Cost of illness of advanced ovarian carcinoma in Italy: results of an empirical, single-centre study

AIM: To perform an empirical, single-centre, retrospective and secondary cost of illness (COI) study of advanced ovarian carcinoma (AOC) in Italy. METHODS: Demographic, clinical, health care and non-health care resource consumption data concerning a convenience sample of subsequent patients in 1st line of treatment (100 patients), 2nd line of treatment A (surgery + chemotherapy; 30 patients) and 2nd line of treatment B (chemotherapy only; 20 patients) were obtained from a database created in 2011 by the Obstetrics and Ginecology Unit at Campus Biomedico teaching hospital, Rome. Patients were followed-up for 2 years. Resources were valued according to the above mentioned database and literature, following the societal viewpoint. Costs are expressed in Euro (€) 2014 and reported as mean and standard deviation (SD). RESULTS: One-year COI for 1st line of treatment reaches € 44,999.7 (SD: €28,757.3), € 55,410.8 (SD: € 32,454.6) and €46,895.6 (SD: € 28,407.4) for 2nd line of treatment A and B, respectively. Regardless the line of treatment, COI is mainly driven by cost borne by patient and her family. Due to the high costs of relapse the mean COI per patient after 2 years from the diagnosis of AOC equals € 81,869.4 (SD: € 30,660.9), or 182% of the COI for the 1st line of treatment. CONCLUSIONS: Despite some limitations, our results show that increasing progression-free survival could well reduce the COI for AOC in Italy

Results of a Five-Year Experience in First Trimester Preeclampsia Screening

Background and Objectives: The study aimed to evaluate the ability defining the risk of developing preeclampsia by a screening test carried out in the first trimester (between 11 + 0 and 13 + 6 weeks of gestational age), in order to identify high-risk women requiring more intensive health surveillance. The secondary objective was to evaluate the ability of this test to predict the risk of adverse obstetric outcomes such as fetal growth restriction, intrauterine fetal death, gestational hypertension, HELLP syndrome, placental abruption, and preterm birth. Materials and Methods: This was a single-center study, conducted at the Operative Unit of Obstetrics of the State Hospital of the Republic of San Marino. Medical history was collected at the time of enrolment in writing. Subsequently, obstetric outcomes were collected for each enrolled woman, through the analysis of medical records. Results: From October 2014 to May 2019, 589 pregnant women were recruited, of whom, 474 (80.5%) were included in the “low-risk” group, and 115 (19.5%) in the “high-risk” group. At the time of analysis of this population, the obstetric outcomes were available for 498 women (84.5%), while 91 cases (15.5%) were current pregnancies. The PI of the uterine arteries was not significantly different between the two study groups. Otherwise, a significant difference was highlighted for MAP, which is higher in the case of pregnancies at high risk based on the risk factors only, and for PAPP-A, higher in the case of low-risk pregnancies. Regarding the percentage of fetal DNA, according to the most recent literature data, in our series, we report a statistically significant difference of the average between the low and high-risk groups. Conclusions: In our study, we demonstrate that the multiparametric screening test for early PE performed well in identifying women at high risk of early PE, which certainly has the most severe maternal–fetal outcomes. The data reported that ASA intake at low doses is significantly higher in the population with high-risk tests for both early PE and late PE suggest once again that anamnestic evaluation plays an essential role in women’s screening

Thyroid physiology and common diseases in pregnancy: review of literature

Thyroid diseases are common during pregnancy and an adequate treatment is important to prevent adverse maternal and fetal outcomes. Subclinical diseases are very frequent but not easily recognized without specific screening programs. In this article we try to summarize the knowledge on the physiologic change of the thyroid and pathological function during pregnancy; we also try to describe the best way of diagnosis and treatment of thyroid dysfunction

Prenatal diagnosis of a fetus with a ring chromosome 20 characterized by array-CGH

Objective: a fetus with a ring chromosome 20 is presented. Methods: at 16 weeks’ gestation, ultrasound examination evidenced no apparent structural malformation. Amniocentesis was performed for maternal anxiety. Results: chromosome analysis identified a ring chromosome 20 and array-CGH demonstrated that the ring including micro-deletion of the short arm in 20p13, that was extended for about 632.2 kb and a micro-deletion of the long arm in 20q13.33 region. Conclusion: this is the first case of a ring chromosome 20 diagnosed prenatally. This reinforces the importance of offering amniocentesis with a-CGH to make more accurate prenatal diagnosis

Quality of life in patients with endometrial cancer treated with or without systematic lymphadenectomy

Objective: To compare the quality of life (QoL) of women affected by endometrial cancer treated with surgery with or without systematic lymphadenectomy. Study design: Consecutive patients affected by stages I and II endometrial cancer and treated with surgery between 2008 and 2011 were selected. Eligible subjects were divided into two groups: Group A consisted of 36 patients who had hysterectomy plus bilateral salpingo-oophorectomy without lymphadenectomy; Group B consisted of 40 patients who had hysterectomy plus salpingo-oophorectomy plus pelvic and aortic lymphadenectomy. The EORTC Quality of Life Questionnaire-Cancer Module (QLQ-C30) and Quality of Life Questionnaire-Endometrial Cancer Module (QLQ-EN24) were administered to selected patients. All data were recorded and then analyzed using the scoring manual of the EORTC Quality of Life Group. Results: Among symptom scales, only lymphedema gave a statistically significant difference among two groups, with a score of 10.64 ± 17.43 in Group A and 21.66 ± 24.51 in Group B (p = 0.0285). The p value obtained comparing the "Global Health Status" (items 29 and 30) in Group A and in Group B was not statistically significant. Conclusion: Lymphadenectomy did not influence negatively global health status, but lymphadenectomy maintained its importance in determining a patient's prognosis and in tailoring adjuvant therapies. We therefore support its practice as part of the surgical procedure in patients affected by high risk endometrial cancer. © 2013 Elsevier Ireland Ltd. All rights reserved

Feasibility and safety of carboplatin plus paclitaxel as neoadjuvant chemotherapy for locally advanced cervical cancer: a pilot study

The aim of this study is to evaluate the efficacy and safety of the combination of carboplatin and paclitaxel as neoadjuvant chemotherapy (NACT) in patients affected by locally advanced cervical cancer. Between June 2007 and May 2012, all patients with a diagnosis of locally advanced cervical cancer (IB2-IIB) were eligible for this protocol. All patients have received 3 cycles of carboplatin (AUC6) and paclitaxel 175 mg/mq in neoadjuvant setting. The NACT-induced toxicity and the response to treatment were evaluated according to the World Health Organization (WHO) criteria. After NACT, all patients with complete or partial response were submitted to classical radical hysterectomy type III or C2, according to different classifications, and were submitted to four adjuvant cycles of platinum-based chemotherapy. The primary endpoints of the study were to evaluate the efficacy and feasibility of carboplatin regimen. Thirty-five patients with locally advanced cervical cancer were considered. A total of 23 patients completed 3 cycles of NACT. The overall clinical response rate after NACT was 78.3 % including 43.5 % (n = 10) with complete response, 34.8 % (n = 8) with partial response, 17.4 % (n = 4) with stable disease and 4.3 % (n = 1) of those who suffered disease progression. The most common toxicity was haematologic, nausea/vomiting and neuropathy with grades 1 and 2 and occurred in 56.5, 56.5 and 17.4 %, respectively. No renal toxicity was registered. Our results suggest that carboplatin is a well-tolerated drug with a response rate similar to standard cisplatin. Then, it represents, in neoadjuvant setting, a valid alternative in patients affected by locally advanced cervical cancer. © 2013 International Society of Oncology and BioMarkers (ISOBM)

Does HE4 have a role as biomarker in the recurrence of ovarian cancer?

Human epididymis protein 4 (HE4) was recently approved by the Food and Drug Administration to monitor recurrence or progressive disease in epithelial ovarian cancer in conjunction with CA125. This is the first prospective controlled study in literature evaluating the sensitivity and specificity of HE4 and CA125 in detecting recurrent ovarian cancer. Serum samples were obtained 24 h before surgery from 34 patients with suspicious recurrent ovarian cancer and from 34 patients with benign adnexal pathology, operated from November 2010 to November 2011 at University Campus Bio-Medico of Rome. The CA125 normal value is considered less than 35 U/mL. Two HE4 cut-off are considered: less than 70 pmol/L and less than 150 pmol/L. The specificity analysis was performed using the parametric t test to compare the CA125 series and the Mann-Whitney test for the HE4 series. The level of statistical significance is set at p < 0.05. The CA125 sensitivity and specificity in detecting recurrent ovarian cancer is 35.29 and 58.82 %, respectively. The HE4 sensitivity is 73.53 and 26.47 %, for 70 pmol/L and 150 pmol/L cut-off, respectively. The HE4 specificity is 100 %. Combining CA125 and HE4 at cut-off of 70 pmol/L, the sensitivity to detect recurrent ovarian cancer is 76.47 % with a specificity of 100 %. The combination of CA125 and HE4 at cut-off of 70 pmol/L improves the overall sensitivity and specificity of CA125 alone, suggesting a useful application of HE4 in strategies for surveillance of ovarian cancer recurrence. © 2012 International Society of Oncology and BioMarkers (ISOBM)

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 262 pmol/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 < 500 mL with a sensitivity of 100% and a specificity of 89.5% (PPV = 94% and NPV = 100%). © 2012 Elsevier Inc

Ovarian cancer recurrence and early detection: may HE4 play a key role in this open challenge? A systematic review of literature

Despite the improvement in overall survival for ovarian cancer (OC) patients, a fraction of patients with advanced-stage disease fails to respond to primary therapy and relapses in 70% of cases. For this reason, new predictive and monitoring tools are needed to identify OC recurrence and new biomarkers were studied, among which human epididymis 4 (HE4), primarily expressed in the reproductive and respiratory tracts, is one of the most promising, reporting a good sensitivity and specificity in detecting OC, overcoming the traditional role of carbohydrate antigen 125 (CA-125). In this review, we aim to discuss the latest evidence reported in the literature about the use of HE4 to monitor ovarian cancer treatment and to detect OC recurrence. We searched MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials, IBECS, BIOSIS, Web of Science, SCOPUS, congress abstracts, and Grey literature (Google Scholar; British Library) from January 1952 to June 2017. The search identified seven papers in line with eligibility criteria for this systematic review; all of them demonstrated a good performance of HE4 in OC recurrence. The challenge to anticipate the diagnosis of OC recurrence and to translate this early diagnosis of relapse in a survival and quality of life improvement is still open, and as reported in this review, HE4 may play a key role in this scenario. More studies are needed to validate and reinforce the role of HE4 in ovarian cancer recurrence and in its early detection