Andrea Miranda

Can the preoperative HE4 level predict optimal cytoreduction in patients with advanced ovarian carcinoma

OBJECTIVE Optimal surgical outcome has been proved to be one of the most powerful survival determinants in the management of ovarian cancer patients. Actually, for ovarian cancer patients there is no general consensus on the preoperatively establishment of cytoreducibility. METHODS Between January 2011 and June 2012 patients affected by suspicious advanced ovarian cancer, referred to the Department of Gynecology of Campus Biomedico of Rome were enrolled in the study. All patients had serum CA125 and HE4 measured preoperatively. After a complete laparoscopy to assess the possibility of optimal debulking surgery defined as no visible residual tumor after cytoreduction (RT=0), patients were submitted to primary cytoreductive surgery (Group A) or addressed to neoadjuvant chemotherapy (Group B). RESULTS After diagnostic open laparoscopy, 36 patients underwent optimal primary cytoreductive surgery (Group A) and 21 patients were addressed to neoadjuvant chemotherapy (Group B). In our population, based on ROC curve, the HE4 value of 262pmol/L is the best cut-off to identify patients candidates to optimal cytoreduction with a sensitivity of 86.1% and a specificity of 89.5% (PPV=93.9% and NPV=77%). In addition, CA125 has a sensitivity of 58.3% and a specificity of 84% at cut-off of 414 UI/mL (AUC is 0.68, 95% C.I.=0.620 to 0.861). CONCLUSION Our data indicate that preoperative HE4 is a better predictor for optimal cytoreduction compared to CA125. The best combination in predicting cytoreduction is HE4≤262 pmol/L and ascites <500mL with a sensitivity of 100% and a specificity of 89.5% (PPV=94% and NPV=100%).

Ten years of HPV vaccines: State of art and controversies

The human papillomavirus (HPV) represents one of the most common sexually transmitted infections and it has been related to cervical cancer. The HPV vaccines prevent infection with certain species of HPV associated with the development of cervical cancer or genital warts. We carried out a PubMed search up to 2015 evaluating all randomized studies published in literature. This review discusses the current status of HPVs vaccines on the global market, efficacy, safety profiles, controversies and future vaccine developments. Three HPVs vaccines are currently on the global market: bivalent, quadrivalent and ninevalent. Bivalent and quadrivalent vaccines can protect against almost 70% of cervical HPV-related cancerous and precancerous conditions and the ninevalent vaccine, instead, provides a protection against almost 90%. The use of vaccinations raised several controversies in the last years and, currently, is not possible to establish which type of vaccine is most effective, however all of them are safe.

The effects of giving patients verbal or written pre-operative information in gynecologic oncology surgery: a randomized study and the medical-legal point of view

OBJECTIVES To evaluate the verbal and written preoperative information in patients undergoing surgery for malignant gynaecologic disease, in terms of satisfaction about preoperative received informations, hospitalization days, postoperative pain experienced using visual analogue scale (VAS) and number of pain drugs used daily. STUDY DESIGN From January 2008 to December 2012, consecutive patients with diagnosis of endometrial cancer, referred to the Division of Gynecology of University Campus Bio-Medico of Rome, were enrolled. Eligible subjects were randomized into two groups: Group V (Verbal information ward) consisted of patients who had verbal preoperative information about surgical procedure and postoperative management and Group W (Written Information ward) consisted of patients who had written preoperative information. All preoperative and postoperative data were recorded. Concerning satisfaction about preoperative received informations, patients were asked to complete the QLQ-C30 and the EORTC INFO25. RESULTS 190 patients were considered in this study. Group W (n=92) has a better info satisfaction (p=0.0008, statistically significant), a mean VAS value lower (p=0.02, statistically significant) and also a lower number of hospitalization days (p=0.0265, statistically significant) and pain medications used daily, (p=0.0120, statistically significant), comparing with group V (n=98). CONCLUSIONS We support the use of preoperative information leaflet to better prepare patients for a surgical procedure, showing a faster recovery, low medications use and a better quality of life outcome.

The role of novel biomarker HE4 in the diagnosis, prognosis and follow-up of ovarian cancer: a systematic review

ABSTRACT Introduction: Ovarian cancer is the leading cause of death from gynecologic cancers, in fact, >80% of cases are diagnosed as advanced-stage disease associated with a high mortality rate (<40% of women cured). A systematic review was performed to estimate the role of HE4 in the diagnosis, prognosis and follow-up of ovarian tumors. Areas covered: A comprehensive search of the literature from January 1952 to August 2016 was conducted using the terms ‘ovarian tumor’ and ‘ovarian cancer’ combined with ‘HE4’ and ‘human epididymis protein 4’. The search identified a total of 259 citations, of which 141 were potentially relevant after initial evaluation. Of these studies, 75 primary studies met the inclusion criteria and were analyzed, with a total of 14,773 patients. Expert commentary: Serum HE4 dosage is a useful preoperative test for predicting the benign or malignant nature of pelvic masses. It seems to have a promising role in the prediction of clinical and surgical outcomes. Moreover, HE4 seems to better predict recurrence in comparison to CA-125.

Further insight into prognostic factors in endometrial cancer: the new serum biomarker HE4

ABSTRACT Introduction: Endometrial cancer (EC) is one of the most common gynecological cancer worldwide. To date, no good markers are routinely used in clinical practice for prognosis and monitoring. Areas covered: During the last years, an increasing interest in literature has been growing on HE4 (Human epididimis 4). Therefore, we aimed to gather all the evidence reported in literature analysing the potential prognostic value of HE4, compared to the well know tumor’s features (histological type and grade, stage of disease, depth of myometrial invasion, lymphovascular space involvement and cervical involvement). Expert commentary: The analysis of data suggests that HE4 seems to have a good performance in prognosis and monitoring of the disease, helping to schedule the appropriste timing of imaging and surgery in a more individualized fashion. However, these findings surely require a validation in a larger cohorts of patients. Probably, in the next five years, prospective randomized trials will be performed to confirm the prognostic role of HE4 in EC and to find a tailored EC management strategy.

Economic Impact Among Family Caregivers of Patients With Advanced Ovarian Cancer.

Objectives The life of a family caregiver changes in many ways when cancer is diagnosed. Changes regard also financial costs. To the authors’ knowledge, little work has been done to estimate the costs associated with caregiving for cancer patients. The aim of the present study is to evaluate for the first time in literature the economic changes among family caregivers of advanced ovarian cancer during the first-line treatment in an Italian survey. Methods Between January 2009 and June 2014, the primary family caregivers of patients with advanced ovarian cancer (N = 172) were recruited from to the Division of Gynecologic Oncology of the University Campus Bio-Medico of Rome within 4 weeks of the patient’s new diagnosis. Caregivers reported demographic, medical information, and economic cost, such as traveling to and from medical appointments, waiting with patients for appointments, missing work, and attending to patients who are hospitalized. Results Between January 2009 and June 2014, 172 primary family caregivers of patients with advanced ovarian cancer were enrolled in the study. The mean age of the study cohort was 54.01 years. They reported 3% of missing workdays. The mean cost for all caregivers was &OV0556;1,888,732 per year. Therefore, the mean cost for each caregiver was &OV0556;10,981 annually. Conclusions This economic analysis of caregiving in patients with advanced ovarian cancer reports the significant burden that cancer treatment places on both families and society. These findings underscore the importance, when appropriate, of including valid estimates of the cost of informal caregiving when evaluating the cost-effectiveness of cancer treatments.

May intraperitoneal irrigation with Betadine improve cesarean delivery outcomes? Results of a 6 years’ single centre experience

Abstract Purpose: Cesarean presents increased risk of adverse outcomes, such as endometritis, bacteremia, peritonitis, and maternal fever. This retrospective study aims to evaluate, for the first time in Literature, the effects Betadine washing versus normal saline washing after uterine closure in women undergoing cesarean delivery (CD) at ≥36 gestational weeks. Methods: Of the 2080 patients identified retrospectively for the analysis at Department of Obstetrics and Gynecology of San Camillo Hospital of Rome, 1042 were assigned to “Betadine group” and 1038 to “No Betadine group”. There were no differences noted for maternal and obstetric characteristics. The outcomes of the present study were to evaluate the incidence of postoperative infections or fever; the reduction of blood white cells among preoperative and postoperative exams; mean and median time of intestinal recanalization, of postoperative ambulation and of 24-h post-CD pain, evaluated using VAS scale. Results: Betadine group patients reported a statistically significant lower white cells increment, a lower mean time to ambulation and intestinal recanalization after CD and a lower 24-h post-CD pain and infections. Conclusions: Betadine intraperitoneal irrigation during CD seems to improve postoperative CD outcomes and patients’ quality of life.

Learning curves of a resident surgeon performing transobturator tape procedures for stress urinary incontinence

To evaluate the number of procedures necessary for an untrained resident surgeon to learn transobturator tension‐free vaginal tape (TVT‐O) procedures for treatment of stress urinary incontinence (SUI).

Chemotherapy as Adjuvant Treatment for Intermediate-High Risk Early-Stage Endometrial Cancer: A Pilot Study.

Objective This study aimed to assess primarily the role of chemotherapy as adjuvant treatment for International Federation of Gynecology and Obstetrics (FIGO) stage IA G3, IB G2-G3, and II endometrial cancer (EC) in terms of disease-free interval and overall survival, and secondarily, the rate of local and distant recurrence. Methods The present prospective pilot study includes 68 patients with surgical staged EC who referred between 2007 and 2011 to the Division of Gynecologic Oncology at the University Campus Bio-Medico of Rome. All enrolled patients received adjuvant chemotherapy every 3 weeks according to the scheme carboplatin, dosed at an area under the curve of 6, and paclitaxel 175 mg/mq given every 3 weeks for at least 3 cycles. Results The median number of chemotherapy cycles was 6 (range, 3–6 cycles). Chemotherapy was well tolerated. The 3-year overall survival was 92.8% and 91.6% for stages I and II, respectively. The 3-year disease-free interval was 91.8% and 83.3% for stages I and II, respectively. Of 68 patients, 7 (10.3%) relapsed: 5 patients with a FIGO stage I and 2 patients with FIGO stage II EC. Conclusions Platinum-based chemotherapy is feasible and safe and it could be used in adjuvant setting for early-stage ECs. Although its effectiveness is comparable to radiotherapy, chemotherapy represents an excellent treatment option due to its systemic action. Further randomized studies will be needed to confirm our promising data.

Placenta accreta and balloon catheterization: the experience of a single center and an update of latest evidence of literature

AbstractPurposeWe studied the efficacy of using pre-cesarean delivery (CD) temporary occlusion of internal iliac arteries with balloon catheters in case of placenta previa–accreta in terms of maternal and neonatal outcomes and to test accuracy of ultrasound (US) and magnetic resonance imaging (MRI) for prenatal diagnosis.MethodsFrom March 2014 to January 2018, women with an US and/or MRI diagnosis of placenta previa–accreta and a planned delivery were enrolled and divided into two groups: balloon catheterization group (women treated with preoperative catheters and CD) and control group (women candidates to elective CD).Results37 patients were enrolled: 16 in balloon catheterization group and 21 in control group. Significant differences were detected in estimated blood loss. Prophylactic balloon catheterization could reduce intraoperative red blood cell transfusion. The incidence of hysterectomy was lower in balloon group. No statistical difference was found for neonatal outcomes. Both US and MRI have showed to be useful and complementary to diagnose placenta previa–accreta.ConclusionsTemporal, perioperative, and prophylactic positioning of balloon vascular catheters is an effective method for managing severe hemorrhage caused by placenta previa–accreta as it reduced intraoperative blood loss, lessened perioperative hemostatic measures and intraoperative red cell transfusions, and reduced hysterectomies.