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1.
J Natl Compr Canc Netw ; 22(2): 117-135, 2024 03.
Artículo en Inglés | MEDLINE | ID: mdl-38503056

RESUMEN

Vulvar cancer is annually diagnosed in an estimated 6,470 individuals and the vast majority are histologically squamous cell carcinomas. Vulvar cancer accounts for 5% to 8% of gynecologic malignancies. Known risk factors for vulvar cancer include increasing age, infection with human papillomavirus, cigarette smoking, inflammatory conditions affecting the vulva, and immunodeficiency. Most vulvar neoplasias are diagnosed at early stages. Rarer histologies exist and include melanoma, extramammary Paget's disease, Bartholin gland adenocarcinoma, verrucous carcinoma, basal cell carcinoma, and sarcoma. This manuscript discusses recommendations outlined in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for treatments, surveillance, systemic therapy options, and gynecologic survivorship.


Asunto(s)
Neoplasias de la Vulva , Femenino , Humanos , Adenocarcinoma/patología , Neoplasias de los Genitales Femeninos , Enfermedad de Paget Extramamaria/diagnóstico , Enfermedad de Paget Extramamaria/etiología , Enfermedad de Paget Extramamaria/terapia , Neoplasias Cutáneas , Neoplasias de la Vulva/diagnóstico , Neoplasias de la Vulva/epidemiología , Neoplasias de la Vulva/etiología
2.
Gynecol Oncol ; 172: 130-137, 2023 05.
Artículo en Inglés | MEDLINE | ID: mdl-36977622

RESUMEN

OBJECTIVE: Assess outcomes of interval debulking surgery (IDS) after neoadjuvant chemotherapy via minimally invasive surgery (MIS) compared with laparotomy in patients with advanced epithelial ovarian cancer. METHODS: Patients diagnosed with stage IIIC or IV epithelial ovarian cancer between 2013 and 2018 who received neoadjuvant chemotherapy and IDS were identified in the National Cancer Database. Primary outcome was overall survival. Secondary outcomes were 5-year survival, 30- and 90-day postoperative mortality, extent of surgery, residual disease, hospitalization duration, surgical conversions, and unplanned readmissions. Propensity score matching was used to compare MIS and laparotomy for IDS. Association of treatment approach with overall survival was assessed using Kaplan-Meier method and Cox regression. Sensitivity analysis was conducted for effect of unmeasured confounders. RESULTS: A total of 7897 patients met inclusion criteria; 2021 (25.6%) underwent MIS. Percentage undergoing MIS increased from 20.3%-29.0% over the study period. After propensity score matching, median overall survival was 46.7 months in the MIS group versus 41.0 months in the laparotomy group [hazard ratio (HR) 0.86 (95%CI 0.79-0.94)]. Five-year survival probability was higher in MIS versus laparotomy (38.3% vs 34.8%, p < 0.01). There was lower 30- and 90-day mortality (0.3% vs 0.7% [p = 0.04] and 1.4% vs 2.5% [p = 0.01], respectively), shorter length of stay (median 3 vs 5 days, p < 0.01), lower residual disease (23.9% vs 26.7%, p < 0.01), and lower additional cytoreductive procedures (59.3% vs 70.8%, p < 0.01) in MIS compared to laparotomy, with similar rates of unplanned readmission (2.7% vs 3.1%, p = 0.39). CONCLUSIONS: Patients who undergo IDS by MIS have similar overall survival and decreased morbidity compared with laparotomy.


Asunto(s)
Terapia Neoadyuvante , Neoplasias Ováricas , Humanos , Femenino , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Carcinoma Epitelial de Ovario/cirugía , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/cirugía , Neoplasias Ováricas/patología , Procedimientos Quirúrgicos de Citorreducción/métodos , Quimioterapia Adyuvante , Estudios Retrospectivos , Procedimientos Quirúrgicos Mínimamente Invasivos , Estadificación de Neoplasias
3.
J Natl Compr Canc Netw ; 21(2): 181-209, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-36791750

RESUMEN

Adenocarcinoma of the endometrium (also known as endometrial cancer, or more broadly as uterine cancer or carcinoma of the uterine corpus) is the most common malignancy of the female genital tract in the United States. It is estimated that 65,950 new uterine cancer cases will have occurred in 2022, with 12,550 deaths resulting from the disease. Endometrial carcinoma includes pure endometrioid cancer and carcinomas with high-risk endometrial histology (including uterine serous carcinoma, clear cell carcinoma, carcinosarcoma [also known as malignant mixed Müllerian tumor], and undifferentiated/dedifferentiated carcinoma). Stromal or mesenchymal sarcomas are uncommon subtypes accounting for approximately 3% of all uterine cancers. This selection from the NCCN Guidelines for Uterine Neoplasms focuses on the diagnosis, staging, and management of pure endometrioid carcinoma. The complete version of the NCCN Guidelines for Uterine Neoplasms is available online at NCCN.org.


Asunto(s)
Adenocarcinoma de Células Claras , Carcinoma Endometrioide , Carcinosarcoma , Neoplasias Endometriales , Neoplasias Uterinas , Femenino , Humanos , Carcinoma Endometrioide/patología , Carcinosarcoma/diagnóstico , Carcinosarcoma/terapia , Neoplasias Endometriales/diagnóstico , Neoplasias Endometriales/terapia , Neoplasias Uterinas/diagnóstico , Neoplasias Uterinas/terapia , Neoplasias Uterinas/patología
4.
J Natl Compr Canc Netw ; 21(12): 1224-1233, 2023 12.
Artículo en Inglés | MEDLINE | ID: mdl-38081139

RESUMEN

The NCCN Guidelines for Cervical Cancer provide recommendations for all aspects of management for cervical cancer, including the diagnostic workup, staging, pathology, and treatment. The guidelines also include details on histopathologic classification of cervical cancer regarding diagnostic features, molecular profiles, and clinical outcomes. The treatment landscape of advanced cervical cancer is evolving constantly. These NCCN Guidelines Insights provide a summary of recent updates regarding the systemic therapy recommendations for recurrent or metastatic disease.


Asunto(s)
Neoplasias del Cuello Uterino , Femenino , Humanos , Neoplasias del Cuello Uterino/diagnóstico , Neoplasias del Cuello Uterino/terapia , Neoplasias del Cuello Uterino/patología , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico
5.
J Natl Compr Canc Netw ; 20(9): 972-980, 2022 09.
Artículo en Inglés | MEDLINE | ID: mdl-36075393

RESUMEN

Epithelial ovarian cancer is the leading cause of death from gynecologic cancer in the United States, with less than half of patients living >5 years following diagnosis. The NCCN Guidelines for Ovarian Cancer provide recommendations for the diagnosis, evaluation, treatment, and follow-up for patients with ovarian, fallopian tube, and primary peritoneal cancers. These NCCN Guidelines Insights summarize the panel discussion behind recent important updates to the guidelines, including revised guidance on alternative chemotherapy regimens for patients with advanced age and/or comorbidities, a new algorithm for recurrent low-grade serous carcinoma based on developing research and novel therapeutic agents, and updated language regarding tumor molecular analysis applications in ovarian cancer.


Asunto(s)
Cistadenocarcinoma Seroso , Neoplasias Ováricas , Neoplasias Peritoneales , Carcinoma Epitelial de Ovario/diagnóstico , Carcinoma Epitelial de Ovario/terapia , Cistadenocarcinoma Seroso/patología , Femenino , Humanos , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/patología , Neoplasias Ováricas/terapia , Estados Unidos
6.
Gynecol Oncol ; 149(3): 447-454, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29525276

RESUMEN

Joe V. Meigs was a visionary clinician and an early adopter of radical techniques in the surgical treatment of ovarian cancer. His 1934 textbook "Tumors of the Female Pelvic Organs", consolidated his approach to this "hopeless" disease, with pearls on diagnosis, outcomes, and even speculations about the benefits of minimally invasive surgery. Decades before adjuvant chemotherapy would prove of value, and in an era when sophisticated statistics were unheard of, he nonetheless tried to eke out what benefits he could using the methods available in his time. We transition his original findings and observations through the advent of platinum-based chemotherapy, retrospective cohort studies supporting the benefits of primary debulking, and finally the long-awaited randomized controlled trial. We aim to provide historical context for the underpinnings of how cytoreductive surgery has evolved into its current role in the treatment of advanced ovarian cancer.


Asunto(s)
Procedimientos Quirúrgicos de Citorreducción/historia , Procedimientos Quirúrgicos de Citorreducción/métodos , Procedimientos Quirúrgicos Ginecológicos/historia , Procedimientos Quirúrgicos Ginecológicos/métodos , Neoplasias Ováricas/historia , Neoplasias Ováricas/cirugía , Femenino , Historia del Siglo XX , Historia del Siglo XXI , Humanos , Neoplasias Ováricas/patología
7.
Gynecol Oncol ; 148(1): 168-173, 2018 01.
Artículo en Inglés | MEDLINE | ID: mdl-29128105

RESUMEN

PURPOSE: To identify clinical and non-clinical factors associated with utilization of primary cytoreductive surgery (PCS) or neoadjuvant chemotherapy (NACT) in women with advanced stage epithelial ovarian cancer (EOC). METHODS: Using the National Cancer Database, we identified women with stage IIIC and IV EOC diagnosed from 2012 to 2014. The primary outcome was receipt of NACT, defined in the primary analysis as utilization of chemotherapy as the first cancer-directed therapy, irrespective of whether interval surgery was performed. Univariable and multivariable associations between clinical and non-clinical factors and receipt of NACT were investigated using mixed-effect logistic regression models. A secondary analysis excluded women who received primary chemotherapy but did not receive interval cytoreductive surgery. RESULTS: Among 17,302 eligible women, 10,948 (63.3%) underwent PCS and 6354 (36.7%) received NACT. Older age, stage IV disease, high-grade, and serous histology were associated with receipt of NACT in univariate (p<0.001) and multivariable analyses (p<0.001). Analysis of non-clinical factors revealed that residency in the Northeast region and receipt of treatment closer to home were associated with NACT in univariate (p<0.05) but not multivariable analysis (p>0.05). In multivariable analysis, African-American race/ethnicity (p=0.04), low-income level (p=0.02), treatment in high-volume centers (p<0.01), and insurance by Medicare or other government insurance (p<0.001) were associated with receipt of NACT. When women who received no surgery were excluded, all factors that were independent predictors of NACT in the main analysis remained significant, except for race/ethnicity. CONCLUSIONS: Non-clinical factors were associated with the use of NACT at a magnitude similar to that of clinically relevant factors.


Asunto(s)
Neoplasias Glandulares y Epiteliales/tratamiento farmacológico , Neoplasias Glandulares y Epiteliales/cirugía , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma Epitelial de Ovario , Quimioterapia Adyuvante/estadística & datos numéricos , Procedimientos Quirúrgicos de Citorreducción/métodos , Procedimientos Quirúrgicos de Citorreducción/estadística & datos numéricos , Bases de Datos Factuales , Femenino , Humanos , Renta/estadística & datos numéricos , Seguro de Salud/estadística & datos numéricos , Modelos Logísticos , Persona de Mediana Edad , Terapia Neoadyuvante/estadística & datos numéricos , Estadificación de Neoplasias , Neoplasias Glandulares y Epiteliales/epidemiología , Neoplasias Glandulares y Epiteliales/patología , Neoplasias Ováricas/epidemiología , Neoplasias Ováricas/patología , Estados Unidos/epidemiología
8.
Gynecol Oncol ; 148(3): 439-444, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29395312

RESUMEN

OBJECTIVE: Clinical registries within medical societies have demonstrated the capacity to promote quality improvement. Opportunities for well-designed data repositories could yield reliable national standards for informing reimbursement, determining adherence to care guidelines, maintaining board certification, and developing bundled payment models. Looking to the future, we set out to develop a gynecologic cancer registry serving the members of the Society of Gynecologic Oncology (SGO). METHODS: The SGO Clinical Outcomes Registry (COR) initiated a web-based data entry platform as a foray into developing a functional registry, compiling data elements specific to gynecologic oncology. Endometrial and ovarian cancer patients began enrollment in early 2014. Within one year, 19 sites were participating with the addition of cervical cancer patients in January 2015. RESULTS: To date, >6500 patients are currently entered from 29 sites, and the COR is being queried to address topics of quality improvement, disparities, and cancer outcomes. CONCLUSIONS: The SGO COR has proven the feasibility of developing a functional gynecologic cancer registry, with high uptake, rapid accrual, and ability to investigate topics of quality and outcome using the COR.


Asunto(s)
Neoplasias de los Genitales Femeninos/terapia , Ginecología/normas , Oncología Médica/normas , Evaluación de Resultado en la Atención de Salud , Garantía de la Calidad de Atención de Salud , Sistema de Registros , Certificación , Neoplasias Endometriales/terapia , Femenino , Adhesión a Directriz , Humanos , Neoplasias Ováricas/terapia , Guías de Práctica Clínica como Asunto , Mejoramiento de la Calidad , Mecanismo de Reembolso , Estados Unidos , Neoplasias del Cuello Uterino/terapia
9.
Gynecol Oncol ; 149(2): 256-262, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29486993

RESUMEN

OBJECTIVE: For patients with advanced stage epithelial ovarian cancer (EOC), substantial emphasis has been placed on diagnostic tests that can discern which of two treatment options - primary cytoreductive surgery (PCS) or neoadjuvant chemotherapy followed by interval cytoreductive surgery (NACT+ICS) - optimizes patient-level outcomes. Our goal was to project potential life expectancy (LE) gains that could be achieved by use of such a test. METHODS: We developed a microsimulation model to project LE for patients with stage IIIC EOC. We compared: a "standard-of-care" strategy, in which patients were triaged to PCS vs. NACT+ICS based on current clinical practice; and a "test" strategy, in which patients were triaged based on results of a hypothetical test. We identified those test performance characteristics for which the test strategy outperformed the standard-of-care strategy, from a LE standpoint. Effects of parameter uncertainty were evaluated in sensitivity analysis. RESULTS: Even with a perfect test, the LE gain was modest (LE with test vs. standard-of-care strategy=67.6 vs. 66.4months; LE gain=1.2months). In order to outperform the standard-of-care, the test had to have a high probability of correctly identifying "resectable" patients at PCS (i.e. those for whom complete or optimal cytoreduction would be possible); this test property was more important than correct triage of unresectable patients to NACT+ICS. Results were sensitive to the proportion of patients whose underlying disease was resectable at PCS. CONCLUSION: Diagnostic tests that are designed to triage patients with advanced stage EOC will likely have only a modest effect on LE.


Asunto(s)
Modelos Estadísticos , Neoplasias Glandulares y Epiteliales/tratamiento farmacológico , Neoplasias Glandulares y Epiteliales/cirugía , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/cirugía , Carcinoma Epitelial de Ovario , Quimioterapia Adyuvante , Procedimientos Quirúrgicos de Citorreducción , Técnicas de Apoyo para la Decisión , Femenino , Humanos , Persona de Mediana Edad , Terapia Neoadyuvante , Estadificación de Neoplasias , Neoplasias Glandulares y Epiteliales/mortalidad , Neoplasias Ováricas/mortalidad , Valor Predictivo de las Pruebas , Resultado del Tratamiento
10.
Gynecol Oncol ; 149(1): 4-11, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29605048

RESUMEN

OBJECTIVE: To examine temporal trends in treatment and survival among black, Asian, Hispanic, and white women diagnosed with endometrial, ovarian, cervical, and vulvar cancer. METHODS: Using the National Cancer Database (2004-2014), we identified women diagnosed with endometrial, ovarian, cervical, and vulvar cancer. For each disease site, we analyzed race/ethnicity-specific trends in receipt of evidence-based practices. Professional societies' recommendations were used to define these practices. Using data from the Surveillance, Epidemiology, and End Results Program (2000-2009) we analyzed trends in 5-year survival. RESULTS: Throughout the study period black (64.8%) and Hispanic (68.3%) women were less likely to undergo lymphadenectomy for stage I ovarian cancer compared to Asian (79.5%) and white patients (74.6%). Black women were the least likely group to undergo lymphadenectomy in all periods. Among patients with stage II-IV ovarian cancer, 76.6% of white and Asian women received both surgery and chemotherapy, compared to 70.8% of black and 73.9% Hispanic women. Hispanic women with deeply invasive or high-grade stage I endometrial cancer underwent lymphadenectomy less frequently (74.5%) than all other groups (80.7%). Black women were less likely to have chemo-radiotherapy for stage IIB-IVA cervical cancer (75.6% versus 80.4% of all others). Black women were also less likely to have a surgical lymph node evaluation for vulvar cancer (58.8% versus 63.5% of all others). Among women diagnosed with ovarian, endometrial, and cervical cancer, black women had lower five-year survival than other groups. CONCLUSION: Significant racial disparities persist in the delivery of evidence-based care. Black women with ovarian, endometrial, and cervical cancer continue to experience higher cancer-specific mortality than other groups.


Asunto(s)
Asiático/estadística & datos numéricos , Negro o Afroamericano/estadística & datos numéricos , Neoplasias de los Genitales Femeninos/mortalidad , Neoplasias de los Genitales Femeninos/terapia , Disparidades en Atención de Salud/etnología , Hispánicos o Latinos/estadística & datos numéricos , Población Blanca/estadística & datos numéricos , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Neoplasias de los Genitales Femeninos/etnología , Humanos , Estimación de Kaplan-Meier , Escisión del Ganglio Linfático/estadística & datos numéricos , Oncología Médica/métodos , Oncología Médica/estadística & datos numéricos , Persona de Mediana Edad , Programa de VERF , Estados Unidos/epidemiología
11.
Gynecol Oncol ; 148(3): 521-526, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29395315

RESUMEN

BACKGROUND: The American Society of Clinical Oncology recommends that patients with advanced cancer receive dedicated palliative care services early in their disease course. This investigation serves to understand how palliative care services are utilized for ovarian cancer patients in a tertiary referral center. METHODS: We conducted a retrospective review of women treated for ovarian cancer at our institution from 2010 through 2015. Clinical variables included presence and timing of palliative care referral. Data were correlated utilizing univariable and multivariable parametric and non-parametric testing, and survivals were analyzed using the Kaplan-Meier method and cox-proportional hazard models. RESULTS: We identified 391 women treated for ovarian cancer, of whom 68% were diagnosed with stage III or IV disease. Palliative care referral was utilized in 28% in the outpatient (42%) and inpatient (58%) settings. Earlier use of referral was observed in those who never underwent surgical cytoreduction or had interval cytoreductive surgery (p < 0.001). Palliative care referral was independently associated with advanced stage (OR 1.7, p = 0.02), recurrence (OR 2.0, p = 0.002) and hospice referral (OR 6.0, p < 0.001). In 38% of women referral occurred within 30 days of death, and 17% within one week of death. Outpatient initial consultation was associated with an unadjusted 1 year overall survival benefit (p < 0.01) compared to inpatient consultation. CONCLUSIONS: The outcomes in this study suggest a late use of palliative care that is reactionary to patient needs and not a routine component of ovarian cancer care as national guidelines recommend.


Asunto(s)
Adenocarcinoma/terapia , Carcinosarcoma/terapia , Neoplasias Quísticas, Mucinosas y Serosas/terapia , Neoplasias de Células Germinales y Embrionarias/terapia , Neoplasias Ováricas/terapia , Cuidados Paliativos , Derivación y Consulta/estadística & datos numéricos , Tumores de los Cordones Sexuales y Estroma de las Gónadas/terapia , Adenocarcinoma/patología , Adenocarcinoma de Células Claras/patología , Adenocarcinoma de Células Claras/terapia , Adenocarcinoma Mucinoso/patología , Adenocarcinoma Mucinoso/terapia , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Atención Ambulatoria , Carcinoma Endometrioide/patología , Carcinoma Endometrioide/terapia , Carcinosarcoma/patología , Procedimientos Quirúrgicos de Citorreducción/estadística & datos numéricos , Femenino , Humanos , Estimación de Kaplan-Meier , Persona de Mediana Edad , Análisis Multivariante , Estadificación de Neoplasias , Neoplasias Quísticas, Mucinosas y Serosas/patología , Neoplasias de Células Germinales y Embrionarias/patología , Oportunidad Relativa , Neoplasias Ováricas/patología , Pronóstico , Modelos de Riesgos Proporcionales , Calidad de Vida , Estudios Retrospectivos , Tumores de los Cordones Sexuales y Estroma de las Gónadas/patología , Tasa de Supervivencia , Factores de Tiempo , Adulto Joven
12.
Ann Surg Oncol ; 24(6): 1677-1687, 2017 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-28074326

RESUMEN

PURPOSE: The aim of this study was to determine factors associated with the adoption of minimally invasive surgery (MIS) compared with laparotomy in the treatment of endometrial cancer and to compare surgical outcomes and survival between these two surgical modalities. METHODS: We utilized the National Cancer Data Base (NCDB) to identify women diagnosed with presumed early-stage endometrial cancer between 2010 and 2012. We also identified factors associated with the performance of MIS and utilized propensity score matching to create a matched cohort of women who underwent minimally invasive staging surgery or laparotomy for surgical staging. RESULTS: Overall, 20,346 women were eligible for inclusion in the study; 12,604 (61.9%) had MIS, while 7742 (38.1%) had a laparotomy. African American race (odds ratio [OR] 0.54, 95% confidence interval [CI] 0.49-0.60], Hispanic ethnicity (OR 0.70, 95% CI 0.61-0.80), Charlson score >2 (OR 0.79, 95% CI 0.69-0.91), high-grade histology (OR 0.63, 95% CI 0.59-0.68), presumed clinical stage II disease (OR 0.53, 95% CI 0.46-0.60), and surgery at a community cancer program (OR 0.46, 95% CI 0.39-0.55) or in the Midwest region (OR 0.70, 95% CI 0.64-0.76) were associated with a decreased likelihood of having MIS, while private insurance (OR 1.69, 95% CI 1.45-1.97) and highest quartile median household income (OR 1.13, 95% CI 1.03-1.24) were associated with an increased likelihood of having MIS. After propensity score matching, there was no association between minimally invasive staging surgery and 3-year overall survival (hazard ratio 1.03, 95% CI 0.92-1.16). CONCLUSION: There are notable racial, ethnic, socioeconomic, and geographic variations in the utilization of MIS for endometrial cancer staging in the US. After controlling for the aforementioned factors, MIS had a similar 3-year survival compared with laparotomy in women undergoing staging surgery for endometrial cancer.


Asunto(s)
Bases de Datos Factuales , Neoplasias Endometriales/cirugía , Laparotomía/mortalidad , Procedimientos Quirúrgicos Mínimamente Invasivos/mortalidad , Anciano , Estudios de Cohortes , Neoplasias Endometriales/mortalidad , Neoplasias Endometriales/patología , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Invasividad Neoplásica , Estadificación de Neoplasias , Tasa de Supervivencia
13.
Gynecol Oncol ; 146(3): 653-660, 2017 09.
Artículo en Inglés | MEDLINE | ID: mdl-28651803

RESUMEN

Clinical outcomes research seeks to understand the real-world manifestations of clinical care. In particular, outcomes research seeks to reveal the effects of pharmaceutical, procedural, and structural aspects of healthcare on patient outcomes, including mortality, disease control, toxicity, cost, and quality of life. Although outcomes research can utilize interventional study designs, insightful use of observational data is a defining feature of this field. Many questions in gynecologic oncology are not amenable to investigation in randomized clinical trials due to cost, feasibility, or ethical concerns. When a randomized trial is not practical or has not yet been conducted, well-designed observational studies have the potential to provide the best available evidence about the effects of clinical care. Such studies may use surveys, medical records, disease registries, and a variety of administrative data sources. Even when a randomized trial has been conducted, observational studies can be used to estimate the real-world effect of an intervention, which may differ from the results obtained in the controlled setting of a clinical trial. This article reviews the goals, methodologies, data sources, and limitations of clinical outcomes research, with a focus on gynecologic oncology.


Asunto(s)
Investigación Biomédica/métodos , Neoplasias de los Genitales Femeninos/terapia , Evaluación de Resultado en la Atención de Salud/métodos , Sesgo , Factores de Confusión Epidemiológicos , Bases de Datos Factuales , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Femenino , Costos de la Atención en Salud , Humanos , Medicare , Estudios Observacionales como Asunto , Readmisión del Paciente , Medición de Resultados Informados por el Paciente , Complicaciones Posoperatorias , Ensayos Clínicos Controlados Aleatorios como Asunto , Programa de VERF , Tasa de Supervivencia , Estados Unidos
14.
Gynecol Oncol ; 145(1): 114-121, 2017 04.
Artículo en Inglés | MEDLINE | ID: mdl-28159409

RESUMEN

PURPOSE: To examine patterns of care and survival for Hispanic women compared to white and African American women with high-grade endometrial cancer. METHODS: We utilized the National Cancer Data Base (NCDB) to identify women diagnosed with uterine grade 3 endometrioid adenocarcinoma, carcinosarcoma, clear cell carcinoma and papillary serous carcinoma between 2003 and 2011. The effect of treatment on survival was analyzed using the Kaplan-Meier method. Factors predictive of outcome were compared using the Cox proportional hazards model. RESULTS: 43,950 women were eligible. African American and Hispanic women had higher rates of stage III and IV disease compared to white women (36.5% vs. 36% vs. 33.5%, p<0.001). African American women were less likely to undergo surgical treatment for their cancer (85.2% vs. 89.8% vs. 87.5%, p<0.001) and were more likely to receive chemotherapy (36.8% vs. 32.4% vs. 32%, p<0.001) compared to white and Hispanic women. Over the entire study period, after adjusting for age, time period of diagnosis, region of the country, urban or rural setting, treating facility type, socioeconomic status, education, insurance, comorbidity index, pathologic stage, histology, lymphadenectomy and adjuvant treatment, African American women had lower overall survival compared to white women (Hazard Ratio 1.21, 95% CI 1.16-1.26). Conversely, Hispanic women had improved overall survival compared to white women after controlling for the aforementioned factors (HR 0.87, 95% CI 0.80-0.93). CONCLUSIONS: Among women with high-grade endometrial cancer, African American women have lower all-cause survival while Hispanic women have higher all-cause survival compared to white women after controlling for treatment, sociodemographic, comorbidity and histopathologic variables.


Asunto(s)
Adenocarcinoma de Células Claras/terapia , Carcinoma Endometrioide/terapia , Carcinosarcoma/terapia , Quimioterapia Adyuvante/estadística & datos numéricos , Neoplasias Endometriales/terapia , Etnicidad/estadística & datos numéricos , Disparidades en Atención de Salud/etnología , Histerectomía/estadística & datos numéricos , Adenocarcinoma de Células Claras/mortalidad , Adenocarcinoma de Células Claras/patología , Adenocarcinoma Papilar/mortalidad , Adenocarcinoma Papilar/patología , Adenocarcinoma Papilar/terapia , Negro o Afroamericano/estadística & datos numéricos , Anciano , Carcinoma Endometrioide/mortalidad , Carcinoma Endometrioide/patología , Carcinosarcoma/mortalidad , Carcinosarcoma/patología , Causas de Muerte , Comorbilidad , Bases de Datos Factuales , Educación , Neoplasias Endometriales/mortalidad , Neoplasias Endometriales/patología , Femenino , Disparidades en Atención de Salud/estadística & datos numéricos , Hispánicos o Latinos/estadística & datos numéricos , Humanos , Cobertura del Seguro , Estimación de Kaplan-Meier , Persona de Mediana Edad , Clasificación del Tumor , Estadificación de Neoplasias , Neoplasias Quísticas, Mucinosas y Serosas/mortalidad , Neoplasias Quísticas, Mucinosas y Serosas/patología , Neoplasias Quísticas, Mucinosas y Serosas/terapia , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Clase Social , Tasa de Supervivencia , Estados Unidos , Población Blanca/estadística & datos numéricos
15.
Gynecol Oncol ; 147(2): 250-256, 2017 11.
Artículo en Inglés | MEDLINE | ID: mdl-28822556

RESUMEN

OBJECTIVE: Surgical cytoreduction has been postulated to affect survival by increasing the efficacy of chemotherapy in ovarian cancer. We hypothesized that women with high-grade serous ovarian cancer, which usually responds to chemotherapy, would derive greater benefit from complete cytoreduction than those with histologic subtypes that are less responsive to chemotherapy, such as mucinous and clear cell carcinoma. METHODS: We conducted a retrospective cohort study of patients who underwent primary cytoreductive surgery and adjuvant chemotherapy for stage IIIC or IV epithelial ovarian cancer from 2011 to 2013 using data from the National Cancer Database. We constructed multivariable models to quantify the magnitude of associations between residual disease status (no residual disease, ≤1cm, or >1cm) and all-cause mortality by histologic type among women with clear cell, mucinous, and high-grade serous ovarian cancer. Because 26% of the sample had unknown residual disease status, we used multiple imputations in the primary analysis. RESULTS: We identified 6,013 women with stage IIIC and IV high-grade serous, 307 with clear cell, and 140 with mucinous histology. The association between residual disease status and mortality hazard did not differ significantly among histologic subtypes of ovarian cancer (p for interaction=0.32). In covariate adjusted models, compared to suboptimal cytoreduction, cytoreduction to no gross disease was associated with a hazard reduction of 42% in high-grade serous carcinoma (hazard ratio [HR]=0.58, 95% confidence interval [CI]=0.49-0.68), 61% in clear cell carcinoma (HR=0.39, 95% CI=0.22-0.69), and 54% in mucinous carcinoma (HR=0.46, 95% CI=0.22-0.99). CONCLUSIONS: We found no evidence that surgical cytoreduction was of greater prognostic importance in high-grade serous carcinomas than in histologies that are less responsive to chemotherapy.


Asunto(s)
Neoplasias Glandulares y Epiteliales/mortalidad , Neoplasias Glandulares y Epiteliales/patología , Neoplasias Ováricas/mortalidad , Neoplasias Ováricas/patología , Adenocarcinoma de Células Claras/mortalidad , Adenocarcinoma de Células Claras/patología , Adenocarcinoma de Células Claras/cirugía , Adenocarcinoma Mucinoso/mortalidad , Adenocarcinoma Mucinoso/patología , Adenocarcinoma Mucinoso/cirugía , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Carcinoma Epitelial de Ovario , Quimioterapia Adyuvante , Estudios de Cohortes , Cistadenocarcinoma Seroso/mortalidad , Cistadenocarcinoma Seroso/patología , Cistadenocarcinoma Seroso/cirugía , Procedimientos Quirúrgicos de Citorreducción , Femenino , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasia Residual , Neoplasias Glandulares y Epiteliales/tratamiento farmacológico , Neoplasias Glandulares y Epiteliales/cirugía , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/cirugía , Pronóstico , Sistema de Registros , Estudios Retrospectivos , Estados Unidos/epidemiología
16.
Am J Obstet Gynecol ; 216(1): 50.e1-50.e12, 2017 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-27567562

RESUMEN

BACKGROUND: Whereas advances in minimally invasive surgery have made laparoscopic staging technically feasible in stage I epithelial ovarian cancer, the practice remains controversial because of an absence of randomized trials and lack of high-quality observational studies demonstrating equivalent outcomes. OBJECTIVE: This study seeks to evaluate the association of laparoscopic staging with survival among women with clinical stage I epithelial ovarian cancer. STUDY DESIGN: We used the National Cancer Data Base to identify all women who underwent surgical staging for clinical stage I epithelial ovarian cancer diagnosed from 2010 through 2012. The exposure of interest was planned surgical approach (laparoscopy vs laparotomy), and the primary outcome was overall survival. The primary analysis was based on an intention to treat: all women whose procedures were initiated laparoscopically were categorized as having had a planned laparoscopic procedure, regardless of subsequent conversion to laparotomy. We used propensity methods to match patients who underwent planned laparoscopic staging with similar patients who underwent planned laparotomy based on observed characteristics. We compared survival among the matched cohorts using the Kaplan-Meier method and Cox regression. We compared the extent of lymphadenectomy using the Wilcoxon rank-sum test. RESULTS: Among 4798 eligible patients, 1112 (23.2%) underwent procedures that were initiated laparoscopically, of which 190 (17%) were converted to laparotomy. Women who underwent planned laparoscopy were more frequently white, privately insured, from wealthier ZIP codes, received care in community cancer centers, and had smaller tumors that were more frequently of serous and less often of mucinous histology than those who underwent staging via planned laparotomy. After propensity score matching, time to death did not differ between patients undergoing planned laparoscopic vs open staging (hazard ratio, 0.77, 95% confidence interval, 0.54-1.09; P = .13). Planned laparoscopic staging was associated with a slightly higher median lymph node count (14 vs 12, P = .005). Planned laparoscopic staging was not associated with time to death after adjustment for receipt of adjuvant chemotherapy, histological type and grade, and pathological stage (hazard ratio, 0.82, 95% confidence interval, 0.57-1.16). CONCLUSION: Surgical staging via planned laparoscopy vs laparotomy was not associated with worse survival in women with apparent stage I epithelial ovarian cancer.


Asunto(s)
Adenocarcinoma de Células Claras/cirugía , Carcinoma Endometrioide/cirugía , Seguro de Salud/estadística & datos numéricos , Laparoscopía/estadística & datos numéricos , Ganglios Linfáticos/patología , Neoplasias Quísticas, Mucinosas y Serosas/cirugía , Neoplasias Glandulares y Epiteliales/cirugía , Neoplasias Ováricas/cirugía , Adenocarcinoma/patología , Adenocarcinoma/cirugía , Adenocarcinoma de Células Claras/patología , Adulto , Anciano , Anciano de 80 o más Años , Instituciones Oncológicas/estadística & datos numéricos , Carcinoma Endometrioide/patología , Carcinoma Epitelial de Ovario , Quimioterapia Adyuvante , Conversión a Cirugía Abierta/estadística & datos numéricos , Bases de Datos Factuales , Femenino , Humanos , Estimación de Kaplan-Meier , Escisión del Ganglio Linfático , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Quísticas, Mucinosas y Serosas/patología , Neoplasias Glandulares y Epiteliales/patología , Neoplasias Ováricas/patología , Puntaje de Propensión , Modelos de Riesgos Proporcionales , Características de la Residencia/estadística & datos numéricos , Tasa de Supervivencia , Carga Tumoral , Población Blanca
17.
Gynecol Oncol ; 142(1): 38-43, 2016 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-27107722

RESUMEN

OBJECTIVE: The aim of this study is to determine if outcomes of patients with ovarian carcinosarcoma (OCS) differ from those of women with high-grade papillary serous ovarian carcinoma (HG-PSOC) when compared by stage and treatment modalities. METHODS: The National Cancer Database was queried to identify patients with OCS and HG-PSOC diagnosed between 2003 and 2011. Demographic and clinical data were compared, and the impact of tumor histology on survival was analyzed using the Kaplan-Meier method. Factors predictive of outcome were compared using the Cox proportional hazards model. RESULTS: The final study group consisted of 45,153 women. 2886 (6.39%) had OCS and 42,267 (93.61%) had HG-PSOC. The mean age at diagnosis was 65.43 (±12.21) years for women with OCS and 61.52 (±12.6) years for HG-PSOC (P<0.001). African-American women had higher rate of OCS relative to white non-hispanic women (7.84% vs. 6.37%; P=0.002). Overall, women with OCS had a worse five-year survival rate, 26.63% [95% Confidence Interval (CI)=24.86%-28.53%] vs. 43.61% (95% CI=43.07%-44.17%). This difference persisted for each FIGO disease stage I-IV, with five-year survival consistently worse for women with OCS compared to those with HG-PSOC. Over the entire study period and after adjusting for histology, age, period of diagnosis, SEER registry, marital status, stage, surgery, radiotherapy, and lymph node dissection, carcinosarcoma histology was associated with decreased survival. CONCLUSION: OCS is associated with a poor prognosis compared to HG-PSOC. This difference was noted across all FIGO stages.


Asunto(s)
Carcinosarcoma/tratamiento farmacológico , Neoplasias Ováricas/tratamiento farmacológico , Adulto , Anciano , Carcinosarcoma/mortalidad , Carcinosarcoma/patología , Carcinosarcoma/cirugía , Cistadenocarcinoma Seroso/tratamiento farmacológico , Cistadenocarcinoma Seroso/mortalidad , Cistadenocarcinoma Seroso/patología , Cistadenocarcinoma Seroso/cirugía , Bases de Datos Factuales , Femenino , Humanos , Estimación de Kaplan-Meier , Persona de Mediana Edad , Clasificación del Tumor , Estadificación de Neoplasias , Neoplasias Ováricas/mortalidad , Neoplasias Ováricas/patología , Neoplasias Ováricas/cirugía , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Resultado del Tratamiento , Estados Unidos/epidemiología
18.
Gynecol Oncol ; 140(3): 463-9, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-26773470

RESUMEN

OBJECTIVE: To investigate racial disparities with respect to adjuvant treatment and survival in patients presenting with malignant ovarian germ cell tumors (OGCT). METHODS: The National Cancer Database (NCDB) was used to identify women diagnosed with OGCT. Demographic data were abstracted, including stratification by race and histology. Standard univariate and multivariate analyses using logistic regression were performed to describe predictors of adjuvant treatment. Kaplan-Meier and Cox proportional hazards survival methods were used to evaluate racial differences in survival between African American (AA) and white (W) women. RESULTS: The study population included 2196 patients, with 1654 (75.3%) W and 328 (14.9%) AA women. Histologic distribution varied significantly by race (p<0.0001), but neither age nor stage at presentation showed racial differences (p=0.086 and p=0.209, respectively). AA received more chemotherapy than W (W: 54.6%, AA: 65.5%, p=0.008), but in multivariate analysis there was no statistically significant difference in any adjuvant treatment modality. Despite similar treatment, and independent of histology, survival varied significantly by race with 91% (CI 0.89-0.93) five year survival in W patients compared to 84% five year survival in AA (CI 0.8-0.89) (p=0.02). These disparities were most pronounced in advanced stage disease, with 5 year survival of 84% (CI 0.79-0.89) in W compared to 61% (CI 0.48-0.78) for AA in stage III (p=0.0002), and 54% (CI 0.42-0.68) compared to 14% (CI 0.03-0.71) for stage IV (p=0.05). CONCLUSIONS: AA with OGCT have significantly worse 5 year survival when compared to W patients despite similar rates and modalities of adjuvant treatment.


Asunto(s)
Negro o Afroamericano/estadística & datos numéricos , Disparidades en Atención de Salud/etnología , Escisión del Ganglio Linfático/estadística & datos numéricos , Neoplasias de Células Germinales y Embrionarias/mortalidad , Neoplasias de Células Germinales y Embrionarias/terapia , Neoplasias Ováricas/mortalidad , Neoplasias Ováricas/terapia , Población Blanca/estadística & datos numéricos , Adulto , Antineoplásicos/uso terapéutico , Quimioterapia Adyuvante/estadística & datos numéricos , Femenino , Humanos , Estadificación de Neoplasias , Neoplasias de Células Germinales y Embrionarias/etnología , Neoplasias de Células Germinales y Embrionarias/patología , Neoplasias Ováricas/etnología , Neoplasias Ováricas/patología , Radioterapia Adyuvante/estadística & datos numéricos , Tasa de Supervivencia , Estados Unidos/epidemiología , Adulto Joven
19.
Gynecol Oncol ; 143(2): 236-240, 2016 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-27612977

RESUMEN

OBJECTIVE: Neoadjuvant chemotherapy and interval debulking surgery for the treatment of advanced ovarian cancer has remained controversial, despite the publication of two randomized trials comparing this modality with primary cytoreductive surgery. This study describes temporal trends in the utilization of neoadjuvant chemotherapy and interval debulking surgery in clinical practice in the United States. METHODS: We completed a time trend analysis of the National Cancer Data Base. We identified women with stage IIIC and IV epithelial ovarian cancer diagnosed between 2004 and 2013. We categorized subjects as having undergone one of four treatment modalities: primary cytoreductive surgery followed by adjuvant chemotherapy, neoadjuvant chemotherapy followed by interval debulking surgery, surgery only, and chemotherapy only. Temporal trends in the frequency of treatment modalities were evaluated using Joinpoint regression, and χ2 tests. RESULTS: We identified 40,694 women meeting inclusion criteria, of whom 27,032 (66.4%) underwent primary cytoreductive surgery and adjuvant chemotherapy, 5429 (13.3%) received neoadjuvant chemotherapy and interval surgery, 5844 (15.4%) had surgery only, and 2389 (5.9%) received chemotherapy only. The proportion of women receiving neoadjuvant chemotherapy and surgery increased from 8.6% to 22.6% between 2004 and 2013 (p<0.001), and adoption of this treatment modality occurred primarily after 2007 (95%CI 2006-2009; p=0.001). During this period, the proportion of women who received primary cytoreductive surgery and chemotherapy declined from 68.1% to 60.8% (p<0.001), and the proportion who underwent surgery only declined from 17.8% to 9.9% (p<0.001). CONCLUSION: Between 2004 and 2013 the frequency of neoadjuvant chemotherapy and interval surgery increased significantly in the United States.


Asunto(s)
Terapia Neoadyuvante , Neoplasias Ováricas/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Quimioterapia Adyuvante , Femenino , Humanos , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Ováricas/diagnóstico , Neoplasias Ováricas/terapia
20.
Int J Gynecol Cancer ; 26(6): 1033-40, 2016 07.
Artículo en Inglés | MEDLINE | ID: mdl-27206282

RESUMEN

OBJECTIVES: The aim of this study was to investigate the impact of body mass index (BMI) on completion, complications, and clinical outcomes of intraperitoneal (IP) chemotherapy in patients with advanced-stage ovarian cancer. METHODS: Patients with optimally cytoreduced International Federation of Gynecology and Obstetrics stage IIIC ovarian cancer treated with IP chemotherapy were retrospectively identified using an institutional review board-approved database. Clinical data were abstracted from the longitudinal medical record. Survival estimates were calculated using the Kaplan-Meier method. RESULTS: Ninety-two patients (35.5%) completed at least one cycle of IP chemotherapy. For these patients, there was no difference in histology, surgical complexity, or degree of cytoreduction based on BMI. Sixty-five percent of normal weight, 70% of overweight, and 59.1% of obese women completed 6 cycles (P = 0.697). There was also no significant difference in IP chemotherapy complications (P = 0.303). Body mass index had no impact on disease-free survival (P = 0.44) or overall survival, with a median overall survival of 68.5 months for normal weight, 65.9 months for overweight, and 61.7 months for obese women (P = 0.25). However, on multivariate analysis, obesity had an odds ratio of 2.92 (P = 0.02) for mortality. There was a trend toward treatment with intravenous chemotherapy (84.2%) over IP (15.8%) in patients with class II obesity (P = 0.06). DISCUSSION: There was no difference in completion of IP chemotherapy or complications with respect to BMI; however, there was a trend away from treatment with IP therapy in extreme obesity. These data suggest that IP chemotherapy is feasible in obese patients without incurring increased morbidity.


Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Índice de Masa Corporal , Neoplasias de las Trompas Uterinas/tratamiento farmacológico , Neoplasias Ováricas/tratamiento farmacológico , Bevacizumab/administración & dosificación , Carboplatino/administración & dosificación , Cisplatino/administración & dosificación , Supervivencia sin Enfermedad , Neoplasias de las Trompas Uterinas/patología , Femenino , Humanos , Infusiones Parenterales , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Ováricas/patología , Paclitaxel/administración & dosificación , Estudios Retrospectivos , Resultado del Tratamiento
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