Giuseppe Scaletta

A new type of absorbable barbed suture for use in laparoscopic myomectomy.

To compare effectiveness, feasibility, and suturing time required between an absorbable barbed wire (V‐Loc) uterine suture and a classic continuous suture with intracorporeal knots among women undergoing laparoscopic myomectomy.

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 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.

A randomized controlled trial comparing four versus six courses of adjuvant platinum-based chemotherapy in locally advanced cervical cancer patients previously treated with neo-adjuvant chemotherapy plus radical surgery

OBJECTIVES. The aim of this study was to compare 4 versus 6 courses of adjuvant chemotherapy after neoadjuvant chemotherapy plus radical surgery in terms of overall survival (OS), disease-free survival (DFS), recurrence rate and toxicity profile. METHODS. We randomly assigned 200 patients with IB2-IIB cervical cancer to receive 4 (Group A) or 6 (Group B) courses of cisplatin 100 mg/mq and paclitaxel 175 mg/mq every 21 days. RESULTS. At 4-years follow-up, the comparison of recurrence rate (p = 1; RR = 1.005; 95% CI = 0.87 to 1.161), OS (p = 0.906) and DFS (p = 0.825) did not show statistically significant differences between the two groups. Data analysis showed statistically significant differences between the two groups in term of episodes of leukopenia (p = 0.0072; RR = 1.513; 95% CI = 1.127-2.03), anemia (p = 0.048; RR = 1.188; CI = 1.012-1.395) and febrile neutropenia (p = 0.042; RR = 1.119; 95% CI = 1.014-1.235), in favor of Group A. As regards non-hematological toxicities, there were no statistically significant differences in terms of gastrointestinal symptoms (p = 0.49; RR = 1.046; CI = 0.948-1.153. On the contrary, there was a statistically significant difference regarding neurological symptoms (p=0.014; RR=1.208; CI=1.046-1.395), that were less frequent in Group A (13%) than in Group B (28%). CONCLUSIONS. Adjuvant treatment with 4 or 6 courses of platinum-based chemotherapy showed similar results in terms of OS and DSF, with a favorable toxicity profile in favor of the first regimen.

Adjuvant chemotherapy after primary treatments for cervical cancer: a critical point of view and review of the literature

Cervical cancer is the second most frequent female malignancy worldwide. Concurrent chemoradiotherapy represents the standard of care for patients with advanced stage cervical cancer, while radical surgery (RS) and radiotherapy is widely used for treating early stage cervical cancer. However, the poor control of micrometastasis, declining operability, the lack of radiotherapy departments and the high incidence of long-term complications due to radiotherapy have brought about the development of different therapeutic approaches such as neoadjuvant chemotherapy followed by RS. Unfortunately, treatment results are still unsatisfactory due to a high recurrence rate and several authors have studied the possibility to add an adjuvant treatment to primary therapy. We reviewed the literature concerning the role of adjuvant chemotherapy in advanced cervical cancer after neoadjuvant chemotherapy followed by RS and after chemoradiotherapy.

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

Abstract 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.

Role of paroxetine in the management of hot flashes in gynecological cancer survivors: Results of the first randomized single-center controlled trial

OBJECTIVES To examine the effects of paroxetine supplementation on hot flashes and sleep in gynecological cancer survivors. METHODS In a randomized, double-blind, placebo-controlled study, postmenopausal women with a prior history of stage 0-III gynecological cancer who had completed active cancer treatment (including hormonal therapy) were randomly assigned 1:1 to either 7.5mg oral paroxetine or placebo daily for 16weeks. Sleep and hot flashes were assessed at baseline, week 4 and week 16. RESULTS Eighty women (91%) completed the study. We found out a statistically significant difference in weekly reductions in VMS frequency and severity for paroxetine 7.5mg than for placebo on week 4 and 16. Regarding sleep characteristics, the analysis of data through week 16 reported a statistically significant reduction in the number of nighttime awakenings attributed to VMS among participants receiving paroxetine than among participants receiving placebo on baseline and weeks. The duration of sleep per night increased significantly more among participants receiving paroxetine than among those receiving placebo at all post baseline time points. No significant differences in sleep-onset latency were noted between the two treatment arms during the course of the study. Paroxetine was well-tolerated with a high level of compliance. In our cohort of patients, no serious adverse events have been reported. CONCLUSIONS This is the first randomized placebo-controlled study in gynecological cancer survivors that demonstrates that paroxetine significantly reduces hot flashes in weekly frequency and severity and the number of nighttime awakenings attributed to vasomotor symptoms, increasing sleep duration.

The Role of He4, a Novel Biomarker, in Predicting Optimal Cytoreduction After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer

Objectives This study aimed to evaluate serum human epididymis protein 4 (HE4) changes during neoadjuvant chemotherapy (NACT) to establish HE4 predebulking surgery cutoff values and to demonstrate that CA125, HE4, and computed tomography (CT) taken together are better able to predict complete cytoreduction after NACT in advanced ovarian cancer patients. Methods From January 2006 to November 2015, patients affected by epithelial advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage III–IV), considered not optimally resectable, were included in this prospective study. After 3 cycles of NACT, all patients underwent debulking surgery and were allocated, according to residual tumor (RT), into group A (RT = 0) and group B (RT > 0). Serum CA125, HE4, and CT images were recorded during NACT and compared singularly and with each other in term of accuracy, sensitivity, specificity, and positive and negative predictive value. Results A total of 94 and 20 patients were included in group A and group B, respectively. The HE4 values recorded before debulking surgery correlated with RT. The identified HE4 cutoff value of 226 pmol/L after NACT was able to classify patients at high or low risk of suboptimal surgery, with a sensitivity of 75% and a specificity of 85% (positive predictive value, 0.87; negative predictive value, 0.70). The combination of CA125, HE4, and CT imaging resulted in the best combination with a sensitivity of 96% and a specificity of 92% (positive predictive value, 0.96; negative predictive value, 0.94). Conclusions The novel biomarker HE4, in addition to CA125 and CT, is better able to predict the RT at debulking surgery and the prognosis of patients.

Total rectosigmoidectomy versus partial rectal resection in primary debulking surgery for advanced ovarian cancer.

PURPOSE To compare in a sample of Italian patients intraoperative, perioperative complications, Quality of Life (QoL), recurrence rate and overall survival of advanced ovarian cancer (AOC) patients according to the type of surgery performed on sigma-rectum, total rectosigmoid resection (TRR) versus partial rectosigmoid resection (PRR). METHODS From May 2004 to May 2010, consecutive patients affected by epithelial AOC (FIGO Stage III-IV) were assessed for this prospective case-control study, According to the type of colorectal surgery performed to approach rectosigmoid involvement, patients were allocated into Group A (TRR) and Group B (PRR). PRR was performed when the complete removal of disease led to a laceration <30-40% of intestinal wall circumference. RESULTS 82 and 72 patients were included in Group A and Group B respectively. Surgical outcomes were statistically similar except hospital stay which was significantly lower in the PRR group. There was not a statistically significant difference as regarding intra-operative, perioperative and postoperative complications, even if a higher rate of major complications were recorded in TRR. An improvement in QoLs scores has been recorded in PRRs group. There was not a statistically difference concerning the optimal debulking rate (92% and 96% respectively) and 5-year Overall Survival (48% and 52% respectively). CONCLUSIONS PRR seems to be feasible in over 40% of patients with advanced ovarian cancer and recto-sigmoid colon involvement. It is related to higher QoL and can be easily performed, without jeopardizing surgical radicality, in those cases in which conservative surgery at intestinal tract does not compromise residual tumor.