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1.
JAMA Netw Open ; 4(6): e2112813, 2021 06 01.
Article En | MEDLINE | ID: mdl-34106265

Importance: Significant demographic disparities have been found to exist in the delivery of health care. Demographic factors associated with clinical decision-making in kidney cancer have not been thoroughly studied. Objective: To determine whether demographic factors, including sex and race/ethnicity, are associated with receipt of non-guideline-based treatment for kidney cancer. Design, Setting, and Participants: This retrospective cohort study was conducted using data from the National Cancer Database for the years 2010 through 2017. Included patients were individuals aged 30 to 70 years with localized (ie, cT1-2, N0, M0) kidney cancer and no major medical comorbidities (ie, Charlson-Deyo Comorbidity Index score of 0 or 1) treated at Commission on Cancer-accredited health care institutions in the United States. Data were analyzed from November 2020 through March 2021. Exposures: Demographic factors, including sex, race/ethnicity, and insurance status. Main Outcomes and Measures: Receipt of non-guideline-based treatment (undertreatment or overtreatment) for kidney cancer, as defined by accepted clinical guidelines, was determined. Results: Among 158 445 patients treated for localized kidney cancer, 99 563 (62.8%) were men, 120 001 individuals (75.7%) were White, and 91 218 individuals (57.6%) had private insurance. The median (interquartile range) age was 58 (50-64) years. Of the study population, 48 544 individuals (30.6%) received non-guideline-based treatment. Female sex was associated with lower adjusted odds of undertreatment (odds ratio [OR], 0.82; 95% CI, 0.77-0.88; P < .001) and higher adjusted odds of overtreatment (OR, 1.27; 95% CI, 1.24-1.30; P < .001) compared with male sex. Compared with White patients, Black and Hispanic patients had higher adjusted odds of undertreatment (Black patients: OR, 1.42; 95% CI, 1.29-1.55; P < .001; Hispanic patients: OR, 1.20; 95% CI, 1.06-1.36; P = .004) and overtreatment (Black patients: OR, 1.09; 95% CI, 1.05-1.13; P < .001; Hispanic patients: OR, 1.06; 95% CI, 1.01-1.11, P = .01). Individuals who were uninsured, compared with those who had insurance, had statistically significantly higher adjusted odds of undertreatment (OR, 2.63; 95% CI, 2.29-3.01; P < .001) and lower adjusted odds of overtreatment (OR, 0.72; 95% CI, 0.67-0.77; P < .001). Conclusions and Relevance: This study found that there were significant disparities in treatment decision-making for patients with kidney cancer, with increased rates of non-guideline-based treatment for women and Black and Hispanic patients. These findings suggest that further research into the mechanisms underlying these disparities is warranted and that clinical and policy decision-making should take these disparities into account.


Antineoplastic Protocols/standards , Demography/statistics & numerical data , Ethnicity/statistics & numerical data , Guideline Adherence/statistics & numerical data , Healthcare Disparities/ethnology , Healthcare Disparities/statistics & numerical data , Kidney Neoplasms/therapy , Racial Groups/statistics & numerical data , Adult , Aged , Aged, 80 and over , Clinical Decision-Making , Cohort Studies , Female , Humans , Male , Middle Aged , Race Factors , Retrospective Studies , Sex Factors , Socioeconomic Factors , United States
2.
J Clin Epidemiol ; 133: 53-60, 2021 05.
Article En | MEDLINE | ID: mdl-33383128

OBJECTIVE: Developing clinical prediction models (CPMs) on data of sufficient sample size is critical to help minimize overfitting. Using prostate cancer as a clinical exemplar, we aimed to investigate to what extent existing CPMs adhere to recent formal sample size criteria, or historic rules of thumb of events per predictor parameter (EPP)≥10. STUDY DESIGN AND SETTING: A systematic review to identify CPMs related to prostate cancer, which provided enough information to calculate minimum sample size. We compared the reported sample size of each CPM against the traditional 10 EPP rule of thumb and formal sample size criteria. RESULTS: About 211 CPMs were included. Three of the studies justified the sample size used, mostly using EPP rules of thumb. Overall, 69% of the CPMs were derived on sample sizes that surpassed the traditional EPP≥10 rule of thumb, but only 48% surpassed recent formal sample size criteria. For most CPMs, the required sample size based on formal criteria was higher than the sample sizes to surpass 10 EPP. CONCLUSION: Few of the CPMs included in this study justified their sample size, with most justifications being based on EPP. This study shows that, in real-world data sets, adhering to the classic EPP rules of thumb is insufficient to adhere to recent formal sample size criteria.


Antineoplastic Protocols/standards , Biomedical Research/standards , Clinical Trial Protocols as Topic , Data Accuracy , Prostatic Neoplasms/therapy , Sample Size , Adult , Aged , Aged, 80 and over , Bayes Theorem , Clinical Decision Rules , Humans , Male , Middle Aged , Research Design
3.
Ned Tijdschr Geneeskd ; 1642020 10 08.
Article Nl | MEDLINE | ID: mdl-33331719

The guideline on brain metastasis from the Netherlands Society of Neurology has been updated. Important changes have been made, particularly with regard to treatment of brain metastases. Treatment of patients with brain metastases is complex and requires a multidisciplinary approach to formulate an optimal, individualized treatment plan. Neurosurgical resection may also be considered in patients with multiple brain metastases and one dominant, symptomatic lesion, if the patient is in good clinical condition. Stereotactic radiosurgery is a treatment option for patients with a maximum of 10 brain metastases, depending on the size and number of metastases. The indication for whole brain radiotherapy is relatively limited. Doctors should be cautious with whole brain radiotherapy in patients with a Karnofsky Performance Status <70. In patients with small, asymptomatic brain metastases, targeted therapy or immune therapy may be considered without locoregional therapy.


Antineoplastic Protocols/standards , Brain Neoplasms/secondary , Brain Neoplasms/therapy , Neurology/standards , Practice Guidelines as Topic , Humans , Karnofsky Performance Status , Netherlands , Radiosurgery/standards , Societies, Medical
4.
Rev. esp. med. nucl. imagen mol. (Ed. impr.) ; 39(4): 204-211, jul.-ago. 2020. ilus, tab
Article Es | IBECS | ID: ibc-198276

INTRODUCCIÓN: Estandarizar los protocolos de adquisición de 18F-Colina PET/TC, que permitan evitar la interferencia urinaria, evaluar el mejor tiempo del estudio de cuerpo completo y valorar si la «doble fase» permite la diferenciación entre lesiones benignas frente a malignas. MÉTODO: Estudio prospectivo que incluye 100 pacientes con cáncer de próstata: 31 estadificación y 69 recidiva bioquímica (32 posprostatectomía y 37 posradioterapia). Adquisición pélvica inmediatamente tras inyección de 18F-Colina y estudio de cuerpo completo, 1 y 2h p.i. Cálculo de media SUVmáx por territorios en todos los estudios secuenciales. Análisis de medias (χ2) y porcentaje de cambio del SUV (2/1h; 1h/0min). Patrón de dinámica metabólica: acumulativo frente a aclaramiento. Seguimiento tras tratamiento en todos los pacientes y de forma dirigida, cuando éticamente es posible. RESULTADOS: Cincuenta y tres focos prostáticos, en ninguna de las imágenes precoces actividad urinaria: Patrón acumulativo en 42, porcentaje de aumento: 0min/1h: +16,7% (X20,94); 1/2h: +10,0% (X20,83). Patrón aclaramiento en 11, porcentaje de reducción: 0min/1h: 21,4% (X20,91); 1/2h: −7,7% (X20,85), correspondiendo en 7 a estadificación y 4 a posradioterapia. Todos los focos infradiafragmáticos (n: 24) mostraron dinámica acumulativa, porcentaje de aumento: +9,1% (χ20,97), todas ellas visibles en el primer estudio. De los 12 focos supradiafragmáticos, 8 mostraron aclaramiento, porcentaje de reducción: −13,0% (χ2 0,95). Los otros 4 dinámica acumulativa, porcentaje de aumento: +13,0% (χ2 0,96), siendo valorados invasivamente. Todos los focos óseos (n: 18) mostraron dinámica acumulativa, porcentaje de aumento: +17,1% (χ20,95), todas ellas visibles en el estudio 1h. CONCLUSIONES: En la valoración prostática la mejor técnica doble fase es 0min/1h. En la diferenciación de adenopatías supradiafragmáticas es aconsejable la técnica de doble fase: 1/2h. Para la infiltración infradiafragmática y ósea, ante hallazgos dudosos, las imágenes 2h aumentan la confianza diagnóstica


AIM: To standardize acquisition protocols for 18F-Choline PET/CT to prevent from urine interference, to determine the best time point for the whole-body study, and to assess whether "dual point" acquisition allows for differentiating malignant vs. benign lesions. METHODS: One hundred consecutive patients with prostate cancer were prospectively studied. Immediately after 18F-Choline injection, a pelvis study was acquired, and a whole-body was subsequently obtained 1 and 2 hours p.i. Mean SUVmax was obtained in regions and for every sequential imaging. Mean analysis (χ2) and SUV percentage change (2/1 hours; 1 hours/0 min) were obtained. Metabolic pattern dynamics were assessed: accumulative vs. clearance. Patient follow-up after therapy and directed classification whenever ethically possible were performed. RESULTS: Fifty-three prostate foci, without disturbing urinary activity was ever found on early images. Accumulative pattern in 42, with percentage increase was: 0 min/1 hour: +16.7% (χ20.94); 1/2 hours: +10,0% (χ2 0.83). Clearance pattern in 11, with percentage decrease: 0 min/1 hour: −21.4% (χ20.91): −7.7% (χ20.85), corresponding in 7 to initial staging and in 4 post-radiotherapy biochemical recurrence. Every infradiaphragmatic uptake (n: 24) showed accumulative pattern, with percentage increase of +9.1% (χ20.97), all of them depicted on early imaging. As for 12 supradiaphragmantic uptake, 8 of them showed clearance pattern with percentage decrease: −13.0% (χ20.95). Accumulative pattern showed in 4 of them with percentage increase +13.0% (χ2 0.96), thus being assessed as invasive/malignant. Every bone uptake (n: 18) showed accumulative pattern, with percentage increase: +17.1% (χ20.95), all of them depicted on 1 hour imaging. CONCLUSIONS: As for prostate assessment is concerned, dual point at 0 min/1 hour proved to be the best procedure. As for supradiaphragmatic lymph-nodes detection, dual point with 1/2 hours performed best. As for infradiaphragmatic and bone involvement, as well as for inconclusive findings, the 2 hour imaging increased our diagnostic confidence


Humans , Male , Middle Aged , Aged , Aged, 80 and over , Positron Emission Tomography Computed Tomography/methods , Prostatic Neoplasms/diagnostic imaging , Antineoplastic Protocols/standards , Choline/analysis , Prostatectomy/statistics & numerical data , Prostate-Specific Antigen/analysis , Prospective Studies , Radiopharmaceuticals/administration & dosage , Neoplasm Recurrence, Local/diagnostic imaging , Neoplasm Staging/methods , Radiometry/methods , Radiation Exposure Measurement
5.
Breast ; 53: 51-58, 2020 Oct.
Article En | MEDLINE | ID: mdl-32629156

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


Antineoplastic Protocols/standards , Breast Neoplasms/mortality , Guideline Adherence/statistics & numerical data , Mastectomy/mortality , Patient Acceptance of Health Care/statistics & numerical data , Adolescent , Adult , Aged , Breast Neoplasms/therapy , Cause of Death , Cohort Studies , Databases, Factual , Female , Humans , Italy , Mastectomy/standards , Middle Aged , Propensity Score , Proportional Hazards Models , Survival Rate , Time Factors , Young Adult
6.
Québec; INESSS; 16 juil. 2020.
Non-conventional Fr | BRISA | ID: biblio-1103460

CONTEXTE: Le présent document ainsi que les constats qu'il énonce ont été rédigés en réponse à une interpellation du ministère de la Santé et des Services sociaux dans le contexte de l'urgence sanitaire liée à la maladie à coronavirus (COVID-19) au Québec. L'objectif est de réaliser une recension sommaire des données publiées et de mobiliser les savoirs clés afin d'informer les décideurs publics et les professionnels de la santé et des services sociaux. Vu la nature rapide de cette réponse, les constats ou les positions qui en découlent ne reposent pas sur un repérage exhaustif des données publiées, une évaluation de la qualité méthodologique des études avec une méthode systématique ou sur un processus de consultation élaboré. Dans les circonstances d'une telle urgence de santé publique, l'INESSS reste à l'affût de toutes nouvelles données susceptibles de lui faire modifier cette réponse rapide. PRÉSENTATION DE LA DEMANDE: La poursuite des traitements anti-cancéreux chez les patients atteints de la COVID-19 n'est généralement pas recommandée en raison du risque d'immunosupprimer davantage le patient, d'entraîner le développement de complications sérieuses en lien avec la COVID-19 et de contaminer le personnel et les autres usagés traités en centre oncologique [ASCO, 2020; INESSS, 2020a; MSSS, 2020]. Une fois rétabli de la COVID-19, le retour au traitement doit être sécuritaire pour ces patients, le personnel soignant et les autres usagers traités en oncologie. Une recension sommaire des principales lignes directrices et prises de position par des associations, des sociétés savantes et des consensus d'experts a été réalisée pour déterminer à quel moment il sera possible d'initier ou reprendre un traitement systémique ou une radiothérapie et quels sont les facteurs pouvant guider ce retour au traitement. Des questions secondaires, en lien avec les critères de guérison généralement utilisés dans les milieux hospitaliers, la persistance de l'ARN du virus SARS-CoV-2 et les risques de réinfections des patients atteints de cancer, ont été ajoutées pour compléter le tout. MÉTHODOLOGIE: Question d'évaluation principale 1- Quels sont les meilleures pratiques et facteurs à considérer au regard de la reprise des traitements chez les patients atteints de cancer et guéris de la COVID-19? Questions d'évaluations secondaires 2- Quels sont les critères permettant de considérer une personne guérie (non contagieuse) de la COVID-19? 3- Quels sont les risques de réinfection chez les patients atteints de cancer devant faire un retour en milieu de soin? SOMMAIRE DES RÉSULTATS: 1- Reprise des traitements oncologiques suivant un report ou une interruption des traitements chez les patients atteints de la COVID-19 État actuel des connaissances scientifiques. 2- Critères de guérison et persistance de l'ARN viral Critères utilisés pour considérer un patient guéri de la COVID-19. Risques de réinfections chez les patients atteints de cancer. État actuel des connaissances scientifiques.


Humans , Coronavirus Infections/prevention & control , Antineoplastic Protocols/standards , Neoplasms/therapy , Technology Assessment, Biomedical , Health Evaluation
9.
Account Res ; 27(4): 179-194, 2020 05.
Article En | MEDLINE | ID: mdl-32088983

The fight against doping in sport is internationally coordinated by the World Anti-Doping Agency (WADA). Through its World Anti-Doping Code, WADA aims to harmonize anti-doping policies, rules and regulations. One key reference document bound to the Code is the International Standard for Laboratories (ISL), which mainly specifies the criteria that must be met for laboratory accreditation, as well as standards to adopt for the production of valid test results and evidentiary data. Within the ISL, the Code of Ethics refers to the Helsinki Declaration as a guiding framework for anti-doping research. However, inasmuch as anti-doping research structurally differs from human subject research as considered by the Helsinki Declaration, the applicability of the latter to anti-doping research can be called into question. In this work, we discuss how key principles of the Helsinki Declaration apply to anti-doping research and highlight frictions, incompatibilities and misalignments. Furthermore, we indicate possible solutions for operationalizing the Helsinki principles within the context of anti-doping research.


Biomedical Research/ethics , Doping in Sports/legislation & jurisprudence , Helsinki Declaration , International Cooperation , Laboratories/standards , Antineoplastic Protocols/standards , Humans , Organizational Objectives , Risk Assessment , Vulnerable Populations
10.
Curr Opin Clin Nutr Metab Care ; 23(2): 82-88, 2020 03.
Article En | MEDLINE | ID: mdl-32004238

PURPOSE OF REVIEW: Recommendations for intakes of n - 3 fatty acids (FAs) in patients who are receiving chemotherapy for cancer are based on weak evidence. This review highlights themes within the emergent literature to suggest improvements in the design of studies that provide n - 3 FA supplements concurrent with cytotoxic agents. RECENT FINDINGS: Following earlier research in animal models and human pilot studies, recent human studies have evaluated the effect of providing n - 3 FAs during delivery of single agent and multiagent chemotherapy regimens for breast and gastro-intestinal cancers. Regimens were based on platinum compounds, fluoropyrimidines or both, and a variety of additional agents. Tumor location and stage, supplement dose and duration, and endpoints were dissimilar across studies. Overall, the recent research continues to support the safety and tolerability of n - 3 FA supplementation with chemotherapy and provides additional evidence, albeit weak, for enhanced tumor response, maintenance of weight and muscle, and reduction in inflammation and toxicities in the host across multiple cancer sites and chemotherapy regimens. SUMMARY: The barriers to implementation in practice remain small study sizes, variations in supplement dosage and methodology, and differences in primary endpoints. Randomized, blinded trials with a justifiable sample size, adequate doses, monitored compliance and measures of clinically important endpoints are required to move these findings to a higher level of evidence for implementation into clinical practice.


Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Protocols/standards , Dietary Supplements , Fatty Acids, Omega-3/administration & dosage , Neoplasms/drug therapy , Animals , Breast Neoplasms/drug therapy , Clinical Trials as Topic , Female , Gastrointestinal Neoplasms/drug therapy , Humans , Male , Treatment Outcome
11.
Acta Oncol ; 59(4): 395-403, 2020 Apr.
Article En | MEDLINE | ID: mdl-32048563

Introduction: Population-based data on the implementation of guidelines for cancer patients in daily practice are scarce, while practice variation may influence patient outcomes. Therefore, we evaluated treatment patterns and associated variables in the systemic treatment of metastatic colorectal cancer (mCRC) in the Netherlands.Material and methods: We selected a random sample of adult mCRC patients diagnosed from 2008 to 2015 from the National Cancer Registry in 20 (4 academic, 8 teaching and 8 regional) Dutch hospitals. We examined the influence of patient, demographic and tumour characteristics on the odds of being treated with systemic therapy according to the current guideline and assessed its association with survival.Results: Our study population consisted of 2222 mCRC patients of whom 1307 patients received systemic therapy for mCRC. Practice variation was most obvious in the use of bevacizumab and anti-EGFR therapy in patients with (K)RAS wild-type tumours. Administration rates did not differ between hospital types but fluctuated between individual hospitals for bevacizumab (8-92%; p < .0001) and anti-EGFR therapy (10-75%; p = .05). Bevacizumab administration was inversely correlated to higher age (OR:0.2; 95%CI: 0.1-0.3) comorbidity (OR:0.6; 95%CI: 0.5-0.8) and the presence of metachronous metastases (OR:0.5; 95%CI: 0.3-0.7), but patient characteristics did not differ between hospitals with low or high bevacizumab administration rates. The hazard ratios for exposure to bevacizumab and anti-EGFR therapy were 0.8 (95%CI: 0.7-0.9) and 0.6 (95%CI: 0.5-0.8), respectively.Discussion: We identified significant inter-hospital variation in targeted therapy administration for mCRC patients, which may affect outcome. Age and comorbidity were inversely correlated with non-administration of bevacizumab but did not explain inter-hospital practice variation. Our data suggest that practice variation is based on individual strategy of hospitals rather than guideline recommendations or patient-driven decisions. Individual hospital strategies are an additional factor that may explain the observed differences between real-life data and results obtained from clinical trials.


Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Antineoplastic Protocols/standards , Biomarkers, Tumor/genetics , Colorectal Neoplasms/drug therapy , Practice Patterns, Physicians'/statistics & numerical data , Practice Patterns, Physicians'/standards , Registries/statistics & numerical data , Aged , Colorectal Neoplasms/epidemiology , Colorectal Neoplasms/genetics , Colorectal Neoplasms/pathology , Female , Humans , Male , Middle Aged , Molecular Targeted Therapy , Mutation , Neoplasm Metastasis , Netherlands/epidemiology , Survival Rate
12.
Eur J Cancer ; 114: 1-7, 2019 06.
Article En | MEDLINE | ID: mdl-31005015

The sentinel lymph node (SLN) biopsy is a highly accurate staging procedure and the most important prognostic factor in melanoma patients. The European Organisation for Research and Treatment of Cancer (EORTC) Melanoma Group aimed to design an updated evolved SLN protocol for the histopathological workup and reporting. We herein recommend extending the distance between steps according to the short axis dimension of the lymph node and optimise both conventional sectioning and staining procedures including immunohistochemistry. We also provide guidance on the description of the spatial localisation of melanoma deposits in a SLN. The histopathological features to be reported include the following: presence or absence of the metastasis, the intranodal location of the metastasis (subcapsular, parenchymal, combined, extensive confluent and extensive multifocal), the number of the metastatic deposits (1, 2-5, 6-10, 11-20 and >20), the maximum dimension of the largest metastasis (indicating its site) and the presence of extracapsular extension and of naevus cells. This updated EORTC protocol is expected to clarify and simplify the existing procedures, ensuring a reasonable workload for the laboratory and for the pathologists resulting in cost saving with no loss, and possible increase, in accuracy.


Antineoplastic Protocols/standards , Lymph Nodes/pathology , Melanoma/pathology , Europe , Female , Humans , Lymphatic Metastasis/pathology , Male , Neoplasm Metastasis , Sentinel Lymph Node/pathology , Skin Neoplasms/pathology
13.
Breast ; 45: 36-42, 2019 Jun.
Article En | MEDLINE | ID: mdl-30826525

The primary aim of the international advance breast cancer (ABC) guidelines are to guide treatment decisions in many different healthcare settings, but need adaptations due to different access to care. These guidelines are based on the most up-to-date evidence. However, Chinese experts have a different national condition and policies to face. The Chinese Anti-Cancer Association Committee of Breast Cancer Society guideline (CBCS guideline) is to guide treatments and to reflect unmet needs of Chinese breast cancer patients. Although, most of the recommendations in the two guidelines are the same, some of them are different. In this article, with regard to country-specific peculiarities, a working group of Chinese breast cancer experts compare the similarities and differences between the ABC guideline and CBCS guideline and commented on the voting results of the ABC panelists. We also discuss why these differences exist, such as lack of access, different tumor biology and epidemiology, and even different culture. The money which patients have to pay out of pocket for their medical cost and the availability of drugs lie at the heart of the issues of guideline differences.


Antineoplastic Protocols/standards , Breast Neoplasms , Practice Guidelines as Topic/standards , Societies, Medical/standards , China , Consensus , Female , Humans
14.
Clin Lymphoma Myeloma Leuk ; 19(4): e172-e183, 2019 04.
Article En | MEDLINE | ID: mdl-30691994

BACKGROUND: Few studies have evaluated real-world treatment patterns and survival in follicular lymphoma (FL). This study evaluated these outcomes among newly diagnosed patients with FL in routine clinical care. PATIENTS AND METHODS: A retrospective study was conducted in newly diagnosed patients with FL from Humedica, a large United States electronic medical record database, from January 1, 2008 to July 31, 2015. Patients were followed from treatment initiation until death, loss to follow-up, or end of study (September 30, 2015). Treatment patterns were assessed in the follow-up period. Progression-free survival (PFS) and overall survival (OS) at 2 years were evaluated in the overall population using Kaplan-Meier analyses. OS was also compared between patients with and without evidence of disease progression within 2 years following first-line therapy (ie, early progressors vs. non-early progressors). RESULTS: A total of 1346 patients were included in the study, with most patients receiving rituximab-based regimens. Fewer early progressors received rituximab-based regimens. Across all lines, combination therapies predominated, particularly bendamustine + rituximab. Following first-line therapy, OS was 86.9% at 2 years, and median OS was not reached. Two-year PFS after first-line therapy was 64.6%, and median PFS was 48.1 months (95% confidence interval, 39.4-58.4 months). OS at 2 years was 76.8% among early progressors versus 90.4% among non-early progressors (P < .001); the median OS was not reached in both groups. CONCLUSION: In routine clinical practice, rituximab-based regimens predominated; however, utilization of these regimens differed among early and non-early progressors. The assessment of survival outcomes also highlights the negative impact of early progression on OS in the rituximab-era.


Antineoplastic Protocols , Lymphoma, Follicular/drug therapy , Lymphoma, Follicular/mortality , Adolescent , Adult , Aged , Aged, 80 and over , Antineoplastic Agents, Immunological/therapeutic use , Antineoplastic Protocols/standards , Disease Progression , Electronic Health Records , Female , Humans , Lymphoma, Follicular/epidemiology , Male , Middle Aged , Progression-Free Survival , Retrospective Studies , Rituximab/therapeutic use , Survival Rate , Young Adult
15.
BMJ Open ; 8(10): e019505, 2018 10 18.
Article En | MEDLINE | ID: mdl-30341109

INTRODUCTION: Oral mucositis is an iatrogenic condition of erythematous inflammatory changes which tends to occur on buccal and labial surfaces, the ventral surface of the tongue, the floor of the mouth and the soft palate of patients receiving chemotherapy. This protocol of ongoing randomised parallel group clinical trial aims to access the therapeutic effect of an herbal gel containing 2.5% Arrabidaea chica Verlot standardised extract on oral mucositis in patients with head and neck cancer compared with low-level laser therapy. METHODS AND ANALYSIS: Patients with head and neck cancer held at Clinics Hospital of University of Campinas, Sao Paulo, who develop early signs/symptoms of oral mucositis are eligible. Baseline characteristics of participants include oral mucositis grade and quality of life assessments. Enrolment started in November 2017 with allocation of patients to one of the study groups by means of randomisation. Patients will be treated either with Arrabidaea chica or laser until wound healing. Monitoring includes daily assessment of mucositis grade and diameter measurement by photographs and millimetre periodontal probe. Treatments will be concluded once mucositis is healed. A blinded assessor will evaluate mucositis cure after referred by the study team. At this point, the gel tube will be weighed to indirectly assess patient's compliance. At close-out, data will be analysed by a blinded researcher following the procedures described in the statistical analyses. ETHICS AND DISSEMINATION: This clinical trial was approved by the ethics committee of research in humans at the Faculty of Medical Sciences of University of Campinas (report no. 1,613,563/2016). Results from this trial will be communicated in peer-reviewed publications and scientific presentations. TRIAL REGISTRATION NUMBER: RBR-5×4397.


Antineoplastic Protocols/standards , Bignoniaceae , Low-Level Light Therapy/methods , Plant Extracts/therapeutic use , Stomatitis/drug therapy , Female , Head and Neck Neoplasms/complications , Humans , Male , Randomized Controlled Trials as Topic
16.
Rev. esp. patol ; 51(3): 154-159, jul.-sept. 2018.
Article Es | IBECS | ID: ibc-179070

La medicina de precisión es un enfoque emergente para el tratamiento y prevención de las enfermedades que tiene en cuenta la variabilidad individual en los genes, el medio ambiente y el estilo de vida de cada persona. La medicina de precisión está transformando la investigación clínica y biomédica así como la asistencia sanitaria, tanto desde un punto de vista conceptual como metodológico, ofertando oportunidades extraordinarias para mejorar la salud pública y reducir los costes del sistema sanitario. Sin embargo, la implementación de la medicina de precisión supone un reto a nivel ético-legal, regulatorio, organizativo y de conocimiento. Sin una estrategia nacional, la medicina de precisión, que se implantará en cualquier caso, lo podría hacer sin la adecuada planificación que permita garantizar la calidad técnica, la equidad de los ciudadanos en el acceso a las mejores prácticas, vulnerando los derechos de pacientes y profesionales y arriesgando la solvencia del sistema de salud. Con este artículo de las sociedades españolas de Oncología Médica (SEOM), Anatomía Patológica (SEAP) y Farmacia Hospitalaria (SEFH), señalamos la necesidad de establecer una estrategia nacional consensuada para el desarrollo de la medicina de precisión en nuestro país, revisamos el contexto nacional e internacional, comentamos las oportunidades y los retos para la implementación de la medicina de precisión, y delineamos los objetivos de una estrategia nacional sobre medicina de precisión en cáncer


Precision medicine is an emerging approach to the prevention and treatment of disease that takes into account variability in genes, environment and lifestyle for each individual. Precision medicine is transforming clinical and biomedical research, as well as health care itself, from a conceptual, as well as a methodological viewpoint, providing extraordinary opportunities to improve public health and lower the costs of the healthcare system. However, the implementation of precision medicine poses ethical-legal, regulatory, organizational and knowledge-related challenges. Without a national strategy, precision medicine -which eventually will be implemented one way or another- could take place without the appropriate planning to guarantee technical quality and equal access to the best practices for all citizens, thus violating the rights of patients and professionals as well as jeopardizing the solvency of the healthcare system. This paper from the Spanish Societies of Medical Oncology (SEOM), Pathology (SEAP) and Hospital Pharmacy (SEFH), highlights the need to institute a consensual national strategy for the development of precision medicine in our country, reviews the national and international context, comments on the opportunities and challenges for implementing precision medicine and outlines the objectives of a national strategy on precision medicine in cancer


Humans , Neoplasms/therapy , Antineoplastic Protocols/standards , Precision Medicine/methods , National Health Strategies , Practice Patterns, Physicians' , Consensus Development Conferences as Topic
17.
Breast ; 40: 54-59, 2018 Aug.
Article En | MEDLINE | ID: mdl-29698925

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.


Ambulatory Care Facilities/standards , Antineoplastic Protocols/standards , Breast Neoplasms/mortality , Guideline Adherence/statistics & numerical data , Quality Improvement/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Breast Neoplasms/therapy , Certification , Disease-Free Survival , Female , Germany , Humans , Middle Aged , Neoplasm Recurrence, Local/mortality , Treatment Outcome , Young Adult
18.
PLoS One ; 13(3): e0193904, 2018.
Article En | MEDLINE | ID: mdl-29505589

In particle radiotherapy, range uncertainty is an important issue that needs to be overcome. Because high-dose conformality can be achieved using a particle beam, a small uncertainty can affect tumor control or cause normal-tissue complications. From this perspective, the treatment planning system (TPS) must be accurate. However, there is a well-known inaccuracy regarding dose computation in heterogeneous media. This means that verifying the uncertainty level is one of the prerequisites for TPS commissioning. We evaluated the range accuracy of the dose computation algorithm implemented in a commercial TPS, and Monte Carlo (MC) simulation against measurement using a CT calibration phantom. A treatment plan was produced for eight different materials plugged into a phantom, and two-dimensional doses were measured using a chamber array. The measurement setup and beam delivery were simulated by MC code. For an infinite solid water phantom, the gamma passing rate between the measurement and TPS was 97.7%, and that between the measurement and MC was 96.5%. However, gamma passing rates between the measurement and TPS were 49.4% for the lung and 67.8% for bone, and between the measurement and MC were 85.6% for the lung and 100.0% for bone tissue. For adipose, breast, brain, liver, and bone mineral, the gamma passing rates computed by TPS were 91.7%, 90.6%, 81.7%, 85.6%, and 85.6%, respectively. The gamma passing rates for MC for adipose, breast, brain, liver, and bone mineral were 100.0%, 97.2%, 95.0%, 98.9%, and 97.8%, respectively. In conclusion, the described procedure successfully evaluated the allowable range uncertainty for TPS commissioning. The TPS dose calculation is inefficient in heterogeneous media with large differences in density, such as lung or bone tissue. Therefore, the limitations of TPS in heterogeneous media should be understood and applied in clinical practice.


Antineoplastic Protocols/standards , Neoplasms/radiotherapy , Proton Therapy , Algorithms , Calibration , Humans , Monte Carlo Method , Phantoms, Imaging , Radiometry , Radiotherapy Dosage , Radiotherapy Planning, Computer-Assisted/methods , Radiotherapy, Intensity-Modulated/methods
19.
J Neurooncol ; 136(1): 73-78, 2018 Jan.
Article En | MEDLINE | ID: mdl-28887756

Measures of treatment intensity for childhood cancer are needed in research in order to control for variability in treatments. Existing measures of treatment intensity for childhood cancers do not reflect the complexities of treatment protocols for central nervous system (CNS) tumors. This paper describes the development of the Pediatric Neuro-Oncology Rating of Treatment Intensity (PNORTI). PNORTI development occurred in three phases. Phase 1: five experts in pediatric neuro-oncology created a 5-point scale of treatment intensity and 42 pediatric neuro-oncology providers completed a three-part online questionnaire to evaluate the classification system and apply the rating system to 16 sample patients. Validity was determined by respondents classifying therapy modalities into intensity levels. Inter-rater reliability was calculated from ratings of the 16 sample patients. Phase 2: three experts revised the PNORTI based on survey results and 18 pediatric neuro-oncology providers evaluated the classification system. Phase 3: ten experts in pediatric neuro-oncology refined and finalized the PNORTI and rated 10 sample patients using the PNORTI. Agreement between median ratings of the survey respondents and criterion raters for chemotherapy intensity (r's = .82 and 1.0) and overall treatment intensity level (r's = .91 and .94) were high in Phases 1 and 2. Inter-rater reliability also was very high when using the PNORTI to classify the 16 sample patients in Phase 1 (median agreement of r = .93 and rICC = .99) and the 10 sample patients in Phase 3 (median agreement of r = .92 and rICC = .98). The PNORTI is a valid and reliable method for classifying the intensity of different treatment modalities used in pediatric neuro-oncology.


Antineoplastic Protocols/standards , Brain Neoplasms/therapy , Medical Oncology/methods , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Child , Humans , Medical Oncology/standards , Needs Assessment , Observer Variation , Psychometrics , Reproducibility of Results
20.
Rev. ABENO ; 18(1): 155-160, 2018. ilus
Article Pt | BBO | ID: biblio-884118

O uso de antibióticos é amplamente difundido em Odontologia, devido ao risco de exposição do paciente a agentes infecciosos durante a prática clínica. Desta forma, é importante que o profissional da área esteja apto a utilizar protocolos antimicrobianos. Este trabalho visa relatar a experiência de construção de mapas conceituais no ensino de antibioticoprofilaxia em Odontologia. Foram considerados os seguintes temas: tipos de fármaco, seleção do fármaco, dosagem, e conduta clínica nas infecções agudas. Inicialmente foi realizada revisão bibliográfica acerca de protocolos profiláticos e da aprendizagem significativa, a fim de apropriar os estudantes ao método em que este trabalho está baseado. Foram montados três mapas conceituais, cada um por dois estudantes. Apesar da dificuldade visível em organizar todas as ideias a serem utilizadas e até a falta de algumas, a estruturação dos mapas conceituais foi considerada satisfatória, dentro de seu papel pedagógico de suscitar a aprendizagem (AU).


The use of antibiotics is widespread in Dentistry because of the risk of exposure of the patient to infectious agents during clinical practice. Thus, it is important that the professional in the area can use antimicrobial protocols. This paper aims to report the experience of conceptual mapping in the teaching of antibiotic prophylaxis in Dentistry. The following topics were considered: drug types, drug selection, dosage, and clinical management in acute infections. Initially, a bibliographic review was performed on prophylactic protocols and meaningful learning in order to appropriate the students to the method on which this work is based. Three conceptual maps were assembled, each by two students. Despite the visible difficulty in organizing all the ideas to be used and even the lack of some, the structuring of conceptual maps was considered satisfactory, within its pedagogical role of provoking learning (AU).


Humans , Problem-Based Learning/methods , Antibiotic Prophylaxis , Antineoplastic Protocols/standards , Education, Dental , Anti-Bacterial Agents/therapeutic use , Brazil , Dental Prophylaxis/methods
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