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1.
Gynecol Oncol ; 178: 23-26, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37742507

RESUMEN

OBJECTIVE: To evaluate the impact of a mobile health patient engagement technology (PET) on postoperative outcomes in gynecologic oncology patients. METHODS: All gynecologic oncology patients undergoing laparotomy on an enhanced recovery program (ERP) were approached from July 2019 to May 2021 to enroll in a PET, which can be accessed by computer, tablet, or smart phone. This platform provides enhanced pre- and postoperative patient education and remote patient monitoring. Patients who elected to participate were provided with targeted education based on their age and comorbidities and were asked to complete daily health checks during the postoperative period. Participants in the PET were compared to patients who opted out as well as to a historical cohort from prior to PET implementation. Patient and procedure-level factors were recorded. The primary outcomes were length of stay (LOS) and 30-day readmission rate. Analysis was performed using SPSS v.26. RESULTS: 682 women met inclusion criteria during the study time; 347 in the PET group and 335 in the control group. Demographic and other factors including race, BMI (kg/m2), Charlson Comorbidity Index (CCI), surgical complexity, and insurance status were not different between the PET and control group; however, patients in the PET cohort were slightly younger (55.0 yo vs. 57.2 yo; p = 0.04). Patients in the PET group had a significantly shorter LOS (2.9 days vs. 3.6 days; p < 0.01) and lower readmission rate (4.3% vs. 8.6%; p < 0.01) when compared with the control group. CONCLUSIONS: Use of a PET in our gynecologic oncology patients decreased LOS by nearly one day despite an absence of differences in other demographic and surgical factors other than age. Furthermore, there was a 50% reduction in readmission rates in the PET group. The use of a PET allows for healthcare professionals to engage, evaluate, and treat patients in a way that improves perioperative care.


Asunto(s)
Neoplasias de los Genitales Femeninos , Humanos , Femenino , Neoplasias de los Genitales Femeninos/cirugía , Neoplasias de los Genitales Femeninos/etiología , Estudios Retrospectivos , Participación del Paciente , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Atención Perioperativa , Tiempo de Internación , Complicaciones Posoperatorias/etiología
2.
Abdom Radiol (NY) ; 48(7): 2443-2448, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-37145314

RESUMEN

PURPOSE: To evaluate the outcomes of uterine artery embolization (UAE) for patients with urgent or emergent abnormal uterine bleeding (AUB). MATERIALS AND METHODS: Retrospective review of all patients from 1/2009-12/2020 who were treated urgently or emergently with UAE for AUB. Urgent and emergent cases were defined as those requiring inpatient admissions. Demographic data were collected for each patient including hospitalizations related to bleeding and length of stay (LOS) for each hospitalization. Hemostatic interventions other than UAE were collected. Hematologic data were collected before and after UAE including hemoglobin, hematocrit, and transfusion products. Data specific to the UAE procedure included complication rates, 30-day readmission, 30-day mortality, embolic agent, site of embolization, radiation dose, and procedure time. RESULTS: 52 patients (median age: 39) underwent 54 urgent or emergent UAE procedures. The most common indications for UAE were malignancy (28.8%), post-partum hemorrhage (21.2%), fibroids (15.4%), vascular anomalies (15.4%), and post-operative bleeding (9.6%). There were no procedure-related complications. Following UAE, 44 patients (84.6%) achieved clinical success and required no additional intervention. Packed red blood cell transfusion decreased from a mean of 5.7 to 1.7 units (p < 0.0001). Fresh frozen plasma transfusion decreased from a mean of 1.8 to 0.48 units (p = 0.012). 50% of patients received a transfusion prior to UAE, while only 15.4% were transfused post-procedure (p = 0.0001). CONCLUSIONS: Emergent or urgent UAE is a safe and effective procedure to control AUB hemorrhage secondary to a variety of etiologies.


Asunto(s)
Embolización de la Arteria Uterina , Hemorragia Uterina , Embolización de la Arteria Uterina/efectos adversos , Hemorragia Uterina/etiología , Hemorragia Uterina/terapia , Urgencias Médicas , Resultado del Tratamiento , Neoplasias Uterinas/complicaciones , Leiomioma/complicaciones , Hemorragia Posparto/terapia , Hemorragia Posoperatoria/terapia , Malformaciones Vasculares/complicaciones , Humanos , Femenino , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años
3.
Obstet Gynecol ; 139(1): 91-96, 2022 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-34856576

RESUMEN

OBJECTIVE: To evaluate the effects of an environmentally friendly drug deactivation bag on opioid disposal among patients undergoing gynecologic surgery. METHODS: This prospective cohort study included patients undergoing gynecologic procedures requiring an opioid prescription from March 2020 to December 2020. Patients were managed on a restrictive opioid prescribing algorithm and given an opioid disposal bag. The carbon drug deactivation bag neutralizes the opioid medication and can be discarded safely in the trash. Patients were educated about pain management goals and the disposal bag. Patients were surveyed at their postoperative visit to evaluate satisfaction, number of leftover pills, and disposal methods. Statistical analysis was performed using SPSS Statistics 26. RESULTS: Two hundred patients were asked to complete the survey, with a response rate of 78%. The most common procedures were exploratory laparotomy (50%) and minimally invasive hysterectomy (41%). Most patients (91%, 95% CI 91-97) filled their opioid prescription and 64 (41%, 95% CI 34-48) had leftover opioid pills. Most patients with leftover opioid pills (73%, 95% CI 67-79) discarded them; 78%, 95% CI 69-80 used the disposal bag. Patients undergoing an exploratory laparotomy most commonly used the disposal bag. All patients who used the disposal bag stated they would use it again. CONCLUSION: Despite a restrictive opioid prescribing algorithm, 41% of gynecologic surgical patients had leftover opioid pills. This study demonstrated that leftover opioid pills were safely discarded 73% of the time when patients were provided an opioid disposal bag and preoperative education.


Asunto(s)
Analgésicos Opioides , Procedimientos Quirúrgicos Ginecológicos , Eliminación de Residuos Sanitarios/instrumentación , Alabama , Algoritmos , Estudios de Cohortes , Ambiente , Femenino , Humanos , Persona de Mediana Edad , Pautas de la Práctica en Medicina , Estudios Prospectivos , Encuestas y Cuestionarios
4.
J Gynecol Oncol ; 32(6): e92, 2021 11.
Artículo en Inglés | MEDLINE | ID: mdl-34708594

RESUMEN

OBJECTIVE: To assess the potential cost-effectiveness of prehabilitation in medically frail patients undergoing surgery for epithelial ovarian cancer (EOC). METHODS: We created a cost-effectiveness model evaluating the impact of prehabilitation on a cohort of medically frail women undergoing primary surgical intervention for EOC. Cost was assessed from the healthcare system perspective via (1) inpatient charges from 2018-2019 institutional Diagnostic Related Grouping data for surgeries with and without major complications; (2) nursing facility costs from published market surveys. Major complication and non-home discharge rates were estimated from the literature. Based on published pilot studies, prehabilitation was determined to decrease these rates. Incremental cost-effectiveness ratio for cost per life year saved utilized a willingness-to-pay threshold of $100,000/life year. Modeling was performed with TreeAge software. RESULTS: In a cohort of 4,415 women, prehabilitation would cost $371.1 Million (M) versus $404.9 M for usual care, a cost saving of $33.8 M/year. Cost of care per patient with prehabilitation was $84,053; usual care was $91,713. When analyzed for cost-effectiveness, usual care was dominated by prehabilitation, indicating prehabilitation was associated with both increased effectiveness and decreased cost compared with usual care. Sensitivity analysis showed prehabilitation was more cost effective up to a cost of intervention of $9,418/patient. CONCLUSION: Prehabilitation appears to be a cost-saving method to decrease healthcare system costs via two improved outcomes: lower complication rates and decreased care facility requirements. It represents a novel strategy to optimize healthcare efficiency. Prospective studies should be performed to better characterize these interventions in medically frail patients with EOC.


Asunto(s)
Neoplasias Ováricas , Ejercicio Preoperatorio , Anciano , Carcinoma Epitelial de Ovario/cirugía , Análisis Costo-Beneficio , Femenino , Anciano Frágil , Humanos , Neoplasias Ováricas/cirugía , Estudios Prospectivos
5.
Int J Gynecol Cancer ; 31(5): 721-726, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33495207

RESUMEN

OBJECTIVE: Enhanced recovery protocols are now established as the standard of care leading to improved perioperative outcomes and associated cost-benefits. The objective of this study was to evaluate the impact of an enhanced recovery program on complication rates in high-risk gynecologic oncology patients undergoing surgery. METHODS: This retrospective cohort study included gynecologic oncology patients with pathology-proven malignancy undergoing non-emergent laparotomy from October 2016 to December 2018 managed on an enhanced recovery protocol, and a control group from October 2015 through September 2016 prior to enhanced recovery protocol implementation. The primary outcome was complication rates in a high-risk population pre- and post-enhanced recovery protocol. High-risk patients were defined as those with obesity (body mass index >30 kg/m2) and/or age ≥65 years. Analysis was performed using Statistical Package for Social Sciences (SPSS) v.24. RESULTS: A total of 363 patients met the inclusion criteria: 104 in the control group and 259 in the enhanced recovery protocol group. Patient demographics, including age, body mass index, diagnosis, and performance status, were similar. Overall complication rates were less in the enhanced recovery protocol group (29% vs 53.8%; p<0.0001). The enhanced recovery protocol group had a shorter length-of-stay compared with control (3.3 vs 4.2 days; p<0.0001). The 30-day readmission rates were similar between the groups (9.6% vs 13.5%; p=0.19). In the enhanced recovery protocol group compared with control, complication rates were less in obese patients (29.4% vs 57.8%; p<0.0001), morbidly obese patients (20.9% vs 76.2%; p<0.0001), and age ≥65 (36.1% vs 57.1%; p<0.0001). The most common complications in the enhanced recovery protocol group were ileus (9.7%), pulmonary complications (2.7%), and blood transfusions (10.8%). CONCLUSIONS: Implementation of an enhanced recovery protocol decreases complication rates and length-of-stay in morbidly obese and geriatric patients with gynecologic malignancy without an increase in readmission rates.


Asunto(s)
Recuperación Mejorada Después de la Cirugía , Neoplasias de los Genitales Femeninos/cirugía , Complicaciones Posoperatorias/epidemiología , Anciano , Estudios de Casos y Controles , Femenino , Humanos , Tiempo de Internación/estadística & datos numéricos , Persona de Mediana Edad , Obesidad Mórbida/complicaciones , Readmisión del Paciente/estadística & datos numéricos , Estudios Retrospectivos
6.
Gynecol Oncol ; 161(2): 339-341, 2021 05.
Artículo en Inglés | MEDLINE | ID: mdl-33516530

RESUMEN

This commentary is presenting opinions and advice on mentorship in the field of gynecologic oncology. Eleven academic gynecologic oncologists from across the country were interviewed and their thoughts about mentorship were recorded with recurring themes and ideas described in this commentary. Trust, respect, and mutual agreement on expectations were all described as vital to a functioning mentor/mentee relationship. Mentorship is critical for fellows and junior faculty to expand and uphold the standards of the field.


Asunto(s)
Ginecología/educación , Liderazgo , Oncología Médica/educación , Tutoría/métodos , Mentores/psicología , Oncólogos/psicología , Actitud del Personal de Salud , Femenino , Ginecología/normas , Humanos , Relaciones Interprofesionales , Entrevistas como Asunto , Masculino , Oncología Médica/normas , Oncólogos/normas , Rol del Médico/psicología , Estados Unidos
7.
Prev Med Rep ; 24: 101596, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34976654

RESUMEN

The goal was to evaluate how provider recommendations regarding Human Papillomavirus (HPV) vaccination impact uptake in a rural setting. The study used a cross-sectional, population-based design with cluster sampling to survey parents/guardians of children ages 9 to 18 in 2019 in Alabama. In addition to demographics/knowledge questions, participants were asked about type of healthcare provider recommendation and impressions they had from this interaction. The primary outcome variable was the result of the healthcare provider recommendation with options including: child got vaccinated day of recommendation, HPV vaccination was scheduled, or HPV vaccination was not scheduled. Bivariate analysis and multinomial logistic regression were performed. Of the 358 respondents, approximately 40% indicated receiving a recommendation from a provider to vaccinate their child. Age of the parent, race/ethnicity, educational attainment, and health insurance coverage were similar across groups. Female parents were more likely to report receiving HPV vaccination recommendation than males (44.1% vs. 23.3%; p = 0.009). The type of provider recommendation was not significantly associated with HPV vaccination uptake. The impression from the recommendation of HPV vaccination being "important" was significantly associated with the child being vaccinated that day (OR = 7.31, 95% CI = 2.20-24.3) as well as scheduling HPV vaccination (OR = 3.17, 95% CI 1.01-9.92). Parents who got the impression that "there was no hurry" were less likely to vaccinate their child that day (OR = 0.23, 95% CI = 0.09-0.59). Provider recommedation is well-established as a significant predictor of HPV vaccination, these findings indicate that how the recommendation is perceived may play a more important role in HPV vaccination uptake.

8.
Gynecol Oncol ; 159(3): 773-777, 2020 12.
Artículo en Inglés | MEDLINE | ID: mdl-32951895

RESUMEN

OBJECTIVE: The objective of this study was to evaluate the impact of a post-surgical restrictive opioid prescribing algorithm (ROPA) in gynecologic oncology patients. METHODS: This cohort study included gynecologic oncology patients undergoing any surgical procedure from 08/2018-7/2019 after implementation of a ROPA. Patients were compared to historical controls managed without a ROPA from 10/2016-9/2017. Patients were educated preoperatively about pain management goals, the ROPA, and opioid disposal. A 4-tiered system was developed to standardize prescriptions at discharge based on surgical complexity and inpatient opioid requirements. Patients were surveyed at their postoperative visit to assess home opioid use and satisfaction. Statistical analysis was performed using SPSS Statistics v.24. RESULTS: 2549 patients met inclusion criteria; 1321 in the historical control group and 1228 in the ROPA group. Demographics, including age, BMI, and performance status were similar. Compared with the control group, the average number of opioid pills prescribed was significantly lower in the ROPA group (30.5 vs 11.3; p < 0.001) along with the morphine milligram equivalents (MME) (152.5 MME vs. 83.3 MME; p < 0.001). The percentage of patients requiring opioid refill within 30 days was similar (13.0% vs. 12.6%; p = 0.71). 95.7% of patients surveyed were satisfied with their pain regimen. The total number of pills prescribed annually decreased from 34,130 in the control group to 13,888 in the ROPA group. CONCLUSIONS: A restrictive prescribing practice allows for a significantly lower number of opioids to be prescribed to postoperative patients while maintaining patient satisfaction. There was no increase in opioid refill requests using a ROPA in patients undergoing surgery.


Asunto(s)
Analgésicos Opioides/administración & dosificación , Neoplasias de los Genitales Femeninos/cirugía , Procedimientos Quirúrgicos Ginecológicos/efectos adversos , Dolor Postoperatorio/tratamiento farmacológico , Pautas de la Práctica en Medicina/organización & administración , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adulto , Anciano , Analgésicos Opioides/efectos adversos , Prescripciones de Medicamentos/normas , Prescripciones de Medicamentos/estadística & datos numéricos , Registros Electrónicos de Salud/estadística & datos numéricos , Femenino , Ginecología/organización & administración , Ginecología/normas , Ginecología/estadística & datos numéricos , Implementación de Plan de Salud , Humanos , Oncología Médica/organización & administración , Oncología Médica/normas , Oncología Médica/estadística & datos numéricos , Persona de Mediana Edad , Epidemia de Opioides/prevención & control , Trastornos Relacionados con Opioides/epidemiología , Trastornos Relacionados con Opioides/etiología , Trastornos Relacionados con Opioides/prevención & control , Manejo del Dolor/métodos , Manejo del Dolor/normas , Manejo del Dolor/estadística & datos numéricos , Dolor Postoperatorio/etiología , Satisfacción del Paciente/estadística & datos numéricos , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina/normas , Evaluación de Programas y Proyectos de Salud , Estudios Prospectivos , Estados Unidos/epidemiología
9.
Int J Gynecol Cancer ; 30(10): 1569-1575, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32753559

RESUMEN

OBJECTIVES: Niraparib maintenance after frontline chemotherapy for advanced ovarian cancer extends progression free survival. The objective of this study was to determine the cost effectiveness of niraparib maintenance therapy in patients with newly diagnosed ovarian cancer. METHODS: Decision analysis models compared the cost of observation versus niraparib maintenance following chemotherapy for five groups: all newly diagnosed ovarian cancer patients (overall), those with homologous recombination deficiency, those harboring BRCA mutations (BRCA), homologous recombination deficiency patients without BRCA mutations (homologous recombination deficiency non-BRCA), and non-homologous recombination deficiency patients. Drug costs were estimated using average wholesale prices. Progression free survival was estimated from published data and used to estimate projected overall survival. Incremental cost effectiveness ratios per quality adjusted life year were calculated. Sensitivity analyses varying the cost of niraparib were performed. The willingness-to-pay threshold was set at US$100 000 per quality adjusted life year saved. RESULTS: For the overall group, the cost of observation was US$5.8 billion versus $20.5 billion for niraparib maintenance, with an incremental cost effectiveness ratio of $72 829. For the homologous recombination deficiency group, the observation cost was $3.0 billion versus $14.8 billion for niraparib maintenance (incremental cost effectiveness ratio $56 329). Incremental cost effectiveness ratios for the BRCA, homologous recombination deficiency non-BRCA, and non-homologous recombination deficiency groups were $58 348, $50 914, and $88 741, respectively. For the overall and homologous recombination deficiency groups, niraparib remained cost effective if projected overall survival was 2.2 and 1.5 times progression free survival, respectively. CONCLUSIONS: For patients with newly diagnosed ovarian cancer, maintenance therapy with niraparib was cost effective. Cost effectiveness was improved when analyzing those patients with homologous recombination deficiency and BRCA mutations. Efforts should continue to optimize poly-ADP-ribose polymerase utilization strategies.


Asunto(s)
Carcinoma Epitelial de Ovario/tratamiento farmacológico , Indazoles/economía , Neoplasias Ováricas/tratamiento farmacológico , Piperidinas/economía , Inhibidores de Poli(ADP-Ribosa) Polimerasas/economía , Carcinoma Epitelial de Ovario/economía , Análisis Costo-Beneficio , Técnicas de Apoyo para la Decisión , Femenino , Humanos , Indazoles/administración & dosificación , Indazoles/efectos adversos , Neoplasias Ováricas/economía , Piperidinas/administración & dosificación , Piperidinas/efectos adversos , Inhibidores de Poli(ADP-Ribosa) Polimerasas/administración & dosificación , Inhibidores de Poli(ADP-Ribosa) Polimerasas/efectos adversos , Supervivencia sin Progresión , Años de Vida Ajustados por Calidad de Vida
10.
Gynecol Oncol ; 156(2): 284-287, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-31776038

RESUMEN

OBJECTIVE: To determine the financial impact of an enhanced recovery after surgery (ERAS) protocol in gynecologic oncology patients. METHODS: This study identified gynecologic oncology patients who were placed on the ERAS protocol after elective laparotomy from 10/2016-6/2017. A control group was identified from the year prior to ERAS implementation. Financial experts assisted in procuring data for these patient encounters, including payer status, direct and indirect costs, contribution margin, and length of stay (LOS). SPSS Statistics v. 24 was used for statistical analysis. RESULTS: 376 patients met criteria for inclusion: 179 in the ERAS group and 197 in the control group. Patient demographics were similar between the two cohorts. Payer status across the groups was not statistically significant in patients with private insurance (control 43.7% vs. ERAS 41.3%), Medicare (38.1% vs. 31.8%), or self-pay patients (12.2% vs. 15.1%). There was a significantly higher number of Medicaid patients in the ERAS group (6.1% vs. 11.7%; p = 0.05). Hospital direct costs ($5596 vs. 5346) and indirect costs ($5182 vs. $4954) per encounter were similar between groups. However, overall contribution margin per encounter decreased in the ERAS group ($11,619 vs. $8528; p = 0.01). LOS was significantly lower in the ERAS group (4.1 vs. 2.9 days; p = 0.04). CONCLUSIONS: Implementation of the ERAS protocol in gynecologic oncology patients does not lead to increased costs for the patient or hospital system. The decreased contribution margin is likely due to a reduction in per diem payments caused by the reduction in LOS. On a per-patient-day basis, contribution margin was the same for both groups ($2877 vs $2857). The reduction in LOS also created capacity for additional cases, the financial impact of which was not evaluated.


Asunto(s)
Neoplasias de los Genitales Femeninos/economía , Neoplasias de los Genitales Femeninos/cirugía , Procedimientos Quirúrgicos Ginecológicos/economía , Procedimientos Quirúrgicos Ginecológicos/métodos , Estudios de Casos y Controles , Estudios de Cohortes , Recuperación Mejorada Después de la Cirugía , Femenino , Procedimientos Quirúrgicos Ginecológicos/normas , Gastos en Salud/estadística & datos numéricos , Costos de Hospital/estadística & datos numéricos , Humanos , Seguro de Salud , Tiempo de Internación/economía , Medicaid/estadística & datos numéricos , Medicare/estadística & datos numéricos , Persona de Mediana Edad , Atención Perioperativa/economía , Atención Perioperativa/métodos , Atención Perioperativa/normas , Cuidados Posoperatorios/economía , Cuidados Posoperatorios/métodos , Cuidados Posoperatorios/normas , Estudios Retrospectivos , Estados Unidos
11.
Int J Gynecol Cancer ; 29(7): 1110-1115, 2019 09.
Artículo en Inglés | MEDLINE | ID: mdl-31366570

RESUMEN

INTRODUCTION: While traditional teaching has been to wait 6 weeks between cervical excisional procedure and hysterectomy, studies have produced conflicting evidence, with data supporting a delay of anywhere between 48 hours to 6 weeks depending on surgical approach. Our study sought to evaluate if the time between cervical excisional procedure and robotic hysterectomy impacts peri-operative complication rates. METHODS: A retrospective cohort of patients who underwent robotic hysterectomy from August 2006 to December 2013 for cervical dysplasia or International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IA1-B1 cervical cancer at a single tertiary care center was performed. Patients were categorized into three groups: early surgical intervention (<6 weeks from excisional procedure), delayed surgical intervention (≥6 weeks from excisional procedure), and no excisional procedure. Secondary analysis was performed by hysterectomy type (simple vs radical). Peri-operative outcomes and complications were compared. Statistical analysis included Chi-square, Fisher's exact test, and Wilcoxon rank sum test. RESULTS: A total of 160 patients were identified. Of these, 32 (20.0%) had early surgical intervention, 52 (32.5%) had delayed surgical intervention, and 76 (47.5%) had no excisional procedure. There was no difference between groups in complication rates, including average estimated blood loss (82 vs 55 vs 71 mL; p=0.07), urologic injury (0% in all groups; p=1.0), anemia (3% vs 0% vs 1%; p=0.47), infection (0% vs 2% vs 3%; p=1.0), vaginal cuff separation (0% in all groups; p=1.0), or venous thromboembolism (0% vs 0% vs 1%; p=1.0). Additionally, there were no differences in length of stay (p=0.18) or 30-day readmission rates (p=1.0). Finally, there were no significant differences in peri-operative outcomes when stratified by radical versus simple hysterectomy. DISCUSSION: Waiting 6 weeks between cervical excisional procedure and robotic hysterectomy does not impact peri-operative complication rates. This suggests that the time from excisional procedure should not factor into surgical planning for those who undergo robotic hysterectomy.


Asunto(s)
Histerectomía/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Displasia del Cuello del Útero/cirugía , Neoplasias del Cuello Uterino/cirugía , Adulto , Electrocirugia/métodos , Femenino , Humanos , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Estudios Retrospectivos , Factores de Tiempo , Displasia del Cuello del Útero/patología , Neoplasias del Cuello Uterino/patología
12.
Gynecol Oncol ; 153(2): 381-384, 2019 05.
Artículo en Inglés | MEDLINE | ID: mdl-30808517

RESUMEN

OBJECTIVE: To determine the cost-effectiveness of pembrolizumab in patients with recurrent endometrial cancer that have failed first-line chemotherapy. METHODS: We created a model to evaluate the cost-effectiveness of pembrolizumab compared to pegylated liposomal doxorubicin (PLD) or bevacizumab for the treatment of women with recurrent endometrial cancer who have failed carboplatin and paclitaxel. Microsatellite instability-high (MSI-H) and non-microsatellite instability-high (non-MSI-H) tumors were evaluated. We included 4400 patients in the model; 800 patients were assumed to have MSI-H tumors. Drug costs were calculated using 2016-2017 wholesale acquisition costs, and cost of Grade III-IV toxicities was estimated from clinical experience. Effectiveness was calculated as 2-year overall survival (OS). We calculated incremental cost-effectiveness ratios (ICERs) to determine the cost per 2-year survivor. Univariate sensitivity analyses were performed. The willingness to pay threshold was $100,000 per year of OS. RESULTS: The cost of therapy with PLD and bevacizumab were $33.2 million (M) and $167.9 M, respectively. The cost of pembrolizumab therapy was $318.3 M for non-MSI-H patients compared to $57.9 M for MSI-H patients. For non-MSI-H patients, bevacizumab was cost-effective relative to PLD with an ICER of $153,028, while pembrolizumab was not cost-effective relative to bevacizumab with an ICER of $341,830. For MSI-H patients, pembrolizumab was cost-effective compared to PLD with an ICER of $147,249, while bevacizumab was subjected to extended dominance. Sensitivity analysis revealed that for non-MSI-H patients, one cycle of pembrolizumab would need to cost $7253 or less to be cost-effective. CONCLUSIONS: For patients with MSI-H recurrent endometrial cancers who have failed first-line chemotherapy, pembrolizumab is cost-effective relative to other single agent drugs. To be cost-effective in non-MSI-H patients, the cost of pembrolizumab should decrease substantially.


Asunto(s)
Anticuerpos Monoclonales Humanizados/economía , Anticuerpos Monoclonales Humanizados/uso terapéutico , Neoplasias Endometriales/tratamiento farmacológico , Neoplasias Endometriales/economía , Recurrencia Local de Neoplasia/tratamiento farmacológico , Antineoplásicos Inmunológicos/economía , Antineoplásicos Inmunológicos/uso terapéutico , Bevacizumab/economía , Bevacizumab/uso terapéutico , Estudios de Cohortes , Análisis Costo-Beneficio , Doxorrubicina/análogos & derivados , Doxorrubicina/economía , Doxorrubicina/uso terapéutico , Neoplasias Endometriales/genética , Neoplasias Endometriales/mortalidad , Femenino , Humanos , Inestabilidad de Microsatélites , Recurrencia Local de Neoplasia/economía , Recurrencia Local de Neoplasia/genética , Polietilenglicoles/economía , Polietilenglicoles/uso terapéutico , Estados Unidos/epidemiología
13.
Cancer ; 124(24): 4657-4666, 2018 12 15.
Artículo en Inglés | MEDLINE | ID: mdl-30423192

RESUMEN

BACKGROUND: Ovarian cancer is poorly immunogenic; however, increased major histocompatibility complex class II (MHCII) expression correlates with improved immune response and prolonged survival in patients with ovarian cancer. The authors previously demonstrated that the histone deacetylase inhibitor entinostat increases MHCII expression on ovarian cancer cells. In the current study, they evaluated whether entinostat treatment and resultant MHCII expression would enhance beneficial immune responses and impair tumor growth in mice with ovarian cancer. METHODS: C57BL/6 mice bearing intraperitoneal ID8 tumors were randomized to receive entinostat 20 mg/kg daily versus control. Changes in messenger RNA (mRNA) expression of 46 genes important for antitumor immunity were evaluated using NanoString analysis, and multicolor flow cytometry was used to measure changes in protein expression and tumor-infiltrating immune cells. RESULTS: Entinostat treatment decreased the growth of both subcutaneously and omental ID8 tumors and prolonged survival in immunocompetent C57BL/6 mice. NanoString analysis revealed significant changes in mRNA expression in 21 of 46 genes, including increased expression of the MHCI pathway, the MHCII transactivator (CIITA), interferon γ, and granzyme B. C57BL/6 mice that received entinostat had increased MHCII expression on omental tumor cells and a higher frequency of tumor-infiltrating, CD8-positive T cells by flow cytometry. In immunocompromised mice, treatment with entinostat had no effect on tumor size and did not increase MHCII expression. CONCLUSIONS: In the current murine ovarian cancer model, entinostat treatment enhances beneficial immune responses. Moreover, these antitumor effects of entinostat are dependent on an intact immune system. Future studies combining entinostat with checkpoint inhibitors or other immunomodulatory agents may achieve more durable antitumor responses in patients with ovarian cancer.


Asunto(s)
Benzamidas/administración & dosificación , Antígenos de Histocompatibilidad Clase II/genética , Inhibidores de Histona Desacetilasas/administración & dosificación , Neoplasias Ováricas/tratamiento farmacológico , Piridinas/administración & dosificación , Regulación hacia Arriba , Inmunidad Adaptativa , Animales , Benzamidas/farmacología , Línea Celular Tumoral , Proliferación Celular/efectos de los fármacos , Supervivencia Celular/efectos de los fármacos , Femenino , Regulación Neoplásica de la Expresión Génica/efectos de los fármacos , Antígenos de Histocompatibilidad Clase II/metabolismo , Inhibidores de Histona Desacetilasas/farmacología , Humanos , Huésped Inmunocomprometido , Ratones , Ratones Endogámicos C57BL , Proteínas Nucleares/genética , Neoplasias Ováricas/genética , Neoplasias Ováricas/inmunología , Medicina de Precisión , Piridinas/farmacología , Distribución Aleatoria , Transactivadores/genética , Ensayos Antitumor por Modelo de Xenoinjerto
14.
Gynecol Oncol ; 151(2): 282-286, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-30244961

RESUMEN

OBJECTIVE: To evaluate the impact of enhanced recovery after surgery (ERAS) on postoperative gastrointestinal function in gynecologic oncology patients. METHODS: This retrospective cohort study compared gynecology oncology patients undergoing non-emergent laparotomy from 10/2016 to 6/2017 managed on an ERAS protocol to a control cohort from the year prior to ERAS implementation. Major changes to postoperative care after ERAS implementation included multimodal analgesia, early feeding, goal-directed fluid resuscitation, and early ambulation. The primary outcome was rate of postoperative ileus, defined as nausea and vomiting requiring nothing-per-mouth status or nasogastric tube (NGT) placement. Secondary outcomes included length of stay (LOS) and 30-day readmission. RESULTS: 376 patients met inclusion criteria; 197 in the control group and 179 in the ERAS group. Patient demographics were similar between groups. Ileus rate was significantly lower in the ERAS group (2.8% vs. 15.7%; p < 0.001), and fewer patients in the ERAS group required NGT placement (2.2% vs. 7.1%; p = 0.06). ERAS remained independently associated with decreased ileus rates when controlling for other patient and surgical factors (OR 0.2; p = 0.01). Epidural use was correlated with a significant increase in ileus risk (OR 2.6; p = 0.03), as was increased Charlson Comorbidity Index (OR 1.2; p < 0.01). LOS was significantly decreased in the ERAS group (2.9 vs. 4.0 days; p = 0.04), while 30-day readmission rates were similar (10.1% vs. 10.7%; p = 0.62). CONCLUSIONS: Implementation of an ERAS protocol significantly decreases the risk of postoperative ileus in gynecologic oncology patients undergoing laparotomy. ERAS also reduced LOS compared to pre-ERAS controls.


Asunto(s)
Neoplasias de los Genitales Femeninos/fisiopatología , Neoplasias de los Genitales Femeninos/cirugía , Ileus/etiología , Ileus/fisiopatología , Estudios de Cohortes , Femenino , Procedimientos Quirúrgicos Ginecológicos/métodos , Procedimientos Quirúrgicos Ginecológicos/normas , Humanos , Ileus/prevención & control , Laparotomía , Persona de Mediana Edad , Atención Perioperativa/métodos , Atención Perioperativa/normas , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/fisiopatología , Complicaciones Posoperatorias/prevención & control , Estudios Retrospectivos
16.
J Low Genit Tract Dis ; 22(4): 269-273, 2018 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-30063575

RESUMEN

OBJECTIVES: Despite screening, disparities exist in cervical cancer incidence and outcomes. Demographic factors are associated with diagnosis at advanced stage (AS), but less is known about geographic factors. We sought to investigate risk factors for developing AS cervical cancer in Alabama. MATERIALS AND METHODS: We identified women treated for cervical cancer from 2005 to 2015 at our institution. Stages II-IV were considered AS. ZIP codes were categorized by federal Rural-Urban Commuting Area Codes, and 16 historically underserved counties were categorized as Black Belt rural. Using data from the American College of Obstetricians and Gynecologists, we identified women's health provider locations. We explored associations between stage and multiple factors using logistic regression. RESULTS: Of 934 patients, 29.2% were black, 52.7% had AS cancer, and 63.4% lived in urban areas. Average distance to nearest American College of Obstetricians and Gynecologists Fellow in urban, rural, and Black Belt rural areas was 5.0, 10.6, and 13.7 miles, respectively. Black race, public insurance and age of older than 65 years were associated with increased risk of AS cancer. Living in a rural area trended toward higher risk but was not significant. When stratified by race, insurance status and age were associated with AS cancer in white women only. CONCLUSIONS: Living further from a women's health provider or in a rural area was not associated with a higher risk of AS cervical cancer. Black women had a higher risk of AS than white women regardless of age, insurance status, and geography. Disparities in cervical cancer are multifactorial and necessitate further research into socioeconomic, biologic, and systems causes.


Asunto(s)
Accesibilidad a los Servicios de Salud , Lesiones Intraepiteliales Escamosas de Cuello Uterino/epidemiología , Lesiones Intraepiteliales Escamosas de Cuello Uterino/patología , Neoplasias del Cuello Uterino/epidemiología , Neoplasias del Cuello Uterino/patología , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Alabama/epidemiología , Estudios de Cohortes , Femenino , Geografía , Humanos , Incidencia , Persona de Mediana Edad , Grupos Raciales , Factores de Riesgo , Factores Socioeconómicos
17.
Int J Gynecol Cancer ; 28(7): 1427-1431, 2018 09.
Artículo en Inglés | MEDLINE | ID: mdl-30036219

RESUMEN

OBJECTIVES: The aim of this study was to determine preoperative risk factors associated with unplanned reoperation within 30 days for patients undergoing major surgery for primary ovarian cancer using the National Surgical Quality Improvement Program database. METHODS: We conducted a retrospective cohort study utilizing the National Surgical Quality Improvement Program database to identify patients undergoing primary ovarian cancer surgery from 2012 to 2014. Patients who had a reoperation within 30 days of their primary surgery were identified. Demographics and clinical covariates were calculated. Adjusted odds ratios (ORs) and 95% confidence intervals (CIs) were calculated using univariate and multivariate logistic regression approaches to assess the association. RESULTS: A total of 4260 patients were identified during the study period. One hundred forty-eight patients (3.5%) underwent a reoperation within 30 days of their primary surgery. In univariate analysis, preoperative creatinine 1.5 mg/dL or greater (P = 0.010), smoking (P = 0.003), and both insulin-dependent (P = 0.029) and non-insulin-dependent diabetes mellitus (P = 0.048) were predictive of a reoperation. Multivariate analysis noted that smoking (OR, 1.94; 95% CI, 1.26-2.99), insulin-dependent diabetes mellitus (OR, 2.18; 95% CI, 1.08-4.40), non-insulin-dependent diabetes mellitus (OR, 1.65; 95% CI, 1.01-2.72), and preoperative creatinine (OR, 2.65; 95% CI, 1.26-5.58) were predictive of a reoperation. Age 50 to 60 years was protective against reoperation when compared with age younger than 50 years (OR, 0.54; 95% CI, 0.32-0.90). CONCLUSIONS: Efforts to reduce reoperation rates should focus on identifying high-risk patients by utilizing objective preoperative data. Optimizing their medical status prior to surgery may decrease the reoperation rate in patients with ovarian cancer, thereby improving outcomes and providing a probable cost benefit.


Asunto(s)
Neoplasias Ováricas/cirugía , Anciano , Estudios de Cohortes , Bases de Datos Factuales , Femenino , Humanos , Laparotomía/métodos , Laparotomía/estadística & datos numéricos , Persona de Mediana Edad , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Oncología Quirúrgica/normas , Oncología Quirúrgica/estadística & datos numéricos
18.
Prev Med ; 113: 124-131, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29800594

RESUMEN

The human papillomavirus (HPV) vaccine is an important tool for cancer prevention. However, vaccination rates in Alabama, a state with high rates of HPV-related cancers, remain below the national average. Our objective was to develop a comprehensive assessment of HPV vaccination in our state, with the goal to make recommendations for tailored multilevel interventions. A multimodal approach with quantitative and qualitative data was used to determine barriers and facilitators to HPV vaccination in Alabama. This included a survey of pediatric care providers and structured interviews with pediatricians, parents, nurses and community stakeholders. Two separate investigators evaluated the interview transcripts for major themes that occurred in 65% or more interviews. Major barriers included lack of knowledge, concerns about vaccine safety, and the link between the HPV vaccine and sexuality. Qualitative interviews further revealed barriers such as misinformation received from the internet and parental vaccine hesitancy. Opportunities for increasing vaccination include parental education, establishment of a reminder system, increasing access to HPV vaccine providers, and education for providers. Additional facilitators revealed through interviews included: trust in physicians, using the internet or social media to propagate positive messaging, physicians and clinical staff education, utilizing existing technology more effectively, highlighting nurses' roles as partners in HPV prevention, and the potential of schools as a venue for promotion of the vaccine. Our data are consistent with prior research showing major barriers to HPV vaccination. Several recommendations for optimizing HPV vaccination uptake in Alabama on the patient, provider and system level are given.


Asunto(s)
Conocimientos, Actitudes y Práctica en Salud , Infecciones por Papillomavirus/prevención & control , Vacunas contra Papillomavirus/uso terapéutico , Vacunación/estadística & datos numéricos , Adolescente , Adulto , Alabama , Actitud del Personal de Salud , Niño , Femenino , Personal de Salud/estadística & datos numéricos , Humanos , Entrevistas como Asunto , Persona de Mediana Edad , Papillomaviridae/aislamiento & purificación , Vacunas contra Papillomavirus/economía , Aceptación de la Atención de Salud/estadística & datos numéricos , Investigación Cualitativa , Encuestas y Cuestionarios , Neoplasias del Cuello Uterino/prevención & control
19.
Mol Cancer Res ; 16(5): 813-824, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29523763

RESUMEN

While high-grade serous ovarian carcinoma (HGSOC) is the most common histologic subtype of ovarian cancer, significant tumor heterogeneity exists. In addition, chemotherapy induces changes in gene expression and alters the mutational profile. To evaluate the notion that patients with HGSOC could be better classified for optimal treatment based on gene expression, we compared genetic variants [by DNA next-generation sequencing (NGS) using a 50 gene Ion Torrent panel] and gene expression (using the NanoString PanCancer 770 gene Panel) in the tumor from 20 patients with HGSOC before and after neoadjuvant chemotherapy (NACT). NGS was performed on plasma cell free DNA (cfDNA) on a select group of patients (n = 14) to assess the utility of using cfDNA to monitor these changes. A total of 86 genes had significant changes in RNA expression after NACT. Thirty-eight genetic variants (including SNPs) from 6 genes were identified in tumors pre-NACT, while 59 variants from 19 genes were detected in the cfDNA. The number of DNA variants were similar after NACT. Of the 59 variants in the plasma pre-NACT, only 6 persisted, whereas 33 of 38 specific variants in the tumor DNA remained unchanged. Pathway analysis showed the most significant alterations in the cell cycle and DNA damage pathways.Implications: Gene expression profiles at the time of interval debulking provide additional genetic information that could help impact treatment decisions after NACT; although, continued collection and analysis of matched tumor and cfDNA from multiple time points are needed to determine the role of cfDNA in the management of HGSOC. Mol Cancer Res; 16(5); 813-24. ©2018 AACR.


Asunto(s)
Cistadenocarcinoma Seroso/tratamiento farmacológico , Cistadenocarcinoma Seroso/genética , Terapia Neoadyuvante/métodos , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/genética , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Cistadenocarcinoma Seroso/patología , Femenino , Humanos , Persona de Mediana Edad , Clasificación del Tumor , Neoplasias Ováricas/patología
20.
J Low Genit Tract Dis ; 22(3): 207-211, 2018 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-29474240

RESUMEN

OBJECTIVE: The aim of the study was to determine rates of cervical intraepithelial neoplasia (CIN) 2 or greater in high-risk, racially diverse, young women with low-grade cytology. MATERIALS AND METHODS: After institutional review board approval, a cross-sectional study of 21- to 24-year-old women with low-grade cytology (atypical squamous cells of undetermined significance, high-risk human papillomavirus+, low-grade squamous intraepithelial lesion, or human papillomavirus+ only) managed with colposcopy at our university-based clinic between May 2011 and April 2013 were identified. Demographics and pathologic data were collected including age, race, parity, smoking status, screening history, and histology. Student t test and χ tests were used to compare women with and without CIN 2 or 3. Univariate analysis was performed with demographic data. RESULTS: One thousand fifty-eight women with a mean (SD) age of 22.5 (1.1) were included. Most patients (59.5%) were parous, 36.1% were smokers, and most (52.9%) were black. These patients were considered high risk because of their lower socioeconomic status, minority status, lack of insurance, or having Medicaid and therefore had limited access to preventative health care. Based on colposcopy, the prevalence of CIN 2+ was 19.1%: 13.9% (95% CI = 11.9-16.1) CIN 2 and 5.1% (95% CI = 3.9-6.6) CIN 3. There was an overall prevalence of 4.7% (95% CI = 3.7%-6.3%) of CIN 3 from excisional pathology from the 157 of 185 patients who returned for a recommended excisional procedure. Smoking (odds ratio = 1.64, 95% CI = 1.2-2.25) and a history of high-grade cytology (odds ratio = 2.06, 95% CI = 1.02-4.01) were associated with CIN 2/3. CONCLUSIONS: High prevalence of CIN 2/3 in young women with low-grade cervical cytology in this population suggests that it may be prudent to consider alternative surveillance such as colposcopy in similar high-risk populations.


Asunto(s)
Lesiones Intraepiteliales Escamosas de Cuello Uterino/epidemiología , Neoplasias del Cuello Uterino/epidemiología , Colposcopía , Estudios Transversales , Femenino , Humanos , Prevalencia , Medición de Riesgo , Adulto Joven
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