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1.
Oncologist ; 22(4): 379-385, 2017 04.
Artículo en Inglés | MEDLINE | ID: mdl-28283585

RESUMEN

BACKGROUND: Although hypomethylating agents (HMAs) are effective and approved therapies for patients with myelodysplastic syndromes (MDS), many patients do not benefit from treatment, and nearly all ultimately stop responding to HMAs. The incidence and cost burden of HMA failure are unknown yet needed to appreciate the magnitude and significance of such failure. METHODS: We analyzed a de-identified dataset of over 5 million individuals with private health insurance in the U.S. to estimate MDS incidence, prevalence, and treatments. Based on MDS provider interviews, a conceptual model of MDS patient management was constructed to create a new, claims-relevant and drug development-relevant definition of HMA treatment failure. This algorithm was used to define resource encumbrance of MDS patients in whom HMA treatment failed. RESULTS: We estimated an MDS incidence rate of ∼70 cases per 100,000 enrollees per year and a prevalence of 155 cases per 100,000 enrollees. The proportion of MDS patients receiving HMA treatment was low (∼3%), and treatment was typically initiated within 1 year of the first MDS claim. Notably, HMA-treated individuals were older and had more comorbidities than the overall MDS cohort. Total health care costs of managing MDS patients after HMA failure were high (∼$77,000 during the first 6 months) and were driven primarily by non-pharmacy costs. CONCLUSION: This study quantifies for the first time the burden of significant unmet need in caring for MDS patients following HMA treatment failure. The Oncologist 2017;22:379-385Implications for Practice: U.S.-based treatment patterns among MDS patients demonstrate the significant clinical, financial, and health care burden associated with HMA failure and call for active therapies for this patient population.


Asunto(s)
Antimetabolitos Antineoplásicos/economía , Seguro de Salud/economía , Síndromes Mielodisplásicos/tratamiento farmacológico , Síndromes Mielodisplásicos/economía , Metilación de ADN/genética , Femenino , Recursos en Salud/economía , Trasplante de Células Madre Hematopoyéticas/economía , Humanos , Masculino , Síndromes Mielodisplásicos/patología , Insuficiencia del Tratamiento
2.
Int J Clin Oncol ; 18(5): 934-41, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23053399

RESUMEN

OBJECTIVES: UNBS5162 is a novel naphthalimide that binds to DNA by intercalation and suppresses CXCL chemokine elaboration. A Phase I study of UNBS5162 was conducted to establish pharmacokinetics (PK), maximum tolerated dose (MTD), dose-limiting toxicity, safety and anti-tumor activity in patients with advanced solid tumors or lymphoma. METHODS: UNBS5162 was administered in a 3 + 3 dose escalation scheme by intravenous infusion over 1 h weekly for 3 weeks of a 4-week cycle. Safety, serial serum PK and tolerability were captured throughout the study. Response Evaluation Criteria in Solid Tumors was utilized every 2 cycles to assess for anti-tumor response. RESULTS: Twenty-four patients with metastatic carcinoma and 1 patient with lymphoma were treated at eight dose levels (18-234 mg/m(2)). All patients were evaluable for tolerability and toxicity. Grade 3 toxicities include nausea (n = 1), fatigue (n = 1) and anorexia (n = 1). Prolongation of QTc [Hodges] was observed in 6 cases (Gr 1 = 2; Gr 2 = 2; Gr 3 = 2). C(max) and area under the curve increased linearly with dose with a t(1/2) of 30-60 min. 16 patients completed 2 cycles of therapy, all with pharmacodynamics at 8 weeks. CONCLUSIONS: The MTD or dose-limiting toxicity for UNBS5162 was not reached due to the magnitude of QTc prolongation at the highest dose of 234 mg/m(2)/week that led to study termination.


Asunto(s)
Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/patología , Linfoma/tratamiento farmacológico , Naftalimidas/administración & dosificación , Urea/análogos & derivados , Adulto , Anciano , Anciano de 80 o más Años , Animales , Perros , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Humanos , Linfoma/sangre , Linfoma/patología , Masculino , Dosis Máxima Tolerada , Ratones , Persona de Mediana Edad , Naftalimidas/efectos adversos , Naftalimidas/sangre , Naftalimidas/farmacocinética , Metástasis de la Neoplasia , Estadificación de Neoplasias , Ratas , Urea/administración & dosificación , Urea/efectos adversos , Urea/sangre , Urea/farmacocinética
3.
J Adv Pract Oncol ; 14(3): 223-226, 2023 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-37197733

RESUMEN

In the popular biomarker-focused session at JADPRO Live 2022, presenters paired biomarkers with tumor types for which their expression is most commonly used to determine targeted therapy, identified key assays used to measure common biomarkers, and reviewed recommendations and guidelines for biomarker testing.

4.
Am J Med ; 136(1): 96-99, 2023 01.
Artículo en Inglés | MEDLINE | ID: mdl-36181789

RESUMEN

BACKGROUND: Coronavirus disease 2019 (COVID-19) is associated with increased morbidity and mortality among immunocompromised patients. Tixagevimab-cilgavimab (Tix-Cil) is a combination of 2 monoclonal antibodies approved for the prevention of COVID-19 complications in this high-risk group. METHODS: We retrospectively reviewed the charts of patients who received Tix-Cil during the Omicron variant period (January 17 to April 23, 2022), with a follow-up period until May 24, 2022. We collected data about patient underlying comorbidities and post Tix-Cil COVID-19 infections, deaths, and hospitalizations. RESULTS: There were 463 patients with a median age of 68 years, of which 51% were male, 79% White, 13.2% Hispanic, 1.7% Black/African American, and 5.8% identified as Other. A total of 18% had undergone a solid organ transplantation or hematopoietic stem cell transplantation. Only 6/98 (6.1%) had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detected by polymerase chain reaction (PCR) at a median 48 days (interquartile range [IQR] 27.5, 69) follow-up. Forty-two patients (9.1%) were hospitalized, and 4 (0.9%) died, but none were attributed to COVID-19 or Tix-Cil. One hospitalized patient had an incidental, asymptomatic, positive SARS-CoV 2 by PCR. The median days from Tix-Cil administration to non-COVID-19-related hospitalization and death were 30 (IQR 17, 55) and 53 (IQR 18, 91), respectively. CONCLUSION: Tix-Cil provides protection against COVID-19 complications in immunocompromised patients with suboptimal immune responses to vaccines.


Asunto(s)
COVID-19 , SARS-CoV-2 , Humanos , Masculino , Anciano , Femenino , Estudios Retrospectivos , Anticuerpos Monoclonales
5.
Expert Opin Pharmacother ; 24(9): 1091-1100, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37163478

RESUMEN

INTRODUCTION: Ruxolitinib has been the cornerstone of pharmacologic therapy for myelofibrosis for over a decade. However, the last several years have witnessed the regulatory approval of other Janus kinase (JAK) inhibitors for myelofibrosis, i.e. fedratinib, pacritinib, and US approval of momelotinib is widely anticipated in 2023. AREAS COVERED: Due to the multifaceted clinical presentation of myelofibrosis, a watertight definition of ruxolitinib failure has remained elusive, as "progression" on ruxolitinib can take many forms and management is highly nuanced. Yet, the availability of other JAK inhibitors and potential future availability of non-JAK inhibitor agents for myelofibrosis make a consensus on management of ruxolitinib failure critically important. This consensus paper summarizes a discussion between multiple academic and community physician experts, a pharmacist and an advanced practice provider around the issues to be considered for the optimal care of patients with myelofibrosis whose disease is refractory to or does not respond adequately to ruxolitinib, or who exhibit intolerance to ruxolitinib. EXPERT OPINION: The panel identified several areas of consensus, as well as some areas where more data to inform evidence-based practice are needed. In some situations, maintaining ruxolitinib while adding another agent, e.g. to address anemia, is appropriate, whereas in others, switching to a different drug has merit.


Asunto(s)
Janus Quinasa 2 , Mielofibrosis Primaria , Humanos , Mielofibrosis Primaria/tratamiento farmacológico , Nitrilos/uso terapéutico , Pirazoles/uso terapéutico , Pirazoles/farmacología
6.
Transl Behav Med ; 13(4): 255-267, 2023 04 15.
Artículo en Inglés | MEDLINE | ID: mdl-36688466

RESUMEN

Shared decision-making (SDM) is a key component of patient-centered healthcare. SDM is particularly pertinent in the relapsed and/or refractory multiple myeloma (RRMM) setting, in which numerous treatment options can present challenges for identifying optimal care. However, few studies have assessed the extent and relevance of SDM and patient-centered communication (PCC) in RRMM. To describe treatment decision-making patterns between physicians and patients in the RRMM setting, we conducted online surveys of patients and physicians in the USA to compare their perspectives on the process of treatment decision-making. We analyzed the surveys descriptively. Two hundred hematologists/oncologists and 200 patients with RRMM receiving second-line (n = 89), third-line (n = 65), and fourth-line (n = 46) therapy participated. Top treatment goals for physicians and patients included extending overall survival (among 76% and 83% of physicians and patients, respectively) and progression-free survival (among 54% and 77% of physicians and patients, respectively), regardless of the number of prior relapses. Thirty percent of physicians believed patients preferred a shared approach to treatment decision-making, while 40% of patients reported most often preferring a shared role in treatment decision-making. One-fourth of patients most often preferred physicians to make the final treatment decision after seriously considering their opinion. Thirty-two percent of physicians and 16% of patients recalled ≥3 treatment options presented at first relapse. Efficacy was a primary treatment goal for patients and physicians. Discrepancies in their perceptions during RRMM treatment decision-making exist, indicating that communication tools are needed to facilitate SDM and PCC.


Shared decision-making (SDM) is an important facet of patient-centered healthcare. Multiple myeloma (MM) is a cancer of the bone marrow that can return (relapse) after treatment. SDM may be especially pertinent for relapsed MM as there is no uniform standard of care and treatment selection can be complex. Few studies have examined the extent and relevance of SDM and patient-centered communication (PCC) in this relapsed and/or refractory (RRMM) setting. We conducted online surveys of 200 patients who had received 1­3 previous therapies and 200 physicians to compare treatment decision-making patterns in RRMM in the USA. Both physicians and patients felt that extending patient survival was a top treatment goal, regardless of the number of prior relapses. A lower percentage of physicians believed patients preferred a shared approach to treatment decision-making than patients who reported preferring such a shared role. Twice as many physicians than patients recalled ≥3 treatment options presented at first relapse. In conclusion, while improving survival was an important treatment goal for physicians and patients, there are discrepancies in physician and patient perceptions during RRMM treatment decision-making. Thus, communication tools are needed to facilitate SDM and PCC.


Asunto(s)
Mieloma Múltiple , Oncólogos , Médicos , Humanos , Mieloma Múltiple/terapia , Toma de Decisiones , Relaciones Médico-Paciente , Participación del Paciente
7.
Transplant Cell Ther ; 29(7): 460.e1-460.e9, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37086851

RESUMEN

Hematopoietic stem cell transplantation (HCT) is indicated for patients with higher-risk (HR) myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Age, performance status, patient frailty, comorbidities, and nonclinical factors (eg, cost, distance to site) are all recognized as important clinical factors that can influence HCT referral patterns and patient outcomes; however, the proportion of eligible patients referred for HCT in routine clinical practice is largely unknown. This study aimed to assess patterns of consideration for HCT among patients with HR-MDS and AML enrolled in the Connect® Myeloid Disease Registry at community/government (CO/GOV)- or academic (AC)-based sites, as well as to identify factors associated with rates of transplantation referral. We assessed patterns of consideration for and completion of HCT in patients with HR-MDS and AML enrolled between December 12, 2013, and March 6, 2020, in the Connect Myeloid Disease Registry at 164 CO/GOV and AC sites. Registry sites recorded whether patients were considered for transplantation at baseline and at each follow-up visit. The following answers were possible: "considered potentially eligible," "not considered potentially eligible," or "not assessed." Sites also recorded whether patients subsequently underwent HCT at each follow-up visit. Rates of consideration for HCT between CO/GOV and AC sites were compared using multivariable logistic regression analysis with covariates for age and comorbidity. Among the 778 patients with HR-MDS or AML enrolled in the Connect Myeloid Disease Registry, patients at CO/GOV sites were less likely to be considered potentially eligible for HCT than patients at AC sites (27.9% versus 43.9%; P < .0001). Multivariable logistic regression analysis with factors for age (<65 versus ≥65 years) and ACE-27 comorbidity grade (<2 versus ≥2) showed that patients at CO/GOV sites were significantly less likely than those at AC sites to be considered potentially eligible for HCT (odds ratio, 1.6, 95% confidence interval, 1.1 to 2.4; P = .0155). Among patients considered eligible for HCT, 45.1% (65 of 144) of those at CO/GOV sites and 35.7% (41 of 115) of those at AC sites underwent transplantation (P = .12). Approximately one-half of all patients at CO/GOV (50.1%) and AC (45.4%) sites were not considered potentially eligible for HCT; the most common reasons were age at CO/GOV sites (71.5%) and comorbidities at AC sites (52.1%). Across all sites, 17.4% of patients were reported as not assessed (and thus not considered) for HCT by their treating physician (20.7% at CO/GOV sites and 10.7% at AC sites; P = .0005). These findings suggest that many patients with HR-MDS and AML who may be candidates for HCT are not receiving assessment or consideration for transplantation in clinical practice. In addition, treatment at CO/GOV sites and age remain significant barriers to ensuring that all potentially eligible patients are assessed for HCT.


Asunto(s)
Trasplante de Células Madre Hematopoyéticas , Leucemia Mieloide Aguda , Síndromes Mielodisplásicos , Humanos , Anciano , Síndromes Mielodisplásicos/terapia , Leucemia Mieloide Aguda/terapia , Sistema de Registros , Accesibilidad a los Servicios de Salud
8.
Can Oncol Nurs J ; 22(4): 222-34, 2012.
Artículo en Inglés, Francés | MEDLINE | ID: mdl-23362656

RESUMEN

Azacitidine (5-azacytidine, VIDAZA) is a disease-modifying agent that improves survival, reduces transfusion dependence, and reduces progression to acute myeloid leukemia in patients with higher risk myelodysplastic syndromes. Azacitidine injection is associated with characteristic adverse events (AEs) that must be managed in order for patients to stay on therapy and achieve optimal therapeutic outcomes. These AEs include injection-site reactions, cytopenias, and gastrointestinal effects. Oncology nurses are uniquely positioned to provide patient support and counselling, thereby helping patients and their families set clear expectations for azacitidine therapy. This article presents a nursing standard designed to support Canadian oncology nurses in the key areas of counselling for patients initiating and continuing azacitidine, as well as nursing strategies for prevention and management of azacitidine-associated AEs. Many of the general principles discussed in this nursing standard can be applied broadly to many diseases and treatments.


Asunto(s)
Antimetabolitos Antineoplásicos/uso terapéutico , Azacitidina/uso terapéutico , Consejo , Síndromes Mielodisplásicos/enfermería , Enfermería Oncológica , Guías de Práctica Clínica como Asunto , Antimetabolitos Antineoplásicos/efectos adversos , Azacitidina/efectos adversos , Canadá , Síndromes Mielodisplásicos/tratamiento farmacológico , Recursos Humanos
9.
J Adv Pract Oncol ; 13(3): 292-297, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-35663183

RESUMEN

In the popular Biomarker Jeopardy session, Sandra E. Kurtin, PhD, ANP-C, AOCN®, Alyssa Henglefelt, PharmD, BCOP, and Haleigh Mistry, MS, PA-C, paired biomarkers with tumor types for which their expression is most commonly used to determine targeted therapy, identified key assays used to measure common biomarkers, and discussed guidelines for biomarker testing.

10.
Clin J Oncol Nurs ; 26(1): 61-70, 2022 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-35073288

RESUMEN

BACKGROUND: The Oncology Care Model requires implementation of processes to reduce urgent care (UC), emergency department (ED), and hospital visits for patients on antineoplastic therapies, including oral antineoplastic agents. OBJECTIVES: The purpose of this project was to develop, implement, and initially evaluate an oral antineoplastic therapy program (OAP) and an oncology antineoplastic nurse navigator (OANN) role aimed at reducing UC, ED, and hospital visits. METHODS: This pilot project used a descriptive correlational design to analyze the impact of the novel role of the OANN on UC, ED, and hospital visits. FINDINGS: The OANN engaged 1,095 patients between January 1, 2019, and December 31, 2020. A reduction in UC, ED, and hospital visits was noted between 2019 and 2020 for patients followed by the OANN and enrolled in the OAP. Patients who were contacted by the OANN three or more times after starting their oral antineoplastic agent were less likely to be seen in UC or the ED or to be hospitalized. The novel role of the OANN within the overall OAP provided a significant benefit in reducing UC and ED visits and hospitalization for patients enrolled in the program.


Asunto(s)
Atención Ambulatoria , Antineoplásicos , Antineoplásicos/uso terapéutico , Servicio de Urgencia en Hospital , Hospitalización , Humanos , Proyectos Piloto
11.
Leuk Res Rep ; 17: 100328, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35663282

RESUMEN

Objectives: Patient education resources that address barriers to health literacy to improve understanding and outcomes in myelodysplastic syndromes (MDS) are limited. The aim of this study was to evaluate the impact and outcomes benefits of An Animated Patient's Guide to Myelodysplastic Syndromes (MDS) cancer educational modules (which includes the 'You and MDS' website and YouTube hosted resources) related to MDS education, awareness, understanding and health outcomes. Methods: This was a retrospective study of learner feedback, metrics, and utilization data from July 2018 to August 2021. We evaluated audience reach (number of visit sessions, unique visitors, page views) and calculated top views by media type (animation, expert video, patient video, and slide show) and top retention videos from the modules. We also assessed the educational impact and utilization through learner feedback surveys. Results: During the study period, 'You and MDS' had 233,743 views worldwide of which 104,214 were unique visitors and 78,161 (or 76% unique visitors) were from the United States. Of these, 61% were patients; 29% family members or caregivers; 5% were healthcare providers and 5% represented other groups. Most popular topics viewed among the animations were "Understanding Myelodysplastic Syndromes (MDS)" (40,219 views), "Managing and Treating MDS" (19,240 views), "Understanding Erythropoiesis" (17,564 views.) The most popular expert videos viewed were "What is iron overload, and how it is treated?" (20,310 views), "How serious a cancer is MDS? What is the prognosis for MDS?" (8,327 views), "What is MDS?" (3,157 views). Of participants who completed the online feedback survey, ≥ 95% reported improved knowledge gains and commitments to change. Conclusions: MDS patients using 'You and MDS - An Animated Patient's Guide to MDS' and its visual formats of learning represented a wide U.S. and global learner audience. This MDS educational resource had a significant impact on improved understanding among patients, families, and caregivers. Continued efforts should be made to provide patient-effective resources that address health literacy, improve patient understanding, and address educational needs that respond to the concerns of patients to achieve better quality of life and improved health outcomes in MDS.

12.
J Adv Pract Oncol ; 12(3): 325-328, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-34084585

RESUMEN

During JADPRO Live Virtual 2020, Sandra Kurtin, PhD, ANP-C, AOCN®, described personalization of the treatment of chronic lymphocytic leukemia (CLL) using molecular attributes of the disease, as well as patient characteristics. Dr. Kurtin discussed front-line treatment in previously untreated patients, treatment for relapsed or refractory CLL, and how to prevent, mitigate, and manage adverse events in order to optimize treatment.

13.
J Adv Pract Oncol ; 12(3): 285-288, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-34084576

RESUMEN

The popular Biomarker Jeopardy session returned this year at JADPRO Live 2020. Sandra E. Kurtin, PhD, ANP-C, AOCN®, led the session, and was joined by Alyssa Henglefelt, PharmD, BCOP, and Allyson Price, PA-C. Using a Jeopardy format, they identified specific biomarkers while discussing targeted therapies and class effects APs should be aware of.

14.
Int J Lab Hematol ; 43(3): 426-432, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-33220019

RESUMEN

INTRODUCTION: The presence of ring sideroblasts (RS) and mutation of the SF3B1 gene are diagnostic of lower-risk (LR) myelodysplastic syndromes (MDS) and are correlated with favorable outcomes. However, information on testing and reporting in community-based clinical settings is scarce. This study from the Connect® MDS/AML Disease Registry aimed to compare the frequency of RS and SF3B1 reporting for patients with LR-MDS, before and after publication of the 2016 World Health Organization (WHO) MDS classification criteria. METHODS: Ring sideroblasts assessment and molecular testing data were collected from patients with LR-MDS at enrollment in the Registry. Patients enrolled between December 2013 and the data cutoff of March 2020 were included in this analysis. RESULTS: Among 489 patients with LR-MDS, 434 (88.8%) underwent RS assessment; 190 were assessed prior to the 2016 WHO guidelines (Cohort A), and 244 after (Cohort B). In Cohort A, 87 (45.8%) patients had RS identified; 29 (33.3%) patients had RS < 15%, none of whom underwent molecular testing for SF3B1. In Cohort B, 96 (39.3%) patients had RS identified; 31 (32.3%) patients had < 15% RS, with 13 undergoing molecular testing of which 10 were assessed for SF3B1. CONCLUSIONS: In the Connect® MDS/AML Registry, only 32% of patients with <15% RS underwent SF3B1 testing after the publication of the WHO 2016 classification criteria. There was no change in RS assessment frequency before and after publication, despite the potential impact on diagnostic subtyping and therapy selection, suggesting an unmet need for education to increase testing rates for SF3B1 mutations.


Asunto(s)
Eritroblastos/patología , Síndromes Mielodisplásicos/diagnóstico , Fosfoproteínas/genética , Factores de Empalme de ARN/genética , Adulto , Anciano , Anciano de 80 o más Años , Eritroblastos/metabolismo , Femenino , Humanos , Hierro/análisis , Masculino , Persona de Mediana Edad , Mutación , Síndromes Mielodisplásicos/genética , Síndromes Mielodisplásicos/patología , Adulto Joven
15.
Support Care Cancer ; 18(4): 509-22, 2010 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-20145956

RESUMEN

BACKGROUND: Accurate grading of dermatologic adverse events (AE) due to epidermal growth factor receptor (EGFR) inhibitors (EGFRIs) is necessary for drug toxicity determinations, interagent comparisons, and supportive care trials. The most widely used severity grading scale, the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0), was not designed specifically for this class of agents and may result in underreporting and poor grading of distinctive adverse events. We believe a class-specific grading scale is needed to help standardize assessment and improve reporting of EGFRI-associated dermatologic AEs. METHODS: The Multinational Association of Supportive Care in Cancer (MASCC) Skin Toxicity Study Group conducted an international multidisciplinary meeting that included 20 clinicians and researchers from academic centers and government agencies. Experts from different disciplines presented current information specific to EGFRI-induced dermatologic toxicities: grading scale development, pharmacovigilance safety reporting, health-related quality of life, patient reporting, and pharmacology. Group discussions, literature reviews, and professional expertise established the theoretical foundation for the proposed grading scale. RESULTS: A new grading system is proposed for the most common events associated with EGFRI-induced dermatologic AEs: papulopustular reaction or acneiform rash, nail changes, erythema, pruritus, xerosis, hair changes, telangiectasias, hyperpigmentation, mucositis, flushing, radiation dermatitis, hyposalivation, and taste changes. The proposed scale maintains consistency with the grading principles and language of the existing CTCAE version 4.0 and MedDRA terminology and includes relevant patient-reported health-related quality of life factors. CONCLUSIONS: A grading scale specific to EGFR inhibitor dermatologic AEs is presented for formal integration into future versions of CTCAE and for validation in clinical trial settings. The study group designed this scale to detect and report EGFRI-related toxicities with greater sensitivity, specificity, and range than the scales currently used. This scale should serve as a foundation for efforts to perform objective interdrug comparisons and assessments of supportive care treatment strategies more effectively than with current methods.


Asunto(s)
Antineoplásicos/efectos adversos , Erupciones por Medicamentos/fisiopatología , Receptores ErbB/antagonistas & inhibidores , Erupciones por Medicamentos/etiología , Humanos , Calidad de Vida , Sensibilidad y Especificidad , Índice de Severidad de la Enfermedad
16.
J Adv Pract Oncol ; 11(7): 736-751, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33575069

RESUMEN

Evidenced-based practice requires timely and accurate integration of scientific advances. This presents a challenge for the oncology clinician given the robust pace of scientific discovery and the increasing number of new drug approvals and expanded indications for previously approved drugs. All currently available antineoplastic therapies have been developed through the clinical trials process. Advanced practitioners (APs) in oncology are often involved in the conduct of clinical trials as primary investigators, sub-investigators, study coordinators, or in the delivery and monitoring of care to patients enrolled in these trials. A prerequisite to evidenced-based practice is understanding how clinical trials are conducted and how to critically analyze published results of studies leading to U.S. Food & Drug Administration approval. Any AP involved in the clinical management and supportive care of patients receiving antineoplastic therapies should be able to critically review published data to glean findings that warrant a change in practice. The goals of this manuscript are to summarize key elements of the clinical trial process for oncology drug development and approval in the United States and to provide a primer for the interpretation of clinical data.

17.
J Adv Pract Oncol ; 11(3): 234-238, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33598317

RESUMEN

This JADPRO Live session tested attendees' knowledge on biomarkers and their use in determining targeted therapy for certain tumor types, key assays used to measure common biomarkers, and guideline-endorsed biomarker testing recommendations.

18.
JCO Oncol Pract ; 16(1): e92-e99, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31765266

RESUMEN

PURPOSE: Geriatric assessment (GA) results predict toxicity/survival in older adults, yet GA is not routinely used in care for patients with multiple myeloma (MM). We tested a tablet-based modified GA (mGA) providing real-time results to clinicians. METHODS: One hundred sixty-five patients with MM aged ≥ 65 years facing a treatment decision from 4 sites completed a tablet-based mGA with Katz Activities of Daily Living (ADL), Lawton Instrumental ADL, Charlson Comorbidity Index, and variables from the Cancer and Aging Research Group's Chemotherapy Toxicity Calculator. Providers reviewed the assessment results at the treatment visit. RESULTS: Patients were white (72%; n = 86), mean age was 72 years (range, 65-85 years), and averaged 7.71 minutes (range, 2-17 minutes) for survey completion. Providers averaged 3.2 minutes (range, 1-10 minutes) to review mGA results. Using International Myeloma Working Group frailty score, patients were fit (39%; n = 64), intermediate fit (33%; n = 55), or frail (28%; n = 46). Providers selected more aggressive treatments in 16.3% of patients and decreased treatment intensity in 34% of patients; treatment intensification was more common for fit patients and milder treatments for frail patients (χ2 = 20.02; P < .0001). Transplant eligibility significantly correlated with fit status and transplant ineligibility with frail status (P = .004). Outcomes on 144 patients 3 months post study visit showed 19.4% (n = 28) had grade ≥ 3 hematologic toxicities, 38.9% (n = 56) had dose modifications, and 18% (n = 26) had early therapy cessation. CONCLUSION: Limited patient time required for survey completion and provider time for results review show mGA can be easily incorporated into clinical workflow. Real-time mGA results indicating fit/frailty status influenced treatment decisions.


Asunto(s)
Evaluación Geriátrica/métodos , Mieloma Múltiple/diagnóstico , Medicina de Precisión/métodos , Anciano , Anciano de 80 o más Años , Femenino , Anciano Frágil , Humanos , Masculino , Tamizaje Masivo , Mieloma Múltiple/patología , Proyectos Piloto , Estudios Prospectivos
19.
EJHaem ; 1(1): 58-68, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35847712

RESUMEN

Diagnostic and molecular genetic testing are key in advancing the treatment of acute myeloid leukemia (AML), yet little is known about testing patterns outside of clinical trials, especially in older patients. We analyzed diagnostic and molecular testing patterns over time in 565 patients aged ≥ 55 years with newly diagnosed AML enrolled in the Connect® MDS/AML Disease Registry (NCT01688011) in the United States. Diagnostic data were recorded at enrolment and compared with published guidelines. The percentage of bone marrow blasts was reported for 82.1% of patients, and cellularity was the most commonly reported bone marrow morphological feature. Flow cytometry, karyotyping, molecular testing, and fluorescence in situ hybridization were performed in 98.8%, 95.4%, 75.9%, and 75.7% of patients, respectively. Molecular testing was done more frequently at academic than community/government sites (84.3% vs 70.2%; P < .001). Enrolment to the Registry after 2016 was significantly associated with molecular testing at academic sites (odds ratio [OR] 2.59; P = .023) and at community/government sites (OR 4.85; P < .001) in logistic regression analyses. Better understanding of practice patterns may identify unmet needs and inform institutional protocols regarding the diagnosis of patients with AML.

20.
Oncology (Williston Park) ; 23(11 Suppl Nurse Ed): 41-5, 2009 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-19856608

RESUMEN

Hypothyroidism is an often underreported complication of cancer treatment. With the growing number of biological and targeted therapies, hypothyroidism may become a more prevalent clinical problem. Signs and symptoms of hypothyroidism may be easily attributed to the cancer or cancer treatment, leading to unnecessary dose modifications or discontinuation of effective therapies. Furthermore, these symptoms have a negative effect on quality of life. Measurement of TSH levels in at-risk patients prior to initiating treatment and at regular intervals during treatment will allow early intervention and effective treatment of hypothyroidism.


Asunto(s)
Antineoplásicos/efectos adversos , Hipotiroidismo/epidemiología , Anticuerpos Monoclonales/efectos adversos , Femenino , Humanos , Hipotiroidismo/inducido químicamente , Hipotiroidismo/tratamiento farmacológico , Incidencia , Yoduro Peroxidasa/uso terapéutico , Lenalidomida , Masculino , Neoplasias/tratamiento farmacológico , Neoplasias/radioterapia , Radioinmunoterapia/efectos adversos , Radioterapia/efectos adversos , Talidomida/efectos adversos , Talidomida/análogos & derivados , Estados Unidos/epidemiología
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