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

RESUMEN

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

ABSTRACT

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