ABSTRACT
OBJECTIVE: In patients with chemotherapy-induced amenorrhea (CIA), the menopausal status is ambiguous and difficult to evaluate. This study aimed to establish a discriminative model to predict and classify the menopausal status of breast cancer patients with CIA. METHODS: This is a single center hospital-based study from 2013 to 2016. The menopausal age distribution and accumulated incidence rate of CIA are described. Multivariate models were adjusted for established and potential confounding factors including age, serum concentration of estradiol (E2) and follicle-stimulating hormone (FSH), feeding, pregnancy, parity, abortions, and body mass index (BMI). The odds ratio (OR) and 95% confidence interval (95% CI) of different risk factors were estimated. RESULTS: A total of 1,796 breast cancer patients were included in this study, among whom, 1,175 (65.42%) were premenopausal patients and 621 (34.58%) were post-menopause patients. Five hundred and fifty patients were included in CIA analysis, and a cumulative CIA rate of 81.64% was found in them. Age (OR: 1.856, 95% CI: 1.732-1.990), serum concentration of E2 (OR: 0.976, 95% CI: 0.972-0.980) and FSH (OR: 1.060, 95% CI: 1.053-1.066), and menarche age (OR: 1.074, 95% CI: 1.009-1.144) were found to be associated with the patients' menopausal status. According to multivariate analysis, the discriminative model to predict the menopausal status is Logit (P)=-28.396+0.536Age-0.014E2+0.031FSH. The sensitivities for this model were higher than 85%, and its specificities were higher than 89%. CONCLUSIONS: The discriminative model obtained from this study for predicting menstrual state is important for premenopausal patients with CIA. This model has high specificity and sensitivity and should be prudently used.
ABSTRACT
OBJECTIVE: To investigate the extent of the cross-reactivity of hybrid capture 2 (HC2) assay and evaluate the potential effect of cross-reactivity on the long-term risk for cervical cancer and precancers. METHODS: Based on the Shanxi Province Cervical Cancer Screening Study-I (SPOCCS-I) cohort from 2005 to 2014 in Shanxi, China, SPF10-line probe assay (LiPA) was performed in all 598 HC2 positive and 300 random-selected HC2 negative cervical specimens. Ten-year cumulative incidence rate (CIR) of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) of these two tests was evaluated using Kaplan-Meier methods. Possible human papillomavirus (HPV) types to be cross-reacted by HC2 were also analyzed. RESULTS: The overall agreement between HC2 and SPF10-LiPA for detecting carcinogenic HPV was 73.27%. The highest 10-year cumulative risk of CIN2+ was observed in both HC2 positive and LiPA-carcinogenic HPV positive women (25.70%; 95% confidence interval [CI]=23.55%-27.91%), followed by HC2 positive but LiPA-non-carcinogenic HPV positive women (9.97%; 95% CI=8.57%-11.50%), HC2 negative but LiPA-carcinogenic HPV positive (2.56%; 95% CI=2.44%-2.70%) and HC2 positive but LiPA-HPV negative (1.85%; 95% CI=1.78%-1.92%) women. The proportion of cross-reactivity of HC2 with untargeted carcinogenic types was 8.9%, most of which were attributable to HPV26, 73, 82, 69, 71, 53, 11, 43, and 54. CONCLUSION: The noticeable high risk of CIN2+ in women infected with cross-reacted non-carcinogenic HPV and low risk in those with miss-to-detective carcinogenic HPV supported an overall good clinical performance of HC2 for a general cervical cancer screening.
