Side effects screening and early intervention to impact in quality of life of patients with gynecological cancers (HALIS study).

BACKGROUND: Advances in the treatment of gynecological cancers have led to increased survival in patients with gynecological cancers. Nevertheless, patients may still experience prevalent long term consequences, including lower limb lymphedema, depression, anxiety, sexual dysfunction, malnutrition, and sarcopenia, that negatively impact their quality of life. PRIMARY OBJECTIVE: To assess the impact on self-perceived quality of life of systematic screening and early treatment of lower limb lymphedema, anxiety and depression, sexual dysfunction, and sarcopenia and malnutrition compared with standard practice. STUDY HYPOTHESIS: Systematic screening with validated questionnaires leading to early diagnosis and treatment of side effects will have a positive impact on quality of life. TRIAL DESIGN: This prospective clinical trial will randomize candidates for surgery to either standard of care or systematic screening every 2 months for 2 years. Quality of life data will be collected every 4 months. After randomization, patients in the control group will follow standard usual care. Their screening scales will not be considered. In the experimental group, positive screenings will generate an alert to the physician, and patients will be referred to the corresponding specific area (rehabilitation unit, psycho-oncology unit, sexual health unit, or nutrition unit). MAJOR INCLUSION AND XCLUSION CRITERIA: Patients aged ≥18 years with ovarian, cervical, or endometrial cancer who are candidates for surgery will be included. PRIMARY ENDPOINT: Self-reported quality of life questionnaire score. SAMPLE SIZE: 168 patients will be randomized to detect a difference of 6 points in the questionnaires. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Study completion is estimated for January 2026 and the results will be presented in May 2026. TRIAL REGISTRATION NUMBER: NCT05918770.

Real-world satisfaction and menstrual bleeding pattern with available LNG-IUD among Spanish young women.

OBJECTIVE: The aim of this study was to evaluate the satisfaction and menstrual bleeding pattern with levonorgestrel-releasing intrauterine systems (LNG-IUD) in young women. METHODS: A prospective, multicentre, non-interventional study with 1-year follow-up was conducted in Spain. Participants were women between 18 and 30 years old who freely choose any available LNG-IUD for contraception. Satisfaction with LNG-IUD was measured with a 5-point Likert scale. Type of LNG-IUD, menstrual bleeding pattern and satisfaction with it, easiness of insertion and pain during procedure were collected. RESULTS: A total of 555 women (37.3% parous, 62.7% nulliparous) (mean age 25.8 ± 3.5) completed the study. After 12 months, 92.4% of women were satisfied or very satisfied with the LNG-IUD, with no differences by parity status, type of IUD or baseline menstrual bleeding pattern. Satisfaction with the LNG-IUD correlated with satisfaction with menstrual bleeding pattern at 12 months. Up to 88.7% of women were satisfied or very satisfied with their menstrual bleeding pattern at 12 months in comparison to 41.5% at baseline (p < 0.001). Adverse events (AE)-related discontinuation rate was low (2.2%). CONCLUSIONS: Satisfaction with LNG-IUD is very high among young Spanish women, regardless of parity and menstrual bleeding pattern at baseline.

Lymphovascular space invasion in endometrial carcinoma: Tumor size and location matter.

OBJECTIVE: To analyze histological factors possibly associated with lymphovascular space invasion (LVSI) and to determine which of those can act as independent surrogate markers. METHODS: Retrospective cohort study performed between January 2001 and December 2014. LVSI was defined as the presence of tumor cells inside a space completely surrounded by endothelial cells. Risk factors evaluated included myometrial invasion, tumor grade, size, location, and cervical invasion. Univariate logistical regression models were applied to study any possible association of LVSI with these factors. Values were adjusted by multivariate logistic regression analysis. RESULTS: A total of 327 patients with endometrial carcinoma treated in our Centre were included. LVSI was observed in 120 patients (36.7%). Lower uterine segment involvement (OR 5.21, 95% CI:2.6-10.4, p < 0.001) and size ≥2 cm (OR 2.62, 95% CI: 1.14-6.1, p < 0.001) were independent factors for LSVI in multivariate analysis. In univariate analysis, LVSI was a surrogate marker in type 1 tumors with deep myometrial invasion (IB, 51.9% vs. IA, 16.0%; p < 0.001), grade 3 (G3 55.8% vs. G1 16.2%; p < 0.001), size ≥2 cm (37.9% vs. 16.1%, p = 0.005), those with involving the lower segment of the uterus (58.9% vs. 22.5%, p < 0.001) and/or with cervical stromal invasion (65.4% vs. 26.1%, p < 0.001), and in type 2 tumors (61.5% vs. 30.5%, p < 0.001). The use of uterine manipulator did not increase the rate of LVSI (35.5% vs. 40.5%, p = 0.612) as compared to no manipulator use. CONCLUSIONS: Size ≥2 cm and involvement of the lower uterine segment are independent factors for LSVI, in type 1 tumors, which can be used for surgical planning. LVSI is also more common in type 1 tumors with deep myometrial invasion, grade 3 and/or cervical stromal invasion, and also in type 2 tumors. The use of a uterine manipulator does not increase LVSI.

Vaginal metastasis as the initial presentation of leiomyosarcoma: a case report.

BACKGROUND: Uterine leiomyosarcomas are very rare and highly aggressive tumors that have a high rate of recurrence and poor prognosis, even when early diagnosed. Due to their relative rarity, there is limited research on optimal management strategies. CASE PRESENTATION: A 60-year-old woman with a history of an asymptomatic uterine leiomyoma presented in October 2015 with postmenopausal bleeding and a friable vaginal cyst that bled when palpated. A partial cystectomy was performed, and malignant-like cystic and solid components were identified. Histopathology diagnosed an unclassifiable malignant epithelioid tumor. Subsequent imaging studies identified a malignant uterine tumor, a metabolically active vaginal lesion, and two benign leiomyomas. An anterior pelvic exenteration (colpectomy, hysterectomy, bilateral adnexectomy, total cystectomy, and cutaneous ureteroileostomy ad modum Bricker) were performed by laparotomy in March 2016. Examination of the surgical specimens identified a 75 × 75-mm leiomyoma, an 80 × 30-mm infiltrating mesenchymal uterine lesion with vascular invasion and tumor emboli, and a 60 × 30-mm perivascular vaginal tumor. Immunohistochemistry indicated a phenotypic transition from a uterine leiomyosarcoma to a vaginal epithelioid lesion; marker expression changed from the uterine tumor actin+/desmin+/caldesmon+/CD10- phenotype, through the tumor emboli, to an actin-/desmin-/caldesmon-/CD10+ phenotype in the vaginal lesion. A high-grade uterine mesenchymal tumor and vaginal metastasis were diagnosed. Adjuvant chemotherapy with docetaxel, gemcitabine, and doxorubicin commenced in May 2016 and treatment has been well tolerated. CONCLUSIONS: Differentiating leiomyosarcoma from leiomyoma is challenging and few tools other than microscopic evaluation are available. Vaginal compromise in leiomyosarcoma usually results from tumor extension, not hematogenous metastasis. A vaginal metastasis is a very rare initial presentation. We have found only two cases like this described on published literature. The atypical clinical and histological presentation in our case complicated diagnosis and delayed treatment. An early diagnosis and complete surgical clearance gives the best chance of survival, and imaging tools should be applied early in instances of new suspicious malignant lesions.

Endometriosis: alternative methods of medical treatment.

Endometriosis is an inflammatory estrogen-dependent disease defined by the presence of endometrial glands and stroma at extrauterine sites. The main purpose of endometriosis management is alleviating pain associated to the disease. This can be achieved surgically or medically, although in most women a combination of both treatments is required. Long-term medical treatment is usually needed in most women. Unfortunately, in most cases, pain symptoms recur between 6 months and 12 months once treatment is stopped. The authors conducted a literature search for English original articles, related to new medical treatments of endometriosis in humans, including articles published in PubMed, Medline, and the Cochrane Library. Keywords included "endometriosis" matched with "medical treatment", "new treatment", "GnRH antagonists", "Aromatase inhibitors", "selective progesterone receptor modulators", "anti-TNF α", and "anti-angiogenic factors". Hormonal treatments currently available are effective in the relief of pain associated to endometriosis. Among new hormonal drugs, association to aromatase inhibitors could be effective in the treatment of women who do not respond to conventional therapies. GnRH antagonists are expected to be as effective as GnRH agonists, but with easier administration (oral). There is a need to find effective treatments that do not block the ovarian function. For this purpose, antiangiogenic factors could be important components of endometriosis therapy in the future. Upcoming researches and controlled clinical trials should focus on these drugs.

Effectiveness of transcervical hysteroscopic endometrial resection based on the prevention of the recurrence of endometrial polyps in post-menopausal women.

BACKGROUND: The objectives of this study were to determine the effectiveness the effectiveness of post-polypectomy hysteroscopic endometrial resection in preventing the recurrence of endometrial polyps in post-menopausal patients and analyse the complications and necessity of additional surgery in patients, in addition to their degree of satisfaction. METHODS: A prospective longitudinal study of post-menopausal patients diagnosed with endometrial polyps was conducted including polypectomy and hysteroscopic endometrial resection following the therapeutic purposes (endometrial polyp removal) and prevention of recurrence of endometrial polyps. We evaluated the general condition and characteristics of the patients, including age, BMI, smoking habits, medical, surgical, and obstetrics history and menstrual status. The results were analysed at several time points, 6, 18, 42 and 60 months by hysteroscopy, including the presence of vaginal bleeding and/or possible intracavitary pathology. RESULTS: A total of 89.5% (n = 355) of our patients had profile factors associated with the increased incidence of endometrial polyps and hyperestrogenism (diabetes mellitus, hypertension and overweight); 89.5% (n = 355) of patients were overweight; 34% had grade I obesity. The surgical procedure was safe, with a 90% (n = 357) success rate without complications, which was higher than the 95-99.5% at the beginning and end time points of the study. Patient acceptance and satisfaction was 90 and 84%, respectively. CONCLUSIONS: Endometrial resection proved effective in preventing the recurrence of endometrial polyps. It is a safe and effective method. Post-menopausal bleeding reduces the presence of endometrial polyps. Patients reported satisfaction and acceptance of the procedure.

Psoas haematoma as a complication of Veress needle insertion: description of a case and literature review.

BACKGROUND: In terms of gynaecological laparoscopic surgery, major complications affecting great vessels, and especially the retroperitoneal ones, are unusual. CASE PRESENTATION: We introduce a case of a retroperitoneal haematoma associated with psoas muscle pseudoaneurysm, as a side effect of Veress needle insertion, during laparoscopic surgery. Such complication was managed conservatively at first, requiring finally arterial embolisation. CONCLUSION: Even though potential complications associated with laparoscopic surgery are infrequent, they must not be underestimated, and in some cases might need a multidisciplinary management.

Overall survival and disease-free survival in endometrial cancer: prognostic factors in 276 patients.

OBJECTIVE: The aim of the study reported here was to assess the disease-free survival and overall survival of patients with endometrial cancer and to determine independent factors affecting the prognosis. MATERIALS AND METHODS: This was a retrospective study of a single-center clinical series of 276 patients (mean age 64 years) with histologically confirmed cancer of the corpus uteri. The standard treatments were extrafascial total hysterectomy and bilateral salpingo-oophorectomy with selective pelvic/para-aortic node dissection, according to risk for recurrence. Actuarial overall survival and disease-free survival were estimated according to the Kaplan-Meier method. Univariate and multivariate Cox proportional hazards analyses were used to assess the prognostic significance of the different variables. RESULTS: The estimated median follow-up, determined using the inverse Kaplan-Meier method, was 45 months (95% confidence interval [CI] 41.2-48.8) for disease-free survival and 46 months (95% CI 43.0-49.0) for overall survival. The statistically significant variables affecting disease-free survival and overall survival were age, serous-papillary and clear-cell histological types, outer-half myometrial invasion, advanced International Federation of Gynecology and Obstetrics (FIGO) stage, tumor grades G2 and G3, incomplete surgical resection, positive lymph nodes, lymphovascular space invasion, tumor remnants of >1 cm after surgery, and high-risk group. In the multivariate Cox regression model, predictors of tumor recurrence included advanced FIGO stage (hazard ratio [HR] 4.90, 95% CI 2.57-9.36, P < 0.001) and tumor grades G2 (HR 4.79, 95% CI 1.73-13.27, P = 0.003) and G3 (HR 7.56, 95% CI 2.75-20.73, P < 0.001). The same variables were also associated with a significantly higher risk of tumor-related mortality. CONCLUSION: FIGO stage and tumor grade were independent prognostic factors of disease-free survival and overall survival in endometrial cancer patients. Outcome was also influenced by histopathologic type, myometrial and lymphovascular space invasion, lymph-node involvement, age, and tumor remnants after surgery, although a larger study sample is probably needed to demonstrate the independent association of these variables with survival.

Márgenes de resección y tumor residual tras una tumorectomía por cáncer de mama / Resection margins and residual tumor after tumorectomy for breast cancer

Objetivo: El análisis de los márgenes de resección y el tumor residual tras la práctica de tumorectomías por cáncer de mama con fines diagnósticos y terapéuticos. Material y métodos: Se incluyó a 163 pacientes con diagnóstico de cáncer de mama infiltrante, intervenidas inicialmente con una tumorectomía amplia en nuestro servicio durante los años 2002 y 2003. Se estudiaron las siguientes variables: edad media, tamaño tumoral, grado y tipo histológicos, tipo de cirugía inicial, frecuencia de afectación marginal, reescisión en función de la afectación de los bordes quirúrgicos y tumor residual. Resultados: Encontramos márgenes con afectación marginal tras la tumorectomía inicial en el 50,9%, con afectación focal en el 34,9% y con afectación extensa en el 62,7%. Se reintervino al 94% de estas pacientes, en las cuales la mastectomía fue el tratamiento definitivo en el 53,8%. Hallamos márgenes libres en 76 pacientes, y en el 51,3% se realizó una ampliación de los bordes quirúrgicos. El criterio para realizar una reescisión fueron unos márgenes libres menores de 2 mm. Practicamos cirugía conservadora en el 59% de estas pacientes. La presencia de tumor residual descendió significativamente del 50% tras una ampliación por márgenes afectados al 17,9% en caso de bordes libres. Conclusiones: En pacientes con márgenes inicialmente afectados es preceptiva la ampliación. En pacientes con una distancia del tumor al borde de la pieza mayor o igual de 2 mm no consideramos precisa la ampliación de los bordes quirúrgicos

Objective: To examine the surgical margins and the residual tumour in the surgical cavity after initial surgery for breast cancer. Material and methods: Between 2002 and 2003, one hundred and sixty-three patients with primary breast cancer undergoing wide local excision were included. The variables analyzed were: mean age, tumour size, tumour grade and histopathologic type, margins status, re-excision if involved margin and residual tumour in the reexcised. Results: Compromised margins following initial excision, were 50.9%, focal involvement in 34.9% and extensive involvement in 62.7%. Ninety-four per cent of these patients underwent a second operation and a mastectomy was performed in the 53.8%. We obtained disease-free margins were found in 76 patients at the first surgery and additional tissue was remove in 51.3% to achieve clear margins more than 2 mms We performed conservative surgery in 59% of those cases. A compromised margin was significatively associated with the presence of residual tumour in the re-operative sample (50% vs 17.9% in clear margins). Conclusions: If one or more margin is involved in pathological specimen, its good clinical practice to re-excise. If a margin <= 2 mm is obtained, reexcision wouldn't be necessary