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Purpose: There is several albeit not univocal evidence suggesting that ovarian reserve is not related to the chance of natural pregnancy, provided that the remnant follicular pool is sufficient to ensure regular menstrual cycles. Nevertheless, available studies have some methodological limitations, and the issue cannot be considered definitively ascertained. Methods: To further address this issue, we retrospectively selected infertile women whose infertility diagnostic work-up was unremarkable (unexplained infertility-cases) and matched them by age and study period to a group of infertile women who were diagnosed with severe male infertility (controls). If ovarian reserve impacts on natural fertility, one had to expect lower ovarian reserve among women with unexplained infertility. Tested biomarkers included AMH, AFC and day 2–3 serum FSH. The primary aim was the frequency of women with serum AMH < 0.7 ng/ml. Results: Two-hundred fifty-two women with unexplained infertility and 252 women with male infertility were included. All biomarkers of ovarian reserve did not differ between the study groups. AMH levels < 0.7 ng/mL were observed in 26 (10%) women with unexplained infertility and 35 (14%) women with male infertility (p = 0.28). The adjusted OR was 0.76 (95% CI: 0.44–1.33). Significant differences did not also emerge when repeating this dichotomous analysis using other biomarkers and other thresholds for the definition of low-ovarian reserve. Conclusion: This study confirms that ovarian reserve is unremarkable to natural conception. Physicians and patients should be aware of this concept to avoid inappropriate counseling and undue clinical decisions. [ABSTRACT FROM AUTHOR]

Purpose: This cross-sectional study aims to assess the interplay between the vaginal microbiota and endometriosis. Methods: 123 consecutive Italian fertile women, aged between 20 and 40 years old, were enrolled during a routine gynecological consultation; 24 were diagnosed with endometriosis and 99 did not complain of any gynecological disease. All women underwent a vaginal swab for the evaluation of the composition and diversity of vaginal microbiota by means of 16 s rDNA metagenomic sequencing. Results: Compared to women with no gynecological disease, the vaginal microbiota in women with endometriosis showed a similar abundance of Lactobacillus spp.; however, a statistically significant lower abundance in the genera Pseudomonas (p < 0.01), Bifidobacterium (p < 0.05), Novispirillum (p < 0.0000001) and Sphingomonas (p < 0.0000001), and a statistically significant increase in the abundance of the genera Escherichia (p < 0.00001), Megasphaera (p < 0.00001), and Sneathia (p < 0.0001) were observed. Conclusions: There is a complex interplay between vaginal microbiota composition and endometriosis, showing a distinct microbial signature in the bacterial genera usually found in dysbiosis. [ABSTRACT FROM AUTHOR]

To evaluate if a preoperative medical treatment with the GnRH-antagonist relugolix in combination therapy in a series of patients with abnormal uterine bleeding associated with uterine myomas may correct the anemia before scheduled surgery for myoma-associated AUB. Thirty-one patients scheduled for surgery underwent a pre-operative three-month course with a daily oral tablet of 40 mg relugolix, 1 mg estradiol, and 0.5 mg norethindrone acetate. Hemoglobin levels, uterine volumes, largest myoma diameter, and VAS score for dysmenorrhea, pelvic pressure and bleeding discomfort, and indication to surgery were evaluated at study enrollment and at the end of therapy. Mean hemoglobin levels increased by 25%, from 9.3 ± 1.1 to 11.6 ± 1.7 g/dL after three months (p < 0.001). Uterine volume decreased from 380.7 ± 273.4 mL to 281.7 ± 198.7 mL (p < 0.001), whereas the diameter of the largest myoma decreased from 6.4 ± 2.8 cm to 5.5 ± 2.2 cm (p < 0.001). Four patients (13%), initially planned for a laparotomy procedure, were converted to a minimally-access procedure, whereas in eight patients (26%) surgery was avoided after medical therapy. Dysmenorrhea score improved from 4.7 ± 3.2 to 0.6 ± 1.1 (p < 0.0001). Pelvic pressure score decreased from 5.9 ± 2.1 to 3.1 ± 2.3 (p < 0.0001), whereas bleeding discomfort decreased from 7.4 ± 3.0 to 0.4 ± 1.6 (p < 0.0001). Preoperative GnRH-antagonist therapy may enhance hemoglobin levels, decrease uterine and myoma size, and alleviate symptoms, potentially enabling safe surgical procedures. [ABSTRACT FROM AUTHOR]

Purpose: Failure to collect oocytes at the time of oocyte pick-up is an unfavorable outcome of in vitro fertilization (IVF) cycles. In these cases, prompt intrauterine insemination (IUI) could be an option (rescue IUI), but this possibility has been poorly studied. Methods: Rescue IUI is routinely offered in our unit in women failing to retrieve oocytes, provided that they have at least one patent tube, normal male semen analysis, and the total number of developed follicles is ≤ 3. We therefore reviewed all oocyte retrievals performed from 2006 to 2022 in our unit to identify these cases. As a comparator, we referred to preplanned IUI performed during the same study period. The 95% confidence interval (95% CI) of proportions was calculated using a binomial distribution model. Results: Rescue IUI was performed in 96 out of 3531 oocyte retrievals (2.7%; 95% CI 2.2–3.3%). Six live births were obtained, corresponding to 6.2% (95% CI 2.3–13.1). All pregnancies were singletons. Conclusions: Rescue IUI in women failing to retrieve oocytes is a possible option that may be considered in selected cases. The efficacy is low, but the procedure is simple, and without significant risks. Generalizability to a conventional IVF protocol setting is however limited. [ABSTRACT FROM AUTHOR]

The procedure of embryo transfer (ET) must be as gentle as possible since any traumatism may cause uterine contractility that interferes with the implantation. However, this ideal conduct is not always possible, and additional measures may be necessary (difficult ET). Different studies have evaluated the impact of difficult ET on the clinical pregnancy rate (CPR), but results were not univocal. The present systematic review and meta-analysis was aimed to provide a precise estimate of the possible detrimental effects of difficult ET on CPR. The study protocol was registered online (PROSPERO number: CRD42023387197). An electronic database search was performed to identify articles published until September 2022. The primary outcome was CPR. Fifteen studies fulfilled the inclusion criteria. Difficult ET significantly reduced the CPR (OR 0.70; 95%CI: 0.64–0.76; p < 0.0001. All pre-planned subgroup analyses according to study design (retrospective vs prospective studies), historical period (studies published before and after 2010), type of catheter, frequency of difficult cases (> or < 19%) and pregnancy rate (> or < 38%) confirmed the significant association. Difficult ET is associated with a significant reduction of CPR. Further studies are warranted to understand how to prevent or manage this common clinical situation. [ABSTRACT FROM AUTHOR]

This study aims to evaluate the role of intraoperative transvaginal three-dimensional ultrasound (3DUS) during hysteroscopic metroplasty. This is a prospective cohort of consecutive patients with septate uterus undergoing hysteroscopic metroplasty with intraoperative transvaginal 3DUS guidance compared to a historical control group of patients undergoing hysteroscopic metroplasty without 3DUS. We conducted our research in a tertiary care university hospital in Rome, Italy. This study involved nineteen patients undergoing 3DUS-guided hysteroscopic metroplasty for recurrent abortion or infertility compared to 19 age-matched controls undergoing metroplasty without 3DUS guidance. During hysteroscopic metroplasty, 3DUS was performed in the study group when the operator considered the procedure to be completed, according to standards of operative hysteroscopy. If 3DUS diagnosed a residual septum, the procedure was continued until a 3DUS diagnosis of a normal fundus was obtained. The patients were followed with a 3DUS performed 3 months after the procedure. The numbers of complete resections (residual septum absent), suboptimal resections (measurable residual septum of less than 10 mm), and incomplete resections (residual septum > 10 mm) in the intraoperative 3DUS group were compared to the numbers in the control group with no intraoperative 3DUS. At follow-up, measurable residual septa were obtained in 0% of the patients in the 3DUS-guided group versus 26% in the control group (p = 0.04). Residual septa of > 10 mm were obtained in 0% of the 3DUS group versus 10.5% in the control group (p = 0.48). Intraoperative 3DUS reduces the incidence of suboptimal septal resections at hysteroscopic metroplasty. [ABSTRACT FROM AUTHOR]

The objective of this study is to determine whether dienogest therapy after endometriosis surgery reduces the risk of recurrence compared with placebo or alternative treatments (GnRH agonist, other progestins, and estro-progestins). The design used in this study is systematic review with meta-analysis. The data source includes PubMed and EMBASE searched up to March 2022. A systematic review and meta-analysis were performed in accordance with guidelines from the Cochrane Collaboration. Keywords such as "dienogest," "endometriosis surgery," "endometriosis treatment," and "endometriosis medical therapy" were used to identify relevant studies. The primary outcome was recurrence of endometriosis after surgery. The secondary outcome was pain recurrence. An additional analysis focused on comparing side effects between groups. Nine studies were eligible, including a total of 1668 patients. At primary analysis, dienogest significantly reduced the rate of cyst recurrence compared with placebo (p < 0.0001). In 191 patients, the rate of cyst recurrence comparing dienogest vs GnRHa was evaluated, but no statistically significant difference was reported. In the secondary analysis, a trend toward reduction of pain at 6 months was reported in patients treated with dienogest over placebo, with each study reporting a significantly higher reduction of pain after dienogest treatment. In terms of side effects, dienogest treatment compared with GnRHa significantly increased the rate of spotting (p = 0.0007) and weight gain (p = 0.03), but it was associated with a lower rate of hot flashes (p = 0.0006) and a trend to lower incidence of vaginal dryness. Dienogest is superior to placebo and similar to GnRHa in decreasing rate of recurrence after endometriosis surgery. A significantly higher reduction of pain after dienogest compared with placebo was reported in two separate studies, whereas a trend toward reduction of pain at 6 months was evident at meta-analysis. Dienogest treatment compared with GnRHa was associated with a lower rate of hot flashes and a trend to lower incidence of vaginal dryness. [ABSTRACT FROM AUTHOR]

Purpose: Random start protocols are commonly used for oocyte cryopreservation in women with cancer. However, albeit generally reassuring, available evidence is still insufficient to rule out a sub-optimal cycle outcome. This study aimed to compare follicular steroidogenesis between women initiating the random start protocol in the luteal phase and those initiating in the follicular phase. Methods: Consecutive women with cancer scheduled for oocyte cryostorage were prospectively recruited. We excluded those requiring a concomitant letrozole assumption. All women received a standardized protocol with recombinant FSH and GnRH antagonists. At the time of oocyte retrieval, follicular fluids were pooled, and a sample was collected and frozen at −80 °C. All samples were assayed concomitantly after thawing by liquid chromatography-tandem mass spectrometry. The concentration of 15 different steroid hormones was determined. Results: Seventy-one women were recruited. Thirty-three initiated the ovarian stimulation in the luteal phase, while the remaining 38 initiated in the follicular phase. Baseline characteristics were generally similar. Cycle outcome did also not differ; the median (interquartile range) number of frozen mature oocytes was 9 (5–14) and 10 (5–21), respectively (p = 0.42). None of the 15 tested steroid hormones differed. Conclusions: The endocrine microenvironment surrounding oocytes is not markedly influenced by the phase of the menstrual cycle at the initiation of ovarian stimulation. This result further supports the validity of random start protocols. [ABSTRACT FROM AUTHOR]

Purpose: The incidence of birth defects is increased in children born after assisted reproductive technologies (ART). However, changes in ART over time could influence this incidence. To investigate this issue, we present the frequency and trends of birth defects in ART and natural pregnancies in Lombardy, Northern Italy, during the period 2014–2020. Methods: This is a population-based study using automated system of healthcare utilization (HCU) databases. ART pregnancies included only those obtained with conventional IVF or ICSI. After identifying the total number of deliveries, the rate of newborns with birth defects was compared between natural and ART pregnancies. A logistic regression model was used to calculate the adjusted odd ratio (OR). Analyses were repeated for every calendar year. Results: Overall, 508,421 deliveries were identified, of which 14,067 (2.8%) were achieved after IVF-ICSI. A decreasing trend in birth defects over time was highlighted. The adjusted OR dropped from 1.40 (95%CI: 1.03–1.91) in 2014 to 0.92 (95%CI: 0.69–1.22) in 2020. During the study period, a significant reduction in multiple pregnancy and in the ratio of ICSI to conventional IVF was also observed, explaining at least in part the positive trend observed for birth defects. Conclusion: The increased risk of birth defects in children born after IVF-ICSI is not steady over time. A decline of this risk emerged in our region. Policy changes in ART may explain this beneficial effect. [ABSTRACT FROM AUTHOR]

Random start protocols are commonly used for oocytes cryopreservation in women with cancer. However, evidence to support their effectiveness is yet modest. This study aims to compare the quality of ovarian response between the ovary carrying the dominant follicle or the corpus luteum (active ovary) and the contralateral ovary (resting ovary). Women with a diagnosis of malignancy who underwent oocytes cryopreservation were reviewed. The main inclusion criterion was the presence of a unilateral dominant follicle or a unilateral corpus luteum on the first day of ovarian hyperstimulation. The primary outcome was the number of mature oocytes retrieved. Intra-patient comparisons between the two ovaries were made using the nonparametric Wilcoxon test for paired data. Forty-three women were included. The number of mature oocytes retrieved from the active and the resting ovaries did not differ, the median [interquartile range—IQR] being 4 [2–7] and 5 [2–8], respectively (p = 0.09). The rate [IQR] of mature oocytes per developed follicle was 58% [40–80%] and 65% [33–87%], respectively (p = 0.42). In addition, no significant difference emerged when repeating the analyses separately for women carrying dominant follicles and for those carrying corpora lutea. This study failed to detect any detrimental effect of the presence of a dominant follicle or a corpus luteus on the ovarian response to hyperstimulation, thus supporting the validity of random start protocols. [ABSTRACT FROM AUTHOR]

Objective: The purpose of this study was to evaluate the feasibility and safety in terms of prognostic significance and perioperative morbidity and mortality of cytoreduction in patients affected by advance ovarian cancer and hepato-biliary metastasis. Methods: Patients with a least one hepatobiliary metastasis who have undergone surgical treatment with curative intent of were considered for the study. Perioperative complications were evaluated and graded with Accordion severity Classification. Five-year PFS and OS were estimated using the Kaplan–Meier curve. Results: Sixty-seven (20.9%) patients had at least one metastasis to the liver, biliary tract, or porta hepatis. Forty-four (65.7%) and 23 (34.3%) patients underwent respectively high and intermediate complexity surgery according. Complete cytoreduction was achieved in 48 (71.6%) patients with hepato-biliary disease. In two patients (2.9%) severe complications related to hepatobiliary surgery were reported. The median PFS for the patients with hepato-biliary involvement (RT = 0 vs. RT > 0) was 19 months [95% confidence interval (CI) 16.2–21.8] and 8 months (95% CI 6.1–9.9). The median OS for the patients with hepato-biliary involvement (RT = 0 vs. RT > 0) 45 months (95% CI 21.2–68.8 months) and 23 months (95% CI 13.9–32.03). Conclusions: Hepatobiliary involvement is often associated with high tumor load and could require high complex multivisceral surgery. In selected patients complete cytoreduction could offer survival benefits. Morbidity related to hepatobiliary procedures is acceptable. Careful evaluation of patients and multidisciplinary approach in referral centers is mandatory. [ABSTRACT FROM AUTHOR]

The aim of the present study was to evaluate the effect of laparoscopic cystectomy on ovarian reserve by means of anti-Müllerian hormone (AMH) serial measurements and to compare AMH values with the number of inadvertently removed follicles in histological specimens. Fifty-two women were enrolled: 34 patients with endometriomas (group 1) and 18 patients with other benign ovarian cysts (group 2). All patients underwent laparoscopic cystectomy performed by a single experienced surgeon. The AMH was measured before, and 1, 3, and 6 months after cystectomy in group 1, and before and 6 months after surgery in group 2. Preoperative AMH levels (mean [standard deviation, SD]) in group 1 (3.39 [2.43] ng/mL) were not significantly different from group 2 (3.74 [2.57] ng/mL; P =.68). In group 1, a significant decrease in AMH levels of 43.4% was observed at 1 month (1.93 [1.36]; P =.003), and of 63.1% at 3 months (1.25 [1.00]; P =.007) postoperatively. The AMH increased not significantly between the third and sixth months in group 1 (+9.4%). Six months after surgery, AMH was reduced by 59.3% compared to baseline values in group 1 (P =.012), and by 29.5% in group 2 (P =.200). A significant difference in the AMH decrease was present between bilateral and monolateral endometriomas (P =.006). There was no correlation between the reduction rate of AMH and the number of follicles inadvertently removed in patients with endometriomas (P =.669). In conclusion, AMH decreases significantly after surgical excision of ovarian endometriomas. The postoperative decrease does not appear to correlate with the amount of ovarian tissue inadvertently excised with the endometrioma wall. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the incidence of infectious complications and effect of prophylactic antibiotic administration during operative hysteroscopic procedures. Methods: A multicentric randomized controlled trial was conducted between January 2012 and December 2013. Women (n = 180) affected by endometrial hyperplasia, myomas, or endometrial polyps undergoing operative hysteroscopy were randomized to receive cefazolin 2 g intravenously 30 minutes prior to the procedure (n = 91) and no treatment (n = 89). Results: No statistical difference in terms of postoperative fever (2.4% vs 2.3%, P = .99), endometritis (0% vs 0%), pain (6.0% vs 10.4%, P = .40), cervicitis-vaginitis (0% vs 0%), pelvic abscess (0% vs 0%), pelvic inflammatory disease (0% vs 0%), and bleeding (0% vs 0%) was noticed. No statistical difference in terms of side effects attributable to antibiotic prophylaxis such as allergy (0% vs 4.8%, P = .12), nausea (10.7% vs 17.4%, P = .27), vomiting (3.6% vs 4.6%, P = .99), diarrhea (4.8% vs 5.4%, P = .99), cephalea (9.5% vs 3.5%, P = .13), dizziness (4.8% vs 2.3%, P = .44), and meteorism (5.4% vs 3.4%, P = .99) was noticed. Conclusion: The results of the current study support the recommendation not to prescribe routine antibiotic prophylaxis prior to operative hysteroscopy. [ABSTRACT FROM AUTHOR]

Background: To assess the clinical efficacy and prognostic outcome of neoadjuvant chemotherapy (NACT) plus radical surgery (RS) as front line treatment in patients with FIGO stage III cervical cancer (CC). Methods: In this retrospective study, 52 FIGO stage III CC patients treated from 2005 to 2015 were included. All patients received platinum-based chemotherapy. Patients reporting clinical response or stable disease after NACT underwent to RS and bilateral systematic pelvic lymphadenectomy with or without aortic lymphadenectomy or anterior exenteration. Patients with progressive disease underwent palliative management. Results: After NACT, clinical response was observed in 23 patients (44 %): 4 (7.7 %) complete and 19 (36.5 %) partial responses, respectively. Also, 15 patients (28.8 %) had stable disease and 14 (26.9 %) showed disease progression. RS was performed in 40 cases (76.9 %): respectively, 28 (70 %) and 7 (17.5 %) underwent type C2 and D radical hysterectomy, while 5 patients (12.5 %) underwent anterior exenteration. At pathological evaluation, 23 patients (57.5 %) had positive pelvic nodes and 4 (10 %) also had positive aortic nodes. In 6 patients (15 %), moderate-severe (G3-G5) complications occurred. A total of 27 patients (67.5 %) received adjuvant therapy: 16 patients (40 %) received chemotherapy, 10 (25 %) received chemoradiation and 1 (2.5 %) received radiotherapy. Disease relapse occurred in 24 cases (60 %). After follow-up period of 60 months, the median OS of the whole population included was 37 months. Among the 40 surgically treated patients, median OS and DFS were 48 and 23 months, respectively. Conclusions: NACT plus RS represent a valid alternative with acceptable morbidity for patients with stage III CC. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to evaluate the feasibility and safety of type B radical hysterectomy (RH) in the management of patients affected by locally advanced cervical cancer with favorable prognostic factors (tumor diameter <40 mm, negative nodes, or lymphovascular space involvement) and clinical response to neoadjuvant chemotherapy (NACT). Methods: The data of women undergoing platinum-based NACT followed by RH plus bilateral systematic pelvic lymphadenectomy were collected. Patients undergoing type B RH (Group A) were compared with those undergoing type C RH (Group B); a propensity-matched comparison (1:1) was carried out to minimize selection biases. Postoperative complications were reported and 5-year survival outcomes were assessed using the Kaplan-Meier model. Results: Thirty-six node-negative patients undergoing type B RH (Group A) were compared with 36 propensity-matched patients undergoing type C RH (Group B). The bladder dysfunction rate was significantly lower in Group A compared with Group B (13.9 vs. 69.4 %; p < 0.0001), and no statistically significant difference in 5-year overall survival (OS) and disease-free survival (DFS) between groups was reported (OS 93.0 vs. 96.7 %, p = 0.42; DFS 88.6 and 85.5 %, p = 0.77). Conclusions: Type B RH after NACT in well-selected patients is a safe procedure that upholds the results of type C, reducing operative time and late postoperative morbidity, without detrimental effect on survival. Further prospective trials are warranted to confirm our results on a large scale. [ABSTRACT FROM AUTHOR]

Despite the dramatic improvements achieved in cancer treatment through a better understanding of the tumor biology, ovarian cancer is still characterized by a poor prognosis: most patients diagnosed with this disease will ultimately die from it. In various clinical trials conducted over a time span of two decades, new combinations of conventional chemotherapy regimens have failed to achieve significant improvements in oncologic outcome in ovarian cancer patients. We have now entered an era of 'personalized medicine' in which new medications are designed to specifically target molecular pathways involved in carcinogenesis and cancer progression. Encouraging results in different tumor types have been reported, applying an increasing number of target therapies that are still under evaluation. In this setting, one of the most successfully targeted molecular pathways is tumor angiogenesis. Bevacizumab, a monoclonal antibody binding vascular endothelial growth factor (VEGF), has been recently incorporated in the treatment of primary and recurrent ovarian cancer patients after multiple phase III randomized controlled trials have proven its clinical benefit. Based on these positive results, more anti-angiogenic molecules using different mechanisms of action have been developed and are currently under investigation. Among these molecules, the tyrosine kinases inhibitors are probably the most promising ones. Cediranib is a tyrosine kinase inhibitor targeting VEGF receptors that has been tested in various trials with promising results. The aim of this manuscript is to review the current role of cediranib in the treatment of ovarian cancer and to present an overview of the ongoing clinical trials in this setting. [ABSTRACT FROM AUTHOR]

Purpose: Bacterial vaginosis (BV) is the most prevalent lower genital tract infection in reproductive-age women worldwide. BV is an ecological disorder of the vaginal microbiota characterized microbiologically by replacement of the lactobacilli, predominant vaginal microbiota. It is characterized by a high rate of relapse in sexual active women, and these patients show three or more relapses each year. A healthy vagina is characterized by hydrogen peroxide and acid-producing lactobacilli, which are crucial to maintain the physiological vaginal ecosystem and their depletion speeds up bacterial overgrowth with pH elevation, salidase and amine production, leading to the observed signs and symptoms of BV. The aim of this study is to evaluate the efficacy of long-term vaginal lactobacilli's implementation in restoring and maintaining vaginal microflora and pH and to collect data about prophylactic approach based on probiotics supplementation with lactobacilli.Methods: This is a prospective case-control study, performed between January 2013 and September 2014 at Department of Gynecological Obstetrics and Urologic Sciences of "Sapienza" University of Rome. 250 non-pregnant sexually active women with diagnoses of BV were collected. Patients selected were divided in Group A (125 patients assigned to standard treatment for BV-metronidazole 500 mg orally twice a day for 7 days) and Group B (125 women undergoing the same standard antibiotic regimen followed by vaginal tablets containing Lactobacillus rhamnosus BMX 54). Patients were evaluated after 2, 6, and 9 months (T0, T2, T6, and T9) in term of recurrences rates of BV, vaginal symptoms, re-establishment of healthy vaginal flora, vaginal pH, and treatment tolerability.Results: Vaginal flora was significantly replaced in Group B patients after 2 months comparing with Group A (p = 0.014). These data were confirmed at 6 and 9 months follow-up: patients that underwent prophylactic therapy with NORMOGIN(®) experienced significantly low rate of recurrences comparing with patients treated with antibiotics only (p < 0.001). During follow-up patients continuing supplementation had significant pH decrease respect to other patients (p < 0.001 at 9 months follow-up visit).Conclusions: Probiotic supplementation with vaginal Lactobacillus rhamnosus BMX54 seems to be useful in hindering bacteria growth especially after antibiotic therapy; therefore this intervention may be considered a new prophylactic treatment for preventing recurrence of BV, in particular in high-risk patients. [ABSTRACT FROM AUTHOR]

Background: Women with BRCA1 and BRCA2 mutations have substantially elevated risk of developing breast cancer. The aim of this study was to clarify the role of bilateral risk-reducing mastectomy (BRRM) in reducing breast cancer risk in women carriers of BRCA1 and BRCA2 mutations. Methods: The Pubmed, MEDLINE and Scopus databases were searched to retrieve articles written in the English language. Two investigators independently extracted the characteristics and results of the selected studies. Only prospective trials with available absolute numbers of breast cancer and death events were included. Pooled hazard ratio (HR) with 95 % confidence interval (CI) was calculated using fixed or random effects model. Results: Meta-analysis of four prospective studies, including 2635 patients, demonstrated a significant risk reduction of breast cancer incidence in BRCA1 and BRCA2 mutation carriers receiving BRRM (HR 0.07; 95 % CI 0.01-0.44; p = 0.004). Among patients without previous risk-reducing salpingo-oophorectomy, a significant benefit was similarly recorded (HR 0.06; 95 % CI 0.01-0.41; p = 0.005). Conclusions: Performing BRRM may lead to highly significant risk reduction of breast cancer in BRCA1 and BRCA2 mutation carriers. These data allow clinicians to discuss more in-depth with patients all the available options in order to design better management strategies. [ABSTRACT FROM AUTHOR]

Purpose: To determine incidence, risk factors, indications, outcomes, and complications of emergency peripartum hysterectomy (EPH) performed in a tertiary teaching hospital and to compare the results with literature data. Methods: Retrospective study of 51 patients who underwent EPH at the Department of Gynecology, Obstetrics and Urology of the University of Rome Sapienza, from January 2000 to December 2013. Maternal characteristics of the index pregnancy and delivery, indications for EPH, operative and postoperative complications, maternal and neonatal outcome were acquired by the hospital records. Fisher's and Chi-square tests were performed for statistical analysis. Results: There were 51 EPH out of 23,384 deliveries, for an incidence of 2.2 per 1,000 deliveries during the study period. Forty-nine EPHs were performed after caesarean delivery (CS) and two after vaginal delivery ( p < 0.0001). The most common indications were abnormal placentation (49.0 %), followed by uterine atony (41.2 %), and uterine rupture (9.8 %). Eighty percent of patients who underwent EPH with abnormal placentation had at least one previous CS ( p < 0.01). Twenty-three patients (45.1 %) underwent total hysterectomy, the most frequent indication being abnormal placentation (76 %, p < 0.01). The remaining 28 patients underwent subtotal hysterectomy (54.9 %), the most frequent indication being uterine atony (85.7 %, p < 0.01). Maternal morbidity was 25.5 % and mortality was 5.9 %. Perinatal mortality was 3.9 %. Conclusions: Abnormal placentation was the most common indication for EPH, requiring in most of the cases a total hysterectomy. Previous CS was a risk factor for abnormal placentation and in particular for pathological adherence of the placenta. EPH remains associated with a high incidence of morbidity and mortality. [ABSTRACT FROM AUTHOR]

Background: Ovarian cancers have been recently categorized into types I and II according to a dualistic model of tumorigenesis. Data on the correlation between this classification and clinical outcome are still scarce and controversial. Methods: A retrospective analysis of patients with ovarian cancer treated from 1998 to 2013 and operated by the same surgeon was conducted. Patients were classified into two groups: type I (125 patients), including low-grade serous, mucinous, endometrioid, and clear cell tumors; and type II (286 patients), including high-grade serous tumors, unspecified adenocarcinomas, and undifferentiated carcinomas. Results: Type II patients had a significantly higher incidence of advanced disease than type I (88.4 vs. 65.6 %, P = 0.0001) and required more aggressive surgical procedures. Rates of optimal tumor debulking were almost similar between groups (92.6 vs. 91.7 %, type I vs. II, P = NS). After a median follow-up of 41 months, 207 patients (50.4 %) were alive and 204 (49.6 %) were dead; 79 type I patients (63.8 %) and 237 type II patients (82.7 %) experienced relapse ( P = 0.02). Progression-free survival was significantly different between groups: 25 months for type I vs. 17 months for type II ( P = 0.023). Overall survival was not significantly different between groups, with a median overall survival of 75 months for type I vs. 62 months for type II ( P = 0.116). Conclusions: The dualistic histotype-based classification into types I and II of ovarian cancer does not seem to correlate with prognosis. Different molecular characteristics of type I and II tumors may have therapeutic implications and should be deeply investigated. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: This is the first case-control study on the use of a fibrin sealant (Tisseel) on uterine suture during laparoscopic myomectomy (LM), with the primary endpoint to evaluate the intraoperative bleeding and postoperative blood loss. In addition, we evaluated the time required to achieve hemostasis using Tisseel and how much it can influence operative time. Methods: From December 2009 to January 2011, consecutive patients older than 18 years with symptomatic isolate intramural myoma with maximal diameter ≤6 cm and ≥4 cm and with a sonographically diagnosed free myometrium margin ≥0.5 cm were included in the study. We selected from our institute's database a group of consecutive patients with homogeneous features of the study group, who underwent laparoscopic myomectomy without Tisseel application. Results: Fifteen women with symptomatic myoma were enrolled in the study (group A). Regarding the control group (group B), we selected a homogenous group of 15 patients with the same preoperative characteristics of the study group. Mean operative time was 47.7 min and 62.1 min, for groups A and B respectively ( p < 0.05). Mean time required to achieve complete haemostasis was 195.5 s in group A and 361.8 in control group B ( p < 0.0001). Mean estimated blood loss was 111.3 mL and 230 mL in groups A and B, respectively ( p < 0.05). Mean hemoglobin decrease was 1.36 g/dL and 2.04 g/dL in groups A and B, respectively ( p < 0.05). Conclusions: The use of Tisseel during LM may represent a valid alternative solution for obtaining hemostasis, reducing intra- and postoperative bleeding. Furthermore, it may help the surgeon to obtain a rapid healing of the injured surfaces, probably reducing the use of electrocoagulation and traumatisms. [ABSTRACT FROM AUTHOR]

Concomitant chemoradiotherapy represents the standard treatment for patients affected by locally advanced cervical cancer. Survival rates in patients affected by FIGO stage IVA disease remain poor. Some authors have suggested that neoadjuvant chemotherapy followed by radical surgery might be a valid alternative to standard treatment. The objective of this study was to analyze the feasibility and results obtained by neoadjuvant chemotherapy in patients affected by stage IVA disease. Eighteen patients affected by FIGO stage IVA cervical cancer were treated with 175 mg/m2 paclitaxel and 75 mg/m2 cisplatin every 21 days for three courses followed by radical surgery when feasible. All patients were subjected to the three planned chemotherapy courses. Two patients achieved a complete clinical response, and 10 patients achieved a partial clinical response. Ten patients were subjected to anterior pelvic exenteration, whereas the remaining eight patients were treated with chemotherapy, radiotherapy, and concomitant chemoradiotherapy. The estimated 3-year and 5-year overall survival rates were 47.4% and 31.6%, respectively. Patients eligible for surgery benefited from significantly longer survival rates. Neoadjuvant chemotherapy followed by radical surgery is feasible in approximately half of patients affected by FIGO stage IVA cervical cancer. Overall survival rates appear similar to those reported with concomitant chemoradiotherapy. Patients who are amenable to radical surgery after chemotherapy may benefit from long-term survival rates. [ABSTRACT FROM AUTHOR]

Ovarian cancer disease recurs predominantly in the abdomen, with the spleen usually involved as part of a vast spread of upper-abdominal disease or, less frequently, as an isolated site of disease recurrence. Very few reports are available in the literature on the outcome of patients subjected to splenectomy during secondary cytoreduction. The aim of this study was to identify prognostic factors and to review surgical and clinical data in order to identify those patients who would benefit the most from splenectomy during secondary cytoreduction. This was a retrospective review of platinum-sensitive recurrent epithelial ovarian cancer patients who underwent splenectomy as part of secondary cytoreduction. Surgical and survival data were recorded. Twenty-four patients were identified. Multiple site disease recurrence was observed in 15 patients. The spleen was involved at the hilus in 12 patients; surface and intraparenchymal metastases were equally present. Optimal cytoreduction was achieved in all patients. At a median follow-up of 30 months, median progression-free and overall survival from the time of secondary surgery were 34 and 56 months, respectively. Overall survival was significantly correlated to residual disease at secondary surgery, disease-free survival, consolidation chemotherapy, and type of adjuvant therapy. Splenectomy as part of secondary cytoreduction is a feasible and safe procedure. Secondary cytoreduction in selected groups of patients is confirmed to be associated with high long-term survival rates even when aggressive surgery of the upper abdomen is required. [ABSTRACT FROM AUTHOR]

Purpose: To determine the prognostic impact of microscopic residual disease after neoadjuvant chemotherapy (NACT) in patients undergoing interval debulking surgery (IDS) for advanced epithelial ovarian cancer (AEOC).Patients affected by FIGO stage IIIC–IV ovarian cancer undergoing IDS between October 2010 and April 2016 were selected. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier analysis.In total, 98 patients were identified. Four patients (4.1%) were considered inoperable. Overall, 67 patients (out of 94; 71.3%) had macroscopic disease, equating Chemotherapy Response Score (CRS) 1 and 2, 7 (7.4%) had microscopic residuals, equating CRS3, rare CRS2, while 20 (21.3%) had both microscopic and macroscopic disease. Median OS and PFS were, respectively, 44 and 14 months in patients with no macroscopic residual disease (RD = 0) compared to 25 and 6 months, in patients with RD > 0 (OS: p = 0.001; PFS: p = 0.002). The median PFS was 9 months compared to 14 months for patients with more or less than 3 areas of microscopic disease at final pathologic evaluation (p = 0.04). The serum Ca125 dosage after NACT was higher in patients with RD > 0 compared to those without residue (986.31 ± 2240.7 µg/mL vs 215.72 ± 349.5 µg/mL; p = 0.01).Even in the absence of macroscopic disease after NACT, the persistence of microscopic residuals predicts a poorer prognosis among AEOC patients undergoing IDS, with a trend towards worse PFS for patients with more than three affected areas. Removing all fibrotic residuals eventually hiding microscopic disease during IDS represents the key to improving the prognosis of these patients.Methods: To determine the prognostic impact of microscopic residual disease after neoadjuvant chemotherapy (NACT) in patients undergoing interval debulking surgery (IDS) for advanced epithelial ovarian cancer (AEOC).Patients affected by FIGO stage IIIC–IV ovarian cancer undergoing IDS between October 2010 and April 2016 were selected. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier analysis.In total, 98 patients were identified. Four patients (4.1%) were considered inoperable. Overall, 67 patients (out of 94; 71.3%) had macroscopic disease, equating Chemotherapy Response Score (CRS) 1 and 2, 7 (7.4%) had microscopic residuals, equating CRS3, rare CRS2, while 20 (21.3%) had both microscopic and macroscopic disease. Median OS and PFS were, respectively, 44 and 14 months in patients with no macroscopic residual disease (RD = 0) compared to 25 and 6 months, in patients with RD > 0 (OS: p = 0.001; PFS: p = 0.002). The median PFS was 9 months compared to 14 months for patients with more or less than 3 areas of microscopic disease at final pathologic evaluation (p = 0.04). The serum Ca125 dosage after NACT was higher in patients with RD > 0 compared to those without residue (986.31 ± 2240.7 µg/mL vs 215.72 ± 349.5 µg/mL; p = 0.01).Even in the absence of macroscopic disease after NACT, the persistence of microscopic residuals predicts a poorer prognosis among AEOC patients undergoing IDS, with a trend towards worse PFS for patients with more than three affected areas. Removing all fibrotic residuals eventually hiding microscopic disease during IDS represents the key to improving the prognosis of these patients.Results: To determine the prognostic impact of microscopic residual disease after neoadjuvant chemotherapy (NACT) in patients undergoing interval debulking surgery (IDS) for advanced epithelial ovarian cancer (AEOC).Patients affected by FIGO stage IIIC–IV ovarian cancer undergoing IDS between October 2010 and April 2016 were selected. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier analysis.In total, 98 patients were identified. Four patients (4.1%) were considered inoperable. Overall, 67 patients (out of 94; 71.3%) had macroscopic disease, equating Chemotherapy Response Score (CRS) 1 and 2, 7 (7.4%) had microscopic residuals, equating CRS3, rare CRS2, while 20 (21.3%) had both microscopic and macroscopic disease. Median OS and PFS were, respectively, 44 and 14 months in patients with no macroscopic residual disease (RD = 0) compared to 25 and 6 months, in patients with RD > 0 (OS: p = 0.001; PFS: p = 0.002). The median PFS was 9 months compared to 14 months for patients with more or less than 3 areas of microscopic disease at final pathologic evaluation (p = 0.04). The serum Ca125 dosage after NACT was higher in patients with RD > 0 compared to those without residue (986.31 ± 2240.7 µg/mL vs 215.72 ± 349.5 µg/mL; p = 0.01).Even in the absence of macroscopic disease after NACT, the persistence of microscopic residuals predicts a poorer prognosis among AEOC patients undergoing IDS, with a trend towards worse PFS for patients with more than three affected areas. Removing all fibrotic residuals eventually hiding microscopic disease during IDS represents the key to improving the prognosis of these patients.Conclusion: To determine the prognostic impact of microscopic residual disease after neoadjuvant chemotherapy (NACT) in patients undergoing interval debulking surgery (IDS) for advanced epithelial ovarian cancer (AEOC).Patients affected by FIGO stage IIIC–IV ovarian cancer undergoing IDS between October 2010 and April 2016 were selected. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier analysis.In total, 98 patients were identified. Four patients (4.1%) were considered inoperable. Overall, 67 patients (out of 94; 71.3%) had macroscopic disease, equating Chemotherapy Response Score (CRS) 1 and 2, 7 (7.4%) had microscopic residuals, equating CRS3, rare CRS2, while 20 (21.3%) had both microscopic and macroscopic disease. Median OS and PFS were, respectively, 44 and 14 months in patients with no macroscopic residual disease (RD = 0) compared to 25 and 6 months, in patients with RD > 0 (OS: p = 0.001; PFS: p = 0.002). The median PFS was 9 months compared to 14 months for patients with more or less than 3 areas of microscopic disease at final pathologic evaluation (p = 0.04). The serum Ca125 dosage after NACT was higher in patients with RD > 0 compared to those without residue (986.31 ± 2240.7 µg/mL vs 215.72 ± 349.5 µg/mL; p = 0.01).Even in the absence of macroscopic disease after NACT, the persistence of microscopic residuals predicts a poorer prognosis among AEOC patients undergoing IDS, with a trend towards worse PFS for patients with more than three affected areas. Removing all fibrotic residuals eventually hiding microscopic disease during IDS represents the key to improving the prognosis of these patients. [ABSTRACT FROM AUTHOR]