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1.
Cancer J ; 30(1): 31-33, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38265924

RESUMO

ABSTRACT: During the COVID-19 pandemic, there was an unprecedented growth in telemedicine due to the need to provide safe access to care during a global pandemic. The regulatory, compliance, and payment policy landscape favorably changed, paving the way for growth in utilization. Despite these favorable changes in the landscape, operational and technical burdens remained barriers to optimal use of telemedicine. Investments in operational processes and vendor selection can improve the patient and clinician experience in using telemedicine, so this digital tool can diminish burnout.


Assuntos
COVID-19 , Telemedicina , Humanos , Saúde Digital , Pandemias/prevenção & controle , Esgotamento Psicológico , COVID-19/epidemiologia , COVID-19/prevenção & controle
2.
Yearb Med Inform ; 32(1): 111-114, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38147854

RESUMO

OBJECTIVE: To summarize significant research contributions on cancer informatics published in 2022. METHODS: An extensive search using PubMed/MEDLINE was conducted to identify the scientific contributions published in 2022 that address topics in cancer informatics. The selection process comprised three steps: (i) ten candidate best papers were first selected by the two section editors, (ii) external reviewers from internationally renowned research teams reviewed each candidate best paper, and (iii) the final selection of three best papers was conducted by the editorial board of the Yearbook. RESULTS: The three selected best papers demonstrate advances in federated learning, drug synergy prediction, and utilization of clinical note data. CONCLUSION: Cancer informatics continues to mature as a subfield of biomedical informatics. Applications of informatics methods to data sharing and federated approaches are especially notable in 2022.


Assuntos
Informática Médica , Neoplasias , Humanos , Disseminação de Informação
3.
JAMA ; 330(24): 2333-2334, 2023 12 26.
Artigo em Inglês | MEDLINE | ID: mdl-37983066

RESUMO

This Viewpoint discusses the use of privacy-preserving record linkage, a token-based record linkage system, as a promising avenue for building a data infrastructure system that bridges isolated data.


Assuntos
Segurança Computacional , Atenção à Saúde , Disseminação de Informação , Registro Médico Coordenado , Privacidade , Atenção à Saúde/métodos , Disseminação de Informação/métodos
4.
JCO Clin Cancer Inform ; 7: e2300182, 2023 09.
Artigo em Inglês | MEDLINE | ID: mdl-37897263

RESUMO

PURPOSE: There is raising interest to implement electronic patient-reported outcomes (ePROs) for symptom monitoring to enhance the quality of cancer care. Step 1 of the Texas Two-Step Study demonstrated successful implementation of an ePRO system in >200 sites of service of a large community oncology practice. We now report step 2 of this study which evaluates the impact of ePROs on outcomes among patients enrolled in the Centers for Medicare & Medicaid Services' Oncology Care Model (OCM) program. METHODS: This observational study focused on patients with metastatic cancer enrolled in OCM at large community oncology practice located in Texas between July 2020 and December 2020. Patients who completed ≥1 survey via the ePRO tool were included in the study group and were propensity score matched with patients in a control group. Adverse events (AEs; hospitalizations, emergency department visits, deaths) and total cost of care were a priori study outcomes. Mann-Whitney U and chi-square tests compared continuous and categorical variables, respectively, with multivariable logistic regression for adjustment of covariates. RESULTS: Of 831 patients with metastatic cancer, 458 matched patients (229/group) were identified, with 52% male and a mean age of 74 years. Mean total AEs were lower in the study group compared with control (0.98 v 1.41; P = .007), with decreased hospitalizations (20% v 32.5%; P = .002), emergency visits (38.4% v 42.3%; P > .05), and deaths (11.8% v 16.6%; P > .05). Average number of hospitalizations was lower (0.28 v 0.52; P = .003) with reduced mean duration of hospitalizations (1.9 vs 3.2 d; P = .03). The total cost of care was reduced by an average of $1,146 per member per month. CONCLUSION: Symptom monitoring with ePROs improved quality and value of cancer care delivery by reducing hospitalizations, emergency visits, and deaths while lowering cost of care in a large oncology practice.


Assuntos
Medicare , Neoplasias , Humanos , Masculino , Idoso , Estados Unidos , Feminino , Texas/epidemiologia , Hospitalização , Neoplasias/diagnóstico , Neoplasias/terapia , Medidas de Resultados Relatados pelo Paciente , Eletrônica
5.
Am Soc Clin Oncol Educ Book ; 43: e390678, 2023 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-37290027

RESUMO

The theme of the 2023 American Society of Clinical Oncology Annual Meeting is Partnering With Patients: The Cornerstone of Cancer Care and Research. As we aim to partner with patients to improve their health care, digital tools have the potential to enhance patient-centered cancer care and make clinical research more accessible and generalizable. Using electronic patient-reported outcomes (ePROs) to collect patients' reports of symptoms, functioning, and well-being facilitates patient-clinician communication and improves care and outcomes. Early studies suggest that racial and ethnic minority populations, older patients, and patients with less education may benefit even more from ePRO implementation. Clinical practices looking to implement ePROs can refer to the resources of the PROTEUS Consortium (Patient-Reported Outcomes Tools: Engaging Users & Stakeholders). Beyond ePROs, in response to the COVID-19 pandemic, cancer practices have rapidly adopted other digital tools (eg, telemedicine, remote patient monitoring). As implementation grows, we must be aware of the limitations of these tools and implement them in ways to promote optimal function, access, and ease of use. Infrastructure, patient, provider, and system-level barriers need to be addressed. Partnerships across all levels can inform development and implementation of digital tools to meet the needs of diverse groups. In this article, we describe how we use ePROs and other digital health tools in cancer care, how digital tools can expand access to and generalizability of oncology care and research, and prospects for broader implementation and use.


Assuntos
COVID-19 , Equidade em Saúde , Neoplasias , Humanos , Etnicidade , Pandemias , Grupos Minoritários , COVID-19/epidemiologia , Medidas de Resultados Relatados pelo Paciente , Neoplasias/epidemiologia , Neoplasias/terapia
6.
Eur J Cancer ; 184: 48-59, 2023 05.
Artigo em Inglês | MEDLINE | ID: mdl-36898233

RESUMO

BACKGROUND: ExteNET showed that neratinib, an irreversible pan-HER tyrosine kinase inhibitor, given for 1 year after trastuzumab-based therapy significantly improved invasive disease-free survival in women with early-stage HER2-positive breast cancer. We report the final analysis of overall survival in ExteNET. METHODS: In this international, randomised, double-blind, placebo-controlled, phase 3 trial, women aged 18 years or older with stage 1-3c (amended to stage 2-3c) HER2-positive breast cancer who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab were eligible. Patients were randomly assigned to oral neratinib 240 mg/day or placebo for 1 year. Randomisation was stratified according to hormone receptor (HR) status (HR-positive vs. HR-negative), nodal status (0, 1-3 or 4+), and trastuzumab regimen (sequentially vs. concurrently with chemotherapy). Overall survival was analysed by intention to treat. ExteNET is registered (Clinicaltrials.gov: NCT00878709) and is complete. RESULTS: Between July 9, 2009, and October 24, 2011, 2840 women received neratinib (n = 1420) or placebo (n = 1420). After a median follow-up of 8.1 (IQR, 7.0-8.8) years, 127 patients (8.9%) in the neratinib group and 137 patients (9.6%) in the placebo group in the intention-to-treat population had died. Eight-year overall survival rates were 90.1% (95% CI 88.3-91.6) with neratinib and 90.2% (95% CI 88.4-91.7) with placebo (stratified hazard ratio 0.95; 95% CI 0.75-1.21; p = 0.6914). CONCLUSIONS: Overall survival in the extended adjuvant setting was comparable for neratinib and placebo after a median follow-up of 8.1 years in women with early-stage HER2-positive breast cancer.


Assuntos
Neoplasias da Mama , Feminino , Humanos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Intervalo Livre de Doença , Método Duplo-Cego , Receptor ErbB-2 , Trastuzumab/efeitos adversos
7.
JCO Clin Cancer Inform ; 7: e2200187, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36857630

RESUMO

PURPOSE: Symptoms are common in patients receiving systemic treatment for metastatic cancer. Monitoring patients with electronic patient-reported outcomes (ePROs) detects severe and worsening symptoms early, enabling care teams to intervene and prevent downstream complications and thereby improving outcomes. The Centers for Medicare & Medicaid Services will require patient-reported outcome (PRO) monitoring in the upcoming Enhancing Oncology Model, and many practices will likely attempt to implement PROs in patient care for the first time. METHODS: To assist practices with the design and implementation of ePRO remote symptom monitoring programs, tenets were drawn from prior ePRO program experiences and research. RESULTS: Successful implementation requires a quality improvement approach to change management with attention to software functionality, measured outcomes, personnel deployment, leadership and culture, workflow, equity, and patient engagement. Specific approaches in each of these areas can optimize program participation and effectiveness. Continuous program monitoring to identify and address barriers is essential to success. Initial challenges with personnel acceptance and patient participation are common and can be overcome by using these tenets. CONCLUSION: Remote symptom monitoring with ePROs is a key component of quality cancer care and population health management that requires organizational commitment and a deliberate approach by practices using established tenets to assure successful implementation.


Assuntos
Medicare , Neoplasias , Idoso , Estados Unidos , Humanos , Oncologia , Participação do Paciente , Medidas de Resultados Relatados pelo Paciente , Eletrônica
8.
Magn Reson Med ; 89(3): 1134-1150, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-36321574

RESUMO

PURPOSE: A method is presented to select the optimal time points at which to measure DCE-MRI signal intensities, leaving time in the MR exam for high-spatial resolution image acquisition. THEORY: Simplicial complexes are generated from the Kety-Tofts model pharmacokinetic parameters Ktrans and ve . A geometric search selects optimal time points for accurate estimation of perfusion parameters. METHODS: The DCE-MRI data acquired in women with invasive breast cancer (N = 27) were used to retrospectively compare parameter maps fit to full and subsampled time courses. Simplicial complexes were generated for a fixed range of Kety-Tofts model parameters and for the parameter ranges weighted by estimates from the fully sampled data. The largest-area manifolds determined the optimal three time points for each case. Simulations were performed along with retrospectively subsampled data fits. The agreement was computed between the model parameters fit to three points and those fit to all points. RESULTS: The optimal three-point sample times were from the data-informed simplicial complex analysis and determined to be 65, 204, and 393 s after arrival of the contrast agent to breast tissue. In the patient data, tumor-median parameter values fit using all points and the three selected time points agreed with concordance correlation coefficients of 0.97 for Ktrans and 0.67 for ve . CONCLUSION: It is possible to accurately estimate pharmacokinetic parameters from three properly selected time points inserted into a clinical DCE-MRI breast exam. This technique can provide guidance on when to capture images for quantitative data between high-spatial-resolution DCE-MRI images.


Assuntos
Neoplasias da Mama , Mama , Humanos , Feminino , Estudos Retrospectivos , Mama/diagnóstico por imagem , Meios de Contraste/farmacocinética , Imageamento por Ressonância Magnética/métodos , Neoplasias da Mama/diagnóstico por imagem
9.
Yearb Med Inform ; 31(1): 131-134, 2022 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-36463870

RESUMO

OBJECTIVE: To summarize significant research contributions on cancer informatics published in 2021. METHODS: An extensive search using PubMed/MEDLINE and Altmetric scores was conducted to identify the scientific contributions published in 2021 that address topics in cancer informatics. The selection process comprised three steps: (i) 15 candidate best papers were first selected by the two section editors, (ii) external reviewers from internationally renowned research teams reviewed each candidate best paper, and (iii) the final selection of two best papers was conducted by the editorial board of the IMIA Yearbook. RESULTS: The two selected best papers demonstrate some of the promises and shortcomings of real-world data. CONCLUSION: Cancer informatics is a maturing subfield of biomedical informatics. Applications of informatics methods to real-world data are especially notable in 2021.


Assuntos
Informática , Neoplasias , Humanos , MEDLINE , Neoplasias/terapia , Resolução de Problemas , Sistema de Registros , Ensaios Clínicos como Assunto
10.
Clin Breast Cancer ; 22(6): 601-610, 2022 08.
Artigo em Inglês | MEDLINE | ID: mdl-35643624

RESUMO

INTRODUCTION: To describe real-world treatment patterns and effectiveness of first-line palbociclib plus an aromatase inhibitor (PAL+AI) and examine the association between PAL initial dose and effectiveness among patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic/advanced breast cancer (HR+/HER2- MBC) in routine clinical practice. PATIENTS AND METHODS: This retrospective analysis used Flatiron Health's database of electronic health records from >280 cancer clinics representing >2.4 million actively treated cancer patients in the United States. Women with HR+/HER2- MBC who received first-line PAL+AI were included. Real-world progression-free survival (rwPFS) was defined as the time from starting PAL+AI to death or disease progression. Real-world best tumor response (rwBTR) was assessed based on the treating clinician's assessment of radiologic evidence for change in disease burden. RESULTS: Of 813 eligible patients, median age was 65.0 years, and median follow-up was 21.0 months. PAL was initiated at 125 mg/d and 75/100 mg/d in 86.5% and 13.5% of patients, respectively. Median duration of PAL+AI was 16.3 months. 43.0% of patients discontinued PAL+ AI; 11.0% discontinued because of toxicity. Median time to subsequent therapy and chemotherapy was 24.6 and 36.6 months, respectively. Median rwPFS was 20.0 months, and best rwBTR rate was 51.9%. Patients starting PAL at 125 versus 75/100 mg/d had longer median rwPFS (27.8 vs. 18.6 months) and higher rwBTR rate (54.0% vs. 40.4%). CONCLUSION: These data demonstrate the benefit of PAL+AI in routine clinical practice and may support the initiation of palbociclib at the recommended dose of 125 mg/d for HR+/HER2- MBC. TRIAL REGISTRATION NUMBER AND DATE OF REGISTRATION: NCT04176354, November 25, 2019.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica , Neoplasias da Mama , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Inibidores da Aromatase/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Feminino , Humanos , Piperazinas/uso terapêutico , Piridinas/uso terapêutico , Receptor ErbB-2/metabolismo , Receptores de Estrogênio/metabolismo , Estudos Retrospectivos , Estados Unidos
11.
Biophys Rev (Melville) ; 3(2): 021304, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35602761

RESUMO

Digital twins employ mathematical and computational models to virtually represent a physical object (e.g., planes and human organs), predict the behavior of the object, and enable decision-making to optimize the future behavior of the object. While digital twins have been widely used in engineering for decades, their applications to oncology are only just emerging. Due to advances in experimental techniques quantitatively characterizing cancer, as well as advances in the mathematical and computational sciences, the notion of building and applying digital twins to understand tumor dynamics and personalize the care of cancer patients has been increasingly appreciated. In this review, we present the opportunities and challenges of applying digital twins in clinical oncology, with a particular focus on integrating medical imaging with mechanism-based, tissue-scale mathematical modeling. Specifically, we first introduce the general digital twin framework and then illustrate existing applications of image-guided digital twins in healthcare. Next, we detail both the imaging and modeling techniques that provide practical opportunities to build patient-specific digital twins for oncology. We then describe the current challenges and limitations in developing image-guided, mechanism-based digital twins for oncology along with potential solutions. We conclude by outlining five fundamental questions that can serve as a roadmap when designing and building a practical digital twin for oncology and attempt to provide answers for a specific application to brain cancer. We hope that this contribution provides motivation for the imaging science, oncology, and computational communities to develop practical digital twin technologies to improve the care of patients battling cancer.

12.
J Clin Oncol ; 40(23): 2636-2655, 2022 08 10.
Artigo em Inglês | MEDLINE | ID: mdl-35640075

RESUMO

PURPOSE: To provide updated evidence- and consensus-based guideline recommendations to practicing oncologists and others on the management of brain metastases for patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer up to 2021. METHODS: An Expert Panel conducted a targeted systematic literature review (for both systemic therapy for non-CNS metastases and for CNS metastases of HER2+ guideline updates) that identified 545 articles. Outcomes of interest included overall survival, progression-free survival, and adverse events. RESULTS: Of the 545 publications identified and reviewed, six on systemic therapy were identified to form the evidentiary basis for the systemic therapy for CNS metastases guideline recommendations. RECOMMENDATIONS: Patients with brain metastases should receive appropriate local therapy and systemic therapy, if indicated. Local therapies include surgery, whole-brain radiotherapy, and stereotactic radiosurgery. Memantine and hippocampal avoidance should be added to whole-brain radiotherapy when possible. Treatments depend on factors such as patient prognosis, presence of symptoms, resectability, number and size of metastases, prior therapy, and whether metastases are diffuse. Other options include systemic therapy, best supportive care, enrollment onto a clinical trial, and/or palliative care. There are insufficient data to recommend for or against performing routine magnetic resonance imaging to screen for brain metastases; clinicians should have a low threshold for magnetic resonance imaging of the brain because of the high incidence of brain metastases among patients with HER2-positive advanced breast cancer.Additional information is available at www.asco.org/breast-cancer-guidelines.


Assuntos
Neoplasias Encefálicas , Neoplasias da Mama , Neoplasias do Sistema Nervoso Central , Radiocirurgia , Receptor ErbB-2 , Neoplasias Encefálicas/secundário , Neoplasias Encefálicas/terapia , Neoplasias da Mama/tratamento farmacológico , Neoplasias do Sistema Nervoso Central/secundário , Neoplasias do Sistema Nervoso Central/terapia , Feminino , Humanos , Receptor ErbB-2/genética
13.
J Clin Oncol ; 40(23): 2612-2635, 2022 08 10.
Artigo em Inglês | MEDLINE | ID: mdl-35640077

RESUMO

PURPOSE: To update evidence-based guideline recommendations to practicing oncologists and others on systemic therapy for patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer. METHODS: An Expert Panel conducted a targeted systematic literature review (for both systemic treatment and CNS metastases) and identified 545 articles. Outcomes of interest included efficacy and safety. RESULTS: Of the 545 publications identified and reviewed, 14 were identified to form the evidentiary basis for the guideline recommendations. RECOMMENDATIONS: HER2-targeted therapy is recommended for patients with HER2-positive advanced breast cancer, except for those with clinical congestive heart failure or significantly compromised left ventricular ejection fraction, who should be evaluated on a case-by-case basis. Trastuzumab, pertuzumab, and taxane for first-line treatment and trastuzumab deruxtecan for second-line treatment are recommended. In the third-line setting, clinicians should offer other HER2-targeted therapy combinations. There is a lack of head-to-head trials; therefore, there is insufficient evidence to recommend one regimen over another. The patient and the clinician should discuss differences in treatment schedule, route, toxicities, etc during the decision-making process. Options include regimens with tucatinib, trastuzumab emtansine, trastuzumab deruxtecan (if either not previously administered), neratinib, lapatinib, chemotherapy, margetuximab, hormonal therapy, and abemaciclib plus trastuzumab plus fulvestrant, and may offer pertuzumab if the patient has not previously received it. Optimal duration of chemotherapy is at least 4-6 months or until maximum response, depending on toxicity and in the absence of progression. HER2-targeted therapy can continue until time of progression or unacceptable toxicities. For patients with HER2-positive and estrogen receptor-positive or progesterone receptor-positive breast cancer, clinicians may recommend either standard first-line therapy or, for selected patients, endocrine therapy plus HER2-targeted therapy or endocrine therapy alone.Additional information is available at www.asco.org/breast-cancer-guidelines.


Assuntos
Neoplasias da Mama , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/patologia , Feminino , Humanos , Guias de Prática Clínica como Assunto , Receptor ErbB-2/metabolismo , Volume Sistólico , Trastuzumab , Função Ventricular Esquerda
14.
Am J Manag Care ; 28(3 Spec. No.): SP136-SP138, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35285592

RESUMO

OBJECTIVES: COVID-19 has caused considerable drops in utilization of breast cancer screening services during the pandemic, especially among certain racial and ethnic groups. Members of the Community Oncology Alliance (COA)-including the COA president, South Carolina oncologist Kashyap Patel, MD-have reported increases in patients, particularly those of color, presenting with stage III and IV cancer at diagnosis. According to data released by the Biden administration, more than 9.5 million recommended cancer screenings had been missed in the United States as a result of the COVID-19 pandemic, as of February 2022. President Joe Biden and First Lady Jill Biden, EdD, aim to address this in the 2022 revitalized Cancer Moonshot Initiative. The findings made by COA as well as by Avalere also suggest that the pandemic has exacerbated existing health care disparities. METHODS: Using a multipayer database, we analyzed breast cancer screening rates for 2 periods-March 1 to September 30, 2019, and March 1 to September 30, 2020-among Medicare fee-for-service (FFS), managed Medicaid, and commercial insurance beneficiaries to understand the potential impact of the COVID-19 pandemic on adherence to the US Preventive Services Task Force breast cancer screening recommendations, which are currently undergoing review. Screening rates were evaluated across 5 racial/ethnic groups and by payer type. RESULTS: Mean monthly mammogram screening rates among eligible White Medicare FFS beneficiaries dropped to 0.6% in April 2020, but these screening rates recovered to 6.5% by June 2020. Screening rates for eligible Black Medicare FFS beneficiaries recovered on a pace slightly slower than that of White beneficiaries, but more rapidly than that of other groups. By comparison, American Indian/Alaska Native beneficiaries had a mean monthly screening rate of 0.5% in April 2020, which recovered to 3.1% in June 2020; these were below 2019 screening rates of 4.2% for April and 3.9% for June. Differences in screening rates by payer type were also observed. Patients with commercial insurance had higher screening rates compared with those covered by Medicare FFS and managed Medicaid. CONCLUSIONS: Our principal finding shows that mean breast cancer screening rates decreased in April 2020 across all payers, but recovery to prepandemic screening levels has occurred more slowly among certain racial and ethnic minority groups. Differences in recovery rates by payer type highlight a strong relationship between income level and screening utilization.


Assuntos
Neoplasias da Mama , COVID-19 , Idoso , Feminino , Humanos , Neoplasias da Mama/diagnóstico , COVID-19/epidemiologia , Detecção Precoce de Câncer , Etnicidade , Medicare , Grupos Minoritários , Pandemias , Estados Unidos
15.
N Engl J Med ; 386(6): 556-567, 2022 02 10.
Artigo em Inglês | MEDLINE | ID: mdl-35139274

RESUMO

BACKGROUND: The addition of pembrolizumab to neoadjuvant chemotherapy led to a significantly higher percentage of patients with early triple-negative breast cancer having a pathological complete response (defined as no invasive cancer in the breast and negative nodes) at definitive surgery in an earlier analysis of this phase 3 trial of neoadjuvant and adjuvant therapy. The primary results regarding event-free survival in this trial have not been reported. METHODS: We randomly assigned, in a 2:1 ratio, patients with previously untreated stage II or III triple-negative breast cancer to receive neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) or placebo every 3 weeks plus paclitaxel and carboplatin, followed by four cycles of pembrolizumab or placebo plus doxorubicin-cyclophosphamide or epirubicin-cyclophosphamide. After definitive surgery, patients received adjuvant pembrolizumab (pembrolizumab-chemotherapy group) or placebo (placebo-chemotherapy group) every 3 weeks for up to nine cycles. The primary end points were pathological complete response (the results for which have been reported previously) and event-free survival, defined as the time from randomization to the date of disease progression that precluded definitive surgery, local or distant recurrence, occurrence of a second primary cancer, or death from any cause. Safety was also assessed. RESULTS: Of the 1174 patients who underwent randomization, 784 were assigned to the pembrolizumab-chemotherapy group and 390 to the placebo-chemotherapy group. The median follow-up at this fourth planned interim analysis (data cutoff, March 23, 2021) was 39.1 months. The estimated event-free survival at 36 months was 84.5% (95% confidence interval [CI], 81.7 to 86.9) in the pembrolizumab-chemotherapy group, as compared with 76.8% (95% CI, 72.2 to 80.7) in the placebo-chemotherapy group (hazard ratio for event or death, 0.63; 95% CI, 0.48 to 0.82; P<0.001). Adverse events occurred predominantly during the neoadjuvant phase and were consistent with the established safety profiles of pembrolizumab and chemotherapy. CONCLUSIONS: In patients with early triple-negative breast cancer, neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab after surgery, resulted in significantly longer event-free survival than neoadjuvant chemotherapy alone. (Funded by Merck Sharp and Dohme, a subsidiary of Merck; KEYNOTE-522 ClinicalTrials.gov number, NCT03036488.).


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Antineoplásicos Imunológicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Intervalo Livre de Progressão , Neoplasias de Mama Triplo Negativas/tratamento farmacológico , Adulto , Idoso , Anticorpos Monoclonais Humanizados/efeitos adversos , Antineoplásicos Imunológicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Quimioterapia Adjuvante , Feminino , Humanos , Análise de Intenção de Tratamento , Estimativa de Kaplan-Meier , Pessoa de Meia-Idade , Terapia Neoadjuvante , Neoplasias de Mama Triplo Negativas/cirurgia
16.
Breast Cancer Res ; 23(1): 110, 2021 11 27.
Artigo em Inglês | MEDLINE | ID: mdl-34838096

RESUMO

BACKGROUND: The purpose of this study was to determine whether advanced quantitative magnetic resonance imaging (MRI) can be deployed outside of large, research-oriented academic hospitals and into community care settings to predict eventual pathological complete response (pCR) to neoadjuvant therapy (NAT) in patients with locally advanced breast cancer. METHODS: Patients with stage II/III breast cancer (N = 28) were enrolled in a multicenter study performed in community radiology settings. Dynamic contrast-enhanced (DCE) and diffusion-weighted (DW)-MRI data were acquired at four time points during the course of NAT. Estimates of the vascular perfusion and permeability, as assessed by the volume transfer rate (Ktrans) using the Patlak model, were generated from the DCE-MRI data while estimates of cell density, as assessed by the apparent diffusion coefficient (ADC), were calculated from DW-MRI data. Tumor volume was calculated using semi-automatic segmentation and combined with Ktrans and ADC to yield bulk tumor blood flow and cellularity, respectively. The percent change in quantitative parameters at each MRI scan was calculated and compared to pathological response at the time of surgery. The predictive accuracy of each MRI parameter at different time points was quantified using receiver operating characteristic curves. RESULTS: Tumor size and quantitative MRI parameters were similar at baseline between groups that achieved pCR (n = 8) and those that did not (n = 20). Patients achieving a pCR had a larger decline in volume and cellularity than those who did not achieve pCR after one cycle of NAT (p < 0.05). At the third and fourth MRI, changes in tumor volume, Ktrans, ADC, cellularity, and bulk tumor flow from baseline (pre-treatment) were all significantly greater (p < 0.05) in the cohort who achieved pCR compared to those patients with non-pCR. CONCLUSIONS: Quantitative analysis of DCE-MRI and DW-MRI can be implemented in the community care setting to accurately predict the response of breast cancer to NAT. Dissemination of quantitative MRI into the community setting allows for the incorporation of these parameters into the standard of care and increases the number of clinical community sites able to participate in novel drug trials that require quantitative MRI.


Assuntos
Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/tratamento farmacológico , Imageamento por Ressonância Magnética Multiparamétrica , Adulto , Idoso , Neoplasias da Mama/patologia , Neoplasias da Mama/cirurgia , Monitoramento de Medicamentos , Feminino , Humanos , Pessoa de Meia-Idade , Terapia Neoadjuvante , Valor Preditivo dos Testes , Curva ROC , Resultado do Tratamento , Carga Tumoral
17.
Nat Protoc ; 16(11): 5309-5338, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34552262

RESUMO

This protocol describes a complete data acquisition, analysis and computational forecasting pipeline for employing quantitative MRI data to predict the response of locally advanced breast cancer to neoadjuvant therapy in a community-based care setting. The methodology has previously been successfully applied to a heterogeneous patient population. The protocol details how to acquire the necessary images followed by registration, segmentation, quantitative perfusion and diffusion analysis, model calibration, and prediction. The data collection portion of the protocol requires ~25 min of scanning, postprocessing requires 2-3 h, and the model calibration and prediction components require ~10 h per patient depending on tumor size. The response of individual breast cancer patients to neoadjuvant therapy is forecast by application of a biophysical, reaction-diffusion mathematical model to these data. Successful application of the protocol results in coregistered MRI data from at least two scan visits that quantifies an individual tumor's size, cellularity and vascular properties. This enables a spatially resolved prediction of how a particular patient's tumor will respond to therapy. Expertise in image acquisition and analysis, as well as the numerical solution of partial differential equations, is required to carry out this protocol.


Assuntos
Neoplasias da Mama , Feminino , Humanos , Processamento de Imagem Assistida por Computador , Imageamento por Ressonância Magnética
19.
Tomography ; 7(3): 253-267, 2021 06 23.
Artigo em Inglês | MEDLINE | ID: mdl-34201654

RESUMO

This study characterizes the error that results when performing quantitative analysis of abbreviated dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) data of the breast with the Standard Kety-Tofts (SKT) model and its Patlak variant. More specifically, we used simulations and patient data to determine the accuracy with which abbreviated time course data could reproduce the pharmacokinetic parameters, Ktrans (volume transfer constant) and ve (extravascular/extracellular volume fraction), when compared to the full time course data. SKT analysis of simulated abbreviated time courses (ATCs) based on the imaging parameters from two available datasets (collected with a 3T MRI scanner) at a temporal resolution of 15 s (N = 15) and 7.23 s (N = 15) found a concordance correlation coefficient (CCC) greater than 0.80 for ATCs of length 3.0 and 2.5 min, respectively, for the Ktrans parameter. Analysis of the experimental data found that at least 90% of patients met this CCC cut-off of 0.80 for the ATCs of the aforementioned lengths. Patlak analysis of experimental data found that 80% of patients from the 15 s resolution dataset and 90% of patients from the 7.27 s resolution dataset met the 0.80 CCC cut-off for ATC lengths of 1.25 and 1.09 min, respectively. This study provides evidence for both the feasibility and potential utility of performing a quantitative analysis of abbreviated breast DCE-MRI in conjunction with acquisition of current standard-of-care high resolution scans without significant loss of information in the community setting.


Assuntos
Neoplasias da Mama , Neoplasias da Mama/diagnóstico por imagem , Meios de Contraste , Feminino , Humanos , Imageamento por Ressonância Magnética
20.
JCO Oncol Pract ; 17(9): 546-564, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34319760

RESUMO

PURPOSE: To provide standards and practice recommendations specific to telehealth in oncology. METHODS: A systematic review of the literature on telehealth in oncology was performed, including the use of technologies and telecommunications systems, and other electronic methods of care delivery and sharing of information with patients. The evidence base was combined with the opinion of the ASCO Telehealth Expert Panel to develop telehealth standards and guidance. Public comments were solicited and considered in preparation of the final manuscript. RESULTS: The Expert Panel determined that general guidance on implementing telehealth across general and specialty settings has been published previously and these resources are endorsed. A systematic search for studies on topics specific to oncology resulted in the inclusion of two clinical practice guidelines, 12 systematic reviews, and six primary studies. STANDARDS AND GUIDANCE: Standards and guidance are provided for which patients in oncology can be seen via telehealth, establishment of the doctor-physician relationship, role of allied health professionals, role of advanced practice providers, multidisciplinary cancer conferences, and teletrials in oncology. Additional information is available at www.asco.org/standards.


Assuntos
Oncologia , Telemedicina , Humanos
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