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The Cochrane Database of Systematic... Dec 2020Adjuvant tamoxifen reduces the risk of breast cancer recurrence in women with oestrogen receptor-positive breast cancer. Tamoxifen also increases the risk of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Adjuvant tamoxifen reduces the risk of breast cancer recurrence in women with oestrogen receptor-positive breast cancer. Tamoxifen also increases the risk of postmenopausal bleeding, endometrial polyps, hyperplasia, and endometrial cancer. The levonorgestrel-releasing intrauterine system (LNG-IUS) causes profound endometrial suppression. This systematic review considered the evidence that the LNG-IUS prevents the development of endometrial pathology in women taking tamoxifen as adjuvant endocrine therapy for breast cancer.
OBJECTIVES
To determine the effectiveness and safety of the levonorgestrel intrauterine system (LNG-IUS) in pre- and postmenopausal women taking adjuvant tamoxifen following breast cancer for the outcomes of endometrial and uterine pathology including abnormal vaginal bleeding or spotting, and secondary breast cancer events.
SEARCH METHODS
We searched the following databases on 29 June 2020; The Cochrane Gynaecology and Fertility Group specialised register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PsycINFO and Cumulative Index to Nursing and Allied Health Literature. We searched the Cochrane Breast Cancer Group specialised register on 4 March 2020. We also searched two trials registers, checked references for relevant trials and contacted study authors and experts in the field to identify additional studies.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) of women with breast cancer on adjuvant tamoxifen that compared the effectiveness of the LNG-IUS with endometrial surveillance versus endometrial surveillance alone on the incidence of endometrial pathology.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures recommended by Cochrane. The primary outcome measure was endometrial pathology (including polyps, endometrial hyperplasia, or endometrial cancer), diagnosed at hysteroscopy or endometrial biopsy. Secondary outcome measures included fibroids, abnormal vaginal bleeding or spotting, breast cancer recurrence, and breast cancer-related deaths. We rated the overall certainty of evidence using GRADE methods.
MAIN RESULTS
We included four RCTs (543 women analysed) in this review. We judged the certainty of the evidence to be moderate for all of the outcomes, due to imprecision (i.e. limited sample sizes and low event rates). In the included studies, the active treatment arm was the 20 μg/day LNG-IUS plus endometrial surveillance; the control arm was endometrial surveillance alone. In tamoxifen users, the LNG-IUS probably reduces the incidence of endometrial polyps compared to the control group over both a 12-month period (Peto odds ratio (OR) 0.22, 95% confidence interval (CI) 0.08 to 0.64, I² = 0%; 2 RCTs, n = 212; moderate-certainty evidence) and over a long-term follow-up period (24 to 60 months) (Peto OR 0.22, 95% CI 0.13 to 0.39; I² = 0%; 4 RCTs, n = 417; moderate-certainty evidence). For long-term follow-up, this suggests that if the incidence of endometrial polyps following endometrial surveillance alone is assumed to be 23.5%, the incidence following LNG-IUS with endometrial surveillance would be between 3.8% and 10.7%. The LNG-IUS probably slightly reduces the incidence of endometrial hyperplasia compared with controls over a long-term follow-up period (24 to 60 months) (Peto OR 0.13, 95% CI 0.03 to 0.67; I² = 0%; 4 RCTs, n = 417; moderate-certainty evidence). This suggests that if the chance of endometrial hyperplasia following endometrial surveillance alone is assumed to be 2.8%, the chance following LNG-IUS with endometrial surveillance would be between 0.1% and 1.9%. However, it should be noted that there were only six cases of endometrial hyperplasia. There was insufficient evidence to reach a conclusion regarding the incidence of endometrial cancer in tamoxifen users, as no studies reported cases of endometrial cancer. At 12 months of follow-up, the LNG-IUS probably increases abnormal vaginal bleeding or spotting compared to the control group (Peto OR 7.26, 95% CI 3.37 to 15.66; I² = 0%; 3 RCTs, n = 376; moderate-certainty evidence). This suggests that if the chance of abnormal vaginal bleeding or spotting following endometrial surveillance alone is assumed to be 1.7%, the chance following LNG-IUS with endometrial surveillance would be between 5.6% and 21.5%. By 24 months of follow-up, abnormal vaginal bleeding or spotting occurs less frequently than at 12 months of follow-up, but is still more common in the LNG-IUS group than the control group (Peto OR 2.72, 95% CI 1.04 to 7.10; I² = 0%; 2 RCTs, n = 233; moderate-certainty evidence). This suggests that if the chance of abnormal vaginal bleeding or spotting following endometrial surveillance alone is assumed to be 4.2%, the chance following LNG-IUS with endometrial surveillance would be between 4.4% and 23.9%. By 60 months of follow-up, there were no cases of abnormal vaginal bleeding or spotting in either group. The numbers of events for the following outcomes were low: fibroids (n = 13), breast cancer recurrence (n = 18), and breast cancer-related deaths (n = 16). As a result, there is probably little or no difference in these outcomes between the LNG-IUS treatment group and the control group. AUTHORS' CONCLUSIONS: The LNG-IUS probably slightly reduces the incidence of benign endometrial polyps and endometrial hyperplasia in women with breast cancer taking tamoxifen. At 12 and 24 months of follow-up, the LNG-IUS probably increases abnormal vaginal bleeding or spotting among women in the treatment group compared to those in the control. Data were lacking on whether the LNG-IUS prevents endometrial cancer in these women. There is no clear evidence from the available RCTs that the LNG-IUS affects the risk of breast cancer recurrence or breast cancer-related deaths. Larger studies are necessary to assess the effects of the LNG-IUS on the incidence of endometrial cancer, and to determine whether the LNG-IUS might have an impact on the risk of secondary breast cancer events.
Topics: Adenocarcinoma; Antineoplastic Agents, Hormonal; Breast Neoplasms; Chemotherapy, Adjuvant; Confidence Intervals; Contraceptive Agents, Female; Endometrial Hyperplasia; Endometrial Neoplasms; Female; Humans; Intrauterine Devices, Medicated; Levonorgestrel; Neoplasm Recurrence, Local; Polyps; Randomized Controlled Trials as Topic; Tamoxifen; Uterine Hemorrhage; Uterus
PubMed: 33348436
DOI: 10.1002/14651858.CD007245.pub4 -
Einstein (Sao Paulo, Brazil) 2017This article presents the first series of robotic single-port hysterectomy cases performed at a hospital in Brazil.
OBJECTIVE
This article presents the first series of robotic single-port hysterectomy cases performed at a hospital in Brazil.
METHODS
From November 2014 to October 2016, 11 patients were indicated to undergo, and nine of them were submitted to single-port hysterectomy using da Vinci Single-Site® platform. However, in two patients, due to multiple previous abdominal surgeries, large uterine volume, and/or a uterus with no mobility, a pneumoperitoneum was performed with a Verres needle, and the pelvic cavity was assessed using a 5mm optics endoscope. In these cases, single-port surgery was not recommended; therefore, multiportal robotic access was chosen, and no intercurrent events were reported. Nine single-port cases were operated on by the same surgeon at Hospital Israelita Albert Einstein. Patient data analyzed included age, body mass index, previous surgeries, and clinical diagnosis. Surgical data included operative time, skin incision, report of intraoperative complications, need for conversion to laparotomy, need for transfer to intensive care unit, need for blood transfusion, inadvertent injury to other organs, length of hospital stay, and death.
RESULTS
All cases were completed with da Vinci Single-Site® system, with no intercurrent events. Four patients presented with adenomyosis as the surgical indication, two had uterine myoma, one endometrial cancer, one endometrial polyp, and one desquamative inflammatory vaginitis. The mean age of patients was 44 years (range, 40 to 54 years), and body mass index varied between 23.4 and 33.2kg/m2 (mean 26.4). No complications occurred in any of the cases, such as intestinal or bladder injury, bleeding, or the need for a second surgery. All nine procedures were completed with the robotic single-port access, and no patient required a blood transfusion.
CONCLUSION
Although this study merely presented an initial series of patients submitted to robotic single-port surgery, it demonstrated that the method is feasible and safe, suggesting the possible use of this technique in elective hysterectomy and other gynecological procedures in the future, as described in large reference centers of advanced surgery worldwide. Specifically, in gynecological practice, existing evidence on the use of robot-assisted, single-port surgery seems promising, and although it is not indicated in all cases, it should be considered as a surgical option. Nonetheless, further randomized and controlled clinical studies are necessary to establish the preeminence of robot-assisted, single-port surgery versus single-incision and conventional laparoscopy.
Topics: Adult; Brazil; Endometrial Neoplasms; Female; Humans; Hysterectomy; Laparoscopy; Leiomyoma; Length of Stay; Middle Aged; Operative Time; Pneumoperitoneum; Robotic Surgical Procedures; Treatment Outcome; Umbilicus; Uterine Diseases; Uterine Neoplasms
PubMed: 29364368
DOI: 10.1590/S1679-45082017AO4134 -
Case Reports in Obstetrics and... 2014The objective of this study is to determine and discuss the causes of a giant endometrial polyp in a postmenopausal woman without hormone/drug use and to submit...
The objective of this study is to determine and discuss the causes of a giant endometrial polyp in a postmenopausal woman without hormone/drug use and to submit interesting clinical presentation. Here we report a seventy-year-old female patient who was admitted to our hospital with lower back pain. There were no other complaints from her. Physical examination was normal. For further examination, computed tomography was performed and a heterogeneous mass, with a diameter of 10 × 9 centimeters, was detected in the uterine cavity. Hysterectomy because of suspected endometrial cancer was performed. Histopathological examination showed us a giant endometrial polyp with edematous and focal fibrotic stroma, large thick walled blood vessels between normal sized and cystically dilated endometrial glands. To the best of our knowledge, this is the first report of a giant endometrial polyp which is unrelated to use of drugs such as tamoxifen and raloxifene; however, based on the history of the patient it may be associated with long-term consumption of thyme, which is a kind of phytoestrogen.
PubMed: 25093134
DOI: 10.1155/2014/518398 -
Computational and Mathematical Methods... 2022In order to explore the ability of vaginal ultrasound combined with bleeding pattern to predict factors related to abnormal uterine bleeding (AUB), a total of 205...
In order to explore the ability of vaginal ultrasound combined with bleeding pattern to predict factors related to abnormal uterine bleeding (AUB), a total of 205 patients with abnormal uterine bleeding were selected as experimental subjects. According to the corresponding diagnostic criteria, patients were divided into the endometrial polyp group (56 cases), endometrial hyperplasia and canceration group (84 cases), and normal cycle endometrial group (65 cases). The efficiency of the method was determined by comparing the prediction efficiency of the single/joint model. The results showed that there were statistically significant differences in the body mass index, dysmenorrhea, endometrial thickness, diabetes, hypertension, and polycystic ovary syndrome among the three groups, < 0.05. The sensitivity, specificity, positive predictive value, negative predictive value, and Youden index of endometrial polyp diagnosis were 86.89%, 88.12%, 83.54%, 90.11%, and 0.74, respectively. The sensitivity, specificity, positive predictive value, negative predictive value, and JordAn index in diagnosing endometrial hyperplasia and canceration were 96.71%, 98.40%, 96.54%, 98.24%, and 0.96, respectively. In summary, the body mass index, dysmenorrhea, endometrial thickness, diabetes, hypertension, and polycystic ovary syndrome were related factors, and the combination of vaginal ultrasound and bleeding pattern had a stronger predictive power for abnormal uterine bleeding.
Topics: Dysmenorrhea; Endometrial Hyperplasia; Endometrium; Female; Humans; Hypertension; Polycystic Ovary Syndrome; Polyps; Sensitivity and Specificity; Ultrasonography; Uterine Hemorrhage; Uterine Neoplasms
PubMed: 35799665
DOI: 10.1155/2022/5653250 -
Acta Medica Lituanica 2021This is the first case describing vaginal papillomatosis with a fibroepithelial polyp of the vulva in a prepubertal girl and vaginal papillomatosis in her twin sister....
This is the first case describing vaginal papillomatosis with a fibroepithelial polyp of the vulva in a prepubertal girl and vaginal papillomatosis in her twin sister. Parents contacted pediatric urologist regarding their eight-year-old daughter (twin A), who had a growth next to the external urethral meatus. The girl was referred to a pediatric surgeon. The exophytic 3 cm long structure with necrosis on top was found. After obtaining informed consent from girl parents, pediatric surgeon removed the exophytic structure and perform cystoscopy and vaginoscopy for possible changes in the bladder and vagina. Cystoscopy findings were normal. On vaginoscopy, numerous macroscopic papillomatous structures were identified on the cervix and vaginal walls. Vaginal biopsies were performed on the areas affected by papillomatosis. Histopathologic examination showed a fibroepithelial polyp with a central fibrovascular core covered by squamous epithelium and vaginal squamous papillomatosis. The decision was made to perform vaginoscopy on her twin sister (twin B), too. On vaginoscopy, solitary small vaginal papillomas were also found. In this case manifestation of vaginal papillomatosis in twins might have been influenced by inheritance and the same bacterial and viral environment.
PubMed: 35474933
DOI: 10.15388/Amed.2021.28.2.18 -
Journal of Medical Cases Jan 2023Uterine inversion may be puerperal or non-puerperal. Puerperal uterine inversion is a rare obstetrics complication, with an estimated incidence of 1 in 30,000...
Uterine inversion may be puerperal or non-puerperal. Puerperal uterine inversion is a rare obstetrics complication, with an estimated incidence of 1 in 30,000 deliveries. The occurrence of non-puerperal uterine inversion is even rarer such that there is no good estimate of its incidence. It is challenging to make the diagnosis of non-puerperal uterine inversion and a high index of suspicion needs to be present. Malignancy is an uncommon cause for non-puerperal uterine inversion, but it is important to keep it in mind so as to counsel patients appropriately and prevent repeat surgery wherever possible. There are also unique complexities in the assessment of a virgo intacta patient which needs to be overcome through the use of different approaches in physical examination and imaging. In this case report, there is a unique interplay of multiple complicating factors in a virgo intacta patient presenting with abnormal uterine bleeding secondary to a malignant fibroid polyp that had prolapsed out of the vagina causing uterine inversion. She eventually required two open surgeries in the management of her condition.
PubMed: 36755999
DOI: 10.14740/jmc4023 -
Cureus Feb 2024Vaginal fibroepithelial polyps are rare benign tumors of the mucosa of the anterior vaginal wall. In extremely rare cases, they may originate from the posterior vaginal...
Vaginal fibroepithelial polyps are rare benign tumors of the mucosa of the anterior vaginal wall. In extremely rare cases, they may originate from the posterior vaginal wall or be complicated by torsion. Our case concerns a 63-year-old patient who presented to the gynecology outpatient clinic of the General Hospital of Trikala with minor vaginal bleeding. On vaginal examination, a large pedunculated painless hemorrhagic polypoid mass was noticed, originating from the posterior vaginal wall. A torsion of the pedunculated vaginal tumor was suspected, leading to its surgical excision with clear resection margins. Due to extensive tissue necrosis, accurate histological identification of the vaginal neoplasm was not possible. Histological examination excluded vaginal malignancy. Based predominantly on the clinical and morphological features of the vaginal lesion, a diagnosis of vaginal fibroepithelial polyp with torsion was made, acknowledging its limitations. The patient was discharged from the clinic the same afternoon following the surgery. Three months later, no recurrence of the lesion in the vaginal wall was noted. Following the case presentation, this paper provides a brief literature review of this rare entity, focusing on the diagnostic and therapeutic approaches.
PubMed: 38558656
DOI: 10.7759/cureus.55157 -
BJR Case Reports Mar 2022A fibroepithelial stromal polyp is a benign soft tissue tumour that can occur in the vagina, vulva and uterine cervix. Magnetic resonance imaging (MRI) findings have...
A fibroepithelial stromal polyp is a benign soft tissue tumour that can occur in the vagina, vulva and uterine cervix. Magnetic resonance imaging (MRI) findings have been reported in patients with vulvar fibroepithelial stromal polyps, not in those with vaginal polyps. We present MRI findings of vaginal fibroepithelial stromal polyp in a postmenopausal female. A 1 to 2 cm firm vaginal mass arising from the left side of the vaginal wall with hypointense signal changes on T1W MRI was identified. A well-defined vaginal mass (1 cm diameter) was detected with inhomogeneous signal intensity on T2W images. However, a major portion had high signal intensity on diffusion-weighted images. A benign vaginal lesion with oedematous changes or myxoid degeneration was suspected. Vaginal resection was performed, and fibroepithelial stromal polyp was pathologically diagnosed. MRI may be a useful non-invasive modality for preoperatively diagnosing vaginal fibroepithelial stromal polyps.
PubMed: 36177268
DOI: 10.1259/bjrcr.20210189 -
Climacteric : the Journal of the... Apr 2014Assessment of 12-month safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA). (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVE
Assessment of 12-month safety of ospemifene 60 mg/day for treatment of postmenopausal women with vulvar and vaginal atrophy (VVA).
METHODS
In this 52-week, randomized, double-blind, placebo-controlled, parallel-group study, women 40-80 years with VVA and an intact uterus were randomized 6 : 1 to ospemifene 60 mg/day or placebo. The primary objective was 12-month safety, particularly endometrial; 12-week efficacy was assessed. Safety assessments included endometrial histology and thickness, and breast and gynecological examinations. Efficacy evaluations included changes from baseline to week 12 in percentage of superficial and parabasal cells and vaginal pH.
RESULTS
Of 426 randomized subjects, 81.9% (n = 349) completed the study with adverse events the most common reason for discontinuation (ospemifene 9.5%; placebo 3.9%). Most (88%) treatment-emergent adverse events with ospemifene were considered mild or moderate. Three cases (1.0%) of active proliferation were observed in the ospemifene group. For one, active proliferation was seen at end of study week 52, and diagnosed as simple hyperplasia without atypia on follow-up biopsy 3 months after the last dose. This subsequently resolved with progestogen treatment and dilatation and curettage. In six subjects (five ospemifene (1.4%), one placebo (1.6%)) endometrial polyps were found (histopathology); however, only one (ospemifene) was confirmed as a true polyp during additional expert review. Endometrial histology showed no evidence of carcinoma. Statistically significant improvements were seen for all primary and secondary efficacy measures and were sustained through week 52 with ospemifene vs. placebo.
CONCLUSIONS
The findings of this 52-week study confirm the tolerance and efficacy of oral ospemifene previously reported in short- and long-term studies.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Atrophy; Double-Blind Method; Female; Humans; Middle Aged; Postmenopause; Tamoxifen; Treatment Outcome; Vagina; Vaginal Diseases; Vulva
PubMed: 23984673
DOI: 10.3109/13697137.2013.834493