RESUMO
Cervical intraepithelial neoplasia (CIN) grade 2/3 has a high spontaneous regression rate, especially among women ≤29 years of age. To reduce overtreatment, reliable prognostic biomarkers would be helpful. The main aim of this study was to analyze the negative predictive value of the methylation marker panel GynTect® for lesion regression. In this prospective, multicenter, longitudinal observational proof-of-concept study, women aged ≤29 years with histologically confirmed CIN2 (n = 24) or CIN3 (n = 36) were closely monitored without treatment for up to 24 or 12 months, respectively. The outcome was either regression, persistence, or progression of the lesion. For each patient, a single baseline sample (V0) for cytology, hrHPV detection and methylation analysis was taken. In a primary analysis, the negative predictive value (NPV) of a GynTect®-negative test result at V0 for regression was determined. We tested the null hypothesis NPV ≤ 70% against the alternative hypothesis NPV ≥ 90%. Twelve of the eighteen GynTect®-negative CIN2 patients showed regression (NPV = 67%, 90% CI 44-85%, p = 0.53). Of the 27 GynTect®-negative CIN3 lesions, 15 regressed (NPV = 56%, 90% CI 38-72%, p = 0.92). Although the majority of GynTect®-negative lesions regressed, the postulated NPV of ≥90% was not observed. Thus, the clinical relevance for an implementation of the GynTect® assay for patients undergoing watchful waiting remains questionable. Further studies with longer observation periods should be undertaken.
RESUMO
PURPOSE: Invasive cervical cancer is today the fourth most common cancer of women in western civilization. Screening programs have led to a continuously decrease. Nevertheless, both screening and a positive test result are known to be associated with a negative psychological impact. Screening programs in European countries differ and thus psychological impact might as well. The aim of this study was to evaluate the psychological impact of women with an abnormal Pap smear in a German cohort. METHODS: Between July 2013 and May 2014, a self-assessment questionnaire was distributed to 595 patients that were referred to a special clinic for cervical dysplasia for further evaluation of an abnormal Pap smear. Patients were recruited in five different centers. RESULTS: Most patients (45.9 %) were informed about the test result via phone call by their doctor. 68.8 % of the patients felt anxious and 26.3 % even felt panic. After having talked to their physician, 51.4 % of our cohort still felt worried and only 24.4 % felt reassured. Concerning disease management, 48.4 % underwent a control Pap smear in 6 months. The preferred information source was the physician (63.9 %). Compared to the results in other European countries, our study cohort showed differences concerning age distribution, patients living in a partnership, number of children and especially disease management. CONCLUSION: Cancer screening itself and abnormal test results have an impact on patient's feelings. To reduce the psychological impact, patients need to be better informed about the risks and benefits of cancer screening programs and in case of cervical cancer screening about the meaning of an abnormal test result. Our results underline the importance of a trustful physician-patient relationship in that matter.