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Objective: To assess the safety of a nutraceutical compound containing soy isoflavones and Lactobacillus sporogenes on endometrium, breast and liver function., Setting: Outpatient Menopausal Clinic., Study Design: 130 healthy postmenopausal women suffering from menopausal symptoms were randomized to receive soy isoflavones 60 mg and Lactobacillus sporogenes 1 billion spores (group E: 65 women) or calcium and vitamin D₃ (group C: 65 women). Safety of the treatment was assessed at baseline and after 1 year taking into account endometrial thickness, mammographic density, serum levels of transaminases, γ-GT and bilirubin. Efficacy of the treatment was evaluated rating the score of menopausal symptoms at baseline and every 3 months. The statistical analysis was carried out with χ², Fisher exact's test and ANOVA., Results: After 12 months of treatment mammographic density, endometrial thickness and hepatic function did not show significant differences between groups, while menopausal symptoms were progressively and significantly reduced in severity and frequency during treatment with soy isoflavones plus Lactobacillus sporogenes versus calcium plus vitamin D₃., Conclusion: A 12 months treatment with a nutraceutical compound based on isoflavones and Lactobacillus sporogenes at the recommended doses is safe for endometrium, mammary glands and liver function in postmenopausal women.

Aim: The aim of this paper was to evaluate the activity of magnolia bark extract added to isoflavones and lactobacilli in menopausal women with typical menopausal symptoms and concomitant borderline psychoaffective and/or sleep alterations, of severity not requiring a psychopharmacological therapy., Methods: Menopausal women were enrolled in a multicenter, controlled, parallel-group study and randomized to E (isoflavones 60 mg + Lactobacillus sporogenes + calcium and vitamin D3 - Estromineral, Rottapharm Madaus) versus ES (magnolia bark extract + E - Estromineral serena) 1 tablet/night for 12 weeks., Results: In 91 gynecological centers, 634 women were treated (300 with E and 334 with ES), mean age 53.1 years and Body Mass Index (BMI) 25.2 kg/m2; 28% were past hormone replacement therapy HRT users and 3.3% had had a previous breast cancer. Both treatments significantly reduced versus baseline the symptoms tested at 0, 4, 8 and 12 weeks. E and ES showed a similar efficacy on hot flushing, nocturnal sweating with awakenings, palpitations and vaginal dryness. ES was more active on insomnia, irritability, anxiety, depressed mood, asthenia and loss of libido. Woman's well-being and physician's final judgment were positive in >70% in both groups. The rate of adverse events was 1% with E (metrorrhagia, cramps and constipation) and 1.2% with ES (gastralgia, blood loss, constipation and breast tension)., Conclusion: Isoflavones are effective in improving the classical menopause symptoms. The clinical activity of magnolia bark extract on the relevant psycho-affective symptoms, particularly anxiety, irritability and insomnia, was evident. ES in the mild psychical alterations that can occur in climacterium avoids to run the known dependence risks linked to psychopharmacological agents withdrawals.

Unlabelled: The aim of this study was to determine whether modulation of expression of cell adhesion molecules may occur in neoplastic transformation of endometrial epithelium., Materials and Methods: E-Cadherin and α-catenin protein expression were evaluated by immunohistochemistry in 124 biopsies representative of normal, hyperplastic and neoplastic endometrium., Results: In normal endometrium (proliferative, secretive and atrophic endometrium) strong homogeneous, E-cadherin and α-catenin reactivity was found; 58.3% and 66.6% of biopsies representative of simple hyperplastic endometrium were homogeneously positive for E-cadherin and α-catenin, respectively, whereas no samples representative of atypical hyperplasia showed evidence of homogeneous E-cadherin or α-catenin expression. No expression of homogeneous E-cadherin was seen in endometrial adenocarcinomas; α-catenin homogeneous immunostaining was observed in 2 G1 and 2 G2 out of 22 adenocarcinoma samples (18.2%). A homogeneous co-expression of both molecules was seen only in normal (70%) and simple hyperplastic (46%) endometrium., Conclusion: These results suggest that E-cadherin and α-catenin down-regulation might be associated with neoplastic transformation of endometrial tissues.

Background: Mucinous cystadenoma of the ovary constitutes about 15% of ovarian tumors. It is more common in women between 20 and 40, but is rare in teenagers and exceptional in pre-menstrual girls. Malignant transformation is possible in 5-10% of cases. Spontaneous or iatrogenic breaks are more common. It makes the different diagnosis of pseudomixoma peritonei more difficult., Case Report: A 13-year-old girl came to the National Cancer Institute "Regina Elena" of Rome, with increasing abdominal distension over 2 months. The abdominal mass was removed and a left salpingo-oophorectomy was performed. Histological examination of the mass revealed a 40-cm diameter mucinous cystadenoma of the ovary., Conclusion: The rapid enlargement of the ovarian mass, the young age and the difficulty of certain pre-operative diagnosis, make this case interesting. Management of this pathology and fertility-conserving treatment need careful follow-up because of the possibility of recurrence in the remaining ovary.

Breast carcinoma survivors suffering from hot-flashes experience a negative impact on their quality of life. Antidepressants have recently been proven to be effective in these women, significantly reducing the vasomotor symptoms. With this in mind, a single-arm clinical trial low-dose regimen of Fluoxetine (10 mg/day for 4 weeks) was given to twenty symptomatic breast cancer patients. Among the 12 women evaluated at the end of treatment, a statistically significant reduction of the mean number of daily hot-flashes (-36.3%, p = 0.001) and hot-flashes score (-46.2%, p = 0.0006) had been detected as compared to the baseline data. Although the dosage of Fluoxetine used in these trials was lower than earlier published, it should be noted that these positive results were achieved without any relevant side effects.

Primary malignant lymphoma of the uterine cervix is an extremely rare condition, with only about 100 cases reported in international literature. The diagnosis can be difficult, as stated by some authors finding only 10 up to 40% of cases of cervical lymphoma diagnosed by positive cytology. We present a case of primary malignant lymphoma of the cervix in a 57 year old woman treated at the Department of Gynecological Oncology at the Regina Elena Cancer Institute in Rome, with a sudden and unfavorable outcome.

Background: Evalutation of the efficacy of laser conization for cervical high-grade squamous intraepithelial lesions (Hg-SIL)., Methods: A retrospective evaluation. Case collection: A total of 77 women, 47 outpatients and 30 inpatients with endocervical CIN3 or CIN2, were treated by carbon dioxide (CO2) laser between 1993 and 1995. A preoperative diagnosis has been made by means of Pap-smear, colposcopy and marked biopsy. In 47 cases a laser conization was performed in Day Surgery, without vessel constrictors or local anesthetics. In 30 cases a narcosis (Diprivan ) was induced. The former were discharged 2-3 hours and the latter 24 hours after treatment., Results: The histological examination confirmed preoperative diagnosis in 64 (86.5%) cases and negligible one grade discrepancy was reported in 7 cases (6 over- and 1 underestimated); missed invasion and no free margins were reported in the remaining 4 and 2 patients respectively, so these latter 6 patients were submitted to other surgical procedures. No serious complications occurred with the exception of mild vaginal postoperative bleeding. During the follow-up of 36-82 months, cervical alterations were described only in 12 out of 71 cases, flat condilomatosy in 8 cases, CIN2 in 2 patients and CIN3 in other 2 patients. At present, all the patients are free of disease., Conclusions: The conization with dioxide laser is a good therapy for cervical intraepithelial neoplasia, even if expensive; infact poor side-effects are observed as well as a very good reliability.

Background: Over the past few years a series of research projects has shown that the scant or deficient immune response in HIV infection may be secondary to reduced cell resistance and/or the uncontrolled formation of free radicals. In line with these findings, subjects with HIV infection present a deficit of polyunsaturated fatty acids (the principal components of cell membranes) and many antioxidating substances, like Vitamin E and glutathione peroxidase. The high incidence of heterosexual transmission of HIV has now shown the close correlation between HIV infection and HPV infection. By analogy, we wanted to ascertain whether these deficits were also present in subjects with HPV infection and dysplastic and neoplastic lesions of the uterine cervix. Published data confirm that a HPV-positive subject has an increased risk, ranging from 40 to 200%, of contracting HIV infection., Methods: Eighty women with HPV infection of the genital tract, at various stages. Blood levels of vitamin E and polyunsaturated fatty acids were measured using gas-chromatography; glutathione was assayed using the spectrophotometric technique., Results: The alternation of the aforesaid parameters is correlated to the progress of infection and increases with the severity of lesions; Statistically significant data were recorded by comparing the group with condylomatosis with patients diagnosed with cervical carcinoma (p<0.001)., Conclusions: The increased possibility that some patients are affected by an association of HPV and HIV depends on the anomalous or scarce function of many immunocompetent cells, as well the quantitative immune deficiency induced by the initial virus and the presence of various mechanisms that facilitate the development of the infection.

Objective: The objective of this study was to determine whether a relationship between the E-caherin molecule and the E-cadherin-associated cytoplasmic molecule, alpha-catenin, could provide additional information in the neoplastic progression of cervical cancer., Methods: In this study we investigated by immunohistochemistry E-cadherin (E-cad) and alpha-catenin (alpha-cat) expression in 57 cervical biopsy samples representative of normal exocervical epithelium, viral (human papillomavirus (HPV) infection) and dysplastic lesions (low- and high-grade lesions), and invasive squamous cell carcinoma. The presence of immunostaining and the pattern of distribution of these molecules were correlated with the histological diagnosis (normal cervical epithelium vs HPV, cervical intraepithelial neoplasia (CIN), and invasive carcinoma)., Results: The correlation between alpha-cat expression and the histological diagnosis was statistically significant (chi2 test, P < 0.0077); moreover, E-cad and alpha-cat distributions were significantly correlated with the histological classification (P < 0.0001 and P < 0.0043, respectively)., Conclusion: These results suggest that not only E-cad but also alpha-cat are associated with the loss of differentiation in CIN and squamous cell carcinomas; thus the coexpression of E-cad and alpha-cat may represent a discriminant of malignant potential and could provide an additional criterion to define high-grade CIN.

Pseudomixoma Peritonei (PMP) is an uncommon neoplasm characterised by mucinous ascites and multifocal amorphous mucous substances involving the peritoneal surface, omentum and bowel loops. Although the origin of the Pseudomixoma Peritonei is still unclear, it could be due to the perforation of an ovarian mucinous cystoadenoma or an appendiceal mucocele. The further pelvic dissemination of the endotumor material, which adhere itself into the peritoneal surface, may induce an intra-abdominal transformation of the peritoneal mesothelium into mucin-producing tissue. A case of Pseudomyxoma Peritonei (PMP) which occurred in a young woman is reported.

Flow cytometric DNA content and proliferative kinetic markers, S-phase fraction (SPF) and thymidine labeling index (TLI), were evaluated in 68 patients with endometrial carcinoma. A high rate of aneuploid tumors was detected (48.4%); median values of SPF and TLI were 6.4 and 6.2, respectively. No significant relationship emerged between ploidy status and proliferative markers in respect to clinical and pathological variables. Aneuploid tumors had a higher recurrence rate than diploid tumors (21.8% vs 9.6%), but the difference was not statistically significant. According to the median value of both kinetic markers, the study population was divided into low and high-risk, where DFS was 100% and 71.4%, respectively (p = 0.05). Furthermore, high-TLI tumors (> 6.2) had a significantly worse DFS (75.4%) than low-TLI (100%) only among patients assigned to Stage I of the disease, regardless of other pathological variables. At multivariate analysis myometrial invasion resulted as an independent and significant factor. Flow cytometric ploidy analysis was useless as a predictive biological parameter and did not add any further prognostic information to the pathologic variables. SPF and TLI values could indicate a subset of women with unexpected poor outcome in a group of patients generally considered at low-risk, i.e. Stage I. If further investigation confirms these data, it could prove useful for therapeutic planning in endometrial cancer patients. At the present time, pathological and clinical factors are still the most reliable predictive parameters.

Among the rhabdomyosarcomas, which represent an uncommon neoplasm of mesoderm origin comprising about 1% of all female genital malignancies, sarcoma botryoides (SB) is an embrional variant usually found in the vagina of infants and young children under 16 years of age. The onset of SB from the uterine cervix is very rare with a peak incidence in the second decade; only a few cases have been published in the international literature so far. The authors report a case of embryonal rhabdomyosarcoma of the uterine cervix which occurred in a young woman treated by radical surgery, followed by adjuvant chemotherapy and radiotherapy.

Background: The role of males who are sexual partners of females with genital human papillomavirus (HPV) infection and premalignant lesions is explored in the present study., Methods: In a period of 6 years, 845 females with genital premalignant and HPV-associated lesions were examined and treated at the Sexual Transmitted Disease Center of S. Gallicano Hospital. The male partners of were asked to attend this Center, and 163 (70%) of them responded. All participants underwent sexual anamnesis, genital inspection and colposcopic examination., Results: Macroscopic lesions were found in 7.4% of the males enrolled. The colposcopic prevalence of HPV infection among the male partners was 21.8% 3 months later among 28 negative patients to the first colposcopic control, 2 were found positive., Conclusions: These data confirm that the colposcopic evaluation of male partners during an HPV infection of the couple is to be considered for the therapeutic assessment and evolution control of the infection in each couple.

DNA nuclear content was evaluated on 46 paraffin-embedded blocks of vulvar cancer by means of flow cytometry. Fifteen of 44 evaluable samples (34%) were found to have an aneuploid DNA pattern. Aneuplody showed a statistically significant relationship with tumor grading (P = 0.0004) and defined a subset of patients who have pathological characteristics of high risk, such as advanced stage of disease, deepest stromal invasion, or positive inguinal nodes. However, when a multivariate regression model was used, ploidy status did not have any prognostic role, while FIGO staging system was confirmed to be the strongest independent prognostic factor (P = 0.009). The integration of a panel of cell kinetic parameters with traditional features is worth investigating on a larger population., (Copyright 1998 Academic Press.)

The authors report a case of Pseudomyxoma Peritonei (PP) which was referred to their attention. PP is a rare pathology which is manifested by an autonomous growth of amorphous mucous material in the peritoneal cavity and serosa. PP may be caused by the perforation of a "mucinous cystoadenoma" with secretion of cellular material capable of implanting itself and spreading throughout the peritoneal cavity, or the presence of a mucocele of the appendix, or lastly the possibility of the intrabdominal transformation of the peritoneal mesothelium into mucin-secreting tissue.

Background: The authors examined 33 patients with symptomatic uterine leiomyomas due to undergo total hysterectomy in order to evaluate the effects of treatment with GnRH analogues on leiomyoma and estrogen and progesterone receptors., Methods: The patients were divided into two groups: one group was treated with leuprolide acetate (Group A) and the other did not receive treatment (Group B)., Results: A significant reduction in the volume of leiomyomas and estrogen and progesterone receptors was noted in patients in Group A., Conclusions: Treatment with GnRH analogues therefore represents a valid aid for patients with uterine leiomyomas and sideropenic anemia awaiting surgery.

The presence of mucous and non-pathologic elements liable to hamper analysis of the smear is one of the main problems in ploidy assessment of precancerous cervical lesions. For our study, we employed a sampling system guided by microcolpohysteroscopy, which we used to identify the pathologic zone and select the morphologically altered elements only. Fifty-five cervical lesions and 6 negative controls were analyzed. All controls and 24 lesions were diploid, 15 polyploid and 16 aneuploid. All but one aneuploid lesions had a histological diagnosis of GIN. We failed to observe any significant difference in the aneuploid percentage of high and low grade lesions while diploid cases decreased in proportion to the severity of the lesion. The samples obtained had the advantage of being representative, technically valid and at the same time extremely suitable for an automated image analysis of ploidy. Thus this new sampling method could be extensively used.

HPV infection of the low genital tract is the most diffuse STD world wide. For this reason it's necessary to follow a simple flow chart to reach a correct diagnosis and to practice an adequate therapy. The authors relate on their experience in the management of a group of patients they have observed in a STD clinic. In this group it was executed a diagnostic protocol including Pap test, in situ hybridization, dot blot and histologic examination on tissue biopsies. From the analysis of the obtained data, the authors state that the Pap test is very useful to start in the diagnostic protocol, for it is precise, inexpensive and allows to identify the patients to follow with further diagnostic procedures such as colposcopy and histologic examination, in order to reach an exhaustive diagnosis and to assess the proper therapy.

The authors report on up to date knowledge of the risk of endometrial carcinoma women operated on mastectomy for breast carcinoma and treated with TAM. Starting from their own clinical and scientific experience, the authors follow a group of such patients with a strict monitoring, to ascertain the eventual comparison of dysplastic and neoplastic endometrial pathologies. The group numbers 18 patients and the aim of the study is to evaluate the importance of hysteroscopy as a diagnostic approach for this iatrogenic pathology. The authors affirm the validity of this partially invasive diagnostic method that has to be integrated with clinical and laboratory parameters that are justified by the cost/benefit ratio always favourable for the diagnosis of a neoplastic pathology.

The immunocytochemical expression of CA 125 in ovarian cysts, serous effusions and peritoneal washings was examined in patients with primary ovarian malignancies (22) and benign gynecologic conditions (96). The immunostaining of CA 125 was assessed in serous ovarian cysts (CA 125 was detected in 3 out of 14 serous ovarian cysts), follicular ovarian cysts (0/5), luteinized cysts (3/3), endometriotic cysts (6/11), serous cystoadenomas (4/4) and mucinous cystoadenomas (0/2). Reactive mesothelial cells (6/6) showed a low but homogeneous staining which was never found in negative peritoneal washings (0/47). Neoplastic cells in positive peritoneal washings were highly positive (20/22), except for 2 mucinous cystoadenocarcinomas. The reactivity of OC 125 with endometrial and reactive mesothelial cells shows the importance of employing a combination of MoAbs to improve conventional morphologic diagnosis.

The authors report a case of bullous erythema observed in a young woman affected with II B stage carcinoma of the cervix, whose clinical course was likely to be a paraneoplastic lesion. The aim of the report is to outline such a rare association between a dermatologic pattern and a gynecologic tumor and to synthesize the literature's data concerning this matter.

Between 1981 and 1988, 58 patients with vulvar carcinoma underwent radical vulvectomy and unilateral inguinal lymphadenectomy. Sixteen patients with inguinal node metastases received complementary radiotherapy as an alternative to pelvic node dissection. They were treated with Co-60 therapy for bilateral inguinal and pelvic lymph nodes. The overall five-year actuarial survival rate in patients without node involvement was 84%; in patients with positive inguinal nodes treated with the combined radiosurgical approach, it was 64%. Patients with 1 node involved had a 74% rate of estimated survival, and those with 2 or more metastatic nodes, considered to be at high risk, had an estimated survival rate of 49%. Only mild to moderate side effects related to the radiation therapy were observed, and in no case was it necessary to interrupt the treatment. In terms of survival, the results obtained in the group of patients with postoperative radiotherapy were better than those normally expected after pelvic lymphadenectomy, and as suggested in recent literature, point to the promising role of irradiation as adjuvant management for vulvar cancer with node involvement.

Twenty-five (10.2%) out of 243 untreated patients with invasive cervical carcinoma were 35 years old or younger. When matching the clinical and pathological variables between the younger and the older women, the former were characterized by a higher rate of Stage IB disease (P = 0.10), G3 and G4 tumors (P = 0.25), bulky lesions (P = 0.05) and node metastases (P = 0.50). In spite of this poorer pathological profile, both the 5-year disease-free survival rate (75%) and survival according to stage of the younger women were similar to those reported in larger series, regardless of the patients' age. No modification of the standard therapy is therefore required in younger patients.

Eighteen cases of endometrial cancer under 45 years were clinically and pathologically reviewed. Epidemiological analysis confirmed obesity as an effective risk factor for this neoplasia. In only three cases the association of adenomatous hyperplasia with endometrial cancer was discovered. These data support the theory that in young women endometrial cancer is not an endocrine related neoplasia.