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OBJECTIVES: Disparities persist in the enrollment of racial/ethnic groups in clinical trials for ovarian cancers. We sought to analyze the enrollment rates of patients by race/ethnicity in phase II/III clinical trials involving poly(ADP-ribose) polymerase (PARP) inhibitors for ovarian cancers and compare these to the racial/ethnic prevalence of ovarian cancers in the United States. METHODS: This study was a retrospective review of clinical trials registered with ClinicalTrials.gov. Studies included evaluated PARP inhibitors for the treatment of ovarian, fallopian tube, and primary peritoneal cancers. Enrollment rates for clinical trials were stratified by race/ethnicity and type of cancer. Enrollment fractions (EFs) were calculated using prevalence data from the Surveillance, Epidemiology, and End Results Program. Odds ratios (OR) and 95% confidence intervals (CI) were calculated to compare racial/ethnic group enrollment rates to Non-Hispanic (NH) White enrollment rates. RESULTS: Forty-eight trials were identified, 15 of which met inclusion criteria. The EFs for included trials, were 1.5% for NH-White, 0.47% for NH-Black, 0.33% for Hispanic, and 2.38% for Asian/Pacific Islander. Patients who identified as NH-Black and Hispanic were significantly underrepresented compared to those who identified as NH-White (OR 0.23, 95% CI [0.18-0.29] and OR 0.3, 95% CI [0.25-0.38] respectively, p < 0.001). CONCLUSIONS: NH-Black and Hispanic patients are significantly underrepresented in clinical trials evaluating PARP inhibitors for ovarian cancers compared to NH-White cohorts. Phase II/III trials assessing PARP inhibitors for ovarian cancers do not accurately represent the populations diagnosed with these malignancies. Enrollment strategies are needed to increase diversity in PARP inhibitor clinical trials for women's cancers.
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Neoplasias de los Genitales Femeninos , Neoplasias Ováricas , Etnicidad , Femenino , Neoplasias de los Genitales Femeninos/tratamiento farmacológico , Humanos , Neoplasias Ováricas/tratamiento farmacológico , Inhibidores de Poli(ADP-Ribosa) Polimerasas/uso terapéutico , Grupos Raciales , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: To demonstrate discrepancies between operative times in the ACS NSQIP (American College of Surgeons National Surgical Quality Improvement Project) and self-reported operative time from the American Medical Association's Relative Value Scale Update Committee (RUC) and their effect on relative value units (RVU) determination. METHODS: This is a cross-sectional review of registry data using the ACS NSQIP 2016 Participant User File and the Centers for Medicare & Medicaid Services physician procedure time file for 2018. We analyzed total RVUs for surgeries by operative time to calculate RVU per hour and stratified by specialty. Multivariate regression analysis adjusted for patient comorbidities, age, length of stay, and ACS NSQIP mortality and morbidity probabilities. The surgeon self-reported operative times from the Centers for Medicare & Medicaid Services physician were compared with operative times recorded in the ACS NSQIP, with excess time from RUC estimates termed "overreported time." RESULTS: Analysis of 901,917 surgeries revealed a wide variation in median RVU per hour between specialties. Orthopedics (14.3), neurosurgery (12.9), and general surgery (12.1) had the highest RVU per hour, whereas gynecology (10.2), plastic surgery (9.5), and otolaryngology (9) had the lowest (P<.001 for all comparisons). These results remained unchanged on multivariate regression analysis. General surgery had the highest median overreported operative time (+26 minutes) followed by neurosurgery (+23.5 minutes) and urology (+20 minutes). Overreporting of the operative time strongly correlated to higher RVU per hour (r=0.87, P=.002). CONCLUSION: Despite reliable electronic records, the AMA-RUC continues to use inaccurate self-reported RUC surveys for operative times. This results in discrepancies in RVU per hour (and subsequent reimbursement) across specialties and a persistent disparity for women-specific procedures in gynecology. Relative value unit levels should be based on the available objective data to eliminate these disparities.
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Tempo Operativo , Mecanismo de Reembolso , Escalas de Valor Relativo , Cirujanos , Procedimientos Quirúrgicos Operativos/economía , Estudios Transversales , Femenino , Procedimientos Quirúrgicos Ginecológicos/economía , Humanos , Procedimientos Neuroquirúrgicos/economía , Procedimientos Ortopédicos/economía , Sistema de Registros , Estados UnidosRESUMEN
OBJECTIVE: To assess abortion-related attitudes, practices, and perceptions among physicians of all specialties at a Wisconsin academic medical center. STUDY DESIGN: We developed and disseminated a cross-sectional web and mail survey to physicians at our academic center using a list generated by Human Resources. We performed descriptive analyses and assessed bivariate relationships between measures of support for abortion, perceived climate of opinion, willingness to consult in abortion-related cases, and sociodemographic and professional characteristics. We used binary logistic regression to model willingness to consult. RESULTS: We sent the survey to 1357 physicians and received 913 (67%) responses. Participants reported strong support for unrestricted access to abortion and the efforts of abortion providers but estimated relatively lower support among peers. Compared to 556 (62%) who reported "a lot" of support for abortion access, only 183 (21%) estimated the same level of support among peers. Similarly, 615 (69%) participants reported "a lot" of support for abortion providers, compared to only 227 (25%) who estimated the same level of support among peers. Participants most commonly estimated that peers "somewhat" support abortion access (381; 43%) and abortion providers (344; 39%). Across specialties, 799 (90%) physicians said they were at least "somewhat" willing to consult in abortion-related cases. Compared to obstetrician-gynecologists and family physicians, other specialists were less likely to be willing to consult (aOR = 0.43, 95% CI 0.29-0.65), though majorities of both groups were willing. Physicians who perceived equal or higher support for abortion among peers were more likely to be willing to consult (aOR = 2.17, 95% CI 1.60-2.95). CONCLUSION: Most physicians at our center reported support for abortion; however, those who perceived less support among peers reported less willingness to consult in abortion-related care, regardless of specialty. IMPLICATIONS: Even among physicians who supported abortion, the perception that peers were less supportive deterred participation in abortion-related care at our institution. Where abortion care is isolated or stigmatized, physicians may be unaware of colleagues' true attitudes about abortion. Efforts to normalize communication about abortion care could improve access and quality.
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Aborto Inducido , Médicos , Centros Médicos Académicos , Actitud del Personal de Salud , Estudios Transversales , Femenino , Humanos , Embarazo , Encuestas y CuestionariosRESUMEN
The primary goal was to convert 50% of all outpatient Gynecologic Oncology (GynOnc) encounters during the COVID-19 pandemic to telemedicine within one week. The secondary goal was to reach 100% documentation of telemedicine consent. The tertiary goal was to analyze patient satisfaction scores. An additional goal was to estimate CO2 emissions prevented from being produced. The period from 3/16/2020-4/15/2020 was targeted. The initial intervention involved transitioning surveillance visits. A second intervention, with nursing and advanced-practice-provider support, included transitioning additional visit types, and distributing a note template. The Telehealth Satisfaction Survey (TeSS) was administered to patients. Descriptive statistics and run charts were used to analyze and depict results. Within four weeks, there were 408 encounters; 217 were telemedicine (53.2%). Following the second intervention, 13 of 15 days (86.7%) reached the 50% telemedicine target and consent was documented in 96.6% of the telemedicine encounters. The TeSS had a 74.8% response-rate. Patients rated the following aspects of the telemedicine encounter as good or excellent: call quality (96.5%), personal comfort (92.9%), length-of-visit (94.7%), treatment explanation (93.8%), overall experience (88.5%). Moreover, 82.3% of patients would use telemedicine again. Additionally, 6.25 metric tons of CO2 emissions from travel were prevented from being produced. A GynOnc clinic can rapidly implement telemedicine systems. With multidisciplinary team planning and standardized note templates, transitioning 50% of encounters to telemedicine and achieving high rates of consent documentation were accomplished in four weeks. This increase in telemedicine represented a measurable decrease in the amount of CO2 emissions. Additionally, patients were overwhelmingly satisfied.
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Cancer treatment-induced bone loss is a known side effect of cancer therapy that increases the risk of osteoporosis and bone fracture. Women with gynecologic cancer are at increased risk of bone loss secondary to the combined effect of oophorectomy and adjuvant therapies. Data regarding bone loss in women with gynecologic cancers are overall lacking compared to other cancer populations. Consequently, guidelines for osteoporosis screening in women with cancer are largely based on data generated among non-gynecologic cancer survivors. This article reviews current available data of bone health in women with gynecologic cancer, summarizes best-available guidelines for screening for osteoporosis in women with cancer, and provides guidance for osteoporosis screening in women with gynecologic cancers based on best available evidence.
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Densidad Ósea/fisiología , Supervivientes de Cáncer/estadística & datos numéricos , Neoplasias de los Genitales Femeninos/terapia , Tamizaje Masivo/normas , Osteoporosis/diagnóstico , Absorciometría de Fotón , Antineoplásicos Hormonales/efectos adversos , Densidad Ósea/efectos de los fármacos , Densidad Ósea/efectos de la radiación , Quimioterapia Adyuvante/efectos adversos , Quimioterapia Adyuvante/métodos , Medicina Basada en la Evidencia/normas , Femenino , Neoplasias de los Genitales Femeninos/complicaciones , Neoplasias de los Genitales Femeninos/mortalidad , Humanos , Menopausia/efectos de los fármacos , Menopausia/metabolismo , Menopausia/efectos de la radiación , Osteoporosis/epidemiología , Osteoporosis/etiología , Osteoporosis/metabolismo , Ovario/efectos de los fármacos , Ovario/metabolismo , Ovario/efectos de la radiación , Ovario/cirugía , Guías de Práctica Clínica como Asunto , Radioterapia Adyuvante/efectos adversos , Factores de Riesgo , Salpingooforectomía/efectos adversos , SupervivenciaRESUMEN
The National Institutes of Health funding for reproductive sciences research, specifically in academic departments of obstetrics and gynecology, is disproportionately low. Research is one of the most important pillars in advancing healthcare. Despite US Congress' vision in providing increased funding to the National Institutes of Health as a whole, underfunding for research in the departments of obstetrics and gynecology remains one of the several critical drivers in the decline in reproductive health and healthcare for women in the United States.
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Investigación Biomédica/economía , Ginecología , National Institutes of Health (U.S.)/economía , Obstetricia , Estados UnidosRESUMEN
Universal access to contraception benefits society: unintended pregnancies, maternal mortality, preterm birth, abortions, and obesity would be reduced by increasing access to affordable contraception. Women should be able to choose when and whether to use contraception, choose which method to use, and have ready access to their chosen method. State and national government should support unrestricted access to all contraceptives. As obstetrician-gynecologists, we have a critical mandate, based on principle and mission, to step up with leadership on this vital medical and public health issue, to improve the lives of women, their families, and society. The field of Obstetrics and Gynecology must provide the leadership for moving forward. The American Gynecological and Obstetrical Society (AGOS), representing academic and public policy leaders from across all disciplines of Obstetrics and Gynecology, is well positioned to serve as a unifying organization, focused on developing a strong unified advocacy voice to fight for accessible contraception for all in the United States.
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Anticoncepción , Accesibilidad a los Servicios de Salud , Mortalidad Materna , Obesidad Materna , Nacimiento Prematuro , Aborto Inducido , Intervalo entre Nacimientos , Femenino , Humanos , Anticoncepción Reversible de Larga Duración , Obesidad , Defensa del Paciente , Embarazo , Embarazo no PlaneadoAsunto(s)
Procedimientos Quirúrgicos de Citorreducción/métodos , Estadificación de Neoplasias , Neoplasias Ováricas/cirugía , Medición de Riesgo/métodos , Factores de Edad , Femenino , Humanos , Persona de Mediana Edad , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/mortalidad , Periodo Posoperatorio , Tasa de Supervivencia/tendencias , Estados Unidos/epidemiologíaRESUMEN
OBJECTIVE: To revise FIGO staging of carcinoma of the cervix uteri, allowing incorporation of imaging and/or pathological findings, and clinical assessment of tumor size and disease extent. METHODS: Review of literature and consensus view of the FIGO Gynecologic Oncology Committee and related societies and organizations. RESULTS: In stage I, revision of the definition of microinvasion and lesion size as follows. Stage IA: lateral extension measurement is removed; stage IB has three subgroups-stage IB1: invasive carcinomas ≥5 mm and <2 cm in greatest diameter; stage IB2: tumors 2-4 cm; stage IB3: tumors ≥4 cm. Imaging or pathology findings may be used to assess retroperitoneal lymph nodes; if metastatic, the case is assigned stage IIIC; if only pelvic lymph nodes, the case is assigned stage IIIC1; if para-aortic nodes are involved, the case is assigned stage IIIC2. Notations 'r' and 'p' will indicate the method used to derive the stage-i.e., imaging or pathology, respectively-and should be recorded. Routine investigations and other methods (e.g., examination under anesthesia, cystoscopy, proctoscopy, etc.) are not mandatory and are to be recommended based on clinical findings and standard of care. CONCLUSION: The revised cervical cancer staging is applicable to all resource levels. Data collection and publication will inform future revisions.
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Carcinoma/patología , Metástasis Linfática/patología , Estadificación de Neoplasias , Neoplasias del Cuello Uterino/patología , Carcinoma/diagnóstico por imagen , Progresión de la Enfermedad , Femenino , Humanos , Metástasis Linfática/diagnóstico por imagen , Invasividad Neoplásica , Estudios Retrospectivos , Neoplasias del Cuello Uterino/diagnóstico por imagenRESUMEN
The American Gynecological and Obstetrical Society (AGOS) has the potential to serve as a unifying organization to advocate for women's reproductive health care, education, and research. This report reviews a strategic plan designed to reinvigorate AGOS to address, together with our partner organizations, the ever more pressing issues and challenges in women's reproductive health.
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Ginecología , Obstetricia , Salud Reproductiva , Derechos Sexuales y Reproductivos , Sociedades Médicas , Planificación Estratégica , Salud de la Mujer , Humanos , Servicios de Salud Reproductiva , Investigación , Estados Unidos , Servicios de Salud para MujeresRESUMEN
OBJECTIVE: Identify the major factors that drive standardized cost in providing surgical care for women with ovarian cancer, characterize the magnitude of variation in resource utilization between centers, and to investigate the relationship between resource utilization and quality of care provided. METHODS: Retrospective cohort study of hospitals across the United States reporting to the Premier Database who cared for patients with ovarian cancer diagnosed between 2007 and 2014. The primary outcome was standardized total cost of the index hospitalization. To assess the relationship between hospital standardized costs and patient outcomes, we identified four measures of quality: 1) complications, 2) re-operation, 3) length of stayâ¯>â¯15â¯days, and 4) unplanned readmission. RESULTS: The study population included 15,857 patients treated at 226 hospitals. The median standardized cost for hospitalizations was $13,267 (IQRâ¯=â¯$3342). Reoperation was associated with 49% increase (95% CIâ¯=â¯43%-56%), and having minor complication was associated with 10% (95% CIâ¯=â¯8%-12%) increase in standardized cost, a moderate complication was associated with 36% (95% CIâ¯=â¯33%-38%) increase, and a major complication was associated with 83% (95% CIâ¯=â¯76%-89%) increase. The average risk-adjusted hospital standardized costs for hospitals in the highest resource use quartiles was 56% higher than the average hospital costs for hospitals in the lowest quartile ($10,826 vs. $16,933). The largest variation was in operating room standardized cost (45.5% of the total variation in operating room cost is explained by differences in hospital practices) and supplies (41.7%). CONCLUSIONS: We identified significant variation in standardized costs among women who underwent surgery for ovarian cancer, operating room and supply costs are the largest drivers of variation.
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Costos de Hospital/estadística & datos numéricos , Neoplasias Ováricas/economía , Neoplasias Ováricas/cirugía , Femenino , Humanos , Laparoscopía/economía , Laparoscopía/métodos , Laparoscopía/estadística & datos numéricos , Persona de Mediana Edad , Modelos Económicos , Calidad de la Atención de Salud , Estados UnidosRESUMEN
OBJECTIVE: Report the up-to-date trends in surgical approach for cervical cancer and compare outcomes between open and minimally invasive routes. METHODS: Radical Hysterectomy (RH) cases from the National Inpatient Sample (NIS) dataset between 2012 and 2015 were grouped into abdominal (ARH) and Minimally Invasive Surgery (MIS). The MIS group was subdivided as "Laparoscopic", "Robotic", and "Converted". Univariate and multivariable logistic regression were used to analyze differences in complication rates. The National Surgical Quality Improvement Dataset 2015 was used for validation. RESULTS: A total of 7180 cases from NIS were identified. Overall, there was 44% decline in RH cases from 2012 (nâ¯=â¯2220) to 2015 (nâ¯=â¯1255). A proportionate increase in robotic cases from 31.5% in 2012 to 41.4% in 2015 was noted. By intention to treat analysis, the rate of at least one complication for abdominal cases was 24.8% compared to 10% for MIS (pâ¯<â¯0.001). On multivariate analysis, abdominal cases had higher odd of any one complication (aOR 2.9,95% CI 2.12-4.00), medical complication (aOR 3.25,95% CI 2.15-4.19), infectious complication (aOR 3.76,95% CI 2.1-6.1) but not for surgical complications (aOR 1.7,95% CI 0.5-5.6). AH resulted in longer hospital stay compared to MIS (4.3 vs 1.9â¯days, pâ¯<â¯0.001). Median cost of AH was $12,624, laparoscopic $12,873, robotic $14,029 and converted cases $17,036. NSQIP analysis supplemented the outcomes to 30-days and showed similar findings. CONCLUSIONS: Perioperative complications are significantly lower for MIS procedures. These data should be used for contemporary cost-effective analysis and comprehensive counseling regarding risks and benefits of the surgical approach for cervical cancer.
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Histerectomía/tendencias , Neoplasias del Cuello Uterino/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Costos de la Atención en Salud , Humanos , Histerectomía/efectos adversos , Histerectomía/economía , Pacientes Internos , Laparoscopía/economía , Laparoscopía/tendencias , Modelos Logísticos , Persona de Mediana Edad , Procedimientos Quirúrgicos Mínimamente Invasivos , Procedimientos Quirúrgicos Robotizados/economía , Procedimientos Quirúrgicos Robotizados/tendenciasRESUMEN
PURPOSE: To analyze National Cancer Institute (NCI) funding distributions to gynecologic cancers compared to other cancers from 2007 to 2014. METHODS: The NCI's Surveillance, Epidemiology and End Results (SEER), Cancer Trends Progress Report, and Funding Statistics were used to analyze 18 cancer sites. Site-specific mortality to incidence ratios (MIR) were normalized per 100 cases and multiplied by person-years of life lost to derive cancer-specific lethality. NCI funding was divided by its lethality to calculate Funding to Lethality scores for gynecologic malignancies and compared to 15 other cancer sites. RESULTS: Ovarian, cervical, and uterine cancers ranked 10th (score 0.097, SD 0.008), 12th (0.087, SD 0.009), and 14th (0.057, SD 0.006) for average Funding to Lethality scores. The highest average score was for prostate cancer (score 1.182, SD 0.364). In U.S. dollars per 100 incident cases, prostate cancer received an average of $1,821,000 per person-years of life lost, while ovarian cancer received $97,000, cervical cancer $87,000, and uterine cancer $57,000. Ovarian and cervical cancers had lower average Funding to Lethality scores compared to nine other cancers, while uterine cancer was lower than 13 other cancers (pâ¯<â¯0.01 for all comparisons). Analyses of eight-, five-, and three-year trends for gynecologic cancers showed nearly universal decreasing Funding to Lethality scores. CONCLUSION: Funding to Lethality scores for gynecologic cancers are significantly lower than other cancer sites, indicating a disparity in funding allocation that persists over the most recent eight years of available data. Prompt correction is required to ensure critical discoveries for women with gynecologic cancers.
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Neoplasias de los Genitales Femeninos/mortalidad , Apoyo a la Investigación como Asunto , Femenino , Humanos , Masculino , Asignación de RecursosRESUMEN
BACKGROUND: Minimally invasive surgery was adopted as an alternative to laparotomy (open surgery) for radical hysterectomy in patients with early-stage cervical cancer before high-quality evidence regarding its effect on survival was available. We sought to determine the effect of minimally invasive surgery on all-cause mortality among women undergoing radical hysterectomy for cervical cancer. METHODS: We performed a cohort study involving women who underwent radical hysterectomy for stage IA2 or IB1 cervical cancer during the 2010-2013 period at Commission on Cancer-accredited hospitals in the United States. The study used inverse probability of treatment propensity-score weighting. We also conducted an interrupted time-series analysis involving women who underwent radical hysterectomy for cervical cancer during the 2000-2010 period, using the Surveillance, Epidemiology, and End Results program database. RESULTS: In the primary analysis, 1225 of 2461 women (49.8%) underwent minimally invasive surgery. Women treated with minimally invasive surgery were more often white, privately insured, and from ZIP Codes with higher socioeconomic status, had smaller, lower-grade tumors, and were more likely to have received a diagnosis later in the study period than women who underwent open surgery. Over a median follow-up of 45 months, the 4-year mortality was 9.1% among women who underwent minimally invasive surgery and 5.3% among those who underwent open surgery (hazard ratio, 1.65; 95% confidence interval [CI], 1.22 to 2.22; P=0.002 by the log-rank test). Before the adoption of minimally invasive radical hysterectomy (i.e., in the 2000-2006 period), the 4-year relative survival rate among women who underwent radical hysterectomy for cervical cancer remained stable (annual percentage change, 0.3%; 95% CI, -0.1 to 0.6). The adoption of minimally invasive surgery coincided with a decline in the 4-year relative survival rate of 0.8% (95% CI, 0.3 to 1.4) per year after 2006 (P=0.01 for change of trend). CONCLUSIONS: In an epidemiologic study, minimally invasive radical hysterectomy was associated with shorter overall survival than open surgery among women with stage IA2 or IB1 cervical carcinoma. (Funded by the National Cancer Institute and others.).
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Histerectomía/métodos , Procedimientos Quirúrgicos Mínimamente Invasivos , Neoplasias del Cuello Uterino/cirugía , Adenocarcinoma/mortalidad , Adenocarcinoma/cirugía , Adulto , Carcinoma Adenoescamoso/mortalidad , Carcinoma Adenoescamoso/cirugía , Carcinoma de Células Escamosas/mortalidad , Carcinoma de Células Escamosas/cirugía , Causas de Muerte , Distribución de Chi-Cuadrado , Estudios de Cohortes , Femenino , Humanos , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Estadificación de Neoplasias , Puntaje de Propensión , Programa de VERF , Análisis de Supervivencia , Tasa de Supervivencia , Neoplasias del Cuello Uterino/mortalidad , Neoplasias del Cuello Uterino/patologíaRESUMEN
PURPOSE: Bevacizumab (BV) monotherapy leads to compensatory upregulation of multiple signaling pathways, resulting in mTOR activation. We evaluated combining BV and everolimus (EV), an mTOR kinase inhibitor, to circumvent BV-resistance in women with recurrent or persistent ovarian, fallopian tube or primary peritoneal cancer (OC). PATIENTS AND METHODS: Eligible OC patients had measurable (RECIST1.1) or detectable disease, 1-3 prior regimens, performance status (PS) 0-2, and no prior m-TOR inhibitor. All patients received BV 10â¯mg/kg IV every 2wks. Patients were randomized (1:1) to oral EV (10â¯mg daily) or placebo stratified by platinum-free interval (PFI), measurable disease and prior BV. Primary endpoint was progression-free survival (PFS); secondary endpoints included safety and response. RESULTS: 150 patients were randomized to BV with (nâ¯=â¯75) and without (nâ¯=â¯75) EV. Arms were well-balanced for age (median 63: range 28-92), PS (0: 73%, 1-2: 27%), prior regimens (1: 37%, 2: 47%, 3: 16%), prior BV (11%), PFI (<6mos: 65%) and measurable disease (81%). The BVâ¯+â¯EV vs BV median PFS was 5.9 vs 4.5â¯months (hazard ratio [HR] 0.95 (95% CI, 0.66-1.37, pâ¯=â¯0.39)). Median OS was 16.6 vs 17.3â¯months (HR 1.16 (95% CI, 0.72-1.87, pâ¯=â¯0.55). Objective measurable responses were higher with BVâ¯+â¯EV (22% vs 12%). Study removal due to toxicity was higher with BVâ¯+â¯EV (29% vs 12%). Toxicity (≥grade 3) from BVâ¯+â¯EV were "other GI (mucositis)" (23 vs 1%) and "metabolic/nutrition" (19 vs. 7%); common ≥â¯grade 2 toxicities with BVâ¯+â¯EV were cytopenia, nausea, fatigue and rash. CONCLUSION: The combination regimen (BVâ¯+â¯EV) did not significantly reduce the hazard of progression or death relative to BV and was associated with higher rates of adverse events and study discontinuation when compared to BV alone.
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Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bevacizumab/uso terapéutico , Neoplasias de las Trompas Uterinas/tratamiento farmacológico , Neoplasias Glandulares y Epiteliales/tratamiento farmacológico , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Peritoneales/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Bevacizumab/administración & dosificación , Carcinoma Epitelial de Ovario , Supervivencia sin Enfermedad , Método Doble Ciego , Everolimus/administración & dosificación , Femenino , Humanos , Persona de Mediana Edad , Recurrencia Local de Neoplasia/tratamiento farmacológicoRESUMEN
OBJECTIVES: To investigate the utility of para-aortic lymph node dissection among women undergoing radical hysterectomy and pelvic lymph adenectomy for FIGO Stage IA2-IB2 cervical cancer using the National Cancer Database (NCDB). METHODS: We identified patients with stage IA2-IB2 squamous cell, adenosquamous, or adenocarcinoma of the cervix diagnosed 2011-2014 in the NCDB. The primary outcome was the negative predictive value of histologically assessed pelvic lymph node status for para-aortic lymph node status among women undergoing pelvic and para-aortic lymph node dissection. We calculated probability of para-aortic lymph node metastasis conditional on pelvic lymph node status. Finally, we compared overall survival between patients undergoing para-aortic lymph node dissection and those in whom this procedure was omitted. RESULTS: A total of 3212 patients met study inclusion criteria, of whom 994 (30.9%) underwent para-aortic lymph node dissection. In this group, the risk of isolated para-aortic metastasis was 0.11%. The negative predictive value of surgically assessed pelvic lymph nodes to predict para-aortic lymph node status was 99.9% (95% CI 99.9-99.9). Among 93 patients with pelvic lymph node metastasis, 18 (19.4%) had concurrent para-aortic lymph node metastasis. There was no difference in overall survival between women undergoing pelvic and para-aortic lymph node dissection compared with those undergoing pelvic lymphadenectomy only (pâ¯=â¯0.69). CONCLUSIONS: In patients undergoing radical hysterectomy and pelvic lymphadenectomy for stage IA2-IB2 cervical cancer, para-aortic lymph node dissection is not warranted based on the low risk of isolated metastatic disease, and lack of survival benefit associated with the procedure.
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Carcinoma/secundario , Escisión del Ganglio Linfático , Ganglios Linfáticos/patología , Ganglios Linfáticos/cirugía , Neoplasias del Cuello Uterino/patología , Aorta , Carcinoma/cirugía , Femenino , Humanos , Histerectomía , Metástasis Linfática , Persona de Mediana Edad , Estadificación de Neoplasias , Pelvis , Valor Predictivo de las Pruebas , Probabilidad , Sistema de Registros , Estudios Retrospectivos , Tasa de Supervivencia , Neoplasias del Cuello Uterino/cirugíaRESUMEN
OBJECTIVES: Thirty-day readmission rate has been proposed as metric of quality and remains an ongoing clinical concern in the primary treatment of patients with advanced-stage ovarian epithelial ovarian cancer. We conducted a review of the literature to identify rates, risk factors, and predictors for 30-day readmission in this population. METHODS: A 10-year period MEDLINE (PubMed) search of English literature studies published between January 01, 2008-January 01, 2018 was performed to identify appropriate studies for review. RESULTS: Thirty -day readmission rates for ovarian cancer patients undergoing primary treatment ranged from 2.5-19.3%. Neoadjuvant chemotherapy and interval cytoreductive surgery (NACT-ICS) surgery was associated with lower readmission rates, when compared to primary debulking surgery (PDS). The most frequently reported adverse events resulting in readmission include inpatient management of ileus/small bowel obstruction, wound-related complications, and thromboembolic events. Readmission predictors included the presence of other medical comorbidities, re-operation, and major complications occurring after initial hospital discharge. Some studies reported lower rates of readmission and survival in patients treated by NACT-ICS. CONCLUSIONS: Policies and programs should be designed to measure short- and long-term outcomes in this patient population to avoid bias in assigning patients to NACT-ICS to maintain low 30-day readmission rates.
Asunto(s)
Procedimientos Quirúrgicos de Citorreducción/efectos adversos , Neoplasias Ováricas/cirugía , Complicaciones Posoperatorias/terapia , Quimioterapia Adyuvante , Procedimientos Quirúrgicos de Citorreducción/métodos , Procedimientos Quirúrgicos de Citorreducción/estadística & datos numéricos , Femenino , Humanos , Terapia Neoadyuvante , Neoplasias Ováricas/tratamiento farmacológico , Readmisión del Paciente/estadística & datos numéricos , Complicaciones Posoperatorias/etiologíaRESUMEN
OBJECTIVE: To evaluate the role of 30-day readmission rate as a quality of care metric in patients undergoing ovarian cancer surgery. METHODS: We performed a retrospective cohort study of women diagnosed between 2004 and 2013 with advanced-stage, high-grade, serous carcinoma who underwent primary treatment. Using the National Cancer Database, we compared the performance of hospital risk-adjusted 30-day readmission rate to other quality of care metrics (risk-adjusted 30- and 90-day mortality, rates of adherence to guideline-based care, and overall survival) within hospitals categorized by yearly case volume (10 or less, 11-20, 21-30, and 31 cases per year or more). RESULTS: A total of 42,931 patients met the inclusion criteria. The overall unplanned 30-day readmission rate was 6.36% (95% CI 6.13-6.59). After adjusting for comorbidity, stage, histology, and sociodemographic and treatment factors, hospitals performing 31 cases per year or more had a 24% higher likelihood of readmission (adjusted odds ratio [OR] 1.25, 95% CI 1.06-1.46) when compared with those performing 10 cases per year or less. However, hospitals performing 31 cases per year or more had a significantly lower risk-adjusted 90-day mortality (adjusted OR 0.74, 95% CI 0.60-0.91) despite higher rates of complex surgical procedures and higher rates of guideline-concordant care delivery (86% vs 77%, P<.001). In the Cox proportional hazards regression model, care at a high-volume hospital was independently predictive of lower hazard of death (adjusted hazard ratio 0.86, 95% CI 0.82-0.90). CONCLUSION: Hospitals with 31 cases per year or more have a lower 30- and 90-day mortality despite performing more complex surgeries, are more likely to be adherent to guideline-based care, and achieved higher overall survival.