Prognostic factors in patients with vulvar cancer: the VULCAN study.

OBJECTIVE: This study aimed to analyze the prognostic factors for overall and progression-free survival in patients with vulvar cancer. METHODS: This international, multicenter, retrospective study included 2453 patients diagnosed with vulvar cancer at 100 different institutions. Inclusion criteria were institutional review board approval from each collaborating center, pathologic diagnosis of invasive carcinoma of the vulva, and primary treatment performed at the participating center. Patients with intraepithelial neoplasia or primary treatment at non-participating centers were excluded. Global survival analysis and squamous cell histology subanalysis was performed. RESULTS: After excluding patients due to incomplete data entry, 1727 patients treated for vulvar cancer between January 2001 and December 2005 were registered for analysis (1535 squamous, 42 melanomas, 38 Paget's disease and 112 other histologic types). Melanomas had the worse prognosis (p=0.02). In squamous vulvar tumors, independent factors for increase in local recurrence of vulvar cancer were: no prior radiotherapy (p<0.001) or chemotherapy (p=0.006), and for distant recurrence were the number of positive inguinal nodes (p=0.025), and not having undergone lymphadenectomy (p=0.03) or radiotherapy (p<0.001), with a HR of 1.1 (95% CI 1.2 to 1.21), 2.9 (95% CI 1.4 to 6.1), and 3.1 (95% CI 1.7 to 5.7), respectively. Number of positive nodes (p=0.008), FIGO stage (p<0.001), adjuvant chemotherapy (p=0.001), tumor resection margins (p=0.045), and stromal invasion >5 mm (p=0.001) were correlated with poor overall survival, and large case volume (≥9 vs <9 cases per year) correlated with more favorable overall survival (p=0.05). CONCLUSIONS: Advanced patient age, number of positive inguinal lymph nodes, and lack of adjuvant treatment are significantly associated with a higher risk of relapse in patients with squamous cell vulvar cancer. Case volume per treating institution, FIGO stage, and stromal invasion appear to impact overall survival significantly. Future prospective trials are warranted to establish these prognostic factors for vulvar cancer.

Mejora coste efectiva en diagnóstico de cáncer endometrial con la incorporación del análisis molecular GynEC(R)-Dx / Cost-effective improvement in endometrial cancer diagnosis by the incorporation of molecular analysis

Objetivo: estimar el número de exploraciones evitables al comparar un algoritmo diagnóstico clásico de la metrorragia posmenopáusica (MPM) frente a un algoritmo que incorpore un test molecular como GynEC(R)-Dx. Material y métodos: estudio de cohortes, prospectivo y aleatorizado por centros realizado en mujeres que presentaron MPM. Las pacientes fueron aleatorizadas a seguir un algoritmo de estudio de MPM clásico vs GynEC(R)-Dx. Se registraron variables demográficas y se comparó el uso de recursos tales como biopsias, ecografías, histeroscopias y visitas entre ambos grupos. Adicionalmente se revalidó la sensibilidad (S), especificidad (E), valor predictivo positivo (VPP) y valor predictivo negativo (VPN) del test. Resultados: se incluyeron un total de 94 pacientes, 51 en grupo clásico y 43 en grupo GynEC(R)-Dx. En el grupo clásico se realizaron 95 exploraciones más respecto al grupo de GynEC(R)-Dx clasificadas en: 11 biopsias, 17 ecografías, 24 histeroscopias y 89 visitas. En el grupo GynEC(R)-Dx se realizaron 92 exploraciones innecesarias consideradas "fuera de protocolo". En la revalidación se observó una S 100%, E 92.5%, VPP 50%, VPN 100%. Conclusiones: la incorporación de un test molecular como GynEC(R)-DX para el estudio de la metrorragia posmenopáusica permite disminuir el número de exploraciones y visitas respecto a los algoritmos convencionales

Objective: The histopathology remains the gold standard to diagnose endometrial cancer (EC) from endometrial biopsy. Molecular tests have recently emerged as a useful tool to classify EC according to its prognosis. However, there is currently no published protocol that includes molecular diagnosis of postmenopausal women with abnormal uterine bleeding (AUB). We hypothesized that the incorporation of a molecular test in the management of postmenopausal women with AUB improves the cost-efectiveness of the diagnostic process. Material and methods: We present a prospective study performed in postmenopausal women who presented AUB between 2009-2014. Seven centers recruited the patients. Three of them follow the classical diagnosis algorithm (group 1) and four centers follow the one that incorporates a molecular test (Gynec(R)-Dx) performed on the remnants of aspirates (group 2). In group 2, when both the endometrial biopsy and the molecular test were negative, the consequent explorations were considered as "out of procotol". Clinical data, number of biopsies, ultrasounds, hysteroscopies and visits were compared between groups. In addition, the sensitivity (S), specificity (E), positive and negative predictive values (PPV and NPV) of the molecular test were calculated. Results: 94 patients were recruited. 51 vs 43 women were included in the classical and the molecular algorithm respectively. There were no differences in age, BMI, parity, use of tamoxifen or hormonal treatment. The detailed outcomes of explorations between classical vs molecular group are shown in Table 1. 324 vs 229 explorations were performed respectively (table 2). In the molecular group, 92 explorations were considered "out of protocol". The test validations showed a 100% S, 92.5% E, 50% PPV and 100% NPV. Conclusions: According to our results, the incorporation of a molecular test for the diagnosis of EC in postmenopausal women who complained with AUB reduces the number of explorations. Consequently, the molecular algorithm is more cost-effective than conventional algorithms

Prognostic factors for recurrence and survival among patients with invasive vulvar Paget disease included in the VULCAN study.

OBJECTIVE: To identify prognostic factors associated with recurrence and overall survival among patients with invasive vulvar Paget disease. METHODS: An analysis was conducted of patients with invasive vulvar Paget disease included in VULCAN, an international multicenter retrospective study of patients diagnosed with vulvar cancer between January 1, 2001, and December 31, 2005. Data regarding diagnosis, treatment, and follow-up were obtained from the patients' medical records. Univariate and multivariate analyses were performed. RESULTS: Among 1727 patients registered in the VULCAN database, 38 patients had invasive vulvar Paget disease. The mean follow-up time for these patients was 44.1±35.7 months, the overall recurrence rate (local lesions and distant metastases) was 58%, and the mean overall survival time was 58.5±0.5 months. Case load at the treating center inversely correlated with local recurrence (P=0.01). Tumor size and FIGO stage were associated with the presence of distant metastases (P<0.001 for both). Adjuvant therapy (radiotherapy or chemotherapy) was associated with a reduced risk of distant metastases and increased overall survival (P<0.001 for both). CONCLUSION: Local recurrences of invasive vulvar Paget disease were associated with the case load at the treating center. Distant recurrences were associated with tumor size and FIGO stage. It is possible that adjuvant radiotherapy or chemotherapy could offer patients benefits by increasing overall survival rates.

Estudio de la incidencia de infección tuberculosa en estudiantes de medicina del Hospital del Mar / No disponible

Objetivo: Evaluar la incidencia de infección tuberculosa en estudiantes de medicina. Material y métodos: La muestra comprendió estudiantes de último curso de medicina de la Unitat Docent de l’Institut Municipal d’Assistència Sanitària (UDIMAS – Hospital del Mar) que cuando cursaban 3º curso eran también tuberculín negativos. Se examinó entre los participantes si había cicatriz de la vacunación con BCG y factores de riesgo de tuberculosis (TB). Además, se estudió la prevalencia entre los estudiantes de 6º curso de los últimos años. El diagnóstico de infección tuberculosa se basó en la intradermorreacción de Mantoux practicada con 2 UTd e PPD RT-23.Resultados: La respuesta a la tuberculina fue negativa en los 38 estudiantes cribados, incluso en los 5 que estaban vacunados con Bacilo de Calmette-Guérin (BCG).Por lo tanto, la incidencia de infección tuberculosa fue nula. Asimismo, la prevalencia presentó un máximo en los alumnos que estudiaban sexto de medicina el curso2001/2002 (9%) para disminuir al 3% en el curso2005/2006.Conclusiones: Estos resultados sugieren que los estudiantes durante su estancia en el hospital adoptan las medidas preventivas adecuadas y/o tienen un contacto limitado con enfermos tuberculosos no diagnosticados o sus muestras. A pesar de estos resultados no se puede negar que la TB es un riesgo profesional para los trabajadores sanitarios (AU)

Objective: To evaluate the incidence of tuberculous infection in medicine students. Material and methods: The sample included medicine students from “Hospital del Mar” in their 6th and last year of studies, who were tuberculin negative when they were in their 3d year. We looked for BCG vaccination scars, and tuberculosis (TB) risk factors. We also studied the prevalence of TB infection in the last years in the same6th year students. The diagnosis of TB infection was based on the Mantoux skin test, with 2 UT of PPD RT-23.Results: The tuberculin test was negative in the 38students we studied, even in five of them who had been vaccinated with Calmette-Guérin bacillus. Therefore, the incidence of TB infection was null. Moreover, the prevalence was maximum in the students who were in their 6th year in 2001/2002 (9%), and it decreased to3% in 2005/2006.Conclusions: These results suggest that medicine students observe the appropriate preventive measures during their clinical practice and/or they have a reduced contact with non-diagnosed TB patients or their samples. In spite of these results, we cannot deny that TB is a professional risk for health workers (AU)