Chemotherapy with cisplatin and paclitaxel in locally advanced cervical cancer: has this regimen still a role as neoadjuvant setting?

AIM: Neoadjuvant chemotherapy represents a promising alternative to concomitant chemo-radiation therapy in locally advanced cervical cancer patients. The aim of this study was the evaluation of pathologic response rates, toxicity and predictors of response in locally advanced cervical cancer patients treated with neoadjuvant cisplatin and paclitaxel followed by radical surgery. METHODS: Fourteen patients with stage IB2 to IIB cervical cancer received three cycles of cisplatin 75 mg/m2 and paclitaxel 175 mg/m2 intravenously every three weeks followed by radical hysterectomy and bilateral pelvic lymphadenectomy. Toxicity, pathologic response and predictors of response were evaluated. RESULTS: Chemotherapy related toxicities we-re as follows: alopecia 100%, asthenia 35.7%; nausea and vomiting 14.3%; paclitaxel hypersensitivity 7.1%, neutropenia 7.1%. Optimal, partial and no pathologic response was achieved in 21.4%, 64.3% and 14.2% of the patients, respectively. Based on lack of pathologic risk factors, 43% of the patients did not receive any adjuvant radiotherapy. Better response rates were obtained in patients with stage IIB, tumor diameter <5 cm, Hb >12 g/dL and SCC antigen <1.5 mg/dL. None of these variables reached statistical significance. CONCLUSION: Neoadjuvant chemotherapy with cisplatin and paclitaxel in locally advanced cervical cancer appeared to be well-tolerated. Even though the TIP regimen has been shown to be more effective than the TP regimen in randomized controlled prospective trial, the TP regimen remains a reasonable alternative in those patients in whom the TIP regimen is considered or shown to be too toxic.

Norethisterone acetate in the treatment of colorectal endometriosis: a pilot study.

BACKGROUND: This pilot study evaluates the efficacy of norethisterone acetate in treating pain and gastrointestinal symptoms of women with colorectal endometriosis. METHODS: This prospective study included 40 women with colorectal endometriosis, who had pain and gastrointestinal symptoms. Patients received norethisterone acetate (2.5 mg/day) for 12 months; in case of breakthrough bleeding, the dose of norethisterone acetate was increased by 2.5 mg/day. The degree of patient satisfaction with treatment (primary end-point) and the changes in symptoms (secondary end-point) were evaluated. Side effects of treatment were recorded. RESULTS: Norethisterone acetate determined a significant improvement in the intensity of chronic pelvic pain, deep dyspareunia, dyschezia. Treatment determined the disappearance of symptoms related to the menstrual cycle (dysmenorrhea, constipation during the menstrual cycle, diarrhoea during the menstrual cycle and cyclical rectal bleeding). The severity of diarrhoea, intestinal cramping and passage of mucus significantly improved during treatment. On the contrary, the administration of norethisterone acetate did not determine a significant effect on constipation, abdominal bloating and feeling of incomplete evacuation after bowel movements. At the completion of treatment, 57% of the patients with diarrhoea or diarrhoea during the menstrual cycle continued the treatment with norethisterone acetate compared with 17% of the patients with constipation or constipation during the menstrual cycle. CONCLUSIONS: In some patients with bowel endometriosis, the administration of norethisterone acetate may determine a relief of pain and gastrointestinal symptoms. This therapy has greater benefits in patients with gastrointestinal symptoms related to the menstrual cycle, diarrhoea and intestinal cramping.

Letrozole combined with norethisterone acetate compared with norethisterone acetate alone in the treatment of pain symptoms caused by endometriosis.

BACKGROUND: The available data on effectiveness of aromatase inhibitors in treating pain symptoms related to endometriosis is limited. We compared the efficacy and tolerability of the aromatase inhibitor letrozole combined with norethisterone acetate versus norethisterone acetate alone in treating pain symptoms. METHODS: This prospective, open-label, non-randomized trial included 82 women with pain symptoms caused by rectovaginal endometriosis. Patients received either a combination of letrozole and norethisterone acetate (group L) or norethisterone acetate alone (group N) for 6 months. Changes in pain symptoms during treatment and in the 12 months of follow-up were evaluated. Side effects of each treatment protocol were recorded. RESULTS: Intensity of chronic pelvic pain and deep dyspareunia significantly decreased during treatment (P < 0.001 versus baseline by 3 months) in both study groups. At both 3- and 6-month assessment, the intensity of chronic pelvic pain (P < 0.001, P = 0.002, respectively) and deep dyspareunia (P < 0.001, P = 0.005, respectively) was significantly lower in group L than group N. At completion of treatment, 63.4% of women in group N were satisfied with treatment compared with 56.1% in group L (P = 0.49). Pain symptoms recurred after the completion of treatment; at 6-month follow-up no difference was observed in the intensity of pain symptoms between the groups. Adverse effects were more frequent in group L than in group N (P = 0.02). CONCLUSIONS: The combination drug regimen was more effective in reducing pain and deep dyspareunia than norethisterone acetate; however, letrozole caused a higher incidence of adverse effects, cost more and did not improve patients' satisfaction or influence recurrence of pain.

A new technique for surgical treatment of stress urinary incontinence: the TVT-secur.

AIM: The aim of this pilot study was to evaluate the surgical feasibility of a new device for the treatment of stress urinary incontinence, named tension-free vaginal tape (TVT)-secur. Fifteen patients underwent the TVT-secur procedure. METHODS: The mean operation time was 13 minutes (range, 7-21). There was no intraoperative complication. Duration of surgery was shorter in the second half of cases than in the first eight procedures. RESULTS: The number of technical difficulties experienced by the surgeon was significantly higher in the first 8 procedures than in the following 7 cases; these difficulties included bleeding reducing the identification of anatomical structures, dislocation or removal of the mesh tape during the removal of the inserter, need to repeat the procedure. The cure rate, determined by urodynamic study, was 80% at 3 months follow-up. The cought test was negative in 86.7% of women at 6 months follow-up. CONCLUSION: The implantation of the TVT-secur is simple, safe, and minimally invasive with a short learning curve.

Does transvaginal ultrasonography combined with water-contrast in the rectum aid in the diagnosis of rectovaginal endometriosis infiltrating the bowel?

BACKGROUND: The aim of this study was to determine whether adding water-contrast in the rectum during transvaginal ultrasonography (RWC-TVS) improves the diagnosis of rectal infiltration in women with rectovaginal endometriosis. METHODS: This prospective study included 90 women, with suspect rectovaginal endometriosis, who underwent operative laparoscopy. TVS and RWC-TVS were independently performed by different investigators. RWC-TVS was performed by injecting saline solution into the rectal lumen under ultrasonographic control through a 6-mm catheter. Presence of rectovaginal nodules, presence and degree of rectal infiltration, and the largest diameter of the bowel nodules were evaluated. Ultrasonographic results were compared to surgical and histological findings. RESULTS: Although RWC-TVS had higher accuracy than TVS in diagnosing rectovaginal endometriosis, the difference between the two techniques was not statistically significant. RWC-TVS was significantly more accurate than TVS in determining the presence of endometriotic infiltration reaching at least the muscular layer of the rectal wall. The sensitivity of RWC-TVS in identifying rectal lesions was 97%, the specificity 100%, the positive predictive value 100% and the negative predictive value 91.3%. RWC-TVS caused a higher intensity of pain than TVS. CONCLUSIONS: RWC-TVS determines the presence of rectovaginal nodules infiltrating the rectal muscularis propria more accurately than TVS; RWC-TVS could be used when TVS cannot exclude the presence of rectal infiltration.

The risk of premalignant and malignant pathology in endometrial polyps: should every polyp be resected?

AIM: There is no wide consensus in the literature on the clinical significance and management of symptomatic and asymptomatic polyps. Aims of the study are to evaluate frequency of premalignant and malignant histo-pathologic features in endometrial polyps resected hysteroscopically and identify clinical parameters able to predict final histopathologic diagnosis. METHODS: Clinical data and pathologic report of 90 consecutive operative hysteroscopies performed on women with endometrial polyps were collected. Frequency of premalignant and malignant histopathologic features on the polyps were calculated and relation to clinical risk factors analyzed. RESULTS: The frequency of premalignant and malignant histopathologic features in polyps was 6.7% and 2.2% respectively. Owing to the small sample size no statistical analysis to detect clinical risk factor for premalignant or malignant histopathologic features could be performed. CONCLUSION: Frequency of premalignant and malignant histopathologic features in symptomatic and asymptomatic patients is not negligible. Reported clinical risk factors for malignant degeneration of endometrial polypoid lesions are the same as those reported for endometrial cancer and are very common in patients with endometrial polyps. Every endometrial polyp should be resected.

Hydrothorax following ovarian hyperstimulation for assisted reproduction. Case report and review of the literature.

In case of ovarian hyperstimulation syndrome, the high incidence of dyspnea in relation with ascites and enlarged ovaries should not justify omission of thoracic evaluation. This manuscript reviews the pathogenesis and clinical presentation of hydrothorax following controlled ovarian hyperstimulation. In addition, we describe the case of a 33-year-old woman with a right massive hydrothorax resulting from controlled ovarian hyperstimulation for intracytoplasmic sperm injection.

Efficacy on menopausal neurovegetative symptoms and some plasma lipids blood levels of an herbal product containing isoflavones and other plant extracts.

OBJECTIVES: To assess the efficacy of a product containing isoflavones and other plant extracts (BIO) on whole menopausal symptomatology and plasma lipids profile. METHODS: Multicentre, randomized, double blind, placebo controlled clinical investigation on 125 menopausal women randomly assigned to two groups treated for 6 months with placebo or one tablet daily of an herbal product containing 72 mg/dose of isoflavones of different plants origin and other plant extracts (BIO). Primary end-point: Kupperman Menopause Index (KI) variations; secondary end-point: activity on plasma lipids profile and clinical global impression (CGI) on efficacy and tolerability by investigators and patients. The usual parametric test (paired Student t test) was performed to evaluate the significance. In case of non-applicability of parametric tests, the non-parametric Mann-Whitney U test was used. The differences where considered significant at p<0.05 level. RESULTS: At the end of treatment in both groups KI showed a significant decrease (p<0.001). However, in the BIO group the KI reduction was significantly higher (p=0.0265) than in the placebo group after 4 and 6 months of treatment. In the BIO treated patients the LDL cholesterol showed a borderline but not significant reduction compared to placebo (p=0.0608) and triglyceride (TG) a significant (p=0.0151) decrease compared to placebo. The investigator's and patient's CGI on BIO group where superior as compared to placebo. Clinical tolerability was good in booth groups. CONCLUSION: On the basis of positive effects on KI and lipids profile as well as of good clinical tolerability, BIO can be considered one of the possible alternative therapy for conventional HRT.

Deep dyspareunia and sex life after laparoscopic excision of endometriosis.

BACKGROUND: Among subjects with endometriosis and deep dyspareunia (DD), those with endometriosis of the uterosacral ligament (USLE) have the most severe impairment of sexual function. This study examines the effect of laparoscopic excision of endometriosis on DD and quality of sex life. METHODS: This observational cohort prospective study included 68 women with endometriosis suffering DD (intensity of pain >or= 6 on a 10-cm visual analogue scale). Patients underwent laparoscopic full excision of endometriosis. Following surgery, they were asked to use nonhormonal contraception devices. Before surgery, at 6- and at 12-month follow-up, patients answered a self-administered questionnaire based on the Sexual Satisfaction Subscale of the Derogatis Sexual Functioning Inventory. RESULTS: At 6- and 12-month follow-up, women with and without USLE had significant improvement in DD. Subjects with USLE reported increased variety in sex life, increased frequency of intercourse, more satisfying orgasms with sex, relaxing more easily during sex and being more relaxed and fulfilled after sex. Similar improvements were observed among women without USLE; however, for some variables statistical significance was not reached. CONCLUSIONS: Surgical excision of endometriosis improves not only DD but also the quality of sex life.

Antiangiogenic therapies in endometriosis.

Oral contraceptives, androgenic agents, progestins and gonadotropin-releasing hormone analogues have all been successfully used in the treatment of endometriosis. However, none of these drugs can eradicate the disease. It is widely accepted that the growth of newly formed blood vessels is essential for the establishment and growth of endometriotic lesions; therefore, inhibition of angiogenesis may offer a new option for treatment of this disorder. In this paper, we reviewed anti-vascular endothelial growth factor agents and other angiostatic drugs (i.e., TNP470, endostatin, anginex, rapamycin) that have been studied in laboratory and animal models of endometriosis. Although preliminary results are interesting, further investigations are required before clinical trials can be planned in humans.

The impact of obesity on surgery in gynecological oncology: a review.

Surgery represents a mainstay in the treatment of gynecological cancers. It is a common belief that operating on obese patients causes more peri- and postoperative complications than operating on nonobese patients. The surgical outcome in gynecological oncology can be evaluated by comparing intra- and postoperative complications, extent of lymphadenectomy, negativity of the specimens' margins, and percentage of optimal debulking between obese and nonobese patients affected by malignancies at the same stage. In this review, we analyze how obesity affects the feasibility of a correct oncologic procedure in case of cervical, endometrial, and ovarian cancer. We also describe the techniques that have been suggested in the literature to improve the surgical outcome on obese patients.

Asthma in women with endometriosis.

INTRODUCTION: This study aimed to investigate asthma prevalence and severity in women with and without endometriosis. METHODS: Before laparoscopy, asthma prevalence was evaluated in 879 women of reproductive age, undergoing surgery because of benign gynaecological conditions. Diagnosis of bronchial asthma was based on the American Thoracic Society criteria; asthma severity was classified in four categories according to the 2002 Global Initiative for Asthma guidelines. Asthmatic patients completed the Living with Asthma Questionnaire (LWAQ). Endometriosis was confirmed histologically and classified according to the revised American Fertility Society criteria. RESULTS: There were no significant differences in age, smoking status, and other demographic and health characteristics between patients with endometriosis (n = 467) and controls (n = 412). Asthma prevalence was similar in women with (23/467, 4.9%; 95% CI, 3.1-7.3) and without (22/412, 5.3%; 95% CI, 3.4-8.0; P = 0.781) endometriosis. Asthma severity was similar in women with and without endometriosis, with 12 (52.2%) women with endometriosis and 13 (59.1%) controls being in the intermittent (mildest) degree of severity. No significant difference was observed between women with and without endometriosis in the LWAQ total score. CONCLUSIONS: Women with endometriosis do not have an increased risk of having asthma.

How complete is full thickness disc resection of bowel endometriotic lesions? A prospective surgical and histological study.

BACKGROUND: This study aims to evaluate the completeness of full thickness disc resection in the treatment of deep endometriotic bowel lesions. METHODS: This study comprised 16 women with bowel endometriotic lesions requiring segmental resection. For the purpose of the study, before intestinal resection, nodulectomy was performed. The presence of endometriotic infiltration in direct continuity with the removed nodule and the presence of fibrosis in the area surrounding the nodule were histologically evaluated. RESULTS: In seven out of 16 cases (43.8%; 95% CI, 19.8-70.1), endometriosis was found in the bowel wall adjacent to the site of nodulectomy; the infiltration was visible in the muscular layer in all cases. In cases of incomplete nodulectomy, the muscular layer of the bowel segment surrounding the endometriotic nodule contained limited or no fibrosis. CONCLUSIONS: Full thickness disc resection is not complete in > or =40% of women with bowel endometriosis. Our finding that fibrosis in the muscular layer, the main landmark during surgical resection, does not always surround bowel endometriotic lesions might explain why incomplete resection may occur.