Development of cardiac risk prediction model in patients with HER-2 positive breast cancer on trastuzumab therapy.

BACKGROUND: 25% of all breast cancer patients have HER-2 overexpression. Breast Cancer patients with HER-2 overexpression are typically treated with HER-2 inhibitors such as Trastuzumab. Trastuzumab is known to cause a decrease in left ventricular ejection fraction. The aim of this study is to create a cardiac risk prediction tool among women with Her-2 positive breast cancer to predict cardiotoxicity. METHOD: Using a split sample design, we created a risk prediction tool using patient level data from electronic medical records. The study included women 18 years of age and older diagnosed with HER-2 positive breast cancer who received Trastuzumab. Outcome measure was defined as a drop in LVEF by more than 10% to less than 53% at any time in the 1-year study period. Logistic regression was used to test predictors. RESULTS: The cumulative incidence of cardiac dysfunction in our study was 9.4%. The sensitivity and specificity of the model are 46% and 84%, respectively. Given a cumulative incidence of cardiotoxicity of 9%, the negative predictive value of the test was 94%. This suggests that in a low-risk population, the interval of screening for cardiotoxicity may be performed less frequently. CONCLUSION: Cardiac risk prediction tool can be used to identify Her-2 positive breast cancer patients at risk of developing cardiac dysfunction. Also, test characteristics in addition to disease prevalence may inform a rational strategy in performing cardiac ultrasound in Her-2 breast cancer patients. We have developed a cardiac risk prediction model with high NPV in a low-risk population which has an appealing cost-effectiveness profile.

Risk-prediction Model for Patients Undergoing Laparoscopic Hysterectomy.

STUDY OBJECTIVE: Develop a model for predicting adverse outcomes at the time of laparoscopic hysterectomy (LH) for benign indications. DESIGN: Retrospective cohort study. SETTING: Large academic center. PATIENTS: All patients undergoing LH for benign indications at our institution between 2009 and 2017. INTERVENTIONS: LH (including robot-assisted and laparoscopically assisted vaginal hysterectomy) was performed per standard technique. Data about the patient, surgeon, perioperative adverse outcomes (intraoperative complications, readmission, reoperation, operative time >4 hours, and postoperative medical complications or length of stay >2 days), and uterine weight were collected retrospectively. Pathologic uterine weight was used as a surrogate for predicted preoperative uterine weight. The sample was randomly split, using a random sequence generator, into 2 cohorts, one for deriving the model and the other to validate the model. MEASUREMENTS AND MAIN RESULTS: A total of 3441 patients were included. The rate of composite adverse outcomes was 14.1%. The final logistic regression risk-prediction model identified 6 variables predictive of an adverse outcome at the time of LH: race, history of laparotomy, history of laparoscopy, predicted preoperative uterine weight, body mass index, and surgeon annual case volume. Specifically included were race (97% increased odds of an adverse outcome for black women [95% confidence interval (CI), 34%-110%] and 34% increased odds of an adverse outcome for women of other races [95% CI, -11% to 104%] when compared with white women), history of laparotomy (69% increased odds of an adverse outcome [95% CI, 26%-128%]), history of laparoscopy (65% increased odds of an adverse outcome [95% CI, 21%-124%]), and predicted preoperative uterine weight (2.9% increased odds of an adverse outcome for each 100-g increase in predicted weight [95% CI, 2%-4%]). Body mass index and surgeon annual case volume also had a statistically significant nonlinear relationship with the risk of an adverse outcome. The c-statistic values for the derivation and validation cohorts were 0.74 and 0.72, respectively. The model is best calibrated for patients at lower risk (<20%). CONCLUSION: The LH risk-prediction model is a potentially powerful tool for predicting adverse outcomes in patients planning hysterectomy.

A comparison of surgical complications between immediate breast reconstruction and mastectomy: the impact on delivery of chemotherapy--an analysis of 391 procedures.

PURPOSE: To compare the postoperative complications after immediate breast reconstruction (IBR) versus mastectomy alone and to examine the impact on the delivery of chemotherapy. METHODS: In this prospective series, there were 391 consecutive women who underwent mastectomy (243 mastectomy alone and 148 mastectomy and IBR). The outcome measures were complications (within 3 months after surgery) and time to adjuvant chemotherapy. RESULTS: Compared to the IBR group, patients in the mastectomy alone group were significantly older (P < 0.0001), smokers (P = 0.007) and less likely to have had previous radiation or lumpectomy (P < 0.0001). Overall, the complication rate was significantly greater in the IBR group than mastectomy alone (27.0% vs. 15.6%, P = 0.009). Univariate analyses revealed that mastectomy with IBR [odds ratio (OR) = 2, 95% confidence interval (CI) 1.21-2.30]; bilateral procedure (OR = 1.84, 95% CI 1.07-3.16); previous radiotherapy (OR = 2.4, 95% CI 1.29-4.47); and previous lumpectomy (OR = 1.84, 95% CI 1.11-3.03) were significant predictors of increased complications. With multivariable analysis, none of these variables were significantly associated with increased complications. 106 patients received adjuvant chemotherapy; median time from mastectomy to chemotherapy was 6.8 (0.71-15) weeks in the mastectomy alone group (n = 96) compared to 8.5 (6.3-11) weeks in the IBR group (n = 10) (P = 0.01). CONCLUSIONS: Although the incidence of overall and major postoperative complications was higher after IBR than mastectomy alone, there were no significant relationships in the multivariable analysis. IBR was associated with a modest increase in time to chemotherapy that was statistically but not clinically significant.

Factors that influence adherence to a gluten-free diet in adults with celiac disease.

OBJECTIVE: The only treatment for celiac disease is lifelong adherence to a gluten-free diet, yet adherence is limited and factors influencing adherence are poorly understood. The purpose of this study was to determine factors influencing gluten-free diet adherence in adults with celiac disease. METHODS: A questionnaire was developed and administered to 154 adults with celiac disease who then underwent a standardized gluten-free diet evaluation by an experienced nutritionist. Multivariate analysis was conducted to determine factors associated with adherence level. RESULTS: Thirteen factors hypothesized to contribute to gluten-free diet adherence were found to be significantly associated with improved adherence including: understanding of the gluten-free diet, membership of a celiac disease advocacy group, and perceived ability to maintain adherence despite travel or changes in mood or stress (P < 0.001). CONCLUSIONS: This study identified specific factors correlated with gluten-free diet adherence. These results provide a foundation for the design of educational interventions to improve adherence.

Risk factors for myelodysplastic syndromes: a case-control study in Greece.

OBJECTIVE: The etiology of most cases of myelodysplastic syndromes (MDS) has not been elucidated. We have undertaken an investigation in Greece to determine the risk profile of adult de-novo MDS. METHODS: A case-control investigation was conducted in a large Veterans' hospital over a five-year period, covering 84 MDS cases and 84 age- and gender-matched controls with minor non-neoplastic non-infectious conditions from the same study base. Cases and controls reported to the medically trained principal investigator lifestyle characteristics and medical histories, with emphasis on autoimmune disorders and allergic conditions. RESULTS: Alcohol intake and tobacco smoking jointly increased significantly the risk of MDS (odd ratio contrasting ever smokers and regular drinkers of at least one glass per day to never smokers and drinkers of less than one glass per day: 9.54. 95% CI 3.52-25.82) whereas each of these factors alone had limited effect. There was also evidence that autoimmune conditions, but not allergic disorders, were positively associated with MDS risk, irrespective of their occurrence during the recent (less than ten years) or the remote (more than ten years) past (OR 3.34, 95% CI 1.15-9.74; OR 3.50, 95% CI 1.19-10.26, respectively). CONCLUSION: We found evidence that both exogenous and endogenous factors may play a role in the etiology of the so-called "de novo" myelodysplastic syndromes, but these findings need further confirmation.