopsy and SNB in SNB positive patients. METHODS: Between 1993 and 2008, 1080 patients were diagnosed with a positive SNB in nine Melanoma Group centers. We selected 1015 patients (94%) with known excisional biopsy date. Time interval was calculated from primary excision until SNB. Kaplan-Meier estimated MSS was calculated for different cutoff values. Multivariable analysis was performed to correct for known prognostic factors. RESULTS: Median age was 51 years (Inter Quartile Range (IQR) 40-62 years), 535 (53%) were men, 603 (59%) primary tumors were located on extremities. Median Breslow thickness was 3.00 mm (IQR 1.90-4.80 mm), 442 (44%) were ulcerated. Median follow-up was 36 months (IQR 20-62 months). Median time interval was 47 days (IQR 32-63 days). Median Breslow thickness was equal for both <47 days and ≥47 days interval: 3.00 mm (1.90-5.00 mm) vs 3.00 mm (1.90-4.43 mm) (p = 0.402). Sentinel node tumor burden was significantly higher in patients operated ≥47 days (p = 0.005). Univariate survival was not significantly different for median time interval. Multivariable analysis confirmed that time interval was no independent prognostic factor for MSS. CONCLUSIONS: Time interval from primary melanoma excision until SNB was no prognostic factor for MSS in this SNB positive cohort. This information can be used to counsel patients.
Assuntos
Melanoma/cirurgia , Biópsia de Linfonodo Sentinela/métodos , Linfonodo Sentinela/patologia , Neoplasias Cutâneas/cirurgia , Adulto , Estudos de Coortes , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Melanoma/mortalidade , Melanoma/patologia , Pessoa de Meia-Idade , Análise Multivariada , Prognóstico , Estudos Retrospectivos , Neoplasias Cutâneas/mortalidade , Neoplasias Cutâneas/patologia , Taxa de Sobrevida , Fatores de Tempo , Carga Tumoral , Listas de EsperaRESUMO
BACKGROUND: Trials failed to demonstrate additional value of completion axillary lymph node dissection in case of limited sentinel lymph node metastases in breast cancer patients undergoing breast conserving therapy. It has been suggested that the low regional recurrence rates in these trials might partially be ascribed to accidental irradiation of part of the axilla by whole breast radiation therapy, which precludes extrapolation of results to mastectomy patients. The aim of the randomized controlled BOOG 2013-07 trial is therefore to investigate whether completion axillary treatment can be safely omitted in sentinel lymph node positive breast cancer patients treated with mastectomy. DESIGN: This study is designed as a non-inferiority randomized controlled multicentre trial. Women aged 18 years or older diagnosed with unilateral invasive clinically T1-2 N0 breast cancer who are treated with mastectomy, and who have a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases, will be randomized for completion axillary treatment versus no completion axillary treatment. Completion axillary treatment can consist of completion axillary lymph node dissection or axillary radiation therapy. Primary endpoint is regional recurrence rate at 5 years. Based on a 5-year regional recurrence free survival rate of 98 % among controls and 96 % for study subjects, the sample size amounts 439 per arm (including 10 % lost to follow-up), to be able to reject the null hypothesis that the rate for study and control subjects is inferior by at least 5 % with a probability of 0.8. Results will be reported after 5 and 10 years of follow-up. DISCUSSION: We hypothesize that completion axillary treatment can be safely omitted in sentinel node positive breast cancer patients undergoing mastectomy. If confirmed, this study will significantly decrease the number of breast cancer patients receiving extensive treatment of the axilla, thereby diminishing the risk of morbidity and improving quality of life, while maintaining excellent regional control and without affecting survival. TRIAL REGISTRATION: The BOOG 2013-07 study is registered in the register of ClinicalTrials.gov since April 10, 2014, Identifier: NCT02112682 .
Assuntos
Neoplasias da Mama/cirurgia , Linfonodos/patologia , Mastectomia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Axila , Neoplasias da Mama/radioterapia , Feminino , Humanos , Excisão de Linfonodo , Metástase Linfática , Pessoa de Meia-Idade , Países Baixos , Biópsia de Linfonodo Sentinela , Adulto JovemRESUMO
BACKGROUND: Using surrogate end points for overall survival, such as disease-free survival, is increasingly common in randomized controlled trials. However, the definitions of several of these time-to-event (TTE) end points are imprecisely which limits interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points. The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for randomized cancer clinical trials (RCTs) in breast cancer. PATIENTS AND METHODS: A literature review was carried out to identify TTE end points (primary or secondary) reported in publications of randomized trials or guidelines. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points based on a validated consensus method that formalize the degree of agreement among experts. RESULTS: Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings. CONCLUSION: The use of standardized definitions should facilitate comparisons of trial results and improve the quality of trial design and reporting. These guidelines could be of particular interest to those involved in the design, conducting, reporting, or assessment of RCT.
Assuntos
Neoplasias da Mama/terapia , Determinação de Ponto Final/normas , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa/normas , Terminologia como Assunto , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/mortalidade , Consenso , Técnica Delphi , Progressão da Doença , Intervalo Livre de Doença , Determinação de Ponto Final/classificação , Feminino , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/classificação , Fatores de Tempo , Falha de TratamentoRESUMO
Curative surgical treatment of recurrent, locally advanced dermatofibrosarcoma protuberans is often limited owing to a close relation of the tumor with important anatomical structures. Targeted therapy with imatinib, a tyrosine kinase inhibitor, may cause significant reduction of tumor volume, thereby enabling radical surgery. This treatment strategy, therefore, offers a chance of cure for selected patients with advanced dermatofibrosarcoma protuberans. In addition, preoperative treatment with imatinib may decrease possible disfigurement related to radical surgery for large tumors.
Assuntos
Benzamidas/uso terapêutico , Dermatofibrossarcoma/tratamento farmacológico , Recidiva Local de Neoplasia/cirurgia , Piperazinas/uso terapêutico , Pirimidinas/uso terapêutico , Neoplasias Cutâneas/tratamento farmacológico , Dermatofibrossarcoma/patologia , Humanos , Mesilato de Imatinib , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/patologia , Inibidores de Proteínas Quinases/uso terapêutico , Neoplasias Cutâneas/patologia , Resultado do TratamentoRESUMO
BACKGROUND AND OBJECTIVE: Excision and histological assessment of the first draining node (sentinel lymph node) is a frequently used method to assess metastatic lymph node involvement related to cutaneous melanoma. Due to the time required for accurate histological assessment, nodal status is not immediately available to the surgeon. Hence, in case histological examination shows metastases, the patient has to be recalled to perform additional lymphadenectomy. To overcome these drawbacks we studied the applicability of photoacoustic tomographic imaging as an intra-operative modality for examining the status of resected lymph nodes. MATERIALS AND METHODS: In melanoma patients undergoing lymphadectomy for metastatic disease, six suspect lymph nodes were photoacoustically (PA) imaged using multiple wavelengths. Histopathologal examination showed three nodes without tumor cells (benign nodes) and three nodes with melanoma cells (malignant nodes). PA images were compared with histology and anatomical features were analyzed. In addition, PA spectral analysis was performed on areas of increased signal intensity. RESULTS: After correlation with histopathology, multiple areas containing melanoma cells could be identified in the PA images due to their increased response. Malignant nodes showed a higher PA response and responded differently to an increase in excitation wavelength than benign nodes. In addition, differences in anatomical features between the two groups were detected. CONCLUSIONS: Photoacoustic detection of melanoma metastases based on their melanin content proves to be possible in resected human lymph nodes. The amount of PA signal and several specific anatomical features seem to provide additional characteristics for nodal analysis. However, it is as yet preliminary to designate a highly accurate parameter to distinguish between malignant and benign nodes. We expect to improve the specificity of the technique with a future implementation of an adjusted illumination scheme and depth correction for photon fluence.
Assuntos
Cuidados Intraoperatórios/métodos , Excisão de Linfonodo , Metástase Linfática/diagnóstico , Melanoma/patologia , Técnicas Fotoacústicas/métodos , Neoplasias Cutâneas/patologia , Tomografia , Axila , Biomarcadores Tumorais/metabolismo , Humanos , Canal Inguinal , Lasers de Estado Sólido , Melaninas/metabolismo , Melanoma/metabolismo , Melanoma/cirurgia , Neoplasias Cutâneas/metabolismo , Neoplasias Cutâneas/cirurgiaRESUMO
BACKGROUND: Evidence-based decision making has permeated the daily practice of healthcare professionals. However, in wound care this seems more difficult than in other medical areas, such as breast cancer, which has a similar incidence, variety of etiologies, financial burden, and diversity of treatment options. This incongruence could be due to a lack in quantity and quality of available evidence. We therefore compared worldwide publication trends to answer whether research in wound care lags behind that in breast cancer. METHODS: In order to assess the trends in quantity and methodological quality of publications as to wound care and breast cancer treatments, we examined relevant publications over the last five decades. Publications in MEDLINE were classified into seven study design categories: (1) guidelines, (2) systematic reviews (SR), (3) randomized (RCT), and controlled clinical trials (CCT), (4) cohort studies, (5) case-control studies, (6) case series and case reports, and (7) other publications. RESULTS: We found a 30-fold rise in publications on wound care, versus a 70-fold increase in those on breast cancer. High-quality study designs like SR, RCT, or CCT were less frequent in wound care (difference 1.9, 95 % CI 1.8-2.0 %) as were guidelines; 76 on wound care versus 231 for breast cancer. CONCLUSIONS: Publications on wound care fall behind in quantity and quality as compared to breast cancer. Nevertheless, SR, RCT, and CCT in wound care are becoming more numerous. These high-quality study designs could motivate clinicians to make evidence-based decisions and researchers to perform proper research in wound care.
Assuntos
Neoplasias da Mama , Medicina Baseada em Evidências/normas , Assistência ao Paciente/normas , Editoração/normas , Ferimentos e Lesões , Pesquisa Biomédica/normas , Ensaios Clínicos como Assunto , Medicina Baseada em Evidências/tendências , Humanos , Estudos Longitudinais , Guias de Prática Clínica como Assunto , Editoração/tendênciasRESUMO
INTRODUCTION: Locoregional recurrence (LRR) after breast-conserving therapy is a well-known independent risk factor associated with unfavourable long-term outcome. Controversy exists concerning the prognostic impact of a LRR after a very long event-free interval. METHOD: Patients who underwent breast-conserving therapy for early stage breast cancer were pooled from four European Organisation for Research and Treatment of Cancer (EORTC) Breast Group trials. Only LRR as a first event was taken into account. Risk factors such as tumour size, nodal status, young age and chemotherapy were assessed in multivariate Cox regression analysis. LRR was used as a time-dependent variable in the landmark analysis for distant disease-free survival (DFS) and overall survival (OS). Patients were categorised as having at least 0, 5 or 10 years event-free survival. RESULTS: In total, 7751 early stage breast cancer patients were included with a median follow-up of 10.9 years. Tumour size, nodal status, young age and chemotherapy are strong independent prognostic factors with a significant impact on long-term outcome, but lose their power and significance over time. Including all patients, LRR was the strongest prognostic factor for OS and distant DFS (resp. HR 5.01 and HR 5.31, p<0.001). In the subgroup of patients developing a LRR after at least 5 or 10 years, LRR remained the strongest independent prognostic factor for OS (resp. HR 3.98, HR 4.96, p ≤ 0.001) and distant DFS (HR 4.42, HR 7.57 p<0.001). CONCLUSION: This is the first study which shows LRR after breast-conserving therapy is a very strong, time-independent prognostic factor for long term outcome in early stage breast cancer patients. These findings suggest that a LRR after a long event-free interval seems to be an indicator rather than an instigator of subsequent distant disease.
Assuntos
Neoplasias da Mama/mortalidade , Mastectomia Segmentar , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Intervalo Livre de Doença , Feminino , Humanos , Pessoa de Meia-Idade , Prognóstico , Recidiva , Fatores de Risco , Fatores de TempoRESUMO
To define a set of quality indicators that should be routinely measured and evaluated to confirm that the clinical outcome reaches the requested standards, Eusoma has organised a workshop during which twenty four experts from different disciplines have reviewed the international literature and selected the main process and outcome indicators available for quality assurance of breast cancer care. A review of the literature for evidence-based recommendations have been performed by the steering committee. The experts have identified the quality indicators also taking into account the usability and feasibility. For each of them it has been reported: definition, minimum and target standard, motivation for selection and level of evidence (graded according to AHRO). In overall 17 main quality indicators have been identified, respectively, 7 on diagnosis, 4 on surgery and loco-regional treatment, 2 on systemic treatment and 4 on staging, counselling, follow-up and rehabilitation. Breast Units in Europe are invited to comply with these indicators and monitor them during their periodic audit meetings.
Assuntos
Neoplasias da Mama/terapia , Indicadores de Qualidade em Assistência à Saúde , Antineoplásicos/uso terapêutico , Detecção Precoce de Câncer , Feminino , Aconselhamento Genético , Mau Uso de Serviços de Saúde , Humanos , Assistência de Longa Duração/normas , Imageamento por Ressonância Magnética , Estadiamento de Neoplasias/normas , Equipe de Assistência ao Paciente , Cuidados Pós-Operatórios/normas , Cuidados Pré-Operatórios/normas , Listas de EsperaRESUMO
INTRODUCTION: Despite high response rates to systemic chemotherapy, 30% of patients with advanced stage testicular carcinoma will have extra-retroperitoneal residual masses that require resection. Most often, these are located in the lungs and mediastinum and neck. Limited data are available concerning the incidence, surgical management, and follow-up of neck metastasis arising from a testicular primary tumor. METHODS: We retrospectively reviewed all 665 patients who were referred to a tertiary referral center with the diagnosis of testicular cancer from January 1997 to June 2009 for the presence of cervical metastases. Patients who underwent concomitant surgical therapy were identified and analyzed. Clinical and pathological data were collected from patient records, including radiology and pathology reports. Furthermore, data on primary treatment strategy, chemotherapeutic regimens, timing of surgical procedures, complications, disease recurrence, and follow-up were collected. RESULTS: Twenty-six patients (4%) had cervical lymph node metastasis. The majority (n = 19) had multiple ERP sites. Nine patients (35%) underwent selective neck dissection: in six patients, this was indicated because of residual masses after chemotherapy, and in three patients, cervical masses represented a late and distant relapse of previously treated disease. Viable cancer cells were present in the resected specimen only in these three patients. Seven patients are currently without evidence of disease. Two patients died of disseminated disease. CONCLUSIONS: Cervical lymph node metastases originating from testicular cancer are rare but are more commonly observed in patients with advanced stage disease. Selective neck dissection can be safely performed both after chemotherapy and in the case of recurrent disease.